- Hutchmed
- | 公告及新闻稿
London: Friday, June 30, 2017: For information purposes, Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) hereby notifies the market that as at June 30, 2017, the issued share capital of Chi-Med consisted of 60,737,204 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 60,737,204 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 60,737,204 ordinary shares would be equivalent to 60,737,204 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 121,474,408 American depositary shares (each equating to one-half of one ordinary share) which are traded on Nasdaq.
About Chi-Med
Chi-Med is an innovative 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
U.K. & 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
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@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
| 阿斯利康制药（“阿斯利康”） (LON/STO/NYSE: AZN) |
和黄中国医药科技有限公司 （简称 “和黄医药”） |
2017年6月29日： 和黄医药今日宣布将与阿斯利康联手启动沃利替尼治疗c-MET异常乳头状肾细胞癌的开放标签随机多中心全球III期关键性注册临床试验，沃利替尼是一种高选择性口服c-Met（也被称作间充质上皮转移因子）受体酪氨酸激酶抑制剂。这是首个以c-MET异常乳头状肾细胞癌为适应症的关键性研究，也是首个以肾细胞癌为适应症以生物标志物筛选患者的临床试验。
和黄中国医药科技有限公司首席执行官贺隽表示：“SAVOIR试验旨在为药品在美国和欧洲的产品注册提供支持，该试验的启动将进一步推动我们向全球主要市场提供创新药品的策略。”基于II期临床研究的数据，我们相信沃利替尼有潜力为c-MET异常表达的乳头状肾细胞癌患者带来有意义的临床获益。也希望通过使用我们最新研发的同伴诊断分析方法，通过流行病学分析进一步解析c-MET突变与患者的治疗效果之间的关系。
阿斯利康肿瘤创新药物部负责人，资深副总裁Susan Galbraith表示：“我们非常高兴看到沃利替尼研发进程中这一里程碑式的进展。早期研究数据十分鼓舞人心，沃利替尼有潜力成为治疗c-MET异常表达的各种癌症（包括肾癌，肺癌和胃癌）的一种重要方案。“
此次III期临床试验的顺利启动，根据和黄医药和阿斯利康2011年签订的授权合作协议（已修订的），阿斯利康将向和黄医药支付500万美元的里程碑付款。
除了SAVOIR，合作双方正以肾癌，肺癌和胃癌为适应症进行一系列Ib期和II期临床研究。这些研究或以沃利替尼作为单一疗法，或将其与其他靶向疗法，例如Tagrisso®（奥希替尼）或Iressa®（吉非替尼）联合进行治疗。与Imfinzi®（durvalumab）及Taxotere®（多西他赛）联合进行治疗的研究也正在进行中。
关于“SAVOIR”研究
SAVOIR是一项开放标签随机对照全球III期临床试验，旨在评估与舒尼替尼相比，沃利替尼治疗c-MET异常且肿瘤不可切除的局部晚期或转移性乳头状肾细胞癌患者的疗效和安全性。约180名患者将在分布于五至十个国家的50至75家研究中心接受随机分组。通过专门为沃利替尼开发的新型靶向下一代测序法（NGS）验证c-MET状态。随后患者将以1：1的比例随机分组，或接受沃利替尼的持续治疗，每日一次口服 600 mg沃利替尼（400 mg，如果体重<50 kg），或接受舒尼替尼的间歇性治疗，每日一次口服舒尼替尼50 mg（服药4周/停药 2周），6周为一个治疗周期。
该研究的主要目标是评估沃利替尼与舒尼替尼相比的主要疗效终点无进展生存期（“PFS”），次要终点包括总生存期，客观缓解率（“ORR”），缓解持续时间，肿瘤大小的最佳百分比变化，疾病控制率以及安全性和耐受性。 也将评估沃利替尼与舒尼替尼相比对疾病症状和生活质量的影响以及沃利替尼的药代动力学特性。该研究详情可登陆clinicaltrials.gov，检索NCT03091192查看。
关于沃利替尼
沃利替尼是一种高选择性口服c-Met（也被称作间充质上皮转移因子）受体酪氨酸激酶抑制剂，研究发现这种酪氨酸激酶在多种实体瘤中表现异常。沃利替尼作为一种强效的高选择性口服抑制剂，旨在克服第一代c-Met抑制剂在临床研究中出现的问题，比如肾毒性。
根据此前的合作协议，沃利替尼由和黄医药和阿斯利康合作开发。目前，双方正在全球展开沃利替尼以多种肿瘤类型为适应症的临床研究，包括肾癌，肺癌和胃癌，沃利替尼作为单一疗法或与其他靶向和免疫治疗药物联合治疗。
关于c-MET异常乳头状肾细胞癌
每年全球新诊断的肾癌病例约为366,000例。肾细胞癌约占全部肾癌的80-85%，且包括数种组织学亚型，其遗传和生化特性各异。乳头状肾细胞癌是最常见的非透明细胞肾癌，约占肾细胞癌的10-15%。根据数个实验的历史数据，c-Met异常乳头状肾细胞癌估计占全部乳头状肾细胞癌的40-70%。
目前还没有专门用于治疗乳头状肾细胞癌的药品获批，乳头状肾细胞癌患者正在使用以肾细胞癌为适应症的获批药品进行治疗，例如舒尼替尼。这些肾细胞癌药品的大部分研究是基于数量庞大的肾透明细胞癌患者，乳头状肾细胞癌患者的预后及治疗效果明显不及肾透明细胞癌患者。美国国家综合癌症网络指南现建议乳头状肾细胞癌患者参加临床试验。
沃利替尼治疗乳头状肾细胞癌
