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Lotte New York Palace Hotel, New York, NY

JW Marriott, Beijing, China

Macquarie Office, London

Hong Kong

Hong Kong

London: Tuesday, August 9, 2016: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has received notification that the spouse of Mr Christopher Nash, Independent Non-executive Director, has purchased 3,120 and 42 ordinary shares of US$1.00 each in Chi-Med (the “Ordinary Shares”) at a price of GBP19.00 and GBP18.99 per share respectively on August 4, 2016.

Following the above transaction, the combined holding of Mr Nash and his spouse is 39,596 Ordinary Shares, representing approximately 0.065% of the current issued share capital of Chi-Med.

The notification set out below is provided in accordance with the requirements of the EU Market Abuse Regulation.

 

1	Details of the person discharging managerial responsibilities/person closely associated
a)	Name	Ms Rebecca Pynt
2	Reason for the notification
a)	Position/status	Spouse of Mr Christopher Nash, an Independent Non-executive Director of Chi-Med
b)	Initial notification/ Amendment	Initial notification
3	Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a)	Name	Hutchison China MediTech Limited
b)	LEI	N/A
4	Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a)	Description of the financial instrument, type of instrument Identification code	Ordinary Shares of US$1.00 each DI ISIN: KYG4672N1016 ADS ISIN: US44842L1035
b)	Nature of the transaction	Acquisition of 3,120 and 42 Ordinary Shares on August 4, 2016 at a price of GBP19.00 and GBP18.99 respectively
c)	Price(s) and volume(s)	Price(s) Volume(s) GBP19.00 3,120 GBP18.99 42
d)	Aggregated information – Aggregated volume – Price	N/A
e)	Date of the transaction	2016-08-04
f)	Place of the transaction	London Stock Exchange (XLON)

 

NOTES TO EDITORS

About Chi-Med

Chi-Med is an innovative China-based biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, 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.

 

Contacts

Investor Enquiries
Christian Hogg, CEO	+852 2121 8200
International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson	+44 7973 611 888 (Mobile)	anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications	+1 (917) 570 7340 (Mobile)	bmiles@bmccommunications.com
Susan Duffy, BMC Communications	+1 (917) 499 8887 (Mobile)	sduffy@bmccommunications.com
Investor Relations
Brian Korb, The Trout Group	+1 (917) 653 5122 (Mobile)	bkorb@troutgroup.com
David Dible,Citigate Dewe Rogerson	+44 7967 566 919 (Mobile)	david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts	+44 (20) 7886 2500

 

London: Tuesday, August 2, 2016: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces with effect from August 1, 2016, Dr Dan Eldar has been appointed as a Non-Executive Director of Chi-Med in place of Mr Salbaing who has tendered his resignation to spend more time on his existing responsibilities within the CK Hutchison Holdings Group.

Dr Eldar (formerly Perlmutter), aged 63, has more than 35 years of experience as a senior executive, leading global operations in telecommunications, water, biotech and healthcare. He is an executive director of Hutchison Water Israel Ltd which focuses on large scale projects including desalination, wastewater treatment and water reuse. He is also an independent non-executive director of Leumi Card, a subsidiary of Bank Leumi Le-Israel B.M., one of Israel’s leading credit card companies. Further, he is also a director of Aqua Blue Water Management Services Ltd, Hutchison Biofilm Medical Solutions Holdings Limited, Hutchison Biofilm Medical Solutions Inc., Hutchison Biofilm Medical Solutions Limited, Hutchison Biofilm Solutions Limited, Hutchison Water General Partner Ltd, Hutchison Water Israel E.P.C. Ltd, TACount Exact Ltd and Yissumim Advanced Management Application Ltd. Dr Eldar was previously a director of WeFindTech Ltd. and Gryphonel Ltd within the past five years.

Dr Eldar holds a Doctor of Philosophy degree in Government from Harvard University, Master of Arts degree in Government from Harvard University, Master of Arts degree in Political Science and Public Administration from Hebrew University of Jerusalem and a Bachelor of Arts degree in Political Science from Hebrew University of Jerusalem.

He does not have any shareholdings in Chi-Med. Save for the information disclosed above, there is no other information in relation to Dr Eldar required to be disclosed pursuant to Rule 17 and Schedule 2(g) of the AIM Rules for Companies.

Mr Christian Hogg, Chief Executive Officer of Chi-Med said “We thank Mr Salbaing for his invaluable contributions during his tenure and welcome Dr Eldar to the Board whose experience in the global high tech and biotech industries will be important to Chi-Med.”

