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London: Thursday, March 31, 2016: For information purposes, Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) hereby notifies the market that as at March 31, 2016, the issued share capital of Chi-Med consisted of 60,283,118 ordinary shares of US$1.00 each, with each share carrying one right to vote and with no shares held in treasury.

The above figure of 60,283,118 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, Chi-Med under the Financial Conduct Authority’s Disclosure Rules and Transparency Rules.

 

Ends

 

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Chi-Med

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U.S. Based Media Enquiries

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Panmure Gordon (UK) Limited

 

Notes to Editors

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.

London: Tuesday, March 29, 2016: Hutchison China MediTech Limited (“Chi-Med”) (AIM / Nasdaq: HCM) received notification on March 25, 2016 that Mr Christian Hogg, Executive Director and Chief Executive Officer, has purchased 36,600 American Depositary Shares (“ADSs”, each representing one-half of one ordinary share) of the Company at a price of US$13.50 per ADS on March 25, 2016.

Following this purchase, Mr Hogg is beneficially interested in 36,600 ADSs and 1,088,182 ordinary shares, representing approximately 1.84% of the current issued share capital of Chi-Med.

Ends

 

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Chi-Med

International Media Enquiries

U.S. Based Media Enquiries

Investor Relations

Panmure Gordon (UK) Limited

 

Notes to Editors

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products.  Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market.  Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.

 

NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION OR DISSEMINATION IN OR INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION

 

London: Tuesday, March 22, 2016: Further to its announcements on October 16, 2015, November 13, 2015, February 11, 2016, March 1, 2016, March 4, 2016, March 16, 2016 and March 18, 2016, Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces the closing of its offering of American depositary shares (“ADSs”) on the Nasdaq Global Select Market (the “Offering”).

The Offering raised gross proceeds of US$101,250,000 through the sale of 7,500,000 ADSs, each representing one-half of one ordinary share of Chi-Med, at a price of US$13.50 per ADS (equivalent to approximately £19.42 per ordinary share on the basis of an assumed exchange rate as quoted in the preliminary prospectus filed on March 4, 2016 of £1.00 to US$1.39).  All of the ADSs in the Offering were sold by Chi-Med. Chi-Med has also granted the underwriters a 30-day option to purchase up to an additional 1,125,000 ADSs at the Offering price.

The ADSs sold in the Offering began trading on the Nasdaq Global Select Market on March 17, 2016. Chi-Med’s ordinary shares continue to be traded on the AIM market of the London Stock Exchange.

BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) acted as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon & Co. and CITIC CLSA acted as co-managers for the Offering.

In connection with the Offering, a registration statement on Form F-1 (the “Form F-1 Registration Statement”) has been filed with, and declared effective by, the U.S. Securities and Exchange Commission (“SEC”).  The Offering was made only by means of a prospectus.  Copies of the final prospectus related to the Offering may be accessed through the SEC’s website at www.sec.gov or obtained from (in alphabetical order): (i) BofA Merrill Lynch, Attn: Prospectus Department, 222 Broadway, New York, NY 10038, or by email at dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, or by email at prospectus.cpdg@db.com.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Application has been made for the 3,750,000 new ordinary shares issued by Chi-Med pursuant to the Offering, represented by the 7,500,000 ADSs, to be admitted to trading on AIM and it is expected that admission will become effective at 8.00am (GMT) on March 23, 2016.  The 3,750,000 new ordinary shares issued by Chi-Med pursuant to the Offering have been credited as fully paid and rank pari passu in all respects with the existing ordinary shares of Chi-Med.  As of the closing of the Offering, the issued share capital of Chi-Med is 60,283,118 and this figure may be used by shareholders as a denominator for the calculations by which they determine if they are required to notify their interest in, or change to their interest in, Chi-Med under the Disclosure and Transparency Rules, as incorporated into Chi-Med’s articles of association.

 

Ends

 

Contact

Chi-Med

International Media Enquiries

U.S. Based Media Enquiries

Investor Relations

Panmure Gordon (UK) Limited

 

Notes to Editors

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products.  Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market.  Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.

Important information

This announcement does not constitute a registration statement on Form F-1 and does not constitute or form, and will not form, part of any offer or invitation to sell or issue, or the solicitation of an offer to purchase or acquire, any of the ordinary shares or ADSs or any other securities in the United States or in any other jurisdiction.  Securities may not be offered or sold in the United States absent registration or an exemption from registration under the United States Securities Act of 1933, as amended (“U.S. Securities Act”). Any public offering of securities to be made in the United States will be made by means of a Form F-1 Registration Statement that has been declared effective by the SEC.  The Form F-1 Registration Statement contains detailed information about the issuer and its management and financial statements.  This announcement is being issued pursuant to and in accordance with Rule 135e under the U.S. Securities Act.

No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.

This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

The distribution of this announcement into jurisdictions other than the United Kingdom may be restricted by law.  Persons into whose possession this announcement come should acquaint themselves with and observe any such restrictions.

For readers in the European Economic Area

In any EEA Member State that has implemented the Prospectus Directive, this announcement is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Directive.  The term “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant Member State), together with any relevant implementing measure in the relevant Member State.

For readers in the United Kingdom

This announcement, insofar as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the Offering described in this announcement or otherwise, is being directed only at (i) persons who are outside the United Kingdom; or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (“Order”); or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”).  The ADSs are only available to, and any invitation, offer or agreement to subscribe for, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons.  Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

Forward-looking statements

This announcement may contain forward-looking statements that reflect Chi‑Med’s current expectations regarding future events.  A list and description of risks, uncertainties and other risks associated with an investment in Chi‑Med can be found in Chi-Med’s filings with the SEC, including the Form F-1 Registration Statement.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  Chi‑Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

London: Monday, March 21, 2016: Hutchison China MediTech Limited (“Chi-Med”) (AIM / Nasdaq: HCM) received notification on 18 March 2016 that Ms Edith Shih, Non-executive Director, has purchased 40,741 American Depositary Shares (“ADSs”, each represents one-half of one ordinary share) of the Company at a price of US$13.50 per ADS on 17 March 2016.

Following this purchase, Ms Shih is beneficially interested in 40,741 ADSs and 60,000 ordinary shares, representing approximately 0.13% of the current issued share capital of Chi-Med.

 

Ends

 

Contact

Chi-Med

International Media Enquiries

U.S. Based Media Enquiries

Investor Relations

Panmure Gordon (UK) Limited

 

Notes to Editors

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.

London: Monday, March 21, 2016: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that Hutchison MediPharma Limited (“HMP”), its drug R&D subsidiary, has initiated SANET-p, a Phase III registration trial of sulfatinib (HMPL-012) in China in patients with pancreatic neuroendocrine tumors (“NETs”).  The first patient was dosed on March 18, 2016.

The protocol for SANET-p is similar to SANET-ep, a Phase III registration trial in patients with extra-pancreatic NETs.  SANET-p is a randomized, double-blind, placebo-controlled, multi-center Phase III sulfatinib registration study to treat patients with low or intermediate grade advanced NET whose disease has progressed, locally advanced or distant metastasized and for whom there is no effective therapy.  Patients are randomized at a 2:1 ratio to receive either 300 milligrams of sulfatinib orally once per day, or placebo, on an every 28-day treatment cycle.  The primary objective of this study is to evaluate the progression-free survival of sulfatinib as compared to that of placebo, with secondary endpoints including objective response rate (“ORR”), disease control rate, time to response, duration of response, overall survival, safety and tolerability.  Approximately 195 patients are expected to be enrolled in the SANET-p study from more than 20 centers across China, with top-line results expected in 2018.  Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02589821.

Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor (“VEGFR”) and fibroblast growth receptor (“FGFR”), two tyrosine kinase receptors associated with angiogenesis and tumor growth.  HMP believes that sulfatinib’s VEGFR/FGFR1 inhibition profile has strong potential in second-line thyroid cancer patients, particularly in China where there are few safe and effective treatment options for this patient population.

Including this trial, HMP is conducting five Phase II and Phase III clinical trials of sulfatinib in China and the U.S.

 

Ends

 

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U.S. Based Media Enquiries

Investor Relations

Panmure Gordon (UK) Limited

 

Notes to Editors

Overview of sulfatinib clinical development

NETs arise from neuroendocrine cells and develop predominantly in the digestive or respiratory tracts but can also occur in many areas of the body.  Diagnosing NETs is difficult due to the small tumor size and diverse occurrence with patients showing varied or no symptoms.  As a result, it has been difficult to accurately estimate the number of NETs incidences per year.  There were approximately 19,000 new cases of NETs and a cumulative prevalence of approximately 144,000 cases in the U.S. in 2015, according to Frost and Sullivan.

In 2014, HMP completed the first-in-human Phase I clinical trial of sulfatinib in China; the detailed results were presented at the American Association for Cancer Research-National Cancer Institute-European Organisation for Research and Treatment of Cancer International Conference on Molecular Targets and Cancer Therapeutics in early November 2015 (www.chi-med.com/sulfatinib-ph1-eortc-2015/).  The Phase I clinical data indicates that sulfatinib has a superior ORR in NET patients.  An ORR of 44% was observed for sulfatinib in 18 evaluable patients, compared to less than 10% for sunitinib and everolimus, the two approved targeted therapies for pancreatic NET patients.  Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02133157.

