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新闻中心及演示文稿

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:和黄医药今日宣布呋喹替尼(HMPL-013)以结直肠癌为适应症的III期临床试验“FRESCO”顺利完成患者入组工作。2012年,中国新发结直肠癌病例约为39万例,呋喹替尼的这项关键性III期临床试验 “FRESCO”,正是以三线局部晚期或已发生转移的结直肠癌作为适应症进行临床研究。

呋喹替尼是一种新型的高选择性小分子候选药物,经研究证实:通过每24小时口服一次剂量可达到抑制血管内皮细胞生长因子受体(VEGFR)的作用,且并未显示出脱靶毒性。呋喹替尼的III期临床试验“FRESCO”旨在评估呋喹替尼对照安慰剂的疗效,所有受试者均接受最佳支持治疗 (“BSC”)。该试验的主要终点是总体生存率 (“OS”)。

“顺利完成首个III期临床试验的患者入组对我们公司而言是一个重要的里程碑”,和黄中国医药科技有限公司首席执行官贺隽先生评论说,“我们相信呋喹替尼有显著改善多种实体瘤预后的潜力。今年我们在等待这项结直肠癌临床试验结果的同时,也将进一步加速呋喹替尼治疗非小细胞肺癌的关键性III期临床试验“FALUCA”,并启动呋喹替尼相关的一系列其他研究,包括与紫杉醇联合用药治疗胃癌的II期临床研究,在美国开展新的临床试验研究项目,以及与其他肿瘤药物联合用药的一些探索性研究。”

“FRESCO”临床试验的开展是基于呋喹替尼以晚期转移性结直肠癌为适应症的II期临床研究的成功,该试验是一项随机双盲安慰剂对照的多中心II期临床研究,共入组71名患者。该研究结果显示呋喹替尼成功达到了无进展生存期的主要终点,呋喹替尼组的中位无进展生存期为4.73个月,而安慰剂对照组仅为0.99个月,风险比为0.30(p<0.001),且未出现超出预期的重大安全性问题。基于II期临床试验的积极结果,和黄医药收到了来自此项目合作伙伴礼来总计1800万美元的付款。

 

关于FRESCO结直肠癌临床研究

呋喹替尼的III期临床试验“FRESCO”为随机双盲安慰剂对照的多中心临床试验,目标受试者为至少经过2轮抗肿瘤治疗失败的三线转移性结肠癌患者,曾用药物包括奥沙利铂和氟尿嘧啶类药物及伊立替康。此前完成的II期临床试验的详细结果公布于2015年欧洲癌症大会(ESMO)上,详情请点击海报

2014年12月12日,FRESCO的首位受试者接受给药治疗。416名受试者按照2:1的比例随机接受每天口服一次5毫克呋喹替尼,周期为服药三周/停药一周,加最佳支持治疗;或安慰剂加最佳支持治疗。

主要试验终点为总体生存率,次要终点包括无进展生存期、客观缓解率、疾病控制率和缓解时间。一旦总体生存率死亡事件达到预先设定的数字,将会随即展开数据分析。研究结果有望于2016年底或2017年初公布。

有关呋喹替尼的III期临床试验“FRESCO”的更多信息,请访问clinicaltrials.gov,检索NCT02314819

根据2012年中国癌症登记处的年度报告,结直肠癌患者新发病例数达到了39万,年发病率占癌症患者的10.2%。

 

其他呋喹替尼临床研究概览

除了结直肠癌,呋喹替尼正在进行的临床研究的适应症还有肺癌和胃癌。

肺癌:2014年6月,和黄医药启动呋喹替尼以非小细胞肺癌为适应症的中国II期临床试验。91名受试者根据2:1的比例接受呋喹替尼加最佳支持治疗或安慰剂加最佳支持治疗。结果显示该试验成功达到了无进展生存期的主要疗效终点,并未出现重大不良安全事件。详细结果将在2016年即将举行的科研大会上进行公布。基于该试验的积极结果,和黄医药收到来自合作伙伴礼来总计1000万美元的付款,并于2015年12月启动了呋喹替尼以三线非小细胞肺癌为适应症的中国III期临床试验“FALUCA”,共将有约520名受试者参与到该项研究。有关该研究的更多信息,请访问clinicaltrials.gov,检索NCT02691299

胃癌:呋喹替尼与紫杉醇联合用药治疗二线胃癌患者的Ib期剂量探索研究已接近尾声,和黄医药计划将于2016后半年启动II期概念验证性临床研究。有关该研究的更多信息,请访问clinicaltrials.gov,检索NCT02415023

和黄医药根据此前与礼来签订的合作协议中约定的比例收到礼来对用于进行呋喹替尼相关临床试验费用的报销。

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