NOTES TO EDITORS

About Chi-Med

Chi-Med is an innovative China-based biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, 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 within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the risk that current or future appointees to Chi-Med’s board of directors are not effective in their respective positions, the difficulty in locating and recruiting suitable candidates for its board of directors and the management difficulties which may arise from changes in Chi-Med’s board of directors. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. 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.

CONTACTS

Investor Inquiries
Christian Hogg, CEO	+852 2121 8200
International Media Inquiries
Anthony Carlisle, Citigate Dewe Rogerson	+44 7973 611 888 (Mobile) anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Inquiries
Brad Miles, BMC Communications	+1 (917) 570 7340 (Mobile) bmiles@bmccommunications.com
Susan Duffy, BMC Communications	+1 (917) 499 8887 (Mobile) sduffy@bmccommunications.com
Investor Relations
Brian Korb, The Trout Group	+1 (917) 653 5122 (mobile) bkorb@troutgroup.com
David Dible, Citigate Dewe Rogerson	+44 7967 566 919 (Mobile) david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts	+44 (20) 7886 2500

• Group revenue up 27% to $104.5 million (H1 2015: $82.5m) and net income attributable to Chi‑Med of $0.5 million (H1 2015: $15.9m), reflecting a sharp increase in clinical investment.

 

• Innovation Platform – Seven drug candidates in 25 clinical trials (H1 2015: 17) including four pivotal Phase III studies (H1 2015: 1). Planning to publish proof-of-concept or pivotal trial data on four drug candidates at scientific meetings through Q1 2017.

 

• Commercial Platform – Total consolidated sales up 48% to $82.3 million (H1 2015: $55.6m); Total sales of non-consolidated joint ventures up 9% to $249.6 million (H1 2015: $229.8m); Total net income attributable to Chi-Med from our Commercial Platform up 12% to $22.1 million (H1 2015: $19.8m). Significant property-related payment expected to come in H2 2016.

 

• Completed Nasdaq listing, raising net proceeds of $95.9 million. Available cash resources of $197.5 million at Group level as of June 30, 2016, which includes cash and cash equivalents, short-term investments and unutilized bank facilities.

 

• Post-period Event: Amendment of collaboration with AstraZeneca AB (publ) (“AstraZeneca”) – Chi-Med investing $50 million, mainly over three years, to accelerate savolitinib global development in return for 5% point increase in tiered royalty range.

 

UK Analysts Meeting and Webcast Scheduled Today at 9:00 a.m. BST U.S. Conference Call Scheduled Today at 9:00 a.m. EDT

London: Tuesday, August 2, 2016: Chi-Med (AIM/NASDAQ: HCM), the China-based biopharmaceutical company focused on discovering and developing targeted therapies for oncology and immunological diseases for the global market, today announces its unaudited financial results for the six months ended June 30, 2016.

Simon To, Chairman of Chi-Med, said:  “Chi-Med has once again made very considerable progress at both the operating and strategic levels.

All aspects of our Innovation Platform’s risk-balanced, innovative drug pipeline have moved forward, including progress in aligning with U.S. and European regulatory authorities in end-of-Phase II meetings on savolitinib and completing enrollment of our first Phase III study on fruquintinib. We have also made great progress in the clinic on sulfatinib, epitinib, HMPL-523, HMPL-689 and theliatinib, all of which are also potential global first-in-class or best-in-class drug candidates.

Once again, our Commercial Platform has generated increased cash flows helping fund our Innovation Platform activities as well as providing a first-class marketing and distribution channel in China for our drug candidates, if they are approved. Our partnerships with major global pharmaceutical companies, created when the global scope of our drug candidates began to emerge, continue to allow us to broaden development plans and represent important global marketing and distribution resources. In the first half, we completed our Nasdaq listing, which broadened our exposure to U.S. specialist investors and strengthened our cash position.

The progress of our drug pipeline and strong cash position, resulting from our increased commercial profits and recent Nasdaq listing, have enabled us to renegotiate our collaboration agreement with AstraZeneca to take a greater share in the potential long-term economic value of savolitinib in return for increasing our investment in savolitinib’s development. We believe this benefits both Chi-Med and AstraZeneca as it allows us to accelerate and broaden savolitinib’s late-stage development in multiple oncology indications.

