HUTCHMED

活動，通告及表格

Hutchmed
| 事件

Lotte New York Palace Hotel, New York, NY

JW Marriott, Beijing, China

Macquarie Office, London

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.

Details of the person discharging managerial responsibilities/person closely associated

Name

Ms Rebecca Pynt

Reason for the notification

Position/status

Spouse of Mr Christopher Nash, an Independent Non-executive Director of Chi-Med

Initial notification/
Amendment

Initial notification

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

Name

Hutchison China MediTech Limited

LEI

N/A

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

Description of the financial instrument, type of instrument

Identification code

Ordinary Shares of US$1.00 each

DI ISIN: KYG4672N1016

ADS ISIN: US44842L1035

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

Price(s) and volume(s)

Price(s)	Volume(s)
GBP19.00	3,120
GBP18.99	42

Aggregated information
– Aggregated volume
– Price

N/A

Date of the transaction

2016-08-04

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 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:

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.
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^®
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”):

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;
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.
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.
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.
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:

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.
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.
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:

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.
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:

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.
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 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

Webcast presentation & conf call: 9am BST (4pm HKT)

» click here for a video of the webcast (available for six months)

» To participate in the call, please dial +44-(0)844-581-9089 (UK), +1-212-999-6659 (US), +852-5808-3370 (HK)

– Alternatively, choose a local number from this list

US conference call: 9am EDT (2pm BST)

» Same dial-in numbers as the Webcast presentation above. Passcode is “Chi-Med”

首個以c-Met 異常乳頭狀腎細胞癌（“PRCC”）為適應症的全球III 期臨床試驗將於近期啟動

2016年8月1日：和黃醫藥和阿斯利康今日宣佈在2011年雙方就沃利替尼達成的合作協議的基礎上簽署補充協議。

多個臨床I/II期試驗數據表明沃利替尼作為一種高選擇性的c-Met抑製劑對數種腫瘤有早期臨床療效。

目前，沃利替尼的全球開發計劃已涵蓋多種c-Met異常實體瘤為適應症，包括非小細胞肺癌，腎癌，胃癌及結直腸癌。欲了解沃利替尼目前所有的臨床試驗詳情，請點擊此處。

雙方此次達成的補充協議旨在加速推進沃利替尼在全球範圍內的開發以及增加和黃醫藥在開發計劃中的參與比例。根據此協議，和黃醫藥將在今後三年內投入高達5000萬美元，主要用於沃利替尼以c-Met異常乳頭狀腎細胞癌為適應症的全球III期臨床試驗聯合開發費用。根據2011年雙方協議，和黃醫藥將獲得沃利替尼在全球範圍內（不包括中國）所有適應症的銷售提成專利費，補充協議簽署後，沃利替尼未來若以乳頭狀腎細胞癌這一適應症成功上市銷售後，該提成比例將增加5個百分點。原協議的其他條款保持不變。

沃利替尼近期完成的開放標籤全球乳頭狀腎細胞癌臨床II期研究（NCT02127710）的最終結果將在近期的科研會議上公佈。和黃醫藥與阿斯利康已達成一致進入到臨床III期研究。

乳頭狀腎細胞癌是由於c-Met基因的一系列改變（如：突變，擴增，和/或染色體變化）而導致的一種罕見的腎細胞癌的組織學亞型，沃利替尼全球III期臨床試驗將是首個以c-Met異常乳頭狀腎細胞癌為適應症的關鍵研究。目前市場上的腎細胞癌療法對乳頭狀腎細胞癌療效不顯著，且尚無專門針對c-Met異常乳頭狀腎細胞癌的療法獲批上市。此全球III期臨床試驗的最終設計方案正在與相關的醫療主管部門討論中，試驗的開展也需要有與之相匹配的c-Met異常乳頭狀腎細胞癌同伴診斷配合。乳頭狀腎細胞癌三期同伴診斷平台將會與非小細胞肺癌和胃癌的平台相似。