In October 2014, HMP initiated a multi-center, single-arm, open-label Phase Ib/II study in broad spectrum NET patients (pancreatic, gastrointestinal, liver, lymph and lung, among others) in China to further evaluate the efficacy, safety, tolerability, and pharmacokinetic characteristics of sulfatinib.  This study completed enrolment of 81 patients in December 2015.  HMP expects to report top line results of this study during the course of 2016.  Additional details about this study may be found using identifier NCT02267967.

In addition to SANET-p, in December 2015 HMP initiated SANET-ep, a Phase III sulfatinib registration trial in China in patients with extra-pancreatic NETs (non-pancreatic).  SANET-ep is a randomized, double-blind, placebo-controlled, multi-center registration study to treat pathologically low or intermediate grade NET patients whose disease has progressed, locally advanced or distant metastasized and for whom there is no effective therapy.  Additional details about this study may be found using identifier NCT02588170.

A Phase I study in Caucasian patients also began in November 2015 in the U.S.  Once HMP has established the Phase II dose among Caucasian patients in this U.S. Phase I study, HMP expects to start a U.S. Phase II study in broad spectrum NET patients in the second half of 2016.  Additional details about this study may be found using identifier NCT02549937.

In addition to these NET studies, in March 2016 HMP initiated a Phase II study in China to evaluate the safety, pharmacokinetics and efficacy of sulfatinib in patients with both medullary and differentiated thyroid cancer.  Additional details about this study may be found using identifier NCT02614495.

 

About VEGFR and FGFR in cancer

At an advanced stage, tumors secrete large amounts of vascular endothelial growth factor (“VEGF”), a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor in order to provide greater blood flow, oxygen, and nutrients to fuel the rapid growth of the tumor.  Anti-angiogenesis drugs have demonstrated benefits in a wide variety of tumor types.  VEGF and other ligands can bind to VEGF receptors, which have been shown to play a role in angiogenesis.  Inhibition of the VEGF/VEGFR signaling pathway can act to stop the growth of the vasculature around the tumor and thereby starve the tumor of the nutrients and oxygen it needs to grow rapidly.

Fibroblast cell growth factor (“FGF”) also plays a key role in tumor angiogenesis.  Aberrant activation of the FGF/FGFR signaling pathway is shown to be associated with cancer progression by promoting growth, survival, migration and invasion of the tumor.  There is evidence that anti-VEGF therapy treatment could increase FGFR pathway activation, leading to drug resistance to anti-VEGF therapies.  It is believed that simultaneously targeting VEGFR and FGFR could be an attractive approach to improve clinical efficacy.

 

About HMP

HMP is a novel drug R&D company focusing on discovering, developing and commercializing innovative therapeutics in oncology and autoimmune diseases.  With a team of around 290 scientists and staff, its pipeline is comprised of novel oral compounds for cancer and inflammation in development in North America, Europe, Australia and Greater China.  HMP is a subsidiary of Chi-Med.  For more information, please visit: www.hmplglobal.com.

 

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products.  Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market.  Its Commercial Platform manufactures, markets and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001).  For more information, please visit: www.chi-med.com.

 

Forward-Looking Statements

This announcement contains forward-looking statements that reflect Chi-Med’s current expectations regarding future events, including its plans to initiate clinical studies for its drug candidates in the targeted indications, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies.  Forward-looking statements involve risks and uncertainties.  Such risks and uncertainties include, among other things, assumptions regarding enrolment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of a drug candidate to meet the primary or secondary endpoint of a study, the ability of a drug candidate to obtain regulatory approval in different jurisdictions, the ability of a drug candidate to gain commercial acceptance after obtaining regulatory approval and the sufficiency of funding.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION OR DISSEMINATION IN OR INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION

 

London: Friday, March 18, 2016: Further to its announcements on October 16, 2015, November 13, 2015, February 11, 2016, March 1, 2016, March 4, 2016 and March 16, 2016, Hutchison China MediTech Limited (“Chi‑Med”) (AIM/Nasdaq: HCM) announces that today it has filed the final prospectus relating to the listing of American depositary shares (“ADSs”) representing its ordinary shares on the Nasdaq Stock Market (the “Offering”) which have been registered with the U.S. Securities and Exchange Commission (“SEC”) by Chi-Med’s registration statement on Form F-1.

The final prospectus contains the previously announced final aggregate Offering price for the ADSs sold in the Offering.

BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) acted as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon & Co. and CITIC CLSA acted as co-managers for the Offering.   

Copies of the final prospectus may be accessed through the SEC’s website at www.sec.gov or obtained from (in alphabetical order): (i) BofA Merrill Lynch, Attn: Prospectus Department, 222 Broadway, New York, NY 10038, or by email at dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, or by email at prospectus.cpdg@db.com.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Ends

 

Contact

 

Investor Enquiries
Christian Hogg, CEO	+852 2121 8200
International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson	+44 7973 611 888 (Mobile)
U.S. Based Media Enquiries
Brad Miles, BMC Communications	+1 (917) 570-7340
Susan Duffy, BMC Communications	+1 (917) 499-8887
Investor Relations
Jillian Connell, The Trout Group	+1 (646) 378 2956
David Dible, Citigate Dewe Rogerson	+44 20 7638 9571 +44 7967 566 919 (Mobile)
Panmure Gordon (UK NOMAD)
Richard Gray / Andrew Potts	+44 (20) 7886 2500

Notes to Editors

About Chi‑Med

Chi‑Med is a China‑based, globally‑focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health‑related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.

Chi‑Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi‑med.com.

Important information

This announcement does not constitute or form, and will not form, part of any offer or invitation to sell or issue, or the solicitation of an offer to purchase or acquire, any of the ordinary shares or ADSs or any other securities in the United States or in any other jurisdiction. This announcement is being issued pursuant to and in accordance with Rule 135e under the U.S. Securities Act of 1933, as amended.

No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.

This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

The distribution of this announcement into jurisdictions other than the United Kingdom may be restricted by law. Persons into whose possession this announcement come should acquaint  themselves with and observe any such restrictions.

For readers in the European Economic Area

In any EEA Member State that has implemented the Prospectus Directive, this announcement is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Directive. The term “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant Member State), together with any relevant implementing measure in the relevant Member State.

For readers in the United Kingdom

This announcement, insofar as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the Offering described in this announcement or otherwise, is being directed only at (i) persons who are outside the United Kingdom; or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (“Order”); or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). The ADSs are only available to, and any invitation, offer or agreement to subscribe for, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

Forward‑looking statements

This announcement may contain forward‑looking statements that reflect Chi‑Med’s current expectations regarding future events. A list and description of risks, uncertainties and other risks associated with an investment in Chi‑Med can be found in Chi‑Med’s filings with the SEC, including the final prospectus. Existing and prospective investors are cautioned not to place undue reliance on these forward‑looking statements, which speak only as of the date hereof. Chi‑Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, TO U.S. NEWSWIRE SERVICES OR FOR
RELEASE, PUBLICATION OR DISSEMINATION IN OR INTO OR FROM THE UNITED STATES,
CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE
TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH
JURISDICTION

London: Wednesday, March 16, 2016: Further to its announcements on October 16, 2015, November 13, 2015, February 11, 2016, March 1, 2016 and March 4, 2016, Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) announces the pricing of its U.S. public offering of American depositary shares (“ADSs”) (the “Offering”), raising gross proceeds of approximately US$101.25 million.

7,500,000 ADSs were sold in the Offering at a price of US$13.50 per ADS, and the offering price is thus equivalent to approximately £19.42 per ordinary share (on the basis of an assumed exchange rate as quoted in the preliminary prospectus of £1.00 to US$1.39). Each ADS represents one-half of one ordinary share of Chi-Med. The ADSs have been approved for listing on the Nasdaq Global Select Market and are expected to begin trading on March 17, 2016 under the ticker symbol “HCM.” Chi-Med’s ordinary shares will continue to be traded on the AIM market of the London Stock Exchange following the Offering under the ticker symbol “HCM.”

In addition, Chi-Med has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 ADSs at the Offering price. Closing of the Offering is expected to occur on or about March 22, 2016, subject to customary closing conditions.

BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon & Co. and CITIC CLSA are acting as co-managers for the Offering.

Mr Simon To, Chairman of Chi-Med, said, “We are delighted with the way our roadshow has been received by investors. We believe investors share our view of Chi-Med’s prospects, and we look forward to our Nasdaq presence increasing our profile within the world’s largest pharmaceutical market.”

In connection with the Offering, a registration statement on Form F-1 (the “Form F-1 Registration Statement”) has been filed with, and declared effective by, the United States Securities and Exchange Commission (the “SEC”). Copies of this document may be accessed through the SEC’s website at www.sec.gov. A final prospectus, when available, may be obtained from (in alphabetical order): (i) BofA Merrill Lynch, Attn: Prospectus Department, 222 Broadway, New York, NY 10038, or by email at dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, or by email at prospectus.cpdg@db.com.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Application will be made for the 3,750,000 new ordinary shares of Chi-Med, represented by the 7,500,000 ADSs to be issued at closing of the Offering, to be admitted to trading on AIM and it is expected that the admission will become effective at 8.00 am (GMT) on March 23, 2016.