Our pragmatic approach to finance and risk management has enabled us to build our drug pipeline over a dozen years. We now have multiple shots at success with four pivotal studies underway today, and three more likely to initiate by H1 2017, on a diversified group of drug candidates. The results of these pivotal studies will emerge during 2017-2019, and we believe that if they prove successful, substantial benefits can be created for patients and shareholders alike. Consequently, we view the future with great confidence.”

FINANCIAL HIGHLIGHTS:

Our consolidated financial results are reported under U.S. generally accepted accounting principles (“U.S. GAAP”) and in U.S. dollar currency unless otherwise stated. We also conduct our business through three non-consolidated joint ventures, which are accounted for under the equity accounting method as non-consolidated entities in our consolidated financial statements. Within this announcement, we refer to certain financial results reported by such non-consolidated joint ventures, which are based on figures reported in their respective consolidated financial statements prepared pursuant to International Financial Reporting Standards (as issued by the International Accounting Standards Board). Unless otherwise indicated, references to “subsidiaries” refer to our consolidated subsidiaries and joint ventures (excluding non-consolidated joint ventures).

Group Results

• Consolidated revenue up 27% to $104.5 million (H1 2015: $82.5m).
• Net income attributable to Chi-Med of $0.5 million (H1 2015: $15.9m).
• Strengthened cash position: Available cash resources of $197.5 million as of June 30, 2016 (December 31, 2015: $38.8m) at the Chi-Med Group level, including cash and cash equivalents, short-term investments and unutilized banking facilities. Increase in cash primarily reflects $95.9 million net proceeds of our March 2016 Nasdaq listing.

Innovation Platform – a broad, risk-balanced, global oncology/immunology pipeline.

• Consolidated revenue of $22.3 million (H1 2015: $26.9m) and net loss attributable to Chi-Med of $13.7 million (H1 2015: net income $2.0m) driven by $36.0 million (H1 2015: $24.9m) spending mainly for 25 clinical trials, four of which are pivotal Phase III studies on fruquintinib and sulfatinib, as well as the continued expansion of our scientific team, which now includes over 310 scientists and staff.
• Amendment yesterday to our collaboration with AstraZeneca under which Chi-Med has agreed to provide up to $50 million for the joint-development costs of savolitinib in return for a 5 percentage point increase in the tiered royalty rates payable on savolitinib sales across all indications in all markets outside of China.

Commercial Platform – a deeply established, cash-generative, pharmaceutical business in China – a commercialization framework for our Innovation Platform candidate drugs.

• Total consolidated sales up 48% to $82.3 million (H1 2015: $55.6m) mainly resulting from solid progress on Seroquel^®.
• Total sales of non-consolidated joint ventures up 9% to $249.6 million (H1 2015: $229.8m) due primarily to continued expansion of coronary artery disease prescription drug business.
• Total net income attributable to Chi-Med from our Commercial Platform up 12% to $22.1 million (H1 2015: $19.8m).
• Solid performance despite the weakening of the Chinese renminbi (“RMB”) over the last year which reduced both our top- and bottom-line growth rates, during the first half of 2016, by -6% in U.S. dollar terms.
• Expect to receive about $70 million second installment of the total approximately $114 million land compensation and subsidies from the Shanghai government, leading to an estimated one-time gain to the Chi-Med Group of over $35 million in Q4 2016.

2016 FINANCIAL GUIDANCE: We provide full year 2016 financial guidance, as detailed below:

Group Level:

• Consolidated revenue: $190-205 million
• Administrative, interest and income tax expenses: $16-18 million
• Net income attributable to Chi-Med: $0-5 million

 Innovation Platform:

• Consolidated revenue: $35-40 million
• Research & development expenses: $80-85 million

Commercial Platform:

• Sales (consolidated): $155-165 million
• Sales of non-consolidated joint ventures: $430-440 million
• One-time gain associated with property-related payments: $35-37 million
• Net income attributable to Chi-Med: $63-66 million

 KEY H1 2016 OPERATIONAL HIGHLIGHTS:

Innovation Platform:  Multiple opportunities for success: four pivotal Phase III studies underway and three more fully funded and expected to begin by H1 2017. Each is expected to read-out over the next three years.

