London: Tuesday, February 25, 2020: Further to its announcement dated January 31, 2020, Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announced that its final results for the year ended December 31, 2019 will be released on Tuesday, March 3, 2020.  The time has been revised to 12:00 noon Greenwich Mean Time (GMT) / 7:00 am Eastern Standard Time (EST) / 8:00 pm Hong Kong Time (HKT).

Due to travel restrictions resulting from the novel coronavirus outbreak, Chi-Med management will not be travelling to London for a live presentation for analysts and investors.  Analysts and investors are instead invited to join a conference call and audio webcast presentation with Q&A, conducted by Chi-Med management in Hong Kong and China.

The conference call and audio webcast will take place at 1:00 pm GMT / 8:00 am EST / 9:00 pm HKT on Tuesday, March 3, 2020 and will be webcast live via the company website at www.chi-med.com/investors/event-information/.  The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website.  A replay will also be available on the website shortly after the event.

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 500 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies for the treatment of cancer 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.

CONTACTS

Investor Enquiries

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

Media Enquiries

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

Nominated Advisor

Atholl Tweedie, Panmure Gordon (UK) Limited

Paul Choi
+1 212 902 5217
paul.k.choi@gs.com

Ziyi Chen
+852 2978 0526
ziyi.chen@gs.com

Emily Field
+44 20 7773 6263
emily.field@barclays.com

Jameel Bakhsh
+44 20 7116 7038
jameel.x.bakhsh@barclays.com

新闻稿

伦敦，2020年2月10日，星期一:  和黄中国医药科技有限公司(简称 “和黄医药” 或 “Chi-Med”)(AIM/Nasdaq: HCM) 今日公布CALYPSO II期临床研究中探索沃利替尼/Imfinzi^®（durvalumab / 度伐利尤单抗）联合疗法治疗转移性乳头状肾细胞癌（PRCC）研究队列的进展。这是一项研究者发起的临床试验，主要研究者为英国Barts癌症研究所实体瘤研究首席研究员Thomas Powles教授，研究的申办方为伦敦玛丽王后大学（Queen Mary University of London）。

CALYPSO 研究中PRCC队列的完整数据将于2020年2月15日（星期六）在美国旧金山举行的美国临床肿瘤学会生殖泌尿癌研讨会(“ASCO GU”) 上进行口头与海报报告。

本次报告的具体细节如下：

本项研究的初步结果早前已于2019年2月16日的ASCO-GU上首次发表 （截止日期为2018年9月25日)。[i]

关于CALYPSO研究中的PRCC队列

乳头状肾细胞癌（PRCC）是肾癌的一种亚型，通常难以治疗，现有疗法能够获得的缓解率较低，目前对此适应症暂无获批的治疗方式。CALYPSO研究为独立资助的开放标签II 期研究，在英国及西班牙进行，旨在探索Imfinzi^®分别与数种其他药物联合治疗肾细胞癌。CALYPSO研究中的数个队列正在评估沃利替尼治疗PRCC或肾透明细胞癌（ccRCC）的情况。沃利替尼为一种高选择性MET受体酪氨酸激酶抑制剂，在该研究中用作单药或与阿斯利康（AstraZeneca）开发的程序性死亡配体1（PD-L1 ）的单克隆抗体Imfinzi^®（durvalumab）联合使用。CALYPSO的入组对象为所有PRCC患者，并将对患者进行预定的回顾式分子特征谱分析。如需了解更多详情，请参考clinicaltrials.gov研究编号NCT02819596。

关于沃利替尼

沃利替尼（Savolitinib）是一种有潜力成为全球首创的间充质上皮转化因子 （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。和黄医药对沃利替尼进行了成功的设计，使其成为强效且高选择性的口服抑制剂，并通过对其化学结构的修饰以避免在其他选择性MET抑制剂研发过程中出现的代谢相关肾毒性问题。迄今为止，在涉及全球范围内逾1000名患者的临床研究中，沃利替尼在多種MET基因异常的腫瘤中均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全球合作，对沃利替尼作为单药疗法或联合疗法进行试验。

关于Chi-Med

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500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。

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，包括对沃利替尼临床开发的预期、启动沃利替尼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、候选药物沃利替尼（包括作为联合治疗）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、沃利替尼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。

联系方式

London: Thursday, February 6, 2020: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announced today that the underwriters of its underwritten public offering of American Depositary Shares (“ADSs”) on the Nasdaq Global Select Market, previously announced by Chi-Med on January 21, 2020 and January 23, 2020 (the “Offering”), have given notice to Chi-Med that they are exercising their over-allotment option. The underwriters have elected to purchase an additional 333,663 ADSs at the Offering price of US$25.00 per ADS, raising approximately an additional US$8.3 million in gross proceeds for the Company and bringing the total gross proceeds of the Offering to approximately US$118.3 million. Closing of the over-allotment portion is expected to occur on February 10, 2020. After the closing, the total number of ADSs sold by Chi-Med in the Offering will have increased to 4,733,663.