Ends

 

Contact

 

Chi-Med
Christian Hogg, CEO	+852 2121 8200
International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson	+44 7973 611 888 (Mobile)
U.S. Based Media Enquiries
Brad Miles, BMC Communications	+1 (917) 570-7340
Susan Duffy, BMC Communications	+1 (917) 499-8887
Investor Relations
Jillian Connell, The Trout Group	+1 (646) 378 2956
David Dible, Citigate Dewe Rogerson	+44 20 7638 9571 +44 7967 566 919 (Mobile)
Panmure Gordon (UK NOMAD)
Richard Gray / Andrew Potts	+44 (20) 7886 2500

 

Notes to Editors

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.

Important information

This announcement does not constitute a registration statement on Form F-1 and does not constitute or form, and will not form, part of any offer or invitation to sell or issue, or the solicitation of an offer to purchase or acquire, any of the ordinary shares or ADSs or any other securities in the United States or in any other jurisdiction. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the United States Securities Act of 1933, as amended (“U.S. Securities Act”). Any potential public offering of securities to be made in the United States will be made by means of a Form F-1 Registration Statement that has been declared effective by the SEC. The Form F-1 Registration Statement contains detailed information about the issuer and its management and financial statements. This announcement is being issued pursuant to and in accordance with Rule 135e under the U.S. Securities Act.

No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.

This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

The distribution of this announcement into jurisdictions other than the United Kingdom may be restricted by law. Persons into whose possession this announcement come should acquaint themselves with and observe any such restrictions.

For readers in the European Economic Area

In any EEA Member State that has implemented the Prospectus Directive, this announcement is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Directive. The term “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant Member State), together with any relevant implementing measure in the relevant Member State.

For readers in the United Kingdom

This announcement, insofar as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the potential Offering described in this announcement or otherwise, is being directed only at (i) persons who are outside the United Kingdom; or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (“Order”); or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). The ADSs are only available to, and any invitation, offer or agreement to subscribe for, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

Forward-looking statements

This announcement may contain forward-looking statements that reflect Chi-Med’s current expectations regarding future events. A list and description of risks, uncertainties and other risks associated with an investment in Chi-Med can be found in Chi-Med’s filings with the SEC, including the Form F-1 Registration Statement. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

Press Release

London: Wednesday, March 16, 2016: Hutchison China MediTech Limited (“Chi Med”) (AIM: HCM) announces the pricing of its U.S. public offering of American depositary shares (“ADSs”) (the “Offering”), raising gross proceeds of approximately US$101.25 million.

7,500,000 ADSs were sold in the Offering at a price of US$13.50 per ADS. Each ADS represents one-half of one ordinary share of Chi-Med. The ADSs have been approved for listing on the Nasdaq Global Select Market and are expected to begin trading on March 17, 2016 under the ticker symbol “HCM.” Chi-Med’s ordinary shares will continue to be traded on the AIM market of the London Stock Exchange following the Offering under the ticker symbol “HCM.”

In addition, Chi-Med has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 ADSs at the Offering price. Closing of the Offering is expected to occur on or about March 22, 2016, subject to customary closing conditions.

BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon & Co. and CITIC CLSA are acting as co-managers for the Offering.

In connection with the Offering, a registration statement on Form F-1 (the “Form F-1 Registration Statement”) has been filed with, and declared effective by, the United States Securities and Exchange Commission (the “SEC”). Copies of this document may be accessed through the SEC’s website at www.sec.gov. A final prospectus, when available, may be obtained from (in alphabetical order): (i) BofA Merrill Lynch, Attn: Prospectus Department, 222 Broadway, New York, NY 10038, or by email at dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, or by email at prospectus.cpdg@db.com.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Application will be made for the 3,750,000 new ordinary shares of Chi-Med, represented by the 7,500,000 ADSs to be issued at closing of the Offering, to be admitted to trading on AIM and it is expected that the admission will become effective at 8.00 am (GMT) on March 23, 2016.

Ends

 

Contact

 

Chi-Med
Christian Hogg, CEO	+852 2121 8200
International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson	+44 7973 611 888 (Mobile)
U.S. Based Media Enquiries
Brad Miles, BMC Communications	+1 (917) 570-7340
Susan Duffy, BMC Communications	+1 (917) 499-8887
Investor Relations
Jillian Connell, The Trout Group	+1 (646) 378 2956
David Dible, Citigate Dewe Rogerson	+44 20 7638 9571 +44 7967 566 919 (Mobile)
Panmure Gordon (UK NOMAD)
Richard Gray / Andrew Potts	+44 (20) 7886 2500

 

Notes to Editors

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.

Chi Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi med.com.

Forward-looking statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties, including statements regarding the potential Offering. Actual results may differ materially from those projected or implied. More information about potential factors that could affect Chi-Med’s business and financial results is contained in the Form F-1 Registration Statement filed with the SEC. Any forward-looking statement made by Chi-Med herein, or elsewhere, speaks only as of the date on which such statement is made. Chi-Med does not intend, and undertakes no duty, to update any forward-looking statements after the date hereof to reflect future events or circumstances.

London: Tuesday, March 15, 2016: Hutchison China MediTech Limited (“Chi-Med”) (AIM:HCM) today announces that its 2015 Annual Report together with the Notice of Annual General Meeting and the Form of Proxy have been posted to shareholders. The documents can be accessed from the website of Chi-Med (www.chi-med.com).

 

Ends

 

Enquiries

 

Christian Hogg, CEO

 

Richard Gray
Andrew Potts

 

Notes to Editors

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chimed.com.

The Notice of Annual General Meeting and the Proxy Form were posted to shareholders.

NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION OR DISSEMINATION IN OR INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION

London: Monday, March 7, 2016: The announcement below is a repeat of RNS No. 1732R originally released on Friday, March 4, 2016 at 17:54 hours GMT.

Fifth Public Filing of Registration Statement on Form F-1 and Launch of Potential U.S. Public Offering of ADSs

 

London: Friday, March 4, 2016: Further to its announcements on October 16, 2015, November 13, 2015, February 11, 2016 and March 1, 2016, Hutchison China MediTech Limited (“Chi Med”) (AIM: HCM) announces that today it publicly filed a fifth draft of the registration statement on Form F-1 (the “Form F-1 Registration Statement”) with the United States Securities and Exchange Commission (the “SEC”) in relation to a potential listing of American depositary shares (“ADSs”) representing its Ordinary Shares on the Nasdaq Stock Market (the “Offering”). The directors of Chi-Med (the “Directors”) believe that a listing in the United States would allow Chi-Med to raise its profile in the U.S. pharmaceutical market, the world’s largest, and increase its recognition amongst the large number of specialist healthcare investors in the United States, thereby potentially resulting in additional trading liquidity.

Chi-Med intends to raise, subject to market and other conditions, approximately US$100.0 million in gross proceeds from the Offering. Based on the closing price of the shares of Chi-Med on AIM on March 3, 2016 of £23.50 per Ordinary Share, 6,123,698 ADSs are expected to be sold by Chi-Med for US$16.33 per ADS (on the basis of each ADS representing one-half of one Ordinary Share and an assumed exchange rate of £1.00 to US$1.39). The closing price on AIM on October 15, 2015, which was the date immediately prior to the first publicly filed Form F-1 Registration Statement, was £19.33 per Ordinary Share. The final price per ADS placed in the potential Offering will be determined following the book-building process and as such, the number of ADSs to be sold may change.

Mr Simon To, Chairman of Chi-Med, said, “We believe that a dual listing on the Nasdaq Stock Market provides the right platform for Chi-Med, as it opens up a new and deep universe of biopharmaceutical investors and analysts.”

Chi-Med will grant the underwriters a 30-day option to purchase up to an additional 918,554 ADSs at the offering price. Chi-Med has applied to have its ADSs approved for listing on the Nasdaq Stock Market under the symbol “HCM.”

In addition to the net proceeds which may be generated by the Offering, Chi-Med plans to continue to utilize its various resources, including existing cash and cash equivalents, short-term investments, credit facilities, expected cash flow from operations and cash compensation from the surrender of land use rights, to pursue the current research and development plans for its drug candidates. Although the final size of the proposed Offering may be subject to change, Chi-Med intends to use the net proceeds of the proposed Offering, together with the cash generated from operations and such other cash resources, primarily to further advance the clinical development of its multiple drug candidates. In particular, Chi-Med expects to apply these estimated net proceeds as follows:

a) approximately US$41.0 million to accelerate and broaden clinical development of the drug candidates for which it retains all worldwide rights, specifically:

i. approximately US$20.0 million to advance HMPL-523 through Phase I and into Proof-of-Concept studies, expected to be conducted in Australia, the United States and China, in rheumatoid arthritis, lupus and hematological cancer;

ii. approximately US$12.0 million to advance sulfatinib toward NDA submission in China as well as through Phase I and into Proof-of-Concept studies, expected to be conducted in the United States, in neuroendocrine tumors and through Phase II and into Proof-of-Concept studies, expected to be conducted in China, in thyroid cancer;

iii. approximately US$7.0 million to advance epitinib into a Phase III registration in China and through Phase I and into Proof-of-Concept studies, expected to be conducted in the United States, in non-small cell lung cancer with brain metastasis; and

iv. approximately US$2.0 million to advance theliatinib through Phase I and into Proof-of-Concept studies, expected to be conducted in China, in head and neck cancer and esophageal cancer;

b) approximately US$27.0 million to support its share of the development costs of its partnered clinical drug candidates, including:

i. approximately US$12.0 million to advance savolitinib through NDA submission globally in papillary renal cell carcinoma and EGFR tyrosine kinase inhibitor-refractory non-small cell lung cancer and through Proof-of-Concept studies in gastric cancer and VEGFR tyrosine kinase inhibitor-refractory clear cell renal cell carcinoma;

ii. approximately US$10.0 million to advance fruquintinib through NDA submission in colorectal cancer and non-small cell lung cancer in China and through Proof-of-Concept in gastric cancer in China and to advance fruquintinib into Proof-of-Concept studies in non-small cell lung cancer and/or other solid tumor indications in the United States either independently or in partnership with Eli Lilly subject to the exercise of its global option;

iii. approximately US$5.0 million to advance either existing or new formulations of HMPL-004 into clinical development in mild-to-moderate ulcerative colitis;

c) approximately US$11.0 million to progress pre-clinical drug candidates, specifically:

i. approximately US$4.0 million to advance HMPL-689 through Phase I and into Proof-of-Concept studies, expected to be conducted in Australia, the United States and China, in hematological cancer;

ii. approximately US$4.0 million to advance HMPL-453 through Phase I and into Proof-of-Concept studies, expected to be conducted in Australia, the United States and China, in bladder cancer; and

iii. approximately US$3.0 million to advance other drug candidates through pre-clinical studies and into Phase I clinical trials; and

d) approximately US$5.0 million to build production facilities to produce both clinical and commercial supply of its drug candidates.