2017年2月，沃利替尼治疗晚期乳头状肾细胞癌的全球II期多中心临床研究结果在2017年美国临床肿瘤学会泌尿生殖道肿瘤研讨会上公布，结果显示沃利替尼作为单药治疗c-MET异常的患者疗效明确。c-MET异常组的中位无进展生存期为6.2个月，而c-MET正常的对照组为1.4个月（双侧p<0.0001）。c-MET异常组的客观缓解率为18.2%，对照组则为0% （双侧p=0.002）。沃利替尼在治疗受试者的过程中提供了持续有效的缓解并显示出了良好的安全特性。
在c-MET异常的胃癌和肺癌中开展的研究表明，c-MET扩增和/或过度表达可能是疾病进展的阴性预后。 在2017年期间，和黄医药和阿斯利康也正在对大约300例乳头状肾细胞癌患者样本进行全面的分子流行病学研究，以进一步解析c-MET突变与患者治疗效果之间的相关性，包括预测性生物标志物的关联。
London: Thursday, June 29, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces the following blocklisting six monthly return:
| 1. | Name of applicant: | Hutchison China MediTech Limited |
| 2. | Name of scheme: | Hutchison China MediTech Limited Share Option Schemes |
| 3. | Period of return: | From December 29, 2016 to June 28, 2017 |
| 4. | Balance under scheme from previous return: | 1,361,308 ordinary shares of US$1 each |
| 5. | The amount by which the block scheme has been increased, if the scheme has been increased since the date of the last return: | Nil |
| 6. | Number of securities issued/allotted under scheme during period: | 31,381 ordinary shares of US$1 each |
| 7. | Balance under scheme not yet issued/allotted at end of the period: | 1,329,927 ordinary shares of US$1 each |
| 8. | Number and class of securities originally listed and the date of admission: | 2,560,606 ordinary shares of US$1 each admitted on June 26, 2007 |
| 9. | Total number of securities in issue at the end of the period: | 60,737,204 ordinary shares of US$1 each |
| Name of contact: | Christian Hogg | |
| Address of contact: | 21/F., Hutchison House, 10 Harcourt Road, Hong Kong | |
| Telephone number of contact: | +852 2121 8200 |
About Chi-Med
Chi-Med is an innovative 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
U.K. & 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
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@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: Thursday, June 29, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) will be announcing its interim results for the six months ended June 30, 2017 on Monday, July 31, 2017 at 7:00 am British Summer Time (BST).
An analyst presentation will be held at 9:00 am BST (4:00 pm Hong Kong Time) on the same day at Panmure Gordon & Co, One New Change, London EC4M 9AF, UK, which will be webcast via the company website at www.chi-med.com/investors/event-information/. The presentation will be available to download before the analyst presentation begins.
For North America based analysts and investors, Chi-Med will also host a conference call with Q&A at 9:00 am Eastern Daylight Time (2:00 pm BST).
Details of the analyst presentation and conference call dial-in will be provided in the financial results announcement. A replay will also be available on the website shortly after each event.
