Dr. Alec W. Stranahan
+1 646 743 2109
alec.stranahan@bofa.com
Dr. Geoff Meacham
+1 646 855 1004
geoff.meacham@bofa.com
地址: 美国纽约 |
日期: 2019年12月3日(星期二) |
时间: 08:50 am EST (01:50 pm GMT, 09:50 pm HKT) |
地址:新加坡文华东方酒店
地址:福田香格里拉大酒店 ,中国深圳
地址:澳门君悦酒店
地址:英国伦敦
伦敦,2019年10月17 日,星期四 :和黄中国医药科技有限公司 (简称“和黄医药”或“Chi-Med”) (AIM/纳斯达克: HCM)今日重点介绍于美国癌症研究协会的期刊《癌症发现(Cancer Discovery)》[1] 发表的VIKTORY (targeted agent eValuation In gastric cancer basKeT KORea studY) II期临床试验结果。VIKTORY主要研究者为韩国首尔三星医学中心成均馆大学医学院的Jeeyun Lee博士。
该研究文章标题为“肿瘤基因组学分析指导转移性胃癌患者进行靶向治疗:VIKTORY伞式临床试验”(Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial) 刊载于《癌症发现》10月号。文章对VIKTORY研究作出详细介绍。该研究旨在根据临床测序对转移性胃癌患者进行分类,并重点关注8个不同的生物标志物组,包括MET扩增,以将患者分配到10项二线治疗相关临床试验其中之一。
Jeeyun Lee博士及其团队一共入组772名胃癌患者,并为其中715名 (92.6%) 患者中成功进行了测序。基于该测序,在3.5% 患者 (25/715) 中观察到MET扩增。在关于VIKTORY的10项相关临床试验中,沃利替尼单药治疗MET扩增病人中观察到最高客观缓解率 (“ORR”),即ORR报告为50%(10/20,95%CI: 28.0–71.9)。 Jeeyun Lee博士及其团队总结出沃利替尼单药治疗亦达到预先指定的6周无进展生存率,认为值得在MET基因扩增的胃癌患者中作进一步研究。
2018年报告的胃癌新发病例超过100万例,死亡病例估计为78.3万例,成为第三大癌症致死病因。直今,患者的预后仍然及其不尽人意,化疗治疗后的中位总生存期不到12个月。
沃利替尼是一种潜在的全球首创MET抑制剂,而MET是一种在许多类型实体瘤中表现出功能异常的酶。和黄医药研发的沃利替尼是一种强效且高选择性的口服抑制剂。沃利替尼通过化学结构优化来解决人体代谢相关肾毒性问题,而肾毒性正是其他选择性MET抑制剂研发停止的主要原因。迄今为止,在涉及900多名患者的临床研究中,沃利替尼在携带多种肿瘤类型中MET基因变异的患者中表现出了良好的临床疗效,并且具有可接受的安全性特征。和黄医药目前正与阿斯利康合作,在Ib/II期临床研究中对沃利替尼(包括单药治疗和联合治疗)用于治疗多种实体瘤适应症进行试验。
和黄中国医药科技有限公司(简称“和黄医药”或“Chi-Med”)(AIM/纳斯达克:HCM)是一家创新型生物医药公司,致力于药品的研究、开发、生产和销售。和记黄埔医药(上海)有限公司是和黄医药的创新药研发平台,现有一支约470人的研发团队,专注于研发和商业开发治疗癌症和自身免疫性疾病的靶向创新药物和免疫疗法,目前共有8个抗癌类候选药物进入临床阶段,正在全球开展临床研究。和黄医药的商业平台负责处方药和健康类消费品在中国的生产和营销,销售网络覆盖中国广大地区医院。
和黄医药总部位于中国香港,在伦敦证券交易所(AIM)和美国纳斯达克全球精选市场均已上市。了解更多详情请访问:www.chi-med.com。
本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期,包括对沃利替尼临床开发的预期、启动沃利替尼的临床研究计划、对此类研究是否能达到其主要或次要终点的预期,以及对此类研究完成时间和结果发布的预期。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设:入组率、满足研究入选和排除标准的受试者的时间和可用性、临床方案或监管要求变更、非预期不良事件或安全性问题、候选药物沃利替尼达到研究的主要或次要终点的疗效、获得不同司法管辖区的监管批准、获得监管批准后获得上市许可、沃利替尼用于目标适应症的潜在市场和资金充足性等。此外,由于一定研究赖于将泰瑞沙®、易瑞莎®、Imfinzi®与沃利替尼联合使用,因此此类风险和不确定性包括对于泰瑞沙®、易瑞莎® 与Imfinzi® 的安全性,疗效,供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述,这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论,请查阅和黄医药向美国证券交易委员会和AIM提交的文件。无论是否出现新信息、未来事件或情况或其他因素,和黄医药均不承担更新或修订本新闻稿所含信息的义务。
投资者咨询 |
|
李健鸿,资深副总裁 | +852 2121 8200 |
郑嘉惠,副总裁 | +1 (973) 567 3786 |
David Dible, Citigate Dewe Rogerson |
+44 7967 566 919 (手机)david.dible@citigatedewerogerson.com |
Xuan Yang, Solebury Trout |
+1 (415) 971 9412(手机) xyang@troutgroup.com |
媒体咨询 |
|
英国及欧洲 – | |
Anthony Carlisle, Citigate Dewe Rogerson | +44 7973 611 888(手机) anthony.carlisle@cdrconsultancy.co.uk |
美洲 — | |
Brad Miles, Solebury Trout | +1 (917) 570 7340(手机) bmiles@troutgroup.com |
中国香港及亚洲其他地区 (不含中国大陆地区) – | |
卢志伦, 博然思维集团 | +852 9850 5033(手机) jlo@brunswickgroup.com |