The expected usage of the proposed net proceeds of the Offering represents intentions of the Directors based upon their current plans and Chi-Med’s business conditions, which could change in their discretion in the future as their plans and Chi-Med’s business conditions evolve. Due to the many variables inherent in the development of its drug candidates at this time, such as the timing of patient enrollment and evolving regulatory requirements, the Directors cannot currently predict the stage of development they expect to achieve for Chi-Med’s pre-clinical and clinical trial and drug candidates with the net proceeds of the proposed Offering. Chi-Med expects to use the remainder of the net proceeds to provide funding for working capital and other general corporate purposes, such as acquiring the commercial rights to other drug products and expanding its research organization and infrastructure.

The amounts and timings of the actual expenditure to be incurred by Chi-Med may vary significantly depending on numerous factors, including the results of the pre-clinical and clinical trial of its drug candidates, its operating costs and expenditures and the amount of cash generated by its operations. Accordingly, the Directors will have broad discretion over the usage of the net proceeds. Pending these uses, the Directors intend to invest these net proceeds in high-quality, investment-grade, short-term fixed income instruments.

BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the potential Offering. Stifel, Canaccord Genuity, Panmure Gordon & Co. and CITIC CLSA are acting as co-managers for the potential Offering.

The Form F-1 Registration Statement relating to the ADSs has been filed with the SEC but has not yet become effective. The ADSs may not be sold, nor may offers to buy be accepted, prior to the time the Form F-1 Registration Statement becomes effective. The Form F-1 Registration Statement and all subsequent amendments may be accessed through the SEC’s website at www.sec.gov.

The potential Offering will be made only by means of a prospectus that will form part of the effective Form F-1 Registration Statement. Copies of the preliminary prospectus may be obtained from (in alphabetical order) (i) BofA Merrill Lynch, Attn: Prospectus Department, 222 Broadway, New York, NY 10038, or by email at dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, or by email at prospectus.cpdg@db.com.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Shareholders and potential investors should note that the potential Offering may or may not proceed, and accordingly are advised to exercise caution when dealing in the securities of Chi-Med.

 

Ends

Enquiries

Christian Hogg, CEO

 

Richard Gray
Andrew Potts

 

 

Notes to Editors

 

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.

 

Important information

This announcement does not constitute a registration statement on Form F 1 and does not constitute or form, and will not form, part of any offer or invitation to sell or issue, or the solicitation of an offer to purchase or acquire, any of the Ordinary Shares or ADSs or any other securities in the United States or in any other jurisdiction. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the United States Securities Act of 1933, as amended (“U.S. Securities Act”). Any potential public offering of securities to be made in the United States will be made by means of a Form F 1 Registration Statement that has been declared effective by the SEC. The Form F 1 Registration Statement contains detailed information about the issuer and its management and financial statements. This announcement is being issued pursuant to and in accordance with Rule 135e under the U.S. Securities Act.

No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.

This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

The distribution of this announcement into jurisdictions other than the United Kingdom may be restricted by law. Persons into whose possession this announcement come should acquaint themselves with and observe any such restrictions.

For readers in the European Economic Area

In any EEA Member State that has implemented the Prospectus Directive, this announcement is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Directive. The term “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant Member State), together with any relevant implementing measure in the relevant Member State.

For readers in the United Kingdom

This announcement, insofar as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the potential Offering described in this announcement or otherwise, is being directed only at (i) persons who are outside the United Kingdom; or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (“Order”); or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). The ADSs are only available to, and any invitation, offer or agreement to subscribe for, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

Forward looking statements

This announcement may contain forward looking statements that reflect Chi Med’s current expectations regarding future events, including completion of the potential Offering. A list and description of risks, uncertainties and other risks associated with an investment in Chi Med can be found in Chi Med’s filings with the SEC, including the Form F 1 Registration Statement. Existing and prospective investors are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date hereof. Chi Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

Defined Terms

For the purposes of this announcement:

“EGFR” means epidermal growth factor receptor;

“NDA submission” means a request for approval to market a drug containing evidence of safety and efficacy which is demonstrated by extensive pre-clinical and clinical testing;

“Ordinary Shares” means the fully paid ordinary shares in the capital of Chi-Med which have a nominal value of US$1 each, and “Ordinary Share” means any one of them;

“Phase I” means a preliminary clinical trial for clinical pharmacology and body safety, conducted to observe the human body tolerance for new medicine and pharmacokinetics, so as to provide a basis for determining the prescription plan;

“Phase II” means a stage of preliminary evaluation of clinical effectiveness, the purpose of which is to preliminarily evaluate the clinical effectiveness and safety of the medicine used on patients with targeted indication, as well as to provide a basis for determining the Phase III clinical trial research plan and the volume under the prescription plan;

“Phase III” means a clinical trial stage to verify the clinical effectiveness, the purpose of which is to test and determine the clinical effectiveness and safety of the medicine used on patients with targeted indication, to evaluate the benefits and risks thereof and, eventually, to provide sufficient basis for review of the medicine registration application;

“Proof-of-Concept” means a clinical trial conducted to establish the clinical effectiveness and safety of the new medicine used on patients with the targeted indication. Generally Proof-of-Concept trials are categorized as either Phase Ib or Phase II trials, which are clinical trials conducted in a larger patient population than for a Phase I trial, but in a smaller patient populations than Phase III registration application trials; and

“VEGFR” means vascular endothelial growth factor receptor.

Press Release

London: Friday, 4 March 2016: Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) announces that it intends to offer and sell, subject to market and other conditions, approximately $100 million of its ordinary shares in the form of American depositary shares (“ADSs”) in the United States (the “Offering”).

The final price per ADS placed in the potential Offering will be determined following the book-building process. Chi-Med intends to grant the underwriters a 30-day option to purchase additional ADSs in connection with the potential Offering at the final offering price.

Chi-Med’s ordinary shares are currently admitted to trading on the AIM market of the London Stock Exchange under the symbol “HCM.” Chi-Med has applied to have its ADSs approved for listing on the Nasdaq Stock Market under the symbol “HCM.”

BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the potential Offering. Stifel, Canaccord Genuity, Panmure Gordon & Co. and CITIC CLSA are acting as co-managers for the potential Offering.

A registration statement on Form F-1 (the “Form F-1 Registration Statement”) relating to the ADSs has been filed with the United States Securities and Exchange Commission (the “SEC”) but has not yet become effective. The ADSs may not be sold nor may offers to buy be accepted prior to the time the Form F-1 Registration Statement becomes effective. The Form F-1 Registration Statement and all subsequent amendments may be accessed through the SEC’s website at www.sec.gov.

The Offering will be made only by means of a prospectus that will form part of the effective Form F-1 Registration Statement. Copies of the preliminary prospectus may be obtained from (in alphabetical order): (i) BofA Merrill Lynch, Attn: Prospectus Department, 222 Broadway, New York, NY 10038, or by email at dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, or by email at prospectus.cpdg@db.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Ends

Enquiries

Christian Hogg, CEO

 

Richard Gray
Andrew Potts

 

 

Notes to Editors

 

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.

 

Forward-looking statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties, including statements regarding the potential Offering. Actual results may differ materially from those projected or implied. More information about potential factors that could affect Chi-Med’s business and financial results is contained in the Form F-1 Registration Statement filed with the SEC. Any forward-looking statement made by Chi-Med herein, or elsewhere, speaks only as of the date on which such statement is made. Chi-Med does not intend, and undertakes no duty, to update any forward-looking statements after the date hereof to reflect future events or circumstances.

NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION OR DISSEMINATION IN OR INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION

London: Friday, March 4, 2016: Further to its announcements on October 16, 2015, November 13, 2015, February 11, 2016 and March 1, 2016, Hutchison China MediTech Limited (“Chi Med”) (AIM: HCM) announces that today it publicly filed a fifth draft of the registration statement on Form F-1 (the “Form F-1 Registration Statement”) with the United States Securities and Exchange Commission (the “SEC”) in relation to a potential listing of American depositary shares (“ADSs”) representing its Ordinary Shares on the Nasdaq Stock Market (the “Offering”). The directors of Chi-Med (the “Directors”) believe that a listing in the United States would allow Chi-Med to raise its profile in the U.S. pharmaceutical market, the world’s largest, and increase its recognition amongst the large number of specialist healthcare investors in the United States, thereby potentially resulting in additional trading liquidity.