BofA Securities, Inc., Goldman Sachs (Asia) L.L.C. and Morgan Stanley & Co. LLC (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering.  Deutsche Bank Securities Inc. and HSBC Securities (USA) Inc. are acting as joint bookrunners, and Canaccord Genuity LLC, CLSA Limited and Panmure Gordon (UK) Limited are acting as co-managers.

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 500 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in cancer 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.

Information about the Offering

The Offering is being made pursuant to a shelf registration statement on Form F-3 filed by Chi-Med with the United States Securities and Exchange Commission (“SEC”) that became automatically effective on April 3, 2017.  The final prospectus supplement relating to and describing the terms of the Offering was filed with the SEC on January 23, 2020 and is available on the SEC’s website at www.sec.gov.  Before you invest, you should read the registration statement, prospectus supplement and other documents the issuer has filed with the SEC for more complete information about Chi-Med and the Offering.  Copies of the final prospectus supplement and the accompanying prospectus relating to the Offering may be obtained from BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or e-mail: dg.prospectus_requests@baml.com; or Goldman Sachs & Co. L.L.C., Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526; or Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014.

This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

The 1,668,315 new ordinary shares to be issued by Chi-Med pursuant to the underwriters’ partial exercise of the over-allotment option  (“New Shares”) will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing ordinary shares of Chi-Med, including the right to receive all dividends and other distributions declared, made or paid in respect of such shares after the date of issue of the New Shares.

Application will be made to the London Stock Exchange for the New Shares to be admitted to the AIM market operated by the London Stock Exchange (“Admission”). It is expected that Admission will become effective at 8:00 a.m. on February 11, 2020.

Following admission of the 1,668,315 New Shares to trading on AIM, the issued share capital of Chi-Med will consist of 690,574,765 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. This figure of 690,574,765 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 Guidance and Transparency Rules. For illustrative purposes only, the 690,574,765 ordinary shares would be equivalent to 690,574,765 depositary interests (each equating to one ordinary share) which are traded on AIM or, if the depositary interests were converted in their entirety, equivalent to 138,114,953 ADSs (each equating to five ordinary shares) which are traded on the Nasdaq Global Select Market.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

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.  These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its management plans and objectives.  Forward-looking statements involve risks and uncertainties.  Such risks and uncertainties include, among other things, the possibility that the closing conditions for the shares being sold as a result of the exercise of the underwriters’ over-allotment option will not be satisfied.  More information about such risks and uncertainties is contained or incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus related to the Offering filed with the SEC. 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 SEC and on AIM.  None of Chi-Med, BofA Securities, Inc., Goldman Sachs (Asia) L.L.C. and Morgan Stanley & Co. LLC undertakes any obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.

Important Notice

No prospectus required for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) or admission document for the purposes of the AIM Rules for Companies will be made available in connection with the matters contained in this announcement.

In any Member State of the European Economic Area, this announcement is only addressed to and directed at persons who are “Qualified Investors” within the meaning of Article 2(e) of the Prospectus Regulation.  The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with Qualified Investors.  This announcement should not be acted upon or relied upon in any Member State of the European Economic Area by persons who are not Qualified Investors.

In addition, this communication, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of s21 Financial Services and Markets Act 2000 as amended) in connection with the securities which are the subject of the Offering described in this announcement or otherwise, is being directed only at persons who (i) are outside the United Kingdom or (ii) have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) are persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000) in connection with the issue or sale of any securities may otherwise lawfully be communicated or caused to be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). This announcement is directed only at relevant persons and must not be acted on or relied on in the United Kingdom by persons who are not relevant persons.  Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.

In connection with the Offering, the underwriters may conduct stabilization activities with respect to the ADSs on Nasdaq, in the over-the-counter market or otherwise, to support the market price of the ADSs at a higher level than that which might otherwise prevail in the open market, in compliance with all applicable laws and regulations, including Regulation M under the U.S. Securities Exchange Act of 1934, as amended. These activities may include short sales, stabilizing transactions and purchases of ordinary shares or ADSs to cover positions created by short sales. Any stabilization action may begin on the date of the final prospectus supplement and, if begun, may be ended at any time but must end no later than 30 calendar days thereafter. However, there is no obligation on the underwriters (or any person acting for them) to conduct any such stabilizing activities, and the stabilization activities may be discontinued at any time. All stabilization activities will be conducted by Goldman Sachs & Co. L.L.C. as stabilization manager (or persons acting on its behalf).