• Savolitinib: Potential global first-in-class mesenchymal epithelial transition factor (“c-Met”) inhibitor currently in 12 main clinical studies worldwide in multiple tumor types including kidney, lung and gastric cancers as a monotherapy and in combination with other targeted and immunotherapy agents:

1. Kidney cancer:
   a. Completed end-of-Phase II meetings with U.S. Food & Drug Administration (“FDA”) and European Medicines Agency (“EMA”); alignment on plans for global savolitinib monotherapy Phase III study in c-Met-driven papillary renal cell carcinoma (“PRCC”) patients.
   b.Initiated global Phase Ib dose finding study of savolitinib in combination with anti-programmed death-1 receptor ligand (“PD-L1”) antibody, durvalumab, in clear cell renal cell carcinoma (“ccRCC”) patients.
2. Non-small cell lung cancer (“NSCLC”):
   a. Initiated global Phase IIb study of savolitinib in combination with Tagrisso^® (osimertinib) in second-line NSCLC patients with epidermal growth factor receptor (“EGFR”) mutations who have failed first-line EGFR tyrosine kinase inhibitor (“TKI”) therapy and harbor c-Met gene amplification. This triggered a $10 million milestone from AstraZeneca to Chi-Med in June 2016.
   b. Initiated or continued four further Phase Ib/II studies in first-, second- and third-line NSCLC patients, including (i) as a monotherapy in NSCLC patients with c-Met mutations that result in Exon 14 skipping; (ii) as a monotherapy in pulmonary sarcomatoid carcinoma (“PSC”) patients with mutations that result in Exon 14 skipping; (iii) as a combination therapy with Iressa^® (gefitinib) in NSCLC patients with EGFR mutations and who have failed first-line EGFR TKI therapy; and (iv) as a combination therapy with Tagrisso^® in third-line NSCLC patients who have failed Tagrisso^®  
3. Gastric Cancer:
   a. Proof-of-concept studies of savolitinib as a monotherapy in gastric cancer patients with c-Met gene amplification are ongoing in South Korea and China; promising response data, was published by Dr. Jeeyun Lee of Samsung Medical Center in April 2016 at the American Association of Cancer Research meeting.
   b. A Phase Ib dose finding study of savolitinib in combination with Taxotere^® (docetaxel) in gastric cancer patients with c-Met over-expression is ongoing in South Korea.

• Fruquintinib: Potential global best-in-class selective inhibitor of vascular endothelial growth factor receptor 1/2/3 (“VEGFR”):

1. Colorectal cancer (third-line or above): Completed enrollment of a Phase III study, named FRESCO, to test fruquintinib as a monotherapy among third-line metastatic colorectal cancer patients in China; top-line Phase III data expected to be reported in early 2017; plan to submit the China NDA, subject to positive FRESCO outcome, by mid-2017;
2. NSCLC (third-line): Began enrolling a Phase III study, named FALUCA, to test fruquintinib in third-line NSCLC patients in China, in late 2015 – now over 30 clinical centers are operational; expect to complete enrollment in H1 2017; top-line Phase III data expected to be reported in late 2017; plan to submit China NDA, subject to positive FALUCA outcome, during H1 2018.
3. Gastric cancer (second-line): Completed dose finding stage of fruquintinib Phase Ib study in combination with Taxol^® (paclitaxel). Continue to enroll patients in Phase Ib expansion stage.
4. NSCLC (first-line): Planning underway to start Phase Ib dose finding study of fruquintinib in combination with Iressa^® in first-line EGFR-mutant NSCLC patients in China in late 2016.
5. Production facility in Suzhou, China, operational and ready to support fruquintinib’s potential commercial launch.

• Sulfatinib: Selective inhibitor of VEGFR/fibroblast growth factor receptor 1 (“FGFR1”) with strong efficacy in neuroendocrine tumors (“NET”) – enrolling two pivotal Phase III studies:
  

1. NET (first-line):
   a. Completed enrollment of a Phase II study of sulfatinib in 81 broad-spectrum NET patients in China; median Progression Free Survival (“PFS”) not yet reached; now enrolling two Phase III studies, named SANET-p (in pancreatic NET patients) and SANET-ep (in extra-pancreatic NET patients), with primary endpoint median PFS; Phase III top-line data expected in 2018.
   b. Initiated U.S. Phase I dose confirmation study in Caucasian patients – currently in 200mg cohort and closing in on China 300mg Phase III dose; expected to complete in H2 2016.
2. Thyroid cancer: Initiated Phase II proof-of-concept study in patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer or medullary thyroid cancer in China.
3. Biliary tract cancer: Planning underway to start a Phase II study in China in late 2016.