About Chi-Med
Chi-Med is an innovative 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
U.K. & 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
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@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
Toni K. Choueiri, Elizabeth Plimack, Hendrik-Tobias Arkenau, Eric Jonasch, Daniel Y.C. Heng, Thomas Powles, Melanie M. Frigault, Edwin A. Clark, Amir A. Handzel, Humphrey Gardner, Shethah Morgan, Laurence Albiges, and Sumanta Kumar Pal
Abstract
Purpose
Patients with advanced papillary renal cell carcinoma (PRCC) have limited therapeutic options. PRCC may involve activation of the MET pathway, for example, through gene amplification or mutations. Savolitinib (AZD6094, HMPL-504, volitinib) is a highly selective MET tyrosine kinase inhibitor. We report results of a single-arm, multicenter, phase II study evaluating the safety and efficacy of savolitinib in patients with PRCC according to MET status.
Patients and Methods
Patients with histologically confirmed locally advanced or metastatic PRCC were enrolled and received savolitinib 600 mg orally once daily. MET-driven PRCC was defined as any of the following: chromosome 7 copy gain, focal MET or HGF gene amplification, or MET kinase domain mutations. Efficacy was assessed according to MET status. Safety, toxicity, and patient-reported health-related quality-of-life outcomes were assessed in all patients.
Results
Of 109 patients treated, PRCC was MET driven in 44 (40%) and MET independent in 46 (42%); MET status was unknown in 19 (17%). MET-driven PRCC was strongly associated with response; there were eight confirmed partial responders with MET-driven disease (18%), but none with MET-independent disease (P = .002). Median progression-free survival for patients with MET-driven and MET-independent PRCC was 6.2 months (95% CI, 4.1 to 7.0 months) and 1.4 months (95% CI, 1.4 to 2.7 months), respectively (hazard ratio, 0.33; 95% CI, 0.20 to 0.52; log-rank P < .001). The most frequent adverse events associated with savolitinib were nausea, fatigue, vomiting, and peripheral edema.
Conclusion
These data show activity and tolerability of savolitinib in the subgroup of patients with MET-driven PRCC. Furthermore, molecular characterization of MET status was more predictive of response to savolitinib than a classification based on pathology. These findings justify investigating savolitinib in MET-driven PRCC.
Citations and Links
Please follow the DOI link to access the publication:
J Clin Oncol. 2017 Jun 23:JCO2017722967
DOI link: 10.1200/JCO.2017.72.2967
Intercontinental, Boston, MA, USA
2017年6月22日：和黄医药近日在中国启动HMPL-453的I/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）的新型高选择性小分子抑制剂。2017年6月19日首位受试者接受给药治疗。该试验是今年早先在澳大利亚展开的I期临床试验的一项补充研究。
该试验是一项多中心单臂开放标签的两阶段研究，旨在评估HMPL‑453作为单一疗法在治疗携带FGFR基因突变的实体瘤患者中的安全性，耐受性，药代动力学特性和初步疗效。剂量爬升阶段将招募局部晚期或转移性实体瘤的患者，这些患者缺乏标准疗法或标准疗法被证实为无效或不耐受，但暂不考虑FGFR基因表达状态，旨在确定最大耐受剂量和临床II期研究的推荐剂量。
