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新聞中心及演示文稿

London: Tuesday, May 31, 2016: For information purposes, Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) hereby notifies the market that as at May 31, 2016, the issued share capital of Chi-Med consisted of 60,649,342 ordinary shares of US$1.00 each, with each share carrying one right to vote and with no shares held in treasury.

The above figure of 60,649,342 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, Chi-Med under the Financial Conduct Authority’s Disclosure Rules and Transparency Rules.

For illustrative purposes only, the 60,649,342 ordinary shares would be equivalent to 60,649,342 CREST depositary interests (each equating to one ordinary share) which are traded on AIM or, if the CREST depositary interests were converted in their entirety, equivalent to 121,298,684 American depositary shares (each equating to one-half of one ordinary share) which are traded on Nasdaq.

 

Ends

Contact

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

 

Jillian Connell, The Trout Group

+1 (646) 378 2956
jconnell@troutgroup.com

David Dible, Citigate Dewe Rogerson

+44 20 7638 9571
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk

Panmure Gordon (UK) Limited

 

Richard Gray / Andrew Potts

+44 (20) 7886 2500

 

Notes to Editors

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform, Hutchison MediPharma Limited, is focused on discovering, developing and commercializing innovative therapeutics in oncology and autoimmune diseases. Its pipeline of eight novel oral compounds for cancer and inflammation is in development in North America, Europe, Australia and Greater China.

Chi-Med’s 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

Shenzhen, China

2016年5月13日:和黃醫藥今日宣布呋喹替尼(HMPL-013)以結直腸癌為適應症的III 期臨床試驗“ FRESCO” 順利完成患者入組工作。2012年,中國新發結直腸癌病例約為39萬例,呋喹替尼的這項關鍵性III期臨床試驗“FRESCO”,正是以三線局部晚期或已發生轉移的結直腸癌作為適應症進行臨床研究。

呋喹替尼是一種新型的高選擇性小分子候選藥物,經研究證實:通過每24小時口服一次劑量可達到抑制血管內皮細胞生長因子受體(VEGFR)的作用,且並未顯示出脫靶毒性。呋喹替尼的III 期臨床試驗“ FRESCO”旨在評估呋喹替尼對照安慰劑的療效,所有受試者均接受最佳支持治療(“BSC”)。該試驗的主要終點是總體生存率(“OS”) 。

“ 順利完成首個III 期臨床試驗的患者入組對我們公司而言是一個重要的里程碑”,和黃中國醫藥科技有限公司首席執行官賀雋先生評論說,“我們相信呋喹替尼有顯著改善多種實體瘤預後的潛力。今年我們在等待這項結直腸癌臨床試驗結果的同時,也將進一步加速呋喹替尼治療非小細胞肺癌的關鍵性III期臨床試驗“FALUCA”,並啟動呋喹替尼相關的一系列其他研究,包括與紫杉醇聯合用藥治療胃癌的II期臨床研究,在美國開展新的臨床試驗研究項目,以及與其他腫瘤藥物聯合用藥的一些探索性研究。”

“ FRESCO” 臨床試驗的開展是基於呋喹替尼以晚期轉移性結直腸癌為適應症的II期臨床研究的成功,該試驗是一項隨機雙盲安慰劑對照的多中心II期臨床研究,共入組71名患者。該研究結果顯示呋喹替尼成功達到了無進展生存期的主要終點,呋喹替尼組的中位無進展生存期為4.73個月,而安慰劑對照組僅為0.99個月,風險比為0.30(p<0.001),且未出現超出預期的重大安全性問題。基於II期臨床試驗的積極結果,和黃醫藥收到了來自此項目合作夥伴禮來總計1800萬美元的付款。

 

關於FRESCO結直腸癌臨床研究

呋喹替尼的III期臨床試驗“FRESCO” 為隨機雙盲安慰劑對照的多中心臨床試驗,目標受試者為至少經過2 輪抗腫瘤治療失敗的三線轉移性結腸癌患者,曾用藥物包括奧沙利鉑和氟尿嘧啶類藥物及伊立替康。此前完成的II期臨床試驗的詳細結果公佈於2015年歐洲癌症大會(ESMO)上,詳情請點擊海報

2014年12月12日,FRESCO的首位受試者接受給藥治療。416名受試者按照2:1的比例隨機接受每天口服一次5毫克呋喹替尼,週期為服藥三週/停藥一周,加最佳支持治療;或安慰劑加最佳支持治療。

主要試驗終點為總體生存率,次要終點包括無進展生存期、客觀緩解率、疾病控制率和緩解時間。一旦總體生存率死亡事件達到預先設定的數字,將會隨即展開數據分析。研究結果有望於2016年底或2017年初公佈。

有關呋喹替尼的III期臨床試驗“FRESCO”的更多信息,請訪問clinicaltrials.gov,檢索NCT02314819

根據2012年中國癌症登記處的年度報告,結直腸癌患者新發病例數達到了39萬,年發病率佔癌症患者的10.2% 。

 

其他呋喹替尼臨床研究概覽

除了結直腸癌,呋喹替尼正在進行的臨床研究的適應症還有肺癌和胃癌。

肺癌:2014年6月,和黃醫藥啟動呋喹替尼以非小細胞肺癌為適應症的中國II期臨床試驗。91名受試者根據2:1的比例接受呋喹替尼加最佳支持治療或安慰劑加最佳支持治療。結果顯示該試驗成功達到了無進展生存期的主要療效終點,並未出現重大不良安全事件。詳細結果將在2016年即將舉行的科研大會上進行公佈。基於該試驗的積極結果,和黃醫藥收到來自合作夥伴禮來總計1000萬美元的付款,並於2015年12月啟動了呋喹替尼以三線非小細胞肺癌為適應症的中國III期臨床試驗“FALUCA”,共將有約520名受試者參與到該項研究。有關該研究的更多信息,請訪問clinicaltrials.gov,檢索NCT02691299

胃癌:呋喹替尼與紫杉醇聯合用藥治療二線胃癌患者的Ib 期劑量探索研究已接近尾聲,和黃醫藥計劃將於2016後半年啟動II期概念驗證性臨床研究。有關該研究的更多信息,請訪問clinicaltrials.gov,檢索NCT02415023

和黃醫藥根據此前與禮來簽訂的合作協議中約定的比例收到禮來對用於進行呋喹替尼相關臨床試驗費用的報銷。

The Westin Hotel, Singapore

London—May 2, 2016—Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announced that Chief Executive Officer Christian Hogg will present a corporate overview at two healthcare investor conferences in May.

Conference Details:

Event: Deutsche Bank 41st Annual Health Care Conference
Date/Time: Thursday, May 5, 2016 at 10:40 a.m. EDT
Location: Boston, MA

Event: Bank of America Merrill Lynch 2016 Health Care Conference
Date/Time: Thursday, May 12, 2016 at 8:00 a.m. PDT
Location: Las Vegas, NV

A live audio webcast for the Bank of America conference will be available in the Events, Circulars & Forms section of the Company’s website (chi-med.com). A replay of the webcast will also be available following the event.

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.

Ends

Contact

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. 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

 

Jillian Connell, The Trout Group

+1 (646) 378 2956
jconnell@troutgroup.com

David Dible, Citigate Dewe Rogerson

+44 20 7638 9571
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk

Panmure Gordon (UK) Limited

 

Richard Gray / Andrew Potts

+44 (20) 7886 2500