Chi-Med intends to raise, subject to market and other conditions, approximately US$100.0 million in gross proceeds from the Offering. Based on the closing price of the shares of Chi-Med on AIM on March 3, 2016 of £23.50 per Ordinary Share, 6,123,698 ADSs are expected to be sold by Chi-Med for US$16.33 per ADS (on the basis of each ADS representing one-half of one Ordinary Share and an assumed exchange rate of £1.00 to US$1.39). The closing price on AIM on October 15, 2015, which was the date immediately prior to the first publicly filed Form F-1 Registration Statement, was £19.33 per Ordinary Share. The final price per ADS placed in the potential Offering will be determined following the book-building process and as such, the number of ADSs to be sold may change.

Mr Simon To, Chairman of Chi-Med, said, “We believe that a dual listing on the Nasdaq Stock Market provides the right platform for Chi-Med, as it opens up a new and deep universe of biopharmaceutical investors and analysts.”

Chi-Med will grant the underwriters a 30-day option to purchase up to an additional 918,554 ADSs at the offering price. Chi-Med has applied to have its ADSs approved for listing on the Nasdaq Stock Market under the symbol “HCM.”

In addition to the net proceeds which may be generated by the Offering, Chi-Med plans to continue to utilize its various resources, including existing cash and cash equivalents, short-term investments, credit facilities, expected cash flow from operations and cash compensation from the surrender of land use rights, to pursue the current research and development plans for its drug candidates. Although the final size of the proposed Offering may be subject to change, Chi-Med intends to use the net proceeds of the proposed Offering, together with the cash generated from operations and such other cash resources, primarily to further advance the clinical development of its multiple drug candidates. In particular, Chi-Med expects to apply these estimated net proceeds as follows:

a) approximately US$41.0 million to accelerate and broaden clinical development of the drug candidates for which it retains all worldwide rights, specifically:

i. approximately US$20.0 million to advance HMPL-523 through Phase I and into Proof-of-Concept studies, expected to be conducted in Australia, the United States and China, in rheumatoid arthritis, lupus and hematological cancer;

ii. approximately US$12.0 million to advance sulfatinib toward NDA submission in China as well as through Phase I and into Proof-of-Concept studies, expected to be conducted in the United States, in neuroendocrine tumors and through Phase II and into Proof-of-Concept studies, expected to be conducted in China, in thyroid cancer;

iii. approximately US$7.0 million to advance epitinib into a Phase III registration in China and through Phase I and into Proof-of-Concept studies, expected to be conducted in the United States, in non-small cell lung cancer with brain metastasis; and

iv. approximately US$2.0 million to advance theliatinib through Phase I and into Proof-of-Concept studies, expected to be conducted in China, in head and neck cancer and esophageal cancer;

b) approximately US$27.0 million to support its share of the development costs of its partnered clinical drug candidates, including:

i. approximately US$12.0 million to advance savolitinib through NDA submission globally in papillary renal cell carcinoma and EGFR tyrosine kinase inhibitor-refractory non-small cell lung cancer and through Proof-of-Concept studies in gastric cancer and VEGFR tyrosine kinase inhibitor-refractory clear cell renal cell carcinoma;

ii. approximately US$10.0 million to advance fruquintinib through NDA submission in colorectal cancer and non-small cell lung cancer in China and through Proof-of-Concept in gastric cancer in China and to advance fruquintinib into Proof-of-Concept studies in non-small cell lung cancer and/or other solid tumor indications in the United States either independently or in partnership with Eli Lilly subject to the exercise of its global option;

iii. approximately US$5.0 million to advance either existing or new formulations of HMPL-004 into clinical development in mild-to-moderate ulcerative colitis;

c) approximately US$11.0 million to progress pre-clinical drug candidates, specifically:

i. approximately US$4.0 million to advance HMPL-689 through Phase I and into Proof-of-Concept studies, expected to be conducted in Australia, the United States and China, in hematological cancer;

ii. approximately US$4.0 million to advance HMPL-453 through Phase I and into Proof-of-Concept studies, expected to be conducted in Australia, the United States and China, in bladder cancer; and

iii. approximately US$3.0 million to advance other drug candidates through pre-clinical studies and into Phase I clinical trials; and

d) approximately US$5.0 million to build production facilities to produce both clinical and commercial supply of its drug candidates.

The expected usage of the proposed net proceeds of the Offering represents intentions of the Directors based upon their current plans and Chi-Med’s business conditions, which could change in their discretion in the future as their plans and Chi-Med’s business conditions evolve. Due to the many variables inherent in the development of its drug candidates at this time, such as the timing of patient enrollment and evolving regulatory requirements, the Directors cannot currently predict the stage of development they expect to achieve for Chi-Med’s pre-clinical and clinical trial and drug candidates with the net proceeds of the proposed Offering. Chi-Med expects to use the remainder of the net proceeds to provide funding for working capital and other general corporate purposes, such as acquiring the commercial rights to other drug products and expanding its research organization and infrastructure.

The amounts and timings of the actual expenditure to be incurred by Chi-Med may vary significantly depending on numerous factors, including the results of the pre-clinical and clinical trial of its drug candidates, its operating costs and expenditures and the amount of cash generated by its operations. Accordingly, the Directors will have broad discretion over the usage of the net proceeds. Pending these uses, the Directors intend to invest these net proceeds in high-quality, investment-grade, short-term fixed income instruments.

BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the potential Offering. Stifel, Canaccord Genuity, Panmure Gordon & Co. and CITIC CLSA are acting as co-managers for the potential Offering.

The Form F-1 Registration Statement relating to the ADSs has been filed with the SEC but has not yet become effective. The ADSs may not be sold, nor may offers to buy be accepted, prior to the time the Form F-1 Registration Statement becomes effective. The Form F-1 Registration Statement and all subsequent amendments may be accessed through the SEC’s website at www.sec.gov.

The potential Offering will be made only by means of a prospectus that will form part of the effective Form F-1 Registration Statement. Copies of the preliminary prospectus may be obtained from (in alphabetical order) (i) BofA Merrill Lynch, Attn: Prospectus Department, 222 Broadway, New York, NY 10038, or by email at dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, or by email at prospectus.cpdg@db.com.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Shareholders and potential investors should note that the potential Offering may or may not proceed, and accordingly are advised to exercise caution when dealing in the securities of Chi-Med.

 

Ends

Enquiries

Christian Hogg, CEO

 

Richard Gray
Andrew Potts

 

 

Notes to Editors

 

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.

 

Important information

This announcement does not constitute a registration statement on Form F 1 and does not constitute or form, and will not form, part of any offer or invitation to sell or issue, or the solicitation of an offer to purchase or acquire, any of the Ordinary Shares or ADSs or any other securities in the United States or in any other jurisdiction. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the United States Securities Act of 1933, as amended (“U.S. Securities Act”). Any potential public offering of securities to be made in the United States will be made by means of a Form F 1 Registration Statement that has been declared effective by the SEC. The Form F 1 Registration Statement contains detailed information about the issuer and its management and financial statements. This announcement is being issued pursuant to and in accordance with Rule 135e under the U.S. Securities Act.

No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.

This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

The distribution of this announcement into jurisdictions other than the United Kingdom may be restricted by law. Persons into whose possession this announcement come should acquaint themselves with and observe any such restrictions.

For readers in the European Economic Area

In any EEA Member State that has implemented the Prospectus Directive, this announcement is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Directive. The term “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant Member State), together with any relevant implementing measure in the relevant Member State.

For readers in the United Kingdom

This announcement, insofar as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the potential Offering described in this announcement or otherwise, is being directed only at (i) persons who are outside the United Kingdom; or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (“Order”); or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). The ADSs are only available to, and any invitation, offer or agreement to subscribe for, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

Forward looking statements

This announcement may contain forward looking statements that reflect Chi Med’s current expectations regarding future events, including completion of the potential Offering. A list and description of risks, uncertainties and other risks associated with an investment in Chi Med can be found in Chi Med’s filings with the SEC, including the Form F 1 Registration Statement. Existing and prospective investors are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date hereof. Chi Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

Defined Terms

For the purposes of this announcement:

“EGFR” means epidermal growth factor receptor;

“NDA submission” means a request for approval to market a drug containing evidence of safety and efficacy which is demonstrated by extensive pre-clinical and clinical testing;

“Ordinary Shares” means the fully paid ordinary shares in the capital of Chi-Med which have a nominal value of US$1 each, and “Ordinary Share” means any one of them;

“Phase I” means a preliminary clinical trial for clinical pharmacology and body safety, conducted to observe the human body tolerance for new medicine and pharmacokinetics, so as to provide a basis for determining the prescription plan;

“Phase II” means a stage of preliminary evaluation of clinical effectiveness, the purpose of which is to preliminarily evaluate the clinical effectiveness and safety of the medicine used on patients with targeted indication, as well as to provide a basis for determining the Phase III clinical trial research plan and the volume under the prescription plan;

“Phase III” means a clinical trial stage to verify the clinical effectiveness, the purpose of which is to test and determine the clinical effectiveness and safety of the medicine used on patients with targeted indication, to evaluate the benefits and risks thereof and, eventually, to provide sufficient basis for review of the medicine registration application;

“Proof-of-Concept” means a clinical trial conducted to establish the clinical effectiveness and safety of the new medicine used on patients with the targeted indication. Generally Proof-of-Concept trials are categorized as either Phase Ib or Phase II trials, which are clinical trials conducted in a larger patient population than for a Phase I trial, but in a smaller patient populations than Phase III registration application trials; and

“VEGFR” means vascular endothelial growth factor receptor.