剂量爬升之后的剂量扩展阶段将进一步评估临床II期研究推荐剂量的安全性，耐受性和药代动力学特性以及初步的抗肿瘤功效。 这一阶段将主要招募有FGFR异常表达的癌症患者，包括晚期膀胱癌，晚期胆管癌等实体肿瘤。 第二阶段研究的主要终点是客观缓解率 （ORR），次要终点包括缓解持续时间（DoR），疾病控制率 (DCR)，无进展生存期(PFS)，总生存期(OS)和安全性。 该研究的详细信息请登陆clinicaltrials.gov，检索NCT03160833查看。
关于膀胱癌和胆管癌
膀胱癌占尿路上皮癌的约90％。 膀胱癌是美国第六大，也是中国第九大最常见的恶性肿瘤，两国每年各有约80,000例新发病例。在美国，疾病已转移的患者五年生存率约为5％。尽管局部晚期或转移性尿路上皮癌的治疗取得了一定进步，但患者的预后仍然很差，需要更多的治疗方案。
作为在世界范围内未得到满足的医疗需求, 胆管癌占全球胃肠癌的3％左右，是胆道（肝，胆囊和胆管的联合系统）最常见的恶性肿瘤。胆管癌根据解剖位置分为肝内或肝外，研究表明肝内胆管癌的发生率有明显的上升。目前胆管癌预后不佳，5年生存率低于 5％。
关于FGFR
FGFR是受体酪氨酸激酶的亚家族。 FGFR信号通路的激活是数个生物过程的关键。 在正常生理情况下，FGF / FGFR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，异常的FGFR信号传导被发现是肿瘤增长，促进血管生成以及针对抗肿瘤治疗产生抗性的驱动力。 目前还没有专门针对FGFR信号通路的疗法获批。
关于HMPL-453
HMPL‑453是一种靶向成纤维细胞生长因子受体FGFR 1，2，3的新型高选择性小分子抑制剂。在临床前研究中，HMPL‑453与同类其他药物相比表现出药效强，激酶选择性高及安全性更佳的特点。和黄医药正在澳大利亚展开HMPL-453的一项I期临床研究，详细内容请登陆clinicaltrials.gov，检索 NCT02966171查看。
Mandarin Oriental, Hong Kong
London: Friday, June 16, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has received notifications that:-
- Dynamic Drive Limited, a person closely associated (“PCA”) with Mr Simon To, Executive Director and Chairman, purchased a total of 11,158 American Depositary Shares of the Company (“ADSs”, each representing one half of one ordinary share of US$1.00 each in the capital of Chi-Med (“Ordinary Share”)) between June 13 and 15, 2017 at an average price of US$21.18 per ADS. Dynamic Drive Limited is controlled by the trustee of Dynamic Drive Trust (the “DDT”) which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor;
- Wencheng Capital Limited (“WCL”), a PCA with Mr To, purchased a total of 25,669 ADSs between June 13 and 15, 2017 at an average price of US$21.15 per ADS. WCL is controlled by the trustee of Wencheng Trust (“WT”) which has been established for the benefit of Mr To’s family member, of which Mr To is the settlor;
- Mr To transferred a total of 70,000 ADSs from an account in his own name to WCL on June 14, 2017; and
- Ms Edith Shih, Non-executive Director and Company Secretary, purchased a total of 25,403 ADSs on June 14 and 15, 2017 at an average price of US$21.17 per ADS.
Following the above purchase of a total of 36,827 ADSs and transfer of 70,000 ADSs, Mr To is interested in 106,827 ADSs (in DDT and WT of which his family members are the beneficiaries) and 180,000 Ordinary Shares (including the holding of 78,000 Ordinary Shares in DDT of which his family members are the beneficiaries), representing in aggregate approximately 0.38% of the current issued share capital of Chi-Med.
Following the above purchase, Ms Shih is interested in 76,144 ADSs and 60,000 Ordinary Shares, representing approximately 0.16% 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.
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||||
| a) | Name | Dynamic Drive Limited | ||||||||
| 2 | Reason for the notification | |||||||||
| a) | Position/status | Person closely associated with Mr Simon To, Executive Director and Chairman. Dynamic Drive Limited is controlled by the trustee of Dynamic Drive Trust which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor. | ||||||||
