伦敦：2020年3月31日（星期二）：和黄中国医药科技有限公司（简称 “和黄医药” 或 “Chi-Med”）（纳斯达克/AIM： HCM）启动了一项HMPL-453治疗晚期恶性间皮瘤患者的II期临床试验。HMPL-453是一种靶向成纤维细胞生长因子受体（“FGFR”）的新型小分子抑制剂。
该研究是一项单臂、多中心、开放标签的临床试验，旨在评估HMPL-453在至少经过一线全身性治疗失败后的晚期恶性间皮瘤患者中的疗效、安全性和药代动力学特性。
该研究的主要结果指标为客观缓解率（ORR）。次要结果指标包括初步疗效，例如疾病控制率（DCR）、到达疾病缓解的时间（TTR）、缓解持续时间（DoR）、无进展生存期（PFS）和总生存期（OS）。该研究的主要研究者为上海交通大学附属胸科医院的陆舜教授。该项研究的其他详情可登录clinicaltrials.gov，检索 NCT04290325查阅。
FGFR是受体酪氨酸激酶的亚族之一。FGFR信号通路的激活是数个生物过程的关键。正常生理情况下，FGF/FGF信号通路参与胚胎发育（器官发生和形态发生）、组织修复、血管生成、神经内分泌和代谢平衡。鉴于其在许多重要生理过程中的复杂性和关键作用，已发现异常的FGFR信号传导是肿瘤生长、促进血管生成以及抗肿瘤治疗抗性产生的诱因。
HMPL‑453是一种新型、强效且高选择性的小分子成纤维细胞生长因子受体（FGFR） 1、2和3抑制剂。在临床前研究中， HMPL‑453较同类其他药物相比表现出更强的效力、更高的激酶选择性及更佳的安全性。在中国进行的HMPL-453 I期临床试验的剂量递增阶段已完成患者招募，详细内容请登录clinicaltrials.gov，检索NCT03160833查阅。
和黄中国医药科技有限公司（简称“和黄医药”或“Chi-Med”）（纳斯达克 / AIM: HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。欲了解更多详情，请访问：www.chi-med.com。
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前瞻性陈述
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-453临床开发的预期、启动HMPL-453进一步临床研究计划、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-453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-453用于目标适应症的潜在市场和资金充足性等。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。
London: Wednesday, March 25, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/ AIM: HCM) today announces that its 2019 Annual Report together with the Notice of Annual General Meeting and the Form of Proxy (“AGM Materials”) have been posted to Shareholders of Chi-Med (“Shareholders”). The documents can be accessed from the website of Chi-Med (www.chi-med.com).
Due to travel restrictions resulting from the novel coronavirus outbreak, the 2020 Annual General Meeting (“AGM”) will be held at the 47th Floor, Cheung Kong Center, 2 Queen’s Road Central, Hong Kong on Monday, April 27, 2020 at 6:00 pm Hong Kong Time (11:00 am London Time).
To safeguard the health and safety of Shareholders, Chi-Med encourages Shareholders to exercise their right to vote at the AGM by appointing the Chairman of the AGM as their proxy instead of attending the AGM in person. Shareholders will be able to view a live webcast of the AGM through the website of the Company at https://www.hutch-med.com/agm2020/. Along with the AGM Materials, all registered Shareholders will also receive a letter containing log in details and information on how to access the webcast. Please note that webcast participation does not constitute formal attendance at the AGM nor would Shareholders be able to vote electronically. Shareholders would need to submit their form of proxy ahead of the AGM in accordance with the instructions printed thereon if they wish to cast their votes.
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+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
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
Corporate Information
Chairman’s Statement
2019 Operating Highlights
2019 Financial Highlights
Financial Review
Operations Review
Innovation Platform
Commercial Platform
Use of Non-GAAP Financial Measures and Reconciliation
Biographical Details Of Directors
Report of the Directors
Corporate Governance Report
Form 20-F (Including Financial Statements)
Information For Shareholders
| 日期：2020年4月27日 |
| 时间：香港时间下午6时 （伦敦时间上午11时） |
| 地址：香港中环皇后大道中2号长江中心47楼 |
线上投资者会议
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Cinney Zhang
czhang429@bloomberg.net
Sam Fazeli
mfazeli@bloomberg.net
Louise Chen
+1 212 915 1794
Louise.Chen@cantor.com
Brandon Folkes
+1 212 294 8081
Brandon.Folkes@cantor.com
Jennifer Kim
+1 212 829 4860
Jennifer.Kim@cantor.com
Carvey Leung
+1 212 915 1917
Carvey.Leung@cantor.com
The previously reported SANET-ep trial (clinicaltrials.gov identifier NCT02588170) demonstrated that surufatinib significantly improves progression-free survival (“PFS”) in patients with advanced extrapancreatic (non-pancreatic) neuroendocrine tumors compared to placebo, with a median PFS of 9.2 months versus 3.8 months, respectively (hazard ratio = 0.334, 95% CI 0.223 to 0.499, p<0.0001). This presented analysis evaluated the safety profile and adverse events of special interest (“AESI”) of surufatinib from SANET-ep data. 93.8% of patients in the surufatinib group and 73.5% of patients in the placebo group had at least one treatment-emergent AESI.