阿斯利康將繼續負責沃利替尼在其他c-Met異常腫瘤類型中的研發。值得一提的是，基於目前正在進行的TATTON 試驗（NCT02143466）的早期數據，一項單臂的全球臨床II期擴展試驗現已啟動，該試驗以沃利替尼聯合塔格瑞斯（奧斯替尼）治療對已批准的EGFR-TKI耐藥的晚期非小細胞肺癌患者，旨在評估沃利替尼治療EGFR突變非小細胞肺癌的療效。

阿斯利康腫瘤創新藥物部負責人，資深副總裁Susan Galbraith表示：“我們一直致力於推進沃利替尼在腎細胞癌和非小細胞肺癌中的研究，希望能夠早日為那些沒有太多治療方案選擇的患者提供一流且有效的治療藥物。同時我們也非常高興能進一步加深與和黃醫藥的合作，鞏固阿斯利康在全球藥物研發領域的領先地位。“

和黃中國醫藥科技有限公司的首席執行官賀雋表示：“我們一直致力於推動沃利替尼的全球上市，希望早日為患者帶去福音。我們相信沃利替尼有潛力成為首個經分子篩選驗證的c-Met表現異常的腎癌，肺癌及胃腸道癌患者的個性化療法。目前沃利替尼在多個適應症中即將進入關鍵研究，我們非常高興能為加快沃利替尼的研究貢獻自己的綿薄之力，相信產品上市後我們將獲得更豐厚的經濟回報。”

沃利替尼，獨特的高選擇性c-Met 抑製劑

沃利替尼是一種高選擇性口服c-Met（也被稱作間充質上皮轉移因子）受體酪氨酸激酶抑製劑，研究發現這種酪氨酸激酶在多種實體瘤中表現異常。沃利替尼作為一種強效的高選擇性口服抑製劑，旨在克服第一代c-Met抑製劑在臨床研究中出現的問題，包括腎毒性。

c-Met 異常乳頭狀腎細胞癌的市場潛力和需求

據Frost & Sullivan數據顯示，每年全球新診斷的腎癌病例約為366,000例，至2020年，腎癌的治療市場總值預計將達到45 億美元。腎細胞癌約佔全部腎癌的80-85%，且數種組織學亞型的遺傳和生化特性各異。腎細胞癌的各組織學亞型中，腎透明細胞癌最為常見，佔總數的75-80% 。

乳頭狀腎細胞癌是最常見的非透明細胞腎癌，約佔腎細胞癌的10-15%。根據歷史數據，c-Met異常乳頭狀腎細胞癌估計佔全部乳頭狀腎細胞癌的40-70%。根據2014年公佈於美國癌症研究協會年會上的一項研究顯示，對法國腎細胞癌網絡收錄的220例冷凍腫瘤樣品分析後發現：55-60%的乳頭狀腎細胞癌患者伴有7號染色體擴增（即c-Met 擴增）。

目前有數種已獲批的用於治療腎細胞癌的藥品（最新的一個獲批於2016年4月），但大部分研究是基於數量龐大的腎透明細胞癌患者。乳頭狀腎細胞癌的生物和分子特性與腎透明細胞癌不同，因此，乳頭狀腎細胞癌患者的預後及治療效果明顯不及腎透明細胞癌患者。對治療乳頭狀腎細胞癌患者的專門藥物及更精確的數據的需求目前還是一個巨大的空缺。

沃利替尼以乳頭狀腎細胞癌為適應症的臨床研究進展

澳大利亞臨床I期研究– 一項在多種實體瘤中進行的臨床I期劑量遞增研究顯示了沃利替尼600mg每日一次的臨床活性和安全性，並在針對一位c-Met異常乳頭狀腎細胞癌患者的研究早期明確觀察到部分緩解。整個研究中，在3/8 （38%）的乳頭狀腎細胞癌患者中明確觀察到部分緩解，全部患者都伴隨c-Met異常，緩解持續約10-37個月（試驗仍在進行中）。臨床I期安全性數據（n=33）報告顯示最常見的3 級或4 級事件包括疲乏（9%），發聲困難（聲音嘶啞）（6%），外周性水腫（6%）及頭痛（3%）。臨床I期研究結果已公佈於美國臨床腫瘤學會2014年會上（點擊此處），阿斯利康與和黃醫藥達成一致推進沃利替尼以乳頭狀腎細胞癌為適應症的全球II期臨床研究。