| 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 one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||
| b) | Nature of the transaction | Acquisition of 11,158 ADSs in the name of Dynamic Drive Limited which holds the ADSs for a family trust (Dynamic Drive Trust) of which Mr To is the settlor between June 13 and 15, 2017 at an average price of US$21.18 per ADS | ||||||||
| c) | Price(s) and volume(s) |
|
||||||||
| d) | Aggregated information
|
Aggregated volume: 11,158 Price information: US$21.18 |
||||||||
| e) | Date of the transaction | 2017-06-13 – acquisition of 6,780 ADSs 2017-06-14 – acquisition of 500 ADSs 2017-06-15 – acquisition of 3,878 ADSs |
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| f) | Place of the transaction | Nasdaq Stock Market | ||||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||||
| a) | Name | Wencheng Capital Limited | ||||||||
| 2 | Reason for the notification | |||||||||
| a) | Position/status | Person closely associated with Mr Simon To, Executive Director and Chairman. Wencheng Capital Limited is controlled by the trustee of Wencheng Trust which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor. | ||||||||
| 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 one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||
| b) | Nature of the transaction | Acquisition of 25,669 ADSs in the name of Wencheng Capital Limited which holds the ADSs for a family trust (Wencheng Trust) of which Mr To is the settlor between June 13 and 15, 2017 at an average price of US$21.15 per ADS | ||||||||
| c) | Price(s) and volume(s) |
|
||||||||
| d) | Aggregated information
|
Aggregated volume: 25,669 Price information: US$21.15 |
||||||||
| e) | Date of the transaction | 2017-06-13 – acquisition of 16,958 ADSs 2017-06-14 – acquisition of 1,300 ADSs 2017-06-15 – acquisition of 7,411 ADSs |
||||||||
| f) | Place of the transaction | Nasdaq Stock Market | ||||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | ||||||||
| a) | Name | Mr Simon To | |||||||
| 2 | Reason for the notification | ||||||||
| a) | Position/status | Executive Director and Chairman | |||||||
| 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 Identificationcode |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
|||||||
| b) | Nature of the transaction | Disposal of 70,000 ADSs from Mr Simon To to Wencheng Capital Limited which holds the ADSs for a trust (Wencheng Trust), established for the benefit of Mr To’s family members, of which Mr To is the settlor on June 14, 2017 | |||||||
| c) | Price(s) and volume(s) |
|
|||||||
| d) | Aggregated information
|
N/A | |||||||
| e) | Date of the transaction | 2017-06-14 | |||||||
| f) | Place of the transaction | Outside a trading venue | |||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||
| a) | Name | Wencheng Capital Limited | ||||
| 2 | Reason for the notification | |||||
| a) | Position/status | Person closely associated with Mr Simon To, Executive Director and Chairman. Wencheng Capital Limited is controlled by the trustee of Wencheng Trust which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor. | ||||