2016年3月2日：和黄医药今日宣布正式启动索凡替尼（HMPL-012）以局部晚期或放射性碘难治性转移分化的甲状腺癌（DTC）或甲状腺髓样癌（MTC）为适应症在中国开展的一项开放式II期临床研究，旨在评估该药的疗效及安全性。2016年3月1日首位受试者接受给药治疗。

此次研究计划招募约50位局部晚期/放射性碘难治性转移分化的甲状腺癌或甲状腺髓样癌患者，每一种肿瘤类型分别招募约25位受试者。研究的主要目的为评价索凡替尼的客观缓解率（ORR），次要和探索性目的为评价该药的安全性及耐受性、其他疗效参数、药代动力学特性及肿瘤生物标志物。该研究将分为两个阶段进行：第一阶段，每一种肿瘤类型将各入组15位受试者；第二阶段，将在对第一阶段受试者进行疗效评估后，每一种肿瘤类型再入组10位受试者。该研究的详细信息可登录网站clinicaltrials.gov，检索NCT02614495进行查阅。

索凡替尼是针对血管细胞内皮生长因子受体（VEGFR）和成纤维细胞生长因子受体（FGFR）双靶点的口服酪氨酸激酶抑制剂，能有效地抑制肿瘤血管生成。索凡替尼的VEGFR/FGFR1抑制特性在治疗二线甲状腺癌方面具有巨大的潜力，尤其是当前国内此患者群体尚无安全有效的治疗方法可选择。

除了以甲状腺癌为适应症的临床试验，和黄医药正在进行或筹备启动以神经内分泌瘤（NETs）为适应症的四项临床研究。

 

甲状腺癌

甲状腺癌是最常见的恶性内分泌肿瘤。过去数十年间全球发病率持续大幅增长。根据美国国家癌症研究所的数据表明，过去十年间，美国甲状腺癌的发病率平均每年增长5%。此外，据著名肿瘤学杂志《Cancer Research》上发表的一篇文章预计，到2030年，甲状腺癌将成为全球第四大常见被诊断的癌症。在中国，根据中国国家癌症登记中心数据显示，甲状腺癌是目前发生率增长最为迅速的肿瘤类型，占2015年登记报告的所有新发癌症病例的约2%。

这一增长在女性患者中尤其突出。中国国家癌症登记中心数据显示，2015年，中国女性甲状腺癌新发病例为67,900例，而男性仅为22,200例。此外，甲状腺癌已成为中国30岁以下女性群体中最常见肿瘤类型。而另据美国国家癌症研究所数据表明，美国女性的甲状腺癌发病率是男性的3倍。

 

索凡替尼以神经内分泌瘤为适应症的临床研究进展概览

神经内分泌瘤是起源于神经内分泌细胞的肿瘤，可以发生在体内很多部位，但最常见的是消化道及呼吸道的神经内分泌瘤。神经内分泌瘤因肿瘤小，患者症状各异，导致诊断难度大。因此，每年神经内分泌肿瘤的病例数据也很难准确预测。2015年，美国大约有19,000例神经内分泌肿瘤新发病例，患者总数约为144,000例。

2014年，和黄医药完成了索凡替尼的中国I期临床研究；详细结果已于2015年11月举办的AACR-NCI-EORTC国际分子靶点和癌症疗法会议上进行了公布，详情亦可参见http://www.chi-med.com/sulfatinib-ph1-eortc-2015/。临床I期的研究数据表明索凡替尼在治疗神经内分泌瘤患者的过程中显现出良好的客观缓解率。在18位可评估的受试者中，索凡替尼的客观缓解率高达44%，而两个已获批的以胰腺神经内分泌瘤为适应症的靶向药物—舒尼替尼和依维莫司，客观缓解率仅不足10%。有关索凡替尼的中国I期临床研究的详细信息可登录网站clinicaltrials.gov，检索NCT02133157进行查阅。

2014年10月，和黄医药在中国的神经内分泌瘤患者中启动了一项多中心、单臂、开放式的Ib/II期临床研究，旨在进一步评估索凡替尼的疗效、安全性、耐受性及药代动力学特性。2015年12月，该研究完成了总计81位受试者的招募工作。研究结果预计将于2016年内公布。有关此临床研究的详细信息可登录网站clinicaltrials.gov，检索NCT02267967进行查阅。

2015年12月，和黄医药启动了索凡替尼以非胰腺神经内分泌肿瘤为适应症的中国III期临床研究（SANET-ep）。该研究为随机双盲安慰剂对照的多中心临床试验，目标受试者为疾病已进展、局部晚期或出现远处转移的低级或中级神经内分泌瘤患者，目前此类患者尚无有效的治疗手段。关于此临床研究的详细信息可登录网站clinicaltrials.gov，检索NCT02588170进行查阅。

2016年第一季度，和黄医药计划启动索凡替尼以胰腺神经内分泌肿瘤为适应症的第二项III期临床研究（SANET-p）。该研究采用与SANET-ep相似的治疗方案，并设置相似的主要及次要试验终点，共计划招募195位受试者。关于此临床研究的详细信息可登录网站clinicaltrials.gov，检索NCT02589821进行查阅。

2015年11月，和黄医药在美国针对高加索人种的患者启动了一项I期临床研究。该研究的目的之一是探索高加索人种患者在II期临床研究中可适用的剂量，据此和黄医药将有望在2016年下半年在美国的广谱神经内分泌瘤患者中启动II期临床研究。有关索凡替尼的美国I期临床研究的详细信息可登录网站clinicaltrials.gov，检索NCT02549937进行查阅。

 

关于肿瘤中的血管细胞内皮生长因子受体（VEGFR）和成纤维生长因子受体（FGFR）

癌症进入到晚期，肿瘤会分泌大量的蛋白配体血管细胞内皮生长因子（VEGF），以促进肿瘤组织周围大量的脉管系统的生成（血管生成），为肿瘤细胞的生长提供更多的血流，氧气和营养。 抗肿瘤血管生成药物已在多个肿瘤类型中证实了作用效果。VEGF 和其它配体可与血管细胞内皮生长因子受体（VEGFR）结合，并在肿瘤的血管生成中起到一定的作用。因此，对VEGF/VEGFR相关通路的抑制可阻断新生血管发展，切断肿瘤迅速生长所需的营养和氧气供给。

成纤维细胞生长因子（FGF）也在肿瘤血管生成中发挥着重要的作用。FGF/FGFR信号通路的异常活跃能够促进肿瘤增长、存活、迁移以及入侵，从而推动疾病进展。有研究显示抗VEGF药物治疗能够促进FGFR通路的异常活跃，从而导致了VEGF药物的抗药性。因此有理由相信同时靶向VEGFR和FGFR信号通路将成为提高临床疗效的一种有效策略。

NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION OR DISSEMINATION IN OR INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION

 

London: Tuesday, 1 March 2016: Further to its announcements on 16 October 2015, 13 November 2015 and 11 February 2016, Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) announces that it has publicly filed today a fourth draft of the registration statement on Form F-1 (the “Form F-1 Registration Statement”) with the United States Securities and Exchange Commission (the “SEC”) in relation to a potential listing of American depositary shares (“ADSs”) representing its ordinary shares on the Nasdaq Stock Market (the “Offering”).

Bank of America Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the potential Offering.

The fourth draft of the Form F-1 Registration Statement relating to the ADSs has been filed with the SEC but has not yet become effective. The ADSs may not be sold, nor may offers to buy be accepted, prior to the time the Form F-1 Registration Statement becomes effective. The Form F-1 Registration Statement and all subsequent amendments may be accessed through the SEC’s website at www.sec.gov.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Shareholders and potential investors should note that the potential Offering may or may not proceed, and accordingly are advised to exercise caution when dealing in the securities of Chi-Med.

Financial results for the year ended 31 December 2015
The Form F-1 Registration Statement contains the audited consolidated financial statements of Chi-Med as of and for the year ended 31 December 2015, prepared in accordance with U.S. GAAP. In addition, the Form F-1 Registration Statement contains audited consolidated accounts for the three non-consolidated joint ventures of Chi-Med, namely, Shanghai Hutchison Pharmaceuticals Limited, Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited and Nutrition Science Partners Limited, as of and for the year ended 31 December 2015, prepared in accordance with IFRS. Such audited consolidated financial statements, as extracted from the Form F-1 Registration Statement, are set out in the appendices to this announcement. A separate announcement in respect of Chi-Med’s financial results for the year ended 31 December 2015 has been released today and the final audited consolidated financial statements will be sent to shareholders as part of Chi-Med’s annual report and accounts in due course.

Ends

Enquiries

Chi-Med
Telephone: +852 2121 8200
Christian Hogg, CEO

Panmure Gordon (UK) Limited
Telephone: +44 20 7886 2500
Richard Gray / Andrew Potts

Citigate Dewe Rogerson
Telephone: +44 20 7638 9571
Anthony Carlisle – Mobile: +44 7973 611 888
David Dible – Mobile: +44 7967 566 919

 

Notes to Editors

 

About Chi-Med

Chi-Med is a China based, globally focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.