• HMPL-523: Potential global first-in-class spleen tyrosine kinase (“Syk”) inhibitor – major potential in immunology and oncology:

1. Hematological cancer: Granted China FDA Phase I to Phase III clinical trial application clearance in H1 2016 – target to start China Phase I dose escalation in patients with hematologic malignancies in H2 2016; Australia Phase I dose escalation currently in second dose cohort (200mg) and expected to complete in H1 2017; U.S. hematological malignancy Investigational New Drug (“IND”) application submitted in June 2016.
2. Immunology: Australia Phase I study completed with no evidence of the hypertension/gastrointestinal toxicities encountered by the first-generation Syk inhibitor (fostamatinib); U.S. immunology IND application submitted in H1 2016 – U.S. FDA feedback received, now preparing to submit additional data; planning global rheumatoid arthritis Phase II study for 2017.

• Epitinib: Highly differentiated inhibitor of the EGFR designed for optimal blood-brain barrier penetration:

1. NSCLC with brain metastasis: Phase Ib study in NSCLC patients with brain metastasis ongoing; granted China FDA Phase II/III clinical trial application clearance granted in July 2016; target to initiate pivotal registration study in H1 2017.
2. Glioblastoma: Planning underway to start a Phase II study in glioblastoma, a primary brain cancer with EGFR gene amplification, in early 2017.

• HMPL-689: Potential global best-in-class, highly selective phosphoinositide 3-kinase delta (“PI3Kδ”) inhibitor, which is over five times more potent than Zydelig^® (idelalisib):
  Hematological cancer: Initiated Phase I study in healthy volunteers in Australia in H1 2016, now in fifth cohort and expected to complete Phase I dose escalation in H2 2016; plan to start Phase I dose escalation in patients with hematologic malignancies in Australia in H1 2017.
• Theliatinib: EGFR inhibitor, over five times more potent than Tarceva^® (erlotinib), with potential in patients with solid tumors presenting EGFR gene amplification:
  Esophageal cancer/Head and Neck:  Phase I dose escalation study ongoing in China; target to start Phase Ib proof-of-concept studies by the end of 2016.

Commercial Platform:  Continued strong growth in cash flow and profit – representing a solid and stable financial base that underpins a significant portion of Chi-Med’s current market value.

• Prescription Drugs business performing very well – consolidated sales up 49% to $67.6 million (H1 2015: $45.4m); and total sales of non-consolidated Prescription Drugs joint venture up 22% to $18 million (H1 2015: $103.9m).
  1.  She Xiang Bao Xin (“SXBX”) pill – our most important commercial product, is a prescription vasodilator proprietary to our joint venture: Accounted for approximately 12% of China’s over $1.5 billion botanical coronary artery disease prescription drug market, full patent protection through 2029; H1 2016 sales up 16% to $110.1 million (H1 2015: $94.9m); SXBX pill represents 87% of the sales of SHPL, our joint venture, which contributed 91% of our $16.3 million (H1 2015: $12.1m) consolidated Prescription Drugs operating profit in H1 2016.
  2. Seroquel^® – prescription antipsychotic under exclusive commercial license from AstraZeneca within China: Accounted for approximately 5% of China’s antipsychotic prescription drug and 46% of the generic quetiapine market; Seroquel^® is the only extended release (“XR”) quetiapine formulation approved in China; H1 2016 sales up 282% to $17.2 million (H1 2015: $4.5m); 2016 is the first full year of Seroquel^® commercialization under Chi-Med.
• Substantially completed move to new factory in Shanghai, almost tripling the manufacturing capacity of our Prescription Drugs joint venture. Triggering about $114 million total cash compensation and subsidies for the surrender of its land-use rights for its old factory site.
• Consumer Health business stable despite over-the-counter (“OTC”) drug capacity constraints – consolidated sales up 44% to $14.6 million (H1 2015: $10.1m); and total sales of non-consolidated Consumer Health joint venture down 2% to $17 million (H1 2015: $125.9m). Sales in our OTC drug joint venture were down marginally due to tight manufacturing capacity resulting from the move to new factory in Bozhou, Anhui province; despite this, our OTC drug joint venture’s portfolio of mature, market leading products, contributed 99% of our $8.6 million (H1 2015: $10.1m) consolidated Consumer Health operating profit in H1 2016.