| 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 Identificationcode |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||
| b) | Nature of the transaction | Acquisition of 70,000 ADSs in the name of Wencheng Capital Limited which holds the ADSs for a family trust (Wencheng Trust) of which Mr To is the settlor on June 14, 2017 | ||||
| c) | Price(s) and volume(s) |
|
||||
| d) | Aggregated information
|
N/A | ||||
| e) | Date of the transaction | 2017-06-14 | ||||
| f) | Place of the transaction | Outside a trading venue | ||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||||
| a) | Name | Ms Edith Shih | ||||||||
| 2 | Reason for the notification | |||||||||
| a) | Position/status | Non-executive Director and Company Secretary | ||||||||
| 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 Identificationcode |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||
| b) | Nature of the transaction | Acquisition of 25,403 ADSs on June 14 and 15, 2017 at an average price of US$21.17 per ADS | ||||||||
| c) | Price(s) and volume(s) |
|
||||||||
| d) | Aggregated information
|
Aggregated volume: 25,403 Price information: US$21.17 |
||||||||
| e) | Date of the transaction | 2017-06-14 – Acquisition of 24,445 ADSs 2017-06-15 – Acquisition of 958 ADSs |
||||||||
| f) | Place of the transaction | Nasdaq Stock Market | ||||||||
About Chi-Med
Chi-Med is an innovative 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
U.K. & 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
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@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
–国家食品药品监督管理局已受理申请，并将由 药品审评中心作技术审核–
–将收到来自礼来共计3080万人民币的里程碑付款–
2017年6月12日：和黄医药今日宣布药物呋喹替尼治疗晚期结直肠癌的新药上市申请已获国家食品药品监督管理局（CFDA）的正式受理，美国礼来因此将向和黄医药支付共计人民币3080万（450万美元）的里程碑付款。此次新药上市申请是基于和黄医药呋喹替尼治疗416名晚期或转移性结直肠癌患者的关键临床III期注册试验“FRESCO”的成功，其试验数据已于2017年6月5日在美国临床肿瘤协会年会上做了口头报告。
关于结直肠癌
结直肠癌是中国第二大最常见的恶性肿瘤，根据全国肿瘤登记中心数据显示，每年新增病例约为38万例。
根据咨询公司Frost & Sullivan的数据，2015年全球新增结直肠癌病例约为150万例，至2020年预计增至170万例。
关于呋喹替尼
呋喹替尼是一种新型的高选择性小分子候选药物，临床研究证实：通过一日一次的口服剂量即可有效的抑制血管内皮生长因子受体（VEGFR），且脱靶毒性低于其他靶向疗法。从药物的耐受性，以及根据目前显示出的无药物相互作用的特性来看，呋喹替尼或能够与其他癌症疗法进行联合用药，例如当前正在进行的临床试验中，呋喹替尼联合化疗及其他靶向疗法治疗不同的肿瘤。
癌症进入到晚期，肿瘤会分泌大量的蛋白配体-血管内皮生长因子(VEGF)，以促进肿瘤组织周围过度的脉管系统的生成(血管生成)，为肿瘤细胞的生长提供更多的血流，氧气和营养。VEGF和其受体VEGFR在肿瘤的血管生成中起到了至关重要的作用，因此，对VEGF/VEGFR相关通路的抑制就成为了阻断新生血管形成，防止肿瘤增长和侵入的一种重要的治疗策略。
根据此前的合作协议，呋喹替尼由和黄医药和美国礼来在中国范围内合作开发。2017年3月3日，合作的双方共同宣布呋喹替尼以结直肠癌为适应症的III期临床试验“FRESCO”的研究结果。此外，呋喹替尼以非小细胞肺癌为适应症的III期临床试验被命名为“FALUCA”，目前正在中国展开研究，另有一项II期临床试验以呋喹替尼联合易瑞沙（吉非替尼）治疗一线晚期或转移性非小细胞肺癌也正在进行中。与紫杉醇联合用药治疗胃癌的中国III期临床研究，在美国的数项新研究，以及与其他肿瘤药物联合用药的多项探索性研究也正在计划中，将于今后逐渐展开。
2017年6月5日：和黄医药宣布在今天于美国芝加哥举行的美国临床肿瘤学会（ASCO）年会上就其自主研发的高选择性血管细胞内皮生长因子受体（VEGFR）抑制剂的关键III期临床研究结果进行了口头报告。“FRESCO”是呋喹替尼以局部晚期或转移性结直肠癌为适应症的一项随机双盲安慰剂对照的多中心中国III期临床研究，结果表明其达到了所有主要和次要终点，显著提高了总生存期和无进展生存期，与其他靶向疗法相比，具有可管理的安全性及更低的脱靶毒性。
同济大学附属上海东方医院肿瘤医学部主任李进教授表示，“416名受试者的试验数据显示，呋喹替尼在治疗既往至少经过2轮治疗失败的转移性结直肠癌患者过程中，为受试者带来了显著的统计学及临床意义的生存获益，且不良事件可管理和可控。特别令人鼓舞的是，与其他靶向疗法相比，呋喹替尼引起的肝功能异常发生率更低且更轻微。”