 

Important information

This announcement, which includes the appendices to it, does not constitute a registration statement on Form F-1 and does not constitute or form, and will not form, part of any offer or invitation to sell or issue, or the solicitation of an offer to purchase or acquire, any of the Ordinary Shares or ADSs or any other securities in the United States or in any other jurisdiction. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the United States Securities Act of 1933, as amended (“U.S. Securities Act”). Any potential public offering of securities to be made in the United States will be made by means of a Form F-1 Registration Statement that has been declared effective by the SEC. The Form F-1 Registration Statement contains detailed information about the issuer and its management and financial statements. This announcement is being issued pursuant to and in accordance with Rule 135e under the U.S. Securities Act.

No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.

This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

The distribution of this announcement into jurisdictions other than the United Kingdom may be restricted by law. Persons into whose possession this announcement come should acquaint themselves with and observe any such restrictions.

For readers in the European Economic Area

In any EEA Member State that has implemented the Prospectus Directive, this announcement, which includes the appendices to it, is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Directive. The term “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant Member State), together with any relevant implementing measure in the relevant Member State.

For readers in the United Kingdom

This announcement, which includes the appendices to it, insofar as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the potential offering described in this announcement or otherwise, is being directed only at (i) persons who are outside the United Kingdom; or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (“Order”); or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). The ADSs are only available to, and any invitation, offer or agreement to subscribe for, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

Forward looking statements

This announcement, which includes the appendices to it, may contain forward looking statements that reflect Chi-Med’s current expectations regarding future events. A list and description of risks, uncertainties and other risks associated with an investment in Chi-Med can be found in Chi-Med’s filings with the SEC, including the Form F 1 Registration Statement. Existing and prospective investors are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date hereof. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

 

— Please download the PDF file for the full Announcement, including the Audited Consolidated Financial Statements of Chi-Med prepared in accordance with U.S. GAAP and the Audited Consolidated Accounts of Non-Consolidated Joint Ventures prepared in accordance with IFRS. —

Record profit from operations at both Group and Commercial Platform levels

Excellent progress on all lead drug candidates – five out of five positive Phase Ib/II outcomes in 2015

Seven drug candidates – 19 active clinical trials – 3 Phase III studies – multiple 2016 catalysts

London: Tuesday, 1 March 2016: Hutchison China MediTech Limited (“Chi-Med” or the “Company”) (AIM: HCM), the China-based healthcare group, today announces its final results for the year ended 31 December 2015.

Results are reported under U.S. Generally Accepted Accounting Principles (“U.S. GAAP”) for the first time, as the Company prepares for its proposed dual listing on the NASDAQ Stock Market (“Nasdaq”), and in US dollar currency unless otherwise stated.

Group Results

• Revenue up 104% to $178.2 million (2014: $87.3m).
• Net profit from operations attributable to Chi-Med of $8.0 million (2014: net loss -$7.3m), including our booking of $3.1 million in one-time preparation costs for our proposed Nasdaq listing.
• Stable cash position:  Available cash, over $90 million as of today, at the Chi-Med Group level, including cash and cash equivalents and unutilized banking facilities.
  1. $31.9 million in cash and cash equivalents at Chi-Med Group level as at 31 December 2015;
  2. $6.9 million in unutilized bank facilities at Chi-Med Group level as at 31 December 2015;
  3. $60.0 million additional unsecured bank facilities established in February 2016;
  4. $76.9 million in further cash and cash equivalents held at 50/50 Joint Venture (“JV”) level and not consolidated at Chi-Med Group level.  Shanghai property compensation of approximately $73.9 million expected at JV level in 2016, which is in addition to the $31.1 million that we already received in late 2015.
• Continued focus on proposed Nasdaq dual listing – fourth public filing of registration statement on Form F-1 expected to be made today.

Innovation Platform

• Revenue up 156% to $52.0 million (2014: $20.3m) primarily as a result of payments from our partners AstraZeneca AB (publ) (“AstraZeneca”), Eli Lilly and Company (“Lilly”), Nutrition Science Partners Limited (“NSP”) (our JV with Nestlé Health Science S.A.) and Janssen Pharmaceuticals, Inc. (part of the Johnson & Johnson group of companies).
• Net loss attributable to Chi-Med down 83% to $3.8 million (2014: net loss -$22.2m).
• Major increased investment in clinical programs by Chi-Med and its partners – estimated up 41% to $64.1 million (2014: $45.5m).  Total of 677 new patients, 249 outside China and 428 inside China, were enrolled during 2015 into our 19 active studies.

Commercial Platform

• Total sales of subsidiaries and JVs from continuing operations up 11% to $518.9 million (2014: $465.4m) driven by 40% increase in prescription drugs sales, namely Seroquel® (quetiapine tablets) and She Xiang Bao Xin pill (“SXBXP”), partly offset by an 11% decline in sales, mainly supply driven, in our consumer health business.
• Net profit attributable to Chi-Med from continuing operations up 10% to $25.2 million (2014: $22.8m) due to strong growth in sales of prescription drugs partly offset by $1.7 million in non-recurring one-time costs from factory relocations and the take-back of commercial rights of certain products.

Christian Hogg, CEO of Chi-Med, said:  “2015 has been a record year, and in 2016 we expect multiple clinical catalysts and continued commercial performance to continue this momentum.

Chi-Med doubled revenues in 2015, made a record net profit from operations at the Group level and has maintained a strong cash position.  We made excellent progress in the Innovation Platform, publishing positive clinical outcomes on all five of the Phase Ib/II proof-of-concept studies that reported results during the year.  On the Commercial Platform, we again recorded double digit sales and profit growth and started to unlock the considerable value of legacy land assets that are held in our JVs in China.  We also committed to list on Nasdaq, to add to the current London Stock Exchange AIM listing.

Over more than a decade, more than $330 million has been invested in the Innovation Platform.  Now with a team of over 290 scientists and staff, and with what we believe are either first-in-class or best-in-class drug candidates against eight molecular targets, we operate one of the leading oncology and immunology drug research and development operations in China.

Our research is founded on the core belief that cancer uses multiple molecular pathways to survive, proliferate and migrate and that treatment would require combinations of drug therapies to shut down these primary and resistance pathways.  To enable drug therapies to be combinable and tolerated by patients, Chi-Med has used a chemistry-focused approach to design clean compounds that are uniquely selective to the intended molecular target, as well as possessing favorable drug-drug interaction profiles and superior pharmacokinetic properties.

Last year, this research approach was validated through the publication of positive Phase Ib/II clinical efficacy on savolitinib, fruquintinib, sulfatinib and epitinib, in addition to solid Phase I clinical safety data on HMPL-523, our Spleen Tyrosine Kinase (“Syk”) inhibitor.  For the first time it has been shown that several Chi-Med compounds are combinable at their full strength with other approved cancer therapies – savolitinib can be used in combination with Tagrisso® (AZD9291/osimertinib) and Iressa® (gefitinib), and fruquintinib can be used in combination with Taxol® (paclitaxel).  We see this as just the start of a multi-year effort to maximize patient outcomes in a range of solid tumors and hematological cancers, through combinations or rotations of treatment of our compounds with other targeted therapies, immunotherapies and chemotherapies.

In our Commercial Platform, Chi-Med has focused on broadening the scope and capacity of the higher margin prescription drug business, which will provide a strong China marketing and distribution channel for the Innovation Platform drugs if approved.  We gained a new 20-year patent on SXBXP, our largest selling proprietary drug; and we remain on-track for two new large-scale factories to come on-line this year to provide a much needed increase in supply through the tripling of our own-brand production capacity.  We are also now starting to realize the considerable, previously hidden, value of the land-use rights of our two old JV factory sites, securing a $105 million compensation deal for our old Shanghai site which had a net book value of only $12.7 million as at 31 December 2015.  We are now working towards the prospect of a potentially larger settlement on our Guangzhou sites.

One of our key differentiators, due primarily to the scale of our clinical pipeline and the speed at which it is progressing, is the quantity of catalyst events that we expect our lead drug candidates to trigger as they move ever closer to their potential approval and launch.  In 2016, for example, savolitinib, subject to positive Phase II data, has a chance to submit for U.S. Food and Drug Administration (“FDA”) approval late this year in papillary renal cell carcinoma (“PRCC”); fruquintinib is expected to complete enrolment of its Phase III registration study in third-line colorectal cancer in China and, again subject to quality data, will look to submit for China FDA approval late this year or early in 2017; sulfatinib should initiate global proof-of-concept studies and a second Phase III registration study in China this year; epitinib is targeting to start both a China Phase III registration study and U.S. development later in 2016; and HMPL-523 aims to consolidate its position as one of the world’s leading Syk inhibitor candidates by starting a global proof-of-concept study in rheumatoid arthritis and completing its Phase I study in lymphoma this year, which will hopefully provide a clear efficacy signal.

Together with the intended Nasdaq dual listing, all the pieces are now in place to accelerate discovery work, expand clinical activities and ultimately commercialize our approved innovations.”