周怡, 博然思维集团 | +852 9783 6894(手机) yzhou@brunswickgroup.com |
中国大陆地区 – | |
沈雁翎, 爱德曼公关公司 | +86 136 7179 1029 (手机) sam.shen@edelman.com |
任命保荐人 |
|
Andrew Potts, Panmure Gordon (UK) Limited | +44 (20) 7886 2500 |
地址:摩根士丹利上海办公室
London: Thursday, October 10, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces that on October 9, 2019, it granted share options under the Share Option Scheme conditionally adopted by Chi-Med at its Annual General Meeting in 2015 (the “2015 HCML Share Option Scheme”).
Chi-Med granted 1,735,000 share options under its 2015 HCML Share Option Scheme to certain employees to subscribe for Ordinary Shares subject to the acceptance of the grantees. Details of such share options granted prescribed are as follows:
Date of grant | : | October 9, 2019 |
Exercise price of share options granted | : | GBP2.978 per Ordinary Share |
Number of share options granted | : | 1,735,000 (each share option shall entitle the holder thereof to subscribe for one Ordinary Share) |
Closing market price of Ordinary Shares on the date of grant | : | GBP2.8775 per Ordinary Share |
Validity period of the share options | : | From October 9, 2019 to October 8, 2029 |
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 470 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. 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. Forward-looking statements involve risks and uncertainties. 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.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
投资者咨询 |
|
李健鸿,资深副总裁 | +852 2121 8200 |
郑嘉惠,副总裁 | +1 (973) 567 3786 |
David Dible, Citigate Dewe Rogerson |
+44 7967 566 919 (手机)david.dible@citigatedewerogerson.com |
Xuan Yang, Solebury Trout |
+1 (415) 971 9412(手机) xyang@troutgroup.com |
媒体咨询 |
|
英国及欧洲 – | |
Anthony Carlisle, Citigate Dewe Rogerson | +44 7973 611 888(手机) anthony.carlisle@cdrconsultancy.co.uk |
美洲 — | |
Brad Miles, Solebury Trout | +1 (917) 570 7340(手机) bmiles@troutgroup.com |
中国香港及亚洲其他地区 (不含中国大陆地区) – | |
卢志伦, 博然思维集团 | +852 9850 5033(手机) jlo@brunswickgroup.com |
周怡, 博然思维集团 | +852 9783 6894(手机) yzhou@brunswickgroup.com |
中国大陆地区 – | |
沈雁翎, 爱德曼公关公司 | +86 136 7179 1029 (手机) sam.shen@edelman.com |
任命保荐人 |
|
Andrew Potts, Panmure Gordon (UK) Limited | +44 (20) 7886 2500 |
伦敦,2019年10月4日,星期五:和黄中国医药科技有限公司(简称“和黄医药”或“Chi-Med”) (AIM/Nasdaq:HCM)启动了一项HMPL-523治疗复发性或难治性淋巴瘤患者的国际I/Ib期临床试验。HMPL-523是一种新型脾酪氨酸激酶 (“Syk”)抑制剂。首位受试者已于2019年9月26日在美国接受给药治疗。
该项国际临床研究是一项多中心、开放标签的两阶段研究,包括剂量递增和扩展研究,旨在研究HMPL-523在复发或难治性淋巴瘤患者中口服给药的疗效。其研究中心位于美国和欧洲。主要结果指标为安全性和耐受性。次要结果指标包括药代动力学参数指标(PK) 以及初步疗效如客观缓解率 (ORR) 等。该项研究的主要研究者为美国德克萨斯大学MD安德森癌症中心,淋巴瘤与骨髓瘤科副教授Nathan Fowler博士。该项研究的额外详情可登录clinicaltrials.gov,检索注册号NCT03779113查看。