“总体的安全性和药效数据表明呋喹替尼为疾病持续进展的结直肠癌患者提供了一种重要的新治疗方案。”李进教授总结道。
药效结果
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轮化疗／治疗 （包括奥沙利铂和氟尿嘧啶类药物及伊立替康）失败的转移性结直肠癌患者。在中国，经2轮治疗失败的结直肠癌患者，最佳支持治疗是一般护理标准。受试者招募于2016年5月全部完成，共筛选了519名患者。416名意向治疗人群受试者以2: 1的比例随机接受每天口服一次5毫克的呋喹替尼（服药三周/停药一周为一周期）联合最佳支持治疗（278名患者）或安慰剂联合最佳支持治疗（138名患者）。以此前患者接受的抗VEGF治疗及K-Ras基因状态为依据进行随机分层。该试验于2017年1月17日全部完成。
总生存期（OS）是FRESCO研究的主要终点，呋喹替尼治疗组的中位OS为9.30个月（95％CI 8.18-10.45），而安慰剂组为6.57个月（95％CI 5.88-8.11），风险比为0.65 [95％CI：0.51-0.83；双侧p<0.001]。
中位无进展生存期（PFS）为次要终点，在呋喹替尼组中为3.71个月（95％CI 3.65-4.63），而安慰剂组为1.84个月（95％CI 1.81-1.84），风险比为0.26 [95％CI：0.21-0.34；双侧p<0.001]。
其他次要终点也有显著效益：呋喹替尼组病情控制率（DCR）为62.2％，而安慰剂组为12.3％（p<0.001）；呋喹替尼组的总体缓解率（ORR）为4.7％，而安慰剂组为0％（p=0.012）。
安全性及耐受性结果
结果表明，与其他靶向治疗相比，呋喹替尼具有可控的安全性，较低的靶外毒性，并没有显示针对结直肠癌的其他靶向药所观察到的偶尔但严重且致命的肝毒性。
最常见的与呋喹替尼相关的≥3级不良事件包括：高血压（21.2％），手足皮肤反应（10.8％），蛋白尿（3.2％）和腹泻（2.9％），均与VEGFR靶点抑制有关。 接受呋喹替尼治疗的人群中，其他≥3级不良事件不超过1.4％，包括肝功能不良事件，如胆红素升高（1.4％），丙氨酸氨基转移酶（ALT）（0.7％）或天冬氨酸氨基转移酶（AST）（0.4％）。
呋喹替尼组的剂量调整或减少发生率仅为35.3%及24.1%，仅有15.1%的受试者中止治疗，安慰剂组则为5.8%。
关于“FRESCO”研究的详细信息，可在clinicaltrials.gov搜索NCT02314819查看。详细报告请点击chi-med.com/wp-content/uploads/2017/06/pre170605-013asco.pdf。
和黄医药将于近期完成向国家食品药品监督管理总局递交呋喹替尼的新药上市申请。同时将于2017年年内启动呋喹替尼在美国的临床研究。
关于呋喹替尼
呋喹替尼是一种新型的高选择性小分子候选药物，临床研究证实：通过一日一次的口服剂量即可有效的抑制血管内皮生长因子受体（VEGFR），且脱靶毒性低于其他靶向疗法。其良好的耐受性加上被证明的无药物相互作用的特性，使得呋喹替尼可以与其他抗癌药物联合使用，例如在正进行的临床试验中，联合化疗／靶向药物与呋喹替尼一起治疗各种癌症。
癌症进入到晚期，肿瘤会分泌大量的蛋白配体-血管内皮生长因子(VEGF)，以促进肿瘤组织周围过度的脉管系统的生成(血管生成)，为肿瘤细胞的生长提供更多的血流，氧气和营养。VEGF和其受体VEGFR在肿瘤的血管生成中起到了至关重要的作用，因此，对VEGF/VEGFR相关通路的抑制就成为了阻断新生血管形成，防止肿瘤增长和侵入的一种重要的治疗策略。
根据此前的合作协议，呋喹替尼由和黄医药和美国礼来在中国范围内合作开发。2017年3月3日，合作的双方共同宣布呋喹替尼以结直肠癌为适应症的III期临床试验“FRESCO”的研究结果。此外，呋喹替尼以非小细胞肺癌为适应症的III期临床试验被命名为“FALUCA”，目前正在中国展开研究，另有一项II期临床试验以呋喹替尼联合易瑞沙（吉非替尼）治疗一线晚期或转移性非小细胞肺癌也正在进行中。与紫杉醇联合用药治疗胃癌的中国III期临床研究，在美国的数项新研究，以及与其他肿瘤药物联合用药的多项探索性研究也正在计划中，将于今后逐渐展开。
A randomized, double-blind, placebo-controlled, multi-centered phase III trial comparing fruquintinib versus placebo plus best supportive care in Chinese patients with metastatic colorectal cancer (FRESCO)
Venue: American Society of Clinical Oncology Annual Meeting in Chicago, IL
Abstract #: 3508
Presenter: Dr. Jin Li, Oncologist and Director of the Tumor Department, Shanghai East Hospital, Tongji University School of Medicine
Authors: J Li, S Qin, RH Xu, J Xu, L Shen, Y Bai, Y Deng, L Yang, ZD Chen, H Zhong, H Pan, W Guo, Y Shu, Y Yuan, J Zhou
Session: Gastrointestinal (Colorectal) Cancer – Oral Abstract Session
Date & Time: Monday, June 5, 2017, 5:24 PM CDT
Location: Hall D2
A phase II multicenter trial of the multitargeted kinase inhibitor sulfatinib in advanced medullary thyroid cancer (MTC) and radioiodine (RAI)-refractory differentiated thyroid cancer (DTC)
Venue: American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, USA
Abstract #: 6037
Authors: J Chen, Q Ji, J Cao, D Ji, C Bai, Y Lin, B Pan, G Sun, J Li, C Qi, Y Hua
Session: Head and Neck Cancer
Date & Time: Monday, June 5, 2017, 1:15 PM CDT
Location: Hall A