全球II期臨床研究– 2014年5月，沃利替尼以局部晚期或轉移性乳頭狀腎細胞癌為適應症的全球開放標籤單臂II期臨床研究正式啟動，至2015年10月，在美國、加拿大、英國以及西班牙的22家臨床研究中心完成109名乳頭狀腎細胞癌受試者的入組工作。該試驗是迄今為止以乳頭狀腎細胞癌為適應症最大型的前瞻性臨床研究。其主要試驗終點是評估沃利替尼治療乳頭狀腎細胞癌的抗腫瘤活性，次要終點包括中位無進展生存期、緩解持續時間、安全性、耐受性、藥代動力學及藥效學特性。值得一提的是，為了更好地了解c-Met突變和臨床研究結果的關係，每位受試者的腫瘤樣本都經過分子分析以了解c-Met狀態。II期臨床研究的最終結果將在近期的科研大會上予以公佈。

同伴診斷的發展

沃利替尼以c-Met異常的乳頭狀腎細胞癌為適應症的III期臨床研究將是在腎細胞癌中開展的第一個以分子篩選為指導的臨床試驗。乳頭狀腎細胞癌II期試驗中通過對每一位受試者的分析，研究人員發現可以通過腫瘤的生物標誌物篩選出最有可能從沃利替尼的相關治療中獲益的患者。阿斯利康和基因測序測試公司Foundation Medicine（Nasdaq: FMI）協議合作進行同伴診斷分析，幫助分辨最有可能受益於靶向新藥（包括沃利替尼）的患者，加快腫瘤個性化藥物的研發。同伴診斷分析能夠評估多種癌症相關的基因以及基因組變化類別，根據協同開發註冊的策略，現正與沃利替尼的臨床研發同步平行進行。乳頭狀腎細胞癌的III期同伴診斷平台將與其他適應症（例如非小細胞肺癌和胃癌等）的大致相似。

和黃醫藥與阿斯利康合作概況

根據2011年雙方簽訂的獨家合作協議，和黃醫藥授權阿斯利康以診斷、預防及治療等目的在全球範圍內生產及商業推廣沃利替尼。協議簽署後，阿斯利康向和黃醫藥支付了2000萬美元首付款項並且會支付銷售提成和開發及銷售里程金。截至2016年6月30日，和黃醫藥已收到的里程碑付款累計2000萬美元。此外，如果臨床開發獲得成功上市且銷售業績喜人，和黃醫藥將可能獲得高達1 億美元收益，另有未來在銷售上可能取得的里程碑付款。

阿斯利康也承擔和黃醫藥一部分的研發費用。此外，阿斯利康將根據中國市場的銷售業績每年向和黃醫藥支付30%的專利費，中國以外市場則每年按銷售的9%至13%支付分層特許權使用費。根據補充協議，和黃醫藥將在今後的三年內總計出資高達5000萬美元用於沃利替尼治療c-Met異常乳頭狀腎細胞癌的全球III期臨床研究。基於沃利替尼在乳頭狀腎細胞癌這一適應症的獲批情況，和黃醫藥可提取沃利替尼在全球（除中國外）市場全部適應症銷售額的分層特許權使用費比例將提高5個百分點，即達到14%至18%。若未來沃利替尼總銷售額達到50 億美元，專利費提取比例在之後的兩年將降至10.5%至14.5%。除上述內容以外，2011年所簽署合作協議其他條款均保持不變。