The analysis concluded that AESIs of Grade 3 or higher hypertension and proteinuria occurred more frequently with surufatinib than with placebo, with the most common (at least 3% of patients) grade 3 or greater AESIs being hypertension (40.3% with surufatinib vs. 16.2% with placebo), proteinuria (23.3% vs. 0) and hemorrhage (3.1% vs. 2.9%). It also concluded that AESIs leading to treatment discontinuation were uncommon, with AESIs leading to dose discontinuation in at least 1% of patients being proteinuria (3.9% with surufatinib vs. 0 with placebo), hemorrhage (1.6% vs 1.5%), and hepatic failure (0.8% vs 1.5%). Surufatinib has a manageable safety profile in patients with advanced extra-pancreatic neuroendocrine tumors.
Title: Safety Profile and Adverse Events of Special Interest for Surufatinib in Chinese Patients with Advanced Extra-Pancreatic Neuroendocrine Tumors: Analysis of the Phase 3 SANET-ep Trial
Authors: Jie Li, Jianming Xu, Zhiwei Zhou, Chunmei Bai, Yihebali Chi, Zhiping Li, Nong Xu, Enxiao Li, Tianshu Liu, Yuxian Bai, Sha Guan, Lin Shen
Abstract: #2914
Introduction The previously reported SANET-ep trial (NCT02588170) demonstrated surufatinib significantly improves progression-free survival (PFS) in patients (pts) with advanced extrapancreatic neuroendocrine tumors (epNETs) compared to placebo; median PFS (9.2 vs. 3.8 months; HR = 0.334, 95% CI 0.223 to 0.499, p<0.0001).
Aims The present analysis evaluates the safety profile and adverse events of special interest (AESIs) of surufatinib from SANET-ep data.
Patients and Methods Pts were randomized (2:1) to receive surufatinib (300 mg once daily continuously) or placebo. Treatment-related AESIs and time-to-first occurrence of AESIs were summarized. Predefined AESIs included hepatic failure (HF), proteinuria (P), hypertension (HTN), haemorrhage (H), and acute renal failure (ARF), which were searched with narrow MedDRA Standardized MedDRA Query (SMQ).
Results A total of 121/129 (93.8%) pts in the surufatinib group and 50/68 (73.5%) in the placebo group had ≥ 1 treatment-emergent AESI; the mean relative dose intensity was 86.42% and 96.78%, respectively. The most commonly reported (>10% of pts) AESIs were P (84.5% vs 57.4%), HTN (68.2% vs 30.9%), and H (55.8% vs 27.9%). The most common (≥3% of pts) grade ≥3 AESIs were HTN (40.3% vs 16.2%), P (23.3% vs 0) and H (3.1% vs 2.9%); the median time-to-onset of these events in the surufatinib group was 13.5, 28, and 32 days, respectively. AESIs (≥1% of pts) leading to dose discontinuation were P (3.9% vs 0), H (1.6% vs 1.5%), and HF (0.8% vs 1.5%).
Conclusions The AESIs of Grade ≥ 3 HTN and P occurred more frequently with surufatinib; however, AESIs leading to treatment discontinuation were uncommon. Surufatinib has a manageable safety profile in pts with advanced epNETs.