EXPECTED MAJOR NEAR-TERM CATALYSTS:  We target to publish data on four drug candidates in five Phase Ib-III studies before the end of Q1 2017, including:

• Savolitinib Phase II data in PRCC patients;
• Epitinib Phase Ib data in NSCLC patients with brain metastasis;
• Fruquintinib Phase II data in third-line NSCLC patients;
• Sulfatinib Phase II data in pancreatic and extra-pancreatic NET patients; and
• Fruquintinib Phase III top-line data in third-line or above colorectal cancer

We target to initiate pivotal registration trials on two further drug candidates before the end of H1 2017, including:

• Savolitinib Phase III in c-Met-driven PRCC patients;
• Epitinib Phase II/III in first-line patients with EGFR-mutant NSCLC patients with brain metastasis; and
• Savolitinib Phase III in combination with Tagrisso^® in second-line NSCLC (T790M-/c-Met+)

POST PERIOD EVENT:  Amendment of Co-Development Agreement with AstraZeneca on Savolitinib global development plan:

In order to accelerate savolitinib’s global development, as announced yesterday, Chi-Med and AstraZeneca agreed to amend the 2011 global licensing, co-development and commercialization agreement regarding savolitinib. Under the amendment, Chi-Med will contribute up to $50 million, spread primarily over three years, to the joint-development costs of the global pivotal Phase III study in c-Met-driven PRCC. Subject to approval in the PRCC indication, Chi-Med will receive a 5 percentage point increase in the global (excluding China) tiered royalty rate payable on savolitinib sales across all indications, thereby increasing the tiered royalty to 14% to 18%. After total aggregate sales of savolitinib have reached $5 billion, the royalty will step down over a two year period, to an ongoing royalty rate of 10.5% to 14.5%. All other provisions of the 2011 Agreement will remain unchanged.

Conference Call and Webcast Information:

An analyst presentation and webcast will be held today at 9:00 a.m. BST (4:00 p.m. HKT) at Citigate Dewe Rogerson, Third Floor, 3 London Wall Buildings, London, EC2M 5SY. Investors may participate in the call or access a live video webcast of the call via the Company’s website at www.chi-med.com/investors/event-information/. A conference call for U.S. investors will also be held today at 9:00 a.m. EDT. To participate in the US call, please dial +1-212-999-6659. For all dial-in numbers please use conference ID “Chi-Med”.

Enquiries

Investor Inquiries
Christian Hogg, CEO	+852 2121 8200
International Media Inquiries
Anthony Carlisle, Citigate Dewe Rogerson	+44 7973 611 888 (Mobile) anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Inquiries
Brad Miles, BMC Communications	+1 (917) 570 7340 (Mobile) bmiles@bmccommunications.com
Susan Duffy, BMC Communications	+1 (917) 499 8887 (Mobile) sduffy@bmccommunications.com
Investor Relations
Brian Korb, The Trout Group	+1 (917) 653 5122 (mobile) bkorb@troutgroup.com
David Dible, Citigate Dewe Rogerson	+44 7967 566 919 (Mobile) david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts	+44 (20) 7886 2500

 

About Chi-Med

Chi-Med is an innovative China-based biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, 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.

References

Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “Chi-Med,” “Chi-Med Group,” “we,” “us” and “our” refer to Chi-Med and its consolidated subsidiaries and joint ventures unless otherwise stated or indicated by context.

Forward-Looking Statements

This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “believe,” “first-in-class,” “best-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

In addition, this announcement contains statistical data and estimates that we obtained from industry publications and reports generated by third-party market research firms, including Frost & Sullivan, an independent market research firm, and publicly available data. All patient population, market size and market share estimates are based on Frost & Sullivan research, unless otherwise noted. Although we believe that the publications, reports and surveys are reliable, we have not independently verified the data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.

Inside Information
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

(For additional information, please see the attached PDFs)

Ends

Announcement released: 7am BST

» See announcement here

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首个以c-Met异常乳头状肾细胞癌（“PRCC”）为适应症的全球III期临床试验将于近期启动

 

2016年8月1日：和黄医药和阿斯利康今日宣布在2011年双方就沃利替尼达成的合作协议的基础上签署补充协议。

多个临床I/II期试验数据表明沃利替尼作为一种高选择性的c-Met抑制剂对数种肿瘤有早期临床疗效。

目前，沃利替尼的全球开发计划已涵盖多种c-Met异常实体瘤为适应症，包括非小细胞肺癌，肾癌，胃癌及结直肠癌。欲了解沃利替尼目前所有的临床试验详情，请点击此处。

双方此次达成的补充协议旨在加速推进沃利替尼在全球范围内的开发以及增加和黄医药在开发计划中的参与比例。根据此协议，和黄医药将在今后三年内投入高达5000万美元，主要用于沃利替尼以c-Met异常乳头状肾细胞癌为适应症的全球III期临床试验联合开发费用。根据2011年双方协议，和黄医药将获得沃利替尼在全球范围内（不包括中国）所有适应症的销售提成专利费，补充协议签署后，沃利替尼未来若以乳头状肾细胞癌这一适应症成功上市销售后，该提成比例将增加5个百分点。原协议的其他条款保持不变。

