The following includes the text of the Announcement, excluding the appendix. For the complete Announcement, please download the PDF.
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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, 13 November 2015: Further to its announcement on 16 October 2015, Hutchison China MediTech Limited (“Chi‑Med”) (AIM: HCM) announces that it has publicly filed today a second 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”). As of the date of this announcement, Chi-Med has not yet set a definite timetable or decided on further details of the potential Offering and there can be no assurance that the potential Offering will be completed. Accordingly, the number of ADSs which may be offered and the offering price of the potential Offering have not yet been determined. The directors of Chi-Med will assess various factors, including market conditions, in considering whether formally to launch the transaction.
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 second 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.
Presentation of Financial Information
As announced by Chi-Med on 16 October 2015, the consolidated financial statements of Chi-Med included in the Form F‑1 Registration Statement have been prepared in accordance with U.S. GAAP, while the historical consolidated financial statements of Chi-Med published prior to the potential Offering were prepared in accordance with IFRS. The second draft of the Form F-1 Registration Statement filed with the SEC today supplementally contains the unaudited condensed consolidated financial statements of Chi-Med as of and for the nine months ended 30 September 2015 and 30 September 2014. In addition, the second draft of the Form F-1 Registration Statement filed today supplementally contains unaudited condensed 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 nine months ended 30 September 2015 and 30 September 2014, which are prepared in accordance with IFRS. Such unaudited condensed consolidated financial statements are set out in the Appendix to this announcement.
Ends
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
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 appendix to it, does not constitute a Form F‑1 Registration Statement 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. Such Form F‑1 Registration Statement will contain 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.
Members of the public outside the United States will not be eligible to take part in the potential Offering described above.
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 inform themselves about 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 appendix 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 appendix to it, may contain forward‑looking statements that reflect Chi‑Med’s current expectations regarding future events, including the launch and completion of the potential Offering. A further 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 United States Securities and Exchange Commission, 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.
Appendix
Unaudited Condensed Consolidated Financial Statements of Chi-Med prepared in accordance with U.S. GAAP
and
Unaudited Condensed Consolidated Accounts of Non‑Consolidated Joint Ventures
prepared in accordance with IFRS
Please download the PDF for the full text of the Announcement including the Appendix.
London: Tuesday, 10 November 2015: Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) today announces that the ordinary resolution and the special resolution put to its Extraordinary General Meeting held on 10 November 2015 (“EGM”) were duly passed.
The EGM follows the announcement by Chi-Med on 16 October 2015 of a potential issuance of new ordinary shares (the “Equity Raise”) in connection with a potential listing of American depositary shares on the Nasdaq Stock Market. The resolutions passed at the EGM were required to be approved by the shareholders in order to enable Chi-Med to proceed with the Equity Raise and these authorities will expire at the next Annual General Meeting of Chi-Med.
The poll results of the resolutions were as follows:
| Number of Votes (%)* | ||||
| Resolutions | For | Against | Withheld# |
|
| Ordinary Resolution: | To grant a general mandate to the directors of Chi-Med to issue additional ordinary shares. |
44,990,518 (99.83997%) |
72,114 (0.16003%) |
0
|
| Special Resolution: | To disapply pre-emption rights. | 44,989,418 (99.83753%) |
73,214 (0.16247%) |
0
|
* Percentages rounded to 5 decimal places
# A vote withheld is not a vote in law and is not counted in the calculation of the proportion of the votes for and against a resolution.
As at the date of the EGM, the number of issued ordinary shares of Chi-Med was 56,533,118, which was the total number of ordinary shares entitling the holders to attend and vote on the ordinary resolution and special resolution proposed at the EGM.
Ends
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
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, 9 November 2015: Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) hereby makes the following amendments to the “Director’s Share Dealing” announcement released on 20 October 2015 subsequent to the notification received from Mr Christopher Nash on 5 November 2015.
The announcement has been corrected to reflect that following the dealings on 19 October 2015, the combined shareholding of Mr Nash and his spouse is 36,434, not the previously reported 36,442, due to the inadvertent sale of 8 shares by Mr Nash’s broker to cover dealing commission in the transaction below.
The full amended announcement is shown below:-
“London: Tuesday, 20 October 2015: Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) received notification on 19 October 2015 that Mr Christopher Nash, Independent Non-executive Director, has:
Following the above transactions, the combined shareholding of Mr Nash and his spouse is 36,434 Shares, representing approximately 0.06% of the current issued share capital of Chi-Med.”
Ends
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
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.