CONTACTS

Investor Enquiries

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

Media Enquiries

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

Nominated Advisor

Atholl Tweedie, Panmure Gordon (UK) Limited

Osimertinib plus savolitinib in patients with EGFR mutation-positive, MET-amplified, non-small-cell lung cancer after progression on EGFR tyrosine kinase inhibitors: interim results from a multicentre, open-label, phase 1b study

Lecia V Sequist; Ji-Youn Han; Myung-Ju Ahn; Byoung Chul Cho; Helena Yu; Prof Sang-We Kim; James Chih-Hsin Yang; Jong Seok Lee; Wu-Chou Su; Dariusz Kowalski; Sergey Orlov; Mireille Cantarini; Remy B Verheijen; Anders Mellemgaard; Lone Ottesen; Paul Frewer; Xiaoling Ou; Geoffrey Oxnard

Summary

Background

Preclinical data suggest that EGFR tyrosine kinase inhibitors (TKIs) plus MET TKIs are a possible treatment for EGFR mutation-positive lung cancers with MET-driven acquired resistance. Phase 1 safety data of savolitinib (also known as AZD6094, HMPL-504, volitinib), a potent, selective MET TKI, plus osimertinib, a third-generation EGFR TKI, have provided recommended doses for study. Here, we report the assessment of osimertinib plus savolitinib in two global expansion cohorts of the TATTON study.

Methods

In this multi-arm, multicentre, open-label, phase 1b study, we enrolled adult patients (aged ≥18 years) with locally advanced or metastatic, MET-amplified, EGFR mutation-positive non-small-cell lung cancer, who had progressed on EGFR TKIs. We considered two expansion cohorts: parts B and D. Part B consisted of three cohorts of patients: those who had been previously treated with a third-generation EGFR TKI (B1) and those who had not been previously treated with a third-generation EGFR TKI who were either Thr790Met negative (B2) or Thr790Met positive (B3). In part B, patients received oral osimertinib 80 mg and savolitinib 600 mg daily; after a protocol amendment (March 12, 2018), patients who weighed no more than 55 kg received a 300 mg dose of savolitinib. Part D enrolled patients who had not previously received a third-generation EGFR TKI and were Thr790Met negative; these patients received osimertinib 80 mg plus savolitinib 300 mg. Primary endpoints were safety and tolerability, which were assessed in all dosed patients. Secondary endpoints included the proportion of patients who had an objective response per RECIST 1.1 and was assessed in all dosed patients and all patients with centrally confirmed MET amplification. Here, we present an interim analysis with data cutoff on March 29, 2019. This study is registered with ClinicalTrials.gov, NCT02143466.

Findings

Between May 26, 2015, and Feb 14, 2019, we enrolled 144 patients into part B and 42 patients into part D. In part B, 138 patients received osimertinib plus savolitinib 600 mg (n=130) or 300 mg (n=8). In part D, 42 patients received osimertinib plus savolitinib 300 mg. 79 (57%) of 138 patients in part B and 16 (38%) of 42 patients in part D had adverse events of grade 3 or worse. 115 (83%) patients in part B and 25 (60%) patients in part D had adverse events possibly related to savolitinib and serious adverse events were reported in 62 (45%) patients in part B and 11 (26%) patients in part D; two adverse events leading to death (acute renal failure and death, cause unknown) were possibly related to treatment in part B. Objective partial responses were observed in 66 (48%; 95% CI 39–56) patients in part B and 23 (64%; 46–79) in part D.

Interpretation

The combination of osimertinib and savolitinib has acceptable risk–benefit profile and encouraging antitumour activity in patients with MET-amplified, EGFR mutation-positive, advanced NSCLC, who had disease progression on a previous EGFR TKI. This combination might be a potential treatment option for patients with MET-driven resistance to EGFR TKIs.

Citations and Links

Please follow the link below to access the publication:

Lancet Oncol. 2020 Mar;21(3):373-386. doi: 10.1016/S1470-2045(19)30785-5. Epub 2020 Feb 3.

DOI: https://doi.org/10.1016/S1470-2045(19)30785-5

Link to article: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30785-5/fulltext