2015 / Q1 2016 Highlights

Group

• Announced plan to dual list Chi-Med on Nasdaq
  Q4-15 – The planned Nasdaq listing, when completed, will open up a new and deep universe of biopharmaceutical investors and analysts that are well positioned to understand our science and support the late-stage development of our pipeline.
• Secured 99.8% ownership of Innovation Platform
  Q3-15 – Completed a transaction (the “Roll-up”) that converted the 12.24% shareholding of Mitsui & Co., Ltd. (“Mitsui”) in our Innovation Platform, Hutchison MediPharma Holdings Limited (“HMHL”), into a 5.69% shareholding in Chi-Med.   The Roll-up eradicated the two downsides of Mitsui’s HMHL preference shares – the risk of the cash drain of a redemption; and the distortion of Chi-Med Group earnings per share caused by the non-cash accretions required under U.S. GAAP.

Innovation Platform:  Reported positive data in five Phase Ib/II proof-of-concept studies – currently enrolling 19 clinical trials on 7 drug candidates including 3 Phase III registration trials 

• Savolitinib:  Potential global first-in-class Mesenchymal Epithelial Transition Factor (“c-Met”) inhibitor – in 9 clinical studies worldwide
  Q2-15 – Reported clear and durable tumor response of savolitinib/Tagrisso® combination in T790M negative c-Met gene amplified non-small cell lung cancer (“NSCLC”) patients at 2015 meeting of the American Society of Clinical Oncology (“ASCO”);
  Q4-15 – Received Phase II/III clinical trial clearance from the China FDA;
  Q4-15 – Completed enrollment of global Phase II study of first-line papillary renal cell carcinoma (“PRCC”) with 109 patients – the largest study in PRCC ever conducted globally.
• HMPL-523:  Potential global first-in-class Syk inhibitor – emerging as a very high value asset
  Q3-15 – Successfully completed Australia Phase I clinical study showing no material toxicities in healthy volunteers; linear dose dependent human drug exposures well above expected efficacious dose; and clear dose dependent inhibition in B-cell activation in human plasma pharmacodynamic models;
  Q1-16 – Initiated Australia Phase I dose escalation study in hematological cancer (lymphoma and leukemia patients).
• Fruquintinib:  Potential global best-in-class small molecule Vascular Endothelial Growth Factor Receptor (“VEGFR”) inhibitor in Phase III development
  Q2-15 – Clearly met Phase II study primary endpoint, in colorectal cancer (third-line), with median Progression Free Survival (“PFS” – the time to disease progression or death) of 4.7 months compared to 1.0 month for the placebo (hazard ratio = 0.30 (p<0.001)), with no major unexpected safety issues;
  Q3-15 – Clearly met Phase II study median PFS primary endpoint, in NSCLC (third-line), with no unexpected safety issues – full data publication in 2016;
  Q4-15 – Initiated pivotal Phase III registration study, named FALUCA, in NSCLC (third-line) in China;
  2015 – Received success-based proof-of-concept cash payments totaling $33.1 million from Lilly in 2015.
• Sulfatinib:  Potential Breakthrough Therapy in neuroendocrine tumors in Phase III development
  Q3-15 – Reported 44.4% Objective Response Rate (“ORR” – the proportion of patients with tumor shrinkage of more than 30%), in a broad range of neuroendocrine tumors (“NET”) in an expanded Phase I study in China – significantly superior to <10% ORR for Sutent® (sunitinib) and Afinitor® (everolimus) reported for pancreatic NET (only ~6.4% of all NET according to Frost & Sullivan);
  Q3-15 – Initiated U.S. Phase I dose confirmation study in Caucasians – sulfatinib is the first wholly-owned cancer drug candidate being developed by Chi-Med in the U.S.;
  Q4-15 – Completed enrollment of an 81 patient Phase Ib/II NET study in China;
  Q4-15 – Initiated pivotal Phase III registration study, named SANET-ep, in extra-pancreatic (i.e. non-pancreatic) NET patients in China.
• Epitinib:  Potential global best-in-class small molecule Epidermal Growth Factor Receptor (“EGFR”) inhibitor
  Q3-15 – Reported highly encouraging early human efficacy data in Phase Ib study of NSCLC patients with brain metastasis – clear responses in both primary lung and metastasized brain lesions.

Commercial Platform:  Focus on broadening scope and capacity of higher margin Prescription Drugs business

• Rapid expansion in our Prescription Drugs business:  Shanghai Hutchison Pharmaceuticals Limited (“SHPL”) and Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited (“Hutchison Sinopharm”) – the Commercial Platform’s core prescription drug operations – grew sales of subsidiaries and JVs by 40% to $286.6 million (2014: $204.9m) with net profit attributable to Chi-Med up 20% to $15.9 million (2014: $13.2m).
• Important 20-year invention patent granted:  A new patent covering formulation was granted in July 2015 on SHPL’s largest prescription drug product, SXBXP (cardiovascular), which will extend proprietary protection in China through 2029.  SXBXP sales grew by 15% to $159.3 million in 2015, representing 56% of the total sales of our Prescription Drugs business.
• Substantial progress on Seroquel®: In the third party Prescription Drugs business, SHPL has now established an over 100-person psychiatric disorder medical sales team to market and sell Seroquel® on behalf of AstraZeneca.  Sales of Seroquel® from April to December 2015 were $21.1 million – evidence of the adaptability of our Commercial Platform in China to enter new therapeutic areas.
• New factories and property compensation on-track:  The new Shanghai and Anhui province factories, which are already about 90% paid for, come on-line in 2016 and will triple production capacity for own-brand products. We expect considerable compensation to our JVs from our Shanghai and Guangzhou old factory site returns.  We received $31.1 million in cash from the Shanghai government in late 2015, as the first installment payment, for the return of our old Shanghai factory site.  The balance of the total Shanghai compensation of about $105 million is expected in 2016.

2016 Innovation Platform Catalysts

• Savolitinib:  Clarity on U.S. FDA filing strategy – potential to submit for U.S. FDA approval in late 2016
  Q1-16 – Expect to initiate Phase Ib dose finding study in renal cell carcinoma combining savolitinib with immunotherapy agents;
  H2-16 – Plan to report PRCC Phase II results, subject to maturity of median PFS, at a scientific conference in 2016;
  H2-16 – Thereafter, subject to positive Phase II data and U.S. FDA guidance, possible initiation of global Phase III in PRCC; potential Breakthrough Therapy application and possible U.S. FDA New Drug Application (“NDA”) submission;
  H2-16 – Expect to report full results of Phase Ib/II proof-of-concept studies in c-Met gene amplified NSCLC patients in combination with EGFR inhibitors, Tagrisso® and Iressa® and, subject to the strength of the data, we could then potentially move directly into registration studies.
• HMPL-523:  Consolidate position as one of the leading global Syk inhibitor candidates
  H2-16 – Expect to initiate global Phase II proof-of-concept study in rheumatoid arthritis;
  H2-16 – Expect to complete Australia Phase I study in lymphoma/leukemia patients with potentially compelling proof-of-concept efficacy signal;
  H2-16 – Plan to initiate clinical development in China.
• Fruquintinib:  Clarity on China FDA filing strategy and timing – potential to submit for China FDA approval in late 2016 or early 2017
  Q2-16 – Expect to complete enrollment of pivotal Phase III registration study, named FRESCO, in colorectal cancer (third-line) in China;
  Q2-16 – Plan to initiate Phase Ib dose finding on exploratory combination studies of fruquintinib/other agents such as targeted therapies, immunotherapies and/or chemotherapies;
  H2-16 – Expect to report full China NSCLC (third-line) Phase II data at a scientific conference;
  H2-16 – Plan to initiate Phase II study in gastric cancer (second-line) in combination with Taxol® in China.
• Sulfatinib:  Global proof-of-concept study planned to initiate in 2016
  Q1-16 – Plan to initiate Phase II proof-of-concept study in thyroid cancer (second-line medullary/non-medullary) in China;
  Q1-16 – Plan to initiate pivotal Phase III registration study, named SANET-p, in pancreatic NET patients in China;
  H2-16 – Expect to report full China Phase II data in broad spectrum NET (first-line);
  H2-16 – Plan to initiate U.S. Phase II NET study.
• Epitinib:  Targeting to start both China Phase III and U.S. clinical development in 2016
  H1-16 – Expect to complete Phase Ib study of NSCLC patients with brain metastasis in China;
  H2-16 – Plan to initiate pivotal Phase III registration study in China;
  H2-16 – Plan to initiate U.S. Phase I dose confirmation study.
• Other clinical/near clinical drug candidates:
  H1-16 – Expect to complete theliatinib Phase I dose escalation study in China;
  H2-16 – Plan to initiate theliatinib Phase Ib studies in esophageal and head & neck cancers in China;
  H1-16 – Plan to initiate Australia Phase I dose escalation study on HMPL-689, our potentially best-in-class Phosphoinositide 3-kinase delta (“PI3Kδ”) inhibitor;
  H2-16 – Plan to initiate China and/or Australia Phase I dose escalation study on HMPL-453, our potentially first-in-class Fibroblast Growth Factor Receptor (“FGFR”) inhibitor.

(For additional information, please see the attached PDFs)

Ends

 

Enquiries

 

Christian Hogg, CEO

 

Richard Gray
Andrew Potts

 

 

An analyst presentation will be held at 9:00 am today at Citigate Dewe Rogerson, Third Floor, 3 London Wall Buildings, London, EC2M 5SY.

About Chi‑Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products.  Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market.  Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (“CK Hutchison”) (SEHK: 0001).  For more information, please visit: www.chi-med.com.