本项研究补充了正在澳大利亚(clinicaltrials.gov,检索注册号:NCT02503033)和中国 (clinicaltrials.gov, 检索注册号:NCT02857998及NCT03483948)进行的HMPL-523 Ib 期剂量扩展临床试验,涉及广泛的血液肿瘤。 复发或难治性B 细胞淋巴瘤患者中开展的HMPL-523 中国I 期临床试验的剂量递增阶段初步结果已于2018 年发布[i]。 除了研究用于肿瘤治疗外,HMPL-523正于中国进行一项治疗免疫性血小板减少性紫癜(ITP)患者的I 期临床试验(clinicaltrials.gov,检索注册号:NCT03951623)。
HMPL-523 是一种新型的强效且高选择性的靶向脾酪氨酸激酶 (Syk) 的口服小分子抑制剂。Syk 作为B 细胞信号传导通路中的一个关键蛋白,是多种亚型的B 细胞淋巴瘤及自身免疫疾病的成熟治疗靶点。由于B细胞恶性肿瘤具有异质性,且尽管采用目前的疗法,患者仍然容易复发,因此亟需寻求新的治疗方法。
和黄中国医药科技有限公司(简称 “和黄医药” 或“Chi-Med”)(AIM/Nasdaq:HCM)是一家创新型生物医药公司,致力于药品的研究、开发、生产和销售。和记黄埔医药(上海)有限公司是Chi-Med的创新药研发平台,现有一支约470人的研发团队,专注于研发和商业开发治疗癌症和自身免疫性疾病的靶向创新药物和免疫疗法,目前共有8个抗癌类候选药物进入临床阶段,正在全球开展临床研究。Chi-Med的商业平台负责处方药和健康类消费品在中国的生产和营销,销售网络覆盖中国广大地区医院。
Chi-Med总部位于中国香港,在伦敦证券交易所(AIM)和美国纳斯达克全球精选市场均已上市。了解更多详情请访问:www.chi-med.com 。
本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期,包括对HMPL-523临床开发的预期(包括与阿扎胞苷联用)、启动HMPL-523用作单药或联合疗法的临床研究计划、对此类研究是否能达到其主要或次要终点的预期,以及对此类研究完成时间和结果发布的预期。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设:入组率、满足研究入选和排除标准的受试者的时间和可用性、临床方案或监管要求变更、非预期不良事件或安全性问题、候选药物HMPL-523(包括作为单药或联合治疗)达到研究的主要或次要终点的疗效、获得不同司法管辖区的监管批准、获得监管批准后获得上市许可、HMPL-523用于目标适应症的潜在市场和资金充足性等。
此外,由于其中一项中国临床试验为HMPL-523联合阿扎胞苷使用,因此此类风险及不确定性亦包括有关阿扎胞苷的安全性、疗效、供应及持续监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述,这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论,请查阅和黄医药向美国证券交易委员会和AIM提交的文件。无论是否出现新信息、未来事件或情况或其他因素,和黄医药均不承担更新或修订本新闻稿所含信息的义务。
投资者咨询 |
|
李健鸿,资深副总裁 | +852 2121 8200 |
郑嘉惠,副总裁 | +1 (973) 567 3786 |
David Dible, Citigate Dewe Rogerson |
+44 7967 566 919 (手机)david.dible@citigatedewerogerson.com |
Xuan Yang, Solebury Trout |
+1 (415) 971 9412(手机) xyang@troutgroup.com |
媒体咨询 |
|
英国及欧洲 – | |
Anthony Carlisle, Citigate Dewe Rogerson | +44 7973 611 888(手机) anthony.carlisle@cdrconsultancy.co.uk |
美洲 — | |
Brad Miles, Solebury Trout | +1 (917) 570 7340(手机) bmiles@troutgroup.com |
中国香港及亚洲其他地区 (不含中国大陆地区) – | |
卢志伦, 博然思维集团 | +852 9850 5033(手机) jlo@brunswickgroup.com |
周怡, 博然思维集团 | +852 9783 6894(手机) yzhou@brunswickgroup.com |
中国大陆地区 – | |
沈雁翎, 爱德曼公关公司 | +86 136 7179 1029 (手机) sam.shen@edelman.com |
任命保荐人 |
|
Andrew Potts, Panmure Gordon (UK) Limited | +44 (20) 7886 2500 |
NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) | ||||||
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached: | Hutchison China MediTech Limited; Legal Entity Identifier: 2138006X34YDQ6OBYE79 |
|||||
1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) | ||||||
Non-UK issuer | X | |||||
2. Reason for the notification (please mark the appropriate box or boxes with an “X”) | ||||||
An acquisition or disposal of voting rights | X | |||||
An acquisition or disposal of financial instruments | ||||||
An event changing the breakdown of voting rights | ||||||
Other (please specify): | ||||||
3. Details of person subject to the notification obligation | ||||||
Name | Hutchison Healthcare Holdings Limited | |||||