Keywords extra-pancreatic, neuroendocrine tumors, safety
London: Monday, March 9, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) announces that following the announcement of the 2019 annual results of Chi-Med on March 3, 2020, the following awards granted under the Long Term Incentive Plan (“LTIP”) on March 15, 2017 to Mr Christian Hogg, Mr Johnny Cheng and Dr Weiguo Su were vested on March 6, 2020:
| Award Holders | Number of American depositary shares (“ADS”) | |
| Person Discharging Managerial Responsibilities | ||
| Mr Christian Hogg (Executive Director and Chief Executive Officer) | 14,975 | |
| Mr Johnny Cheng (Executive Director and Chief Financial Officer) | 5,857 | |
| Dr Weiguo Su (Executive Director and Chief Scientific Officer) | 10,475 | |
| Total | 31,307 |
The notifications set out below are 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 | Mr Christian Hogg | ||||
| 2 | Reason for the notification | |||||
| a) | Position/status | Executive Director and Chief Executive Officer | ||||
| 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 | 2138006X34YDQ6OBYE79 | ||||
| 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 |
ADS each representing five Ordinary Shares of US$0.10 ADS ISIN: US44842L1035 |
||||
| b) | Nature of the transaction | Vesting of awards granted on March 15, 2017 under Chi-Med’s LTIP | ||||
| c) | Price(s) and volume(s) |
|
||||
| d) | Aggregated information
|
N/A | ||||
| e) | Date of the transaction | 2020-03-06 | ||||
| f) | Place of the transaction | Outside a trading venue | ||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||
| a) | Name | Mr Johnny Cheng | ||||
| 2 | Reason for the notification | |||||
| a) | Position/status | Executive Director and Chief Financial Officer | ||||
| 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 | 2138006X34YDQ6OBYE79 | ||||
| 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 |
ADS each representing five Ordinary Shares of US$0.10 ADS ISIN: US44842L1035 |
||||
| b) | Nature of the transaction | Vesting of awards granted on March 15, 2017 under Chi-Med’s LTIP | ||||
| c) | Price(s) and volume(s) |
|
||||
| d) | Aggregated information
|
N/A | ||||
| e) | Date of the transaction | 2020-03-06 | ||||
| f) | Place of the transaction | Outside a trading venue | ||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||
| a) | Name | Dr Weiguo Su | ||||
| 2 | Reason for the notification | |||||
| a) | Position/status | Executive Director and Chief Scientific Officer | ||||
| 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 | 2138006X34YDQ6OBYE79 | ||||
| 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 |
ADS each representing five Ordinary Shares of US$0.10 ADS ISIN: US44842L1035 |
||||
| b) | Nature of the transaction | Vesting of awards granted on March 15, 2017 under Chi-Med’s LTIP | ||||
| c) | Price(s) and volume(s) |
|
||||
| d) | Aggregated information
|
N/A | ||||
| e) | Date of the transaction | 2020-03-06 | ||||
| f) | Place of the transaction | Outside a trading venue | ||||
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
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, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+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
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
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注：本文件的中文本为翻译稿，仅供参考用。本文件的英文及中文版本如有歧义，概以英文版本为准。完整版本（仅备英文版）请参阅此处。
伦敦，2020年3月3日，星期二: 和黄中国医药科技有限公司（简称 “和黄医药” 或 “Chi-Med”）（纳斯达克 / AIM: HCM） 是一家处于商业化阶段的生物制药公司，目前在全球范围内共有8个抗癌类候选药物在开发中，并在中国具有广泛的商业网络。和黄医药今日发布截至2019年12月31日止年度之经审计财务业绩，并报告关键临床项目及商业平台方面的最新进展。
和黄医药主席杜志强表示：“2019年是我们为和黄医药开创新纪元奠定基础的一年。我们首个上市的药物爱优特®最近被纳入中国国家医保药品目录（NRDL），有望在今年让更多患者受惠。我们首个具有全球专利和权益、用于治疗非胰腺神经内分泌瘤的抗癌候选药物索凡替尼（surufatinib）有望在年底上市。我们正在扩大自己的肿瘤商业化团队为其上市做好充分准备。此外，我们即将提交另外两项新药上市申请（NDA），其中一项为沃利替尼（savolitinib）用于治疗肺癌，另一项为索凡替尼用于治疗胰腺神经内分泌瘤，均预计可在2021年上市。”
“基于大量临床数据，我们计划于今年开始对呋喹替尼 (fruquintinib）和索凡替尼开展多项全球注册研究, 而沃利替尼的全球注册研究也有望展开。此外，一些抗血液恶性肿瘤药物在中国的注册研究也在筹划中。”
“我们相信，多个有望上市的全新抗肿瘤药物，将解决广泛未被满足的医疗需求并令广大患者受益，进而推动和黄医药快速发展。”
以下为和黄医药2019年至今的运营亮点。如欲了解更多详细资料，请参阅英文版公告全文有关 “Operations Review” 的部分。
沃利替尼 – 全球
和黄中国医药科技有限公司（简称“和黄医药”或“Chi-Med”）（纳斯达克 / AIM: HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。欲了解更多详情，请访问：www.chi-med.com。