沃利替尼近期完成的开放标签全球乳头状肾细胞癌临床II期研究（NCT02127710）的最终结果将在近期的科研会议上公布。和黄医药与阿斯利康已达成一致进入到临床III期研究。

乳头状肾细胞癌是由于c-Met基因的一系列改变（如：突变，扩增，和/或染色体变化）而导致的一种罕见的肾细胞癌的组织学亚型，沃利替尼全球III期临床试验将是首个以c-Met异常乳头状肾细胞癌为适应症的关键研究。目前市场上的肾细胞癌疗法对乳头状肾细胞癌疗效不显著，且尚无专门针对c-Met异常乳头状肾细胞癌的疗法获批上市。此全球III期临床试验的最终设计方案正在与相关的医疗主管部门讨论中，试验的开展也需要有与之相匹配的c-Met异常乳头状肾细胞癌同伴诊断配合。乳头状肾细胞癌三期同伴诊断平台将会与非小细胞肺癌和胃癌的平台相似。

阿斯利康将继续负责沃利替尼在其他c-Met异常肿瘤类型中的研发。值得一提的是，基于目前正在进行的TATTON试验（NCT02143466）的早期数据，一项单臂的全球临床II期扩展试验现已启动，该试验以沃利替尼联合塔格瑞斯（奥斯替尼）治疗对已批准的EGFR-TKI耐药的晚期非小细胞肺癌患者，旨在评估沃利替尼治疗EGFR突变非小细胞肺癌的疗效。

阿斯利康肿瘤创新药物部负责人，资深副总裁Susan Galbraith表示：“我们一直致力于推进沃利替尼在肾细胞癌和非小细胞肺癌中的研究，希望能够早日为那些没有太多治疗方案选择的患者提供一流且有效的治疗药物。同时我们也非常高兴能进一步加深与和黄医药的合作，巩固阿斯利康在全球药物研发领域的领先地位。“

和黄中国医药科技有限公司的首席执行官贺隽表示：“我们一直致力于推动沃利替尼的全球上市，希望早日为患者带去福音。我们相信沃利替尼有潜力成为首个经分子筛选验证的c-Met表现异常的肾癌，肺癌及胃肠道癌患者的个性化疗法。目前沃利替尼在多个适应症中即将进入关键研究，我们非常高兴能为加快沃利替尼的研究贡献自己的绵薄之力，相信产品上市后我们将获得更丰厚的经济回报。”

 

沃利替尼，独特的高选择性c-Met抑制剂

沃利替尼是一种高选择性口服c-Met（也被称作间充质上皮转移因子）受体酪氨酸激酶抑制剂，研究发现这种酪氨酸激酶在多种实体瘤中表现异常。沃利替尼作为一种强效的高选择性口服抑制剂，旨在克服第一代c-Met抑制剂在临床研究中出现的问题，包括肾毒性。

 

c-Met异常乳头状肾细胞癌的市场潜力和需求

据Frost & Sullivan数据显示， 每年全球新诊断的肾癌病例约为366,000例，至2020年，肾癌的治疗市场总值预计将达到45亿美元。肾细胞癌约占全部肾癌的80-85%，且数种组织学亚型的遗传和生化特性各异。肾细胞癌的各组织学亚型中，肾透明细胞癌最为常见，占总数的75-80%。

乳头状肾细胞癌是最常见的非透明细胞肾癌，约占肾细胞癌的10-15%。根据历史数据，c-Met异常乳头状肾细胞癌估计占全部乳头状肾细胞癌的40-70%。根据2014年公布于美国癌症研究协会年会上的一项研究显示，对法国肾细胞癌网络收录的220例冷冻肿瘤样品分析后发现：55-60%的乳头状肾细胞癌患者伴有7号染色体扩增（即c-Met扩增）。