Abstract (please download the poster for full details):
Authors: Yongxin Ren, Shiming Fan, Yunxin Chen, Renxiang Tang, Wei Zhang, Jianxing Tang, Linfang Wang, Dongxia Shi, Hongbo Chen, Min Cheng, Weiguo Qing, Weiguo Su
Renal cell carcinoma (RCC) is the most common type of kidney tumour in human. Approximately 80~85% of RCC is clear cell renal cell carcinoma (ccRCC). Although VEGF/VEGFR targeted therapies bring significant advances in the treatment of RCC, ultimate resistance occurs in most cases following a transient period of clinical benefit. The hepatocyte growth factor (HGF) receptor c-Met activation emerges as one of the mechanisms for resistance to anti-VEGF/VEGFR therapies in ccRCC, implying that a combinational inhibition of c-Met and VEGFR pathways may induce a synergistic anti-tumour effect and could produce additional clinical benefit. The aim of this study was to assess the effect of a combination strategy targeting the VEGFR and c-MET pathways in ccRCC xenograft models.
Savolitinib (AZD6094, HMPL‑504) is a highly selective inhibitor against c-Met. Fruquintinib (HMPL-013) strongly inhibits VEGFR1, 2 and 3. Both of them were discovered by HMP and are currently being evaluated in clinical trials for the treatment of various cancers. Several subcutaneous xenograft models were established in nude mice with human ccRCC cell lines or patient derived tumours (PDX) to investigate the anti-tumour effect of combination of savolitinib with fruquintinib. Treatment with savolitinib or fruquintinib at clinically relevant dose only exhibited mild to moderate tumour growth inhibition as a single agent in all of tested models, but significantly increased anti-tumour effect was observed in all of tested models for the combination group. It seemed that the enhanced anti-tumour effect was associated with c-Met inhibition. In a ccRCC PDX model KIN1T1342, the increased anti-tumour effect was correlated with dose increment of savolitinib. Immunohistochemistry (IHC) analysis revealed that combination treatment produced stronger inhibition on tumour proliferation marker Ki67 and angiogenesis marker CD31, compared to either savolitinib or fruquintinib alone, indicating that the observed synergistic effect might be attributed to the dual inhibition on tumour signalling and tumour microenvironment. C-Met expression was observed in all tested models, and treatment with savolitinib effectively suppressed phospho-MET.
To evaluate c-Met expression in Chinese ccRCC patients, Formalin-Fixed and Paraffin-Embedded (FFPE) tumour sections were collected from sixty-two treatment-naive patients during surgical resection. Positive c-Met expression was found in 69% (43/62) of ccRCC samples under IHC staining.
Overall our data demonstrated that c-Met was widely expressed in Chinese ccRCC patients and provided a rationale to test the combined HGF/c-Met and VEGF/VEGFR pathway blockade in the treatment of ccRCC in the clinical trials.
Abstract (download poster for full details):
Authors: Jian-Ming Xu, Lin Shen, Yan Wang, Yu-ling Chen, Ru Jia, Jian Wang, Ke Li, Yang Sai, Jing Li, Chuan Qi, Hua Ye, Su Weiguo
Background: Sulfatinib is a highly selective oral small molecule inhibitor targeting both vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptors (FGFR). A phase I dose-escalation study was carried out to determine sulfatinib maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), pharmacokinetic (PK) profiles, and preliminary antitumor activity in patients with advanced solid tumours.
Methods: Sulfatinib was administered orally in 28-day treatment cycles until disease progression or unacceptable toxicity. The study utilized 3+3 dose escalation method, with ascending dose cohorts from 50mg to 350mg daily. During the study, a milled formulation was developed to reduce the inter-patient PK variations and optimize drug absorption. The milled formulation was used in 200mg once daily (QD) to 350mg QD dose cohorts.