City and country of registered office (if applicable) | British Virgin Islands | |||||
4. Full name of shareholder(s) (if different from 3.) | ||||||
Name | ||||||
City and country of registered office (if applicable) | ||||||
5. Date on which the threshold was crossed or reached: | 02/10/2019 | |||||
6. Date on which issuer notified (DD/MM/YYYY): | 03/10/2019 | |||||
7. Total positions of person(s) subject to the notification obligation | ||||||
% of voting rights attached to shares (total of 8. A) | % of voting rights through financial instr-uments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights of issuer | |||
Resulting situation on the date on which threshold was crossed or reached | 49.86% | – | 49.86% | 666,786,450 | ||
Position of previous notification (if applicable) | 51.15% | – | 51.15% | |||
8. Notified details of the resulting situation on the date on which the threshold was crossed or reached | |||||||||
A: Voting rights attached to shares | |||||||||
Class/type of sharesISIN code (if possible) |
Number of voting rights | % of voting rights | |||||||
Direct (Art 9 of Directive 2004/ 109/ EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/ 109/ EC) (DTR5.2.1) |
Direct (Art 9 of Directive 2004/ 109/ EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/ 109/ EC) (DTR5.2.1) |
||||||
Ordinary Shares (KYG4672N1198) |
332,478,770 | – | 49.86% | – | |||||
American Depositary Shares (US44842L1035) |
– | – | – | – | |||||
SUBTOTAL 8. A | 332,478,770 | 49.86% | |||||||
B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a)) | |||||||
Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights | |||
N/A | |||||||
SUBTOTAL 8. B 1 | |||||||
B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b)) | |||||||
Type of financial instrument | Expiration datex |
Exercise/ Conversion Period xi |
Physical or cash settlementxii |
Number of voting rights | % of voting rights | ||
N/A | |||||||
SUBTOTAL 8.B.2 |
9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) | ||||
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer | ||||
Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) |
X | |||
Name | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
CK Hutchison Holdings Limited – indirect, but ultimate, owner of the shareholder | 49.86% | 49.86% | ||
Hutchison Whampoa (China) Limited – direct owner of the shareholder and a subsidiary of CK Hutchison Holdings Limited | 49.86% | 49.86% | ||
10. In case of proxy voting, please identify: | ||||
Name of the proxy holder | ||||
The number and % of voting rights held | ||||
The date until which the voting rights will be held | ||||
11. Additional information | ||||
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Place of completion | Hong Kong |
Date of completion | 3 October 2019 |