目前有数种已获批的用于治疗肾细胞癌的药品（最新的一个获批于2016年4月），但大部分研究是基于数量庞大的肾透明细胞癌患者。乳头状肾细胞癌的生物和分子特性与肾透明细胞癌不同，因此，乳头状肾细胞癌患者的预后及治疗效果明显不及肾透明细胞癌患者。对治疗乳头状肾细胞癌患者的专门药物及更精确的数据的需求目前还是一个巨大的空缺。

 

沃利替尼以乳头状肾细胞癌为适应症的临床研究进展

澳大利亚临床I期研究 –  一项在多种实体瘤中进行的临床I期剂量递增研究显示了沃利替尼600mg每日一次的临床活性和安全性，并在针对一位c-Met异常乳头状肾细胞癌患者的研究早期明确观察到部分缓解。整个研究中，在3/8 （38%）的乳头状肾细胞癌患者中明确观察到部分缓解，全部患者都伴随c-Met异常，缓解持续约10-37个月（试验仍在进行中）。临床I期安全性数据（n=33）报告显示最常见的3级或4级事件包括疲乏（9%），发声困难（声音嘶哑）（6%），外周性水肿（6%）及头痛（3%）。临床I期研究结果已公布于美国临床肿瘤学会2014年会上（点击此处），阿斯利康与和黄医药达成一致推进沃利替尼以乳头状肾细胞癌为适应症的全球II期临床研究。

全球II期临床研究 – 2014年5月，沃利替尼以局部晚期或转移性乳头状肾细胞癌为适应症的全球开放标签单臂II期临床研究正式启动，至2015年10月，在美国、加拿大、英国以及西班牙的22家临床研究中心完成109名乳头状肾细胞癌受试者的入组工作。该试验是迄今为止以乳头状肾细胞癌为适应症最大型的前瞻性临床研究。其主要试验终点是评估沃利替尼治疗乳头状肾细胞癌的抗肿瘤活性，次要终点包括中位无进展生存期、缓解持续时间、安全性、耐受性、药代动力学及药效学特性。值得一提的是，为了更好地了解c-Met突变和临床研究结果的关系，每位受试者的肿瘤样本都经过分子分析以了解c-Met状态。II期临床研究的最终结果将在近期的科研大会上予以公布。

 

同伴诊断的发展

沃利替尼以c-Met异常的乳头状肾细胞癌为适应症的III期临床研究将是在肾细胞癌中开展的第一个以分子筛选为指导的临床试验。乳头状肾细胞癌II期试验中通过对每一位受试者的分析，研究人员发现可以通过肿瘤的生物标志物筛选出最有可能从沃利替尼的相关治疗中获益的患者。阿斯利康和基因测序测试公司Foundation Medicine（Nasdaq: FMI）协议合作进行同伴诊断分析，帮助分辨最有可能受益于靶向新药（包括沃利替尼）的患者，加快肿瘤个性化药物的研发。同伴诊断分析能够评估多种癌症相关的基因以及基因组变化类别，根据协同开发注册的策略，现正与沃利替尼的临床研发同步平行进行。乳头状肾细胞癌的III期同伴诊断平台将与其他适应症（例如非小细胞肺癌和胃癌等）的大致相似。

 

和黄医药与阿斯利康合作概况

根据2011年双方签订的独家合作协议，和黄医药授权阿斯利康以诊断、预防及治疗等目的在全球范围内生产及商业推广沃利替尼。协议签署后，阿斯利康向和黄医药支付了2000万美元首付款项并且会支付销售提成和开发及销售里程金。截至2016年6月30日，和黄医药已收到的里程碑付款累计2000万美元。此外，如果临床开发获得成功上市且销售业绩喜人，和黄医药将可能获得高达1亿美元收益，另有未来在销售上可能取得的里程碑付款。

阿斯利康也承担和黄医药一部分的研发费用。此外，阿斯利康将根据中国市场的销售业绩每年向和黄医药支付30%的专利费，中国以外市场则每年按销售的9%至13%支付分层特许权使用费。根据补充协议，和黄医药将在今后的三年内总计出资高达5000万美元用于沃利替尼治疗c-Met异常乳头状肾细胞癌的全球III期临床研究。基于沃利替尼在乳头状肾细胞癌这一适应症的获批情况，和黄医药可提取沃利替尼在全球（除中国外）市场全部适应症销售额的分层特许权使用费比例将提高5个百分点，即达到14%至18%。若未来沃利替尼总销售额达到50亿美元，专利费提取比例在之后的两年将降至10.5%至14.5%。除上述内容以外，2011年所签署合作协议其他条款均保持不变。