Results: As of July 6, 2015, a total of 77 patients had been enrolled. Forty‑three of the 77 patients received original formulation in dose cohorts from 50mg to 300mg daily. The data of patients treated with original formulation dosing from 50 to 300mg once daily, or 125mg and 150mg twice daily were reported in ASCO 2012(#3040). Thirty-four of the 77 patients received milled formulation. Among the 34 patients, 23 were enrolled in the dose-escalation phase, receiving sulfatinib 200mg to 350mg QD whereas 11 patients were enrolled in the dose-expansion phase receiving sulfatinib 300mg or 350 mg QD. Among the 34 patients, there were 24 male patients (70.6%) and 10 female patients (29.4%). The median age was 55.97 (23.35-73.17) years. The most common adverse events of 34 patients were hypertension, proteinuria, diarrhoea, elevated AST/ALT and decreased blood albumin, mostly grade1/2. One DLT (grade 3 ALT/AST increase) was observed in the 200 mg QD dose group. MTD was not reached up to 350mg QD. Among the 34 subjects treated with milled formulation, 22 subjects were diagnosed with neuroendocrine tumours (NETs). Eight NET patients (5 in 300mg QD and 3 in 350mg QD cohort) had confirmed partial response (PR) with median duration of response (DoR) of 13.8 months. The tumour origins of the 8 NET patients include pancreas (3 patients), duodenum (1 patient), rectum (1 patient), thymus (1 patient) and unknown origin (2 patients). Objective response rate among the 18 efficacy evaluable NET patients was 44.4% and disease control rate was 100%. Sulfatinib half-life (t1/2) in plasma averaged 14-20 hours at the test dose levels, which supported sulfatinib QD dosing frequency. Following QD multiple dosing, sulfatinib achieved steady state on Day 14. The drug exposure increased when the dose increased from 200 mg to 300 mg, and then plateaued from 300 mg to 350 mg. Based on the clinical safety, efficacy, and PK data, the recommended Phase II dose is determined to be 300 mg QD.
Conclusions: Sulfatinib was well tolerated with an acceptable safety profile. Promising anti-tumour activity was observed in NET patients. Further clinical studies with sulfatinib are warranted.
London: Friday, 6 November 2015: Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) today announces that Hutchison MediPharma Limited (“HMP”), its drug R&D subsidiary, has initiated the Phase I clinical trial of sulfatinib (HMPL-012) in the United States. Its U.S. Investigational New Drug application was submitted and cleared earlier this year and the first patient was dosed on 4 November 2015. HMP is also planning to initiate two Phase III registration studies for the treatment of neuroendocrine tumours (“NET”) and a Phase Ib study for the treatment of thyroid cancer with sulfatinib in China by the end of 2015.
This Phase I dose escalation study is to assess the safety and tolerability of sulfatinib in U.S. patients with advanced solid tumours. A U.S. Phase II study in NET is expected to be initiated based on the conclusion of this Phase I dose escalation study.
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”), a receptor for a protein which also plays a role in tumour growth. In a Phase I clinical trial in China focusing on NET patients, sulfatinib’s objective response rate among the 18 efficacy-evaluable NET patients was 44.4%. By comparison, sunitinib and everolimus, the two approved single agent therapies for pancreatic NET, achieved objective response rates of less than 10% in their pivotal clinical trials. Furthermore, NET responses to sulfatinib have been observed to improve gradually with time. Results of the Phase I trial in China will be reported at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in November 2015 and will be made available at www.chi‑med.com/news/.
Sulfatinib is the first oncology candidate that HMP has taken through proof-of-concept in China and expanded to a U.S. clinical study without a partner.
Ends
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
In addition to the U.S. Phase I clinical trial, HMP is conducting or in the process of initiating four clinical trials in China.
In October 2014, HMP initiated a multi-centre, 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, projected to enrol approximately 80 patients, is near to completion of patient enrolment. Results to date of this open-label Phase Ib study appear generally in line with the positive results from the Phase I study.
Encouraged by these results, HMP now plans to start two Phase III registration studies in China by the end of 2015, one in pancreatic NET patients and a second in advanced carcinoid (non-pancreatic) NET patients.
HMP plans to initiate a Phase Ib study in China to evaluate the safety, pharmacokinetics and efficacy of sulfatinib in patients with both medullary and differentiated thyroid cancer by the end of 2015. Sulfatinib’s VEGFR/FGFR1 inhibition profile is believed to have strong potential in second-line thyroid cancer patients, particularly in China where there are few safe and effective treatment options for this patient population. HMP plans to enrol approximately 50 patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer or medullary thyroid cancer into this study, with approximately 25 patients in each tumour type.
NET arises from neuroendocrine cells and develop predominantly in the digestive or respiratory tracts but can also occur in many areas of the body. Diagnosing NET is difficult due to the small tumour size and diverse occurrence with patients showing varied or no symptoms. As a result, it has been difficult to accurately estimate the number of NET incidences per year. There were approximately 19,000 new cases of NET and a cumulative prevalence of approximately 141,000 cases in the United States in 2014.
HMP is a novel drug R&D company focusing on discovering, developing and commercialising innovative therapeutics in oncology and autoimmune diseases. With a team of around 250 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.
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.
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.