2017年10月31日：和黄医药今日宣布在中国启动呋喹替尼联合紫杉醇（泰素®）以晚期胃癌或胃食管结合部（GEJ）腺癌为适应症的关键性III期临床研究，这项研究被命名为FRUTIGA 。呋喹替尼是一种高选择性强效口服血管内皮生长因子受体（VEGFR）1，2及3的抑制剂。这项随机双盲安慰剂对照的多中心临床研究受试者为既往接受一线标准化疗后进展的晚期胃癌患者。晚期胃癌的治疗，尤其在亚洲人群中，目前尚存在着巨大的未获满足的医疗需求。对于既往接受5-氟尿嘧啶（5-FU）和含铂双药组合化疗失败的患者，可供选择的治疗方案非常有限。中国每年胃癌发病数约为679,100例，死亡数约为498,000例。
“呋喹替尼可以高选择性地抑制VEGFR 1，2及3，展现出了良好的与化疗联合的潜力，这种联合疗法是针对晚期胃癌的一种创新性的尝试。” 和黄中国医药科技有限公司首席执行官贺隽先生表示，“目前呋喹替尼以三线结直肠癌（CRC）为适应症的新药上市申请（NDA）正在审评中，以三线非小细胞肺癌为适应症的III期临床研究也将要完成入组。我们非常高兴地看到，呋喹替尼以二线胃癌为适应症的临床研究也进入了最后的阶段。胃癌的二线治疗涉及到的病患人数非常多，中国的胃癌患者对新的二线治疗方案的需求极其急迫。”
FRUTIGA研究是一项随机双盲III期临床试验，旨在评估呋喹替尼联合紫杉醇对比紫杉醇单药化疗治疗二线晚期胃癌或GEJ腺癌的疗效和安全性。研究计划纳入500名患者，目标受试者为经组织学或细胞学确诊为晚期胃癌或GEJ腺癌，且对含有铂类和氟尿嘧啶的一线标准化疗无应答的患者。受试者将以1:1的比例接受呋喹替尼联合紫杉醇或安慰剂联合紫杉醇的治疗，并根据胃癌 vs. GEJ腺癌和ECOG评分等因素进行分层。这项研究的安全性和疗效数据将由独立的数据监察委员会（IDMC）进行评审。
研究的主要疗效终点为总生存期（OS）。次要疗效终点包括无进展生存期（PFS，依据RECIST 1.1进行评估）、客观缓解率（ORR）、疾病控制率（DCR）、疾病缓解时间和生存质量评分（依据EORTC QLQ-C30，3.0版进行评估）。研究也将探索与呋喹替尼抗肿瘤活性相关的生物标志物。
该研究详情可登陆clinicaltrials.gov，检索NCT03223376查看。
呋喹替尼联合紫杉醇（泰素®）以二线晚期胃癌为适应症的多中心开放标签Ib期剂量探索/剂量扩展临床试验（clinicaltrials.gov 注册号 NCT02415023）的研究结果为FRUTIGA的开展提供了基础。该项Ib期临床试验的研究结果已在2017年1月召开的美国临床肿瘤学会胃肠道肿瘤论坛上公布。该项Ib期研究共入组32名受试者，其中可进行疗效评估的有28名，ORR为36%，DCR为68%。在呋喹替尼的II期临床试验推荐剂量（RP2D）下，50%的患者PFS≥16周，50%的患者OS≥7个月。联合方案在RP2D下的耐受性与预期一致，常见的与治疗相关的3级及以上不良事件（AEs）包括中性粒细胞减少（41%）、白细胞减少（28%）、血红蛋白下降（6%）和手足综合征（6%）。
根据Frost & Sullivan公司的估计，全球每年新增胃癌病例数约为1百万。2015年中国新增胃癌病例数约占全球新增胃癌病例数的44%。根据全国肿瘤登记中心估计，2015年中国胃癌发病数约为679,100例，死亡数约为498,000例。
胃癌引起的死亡病例数在各项癌症中排名第三。胃癌在确诊时常常已经发展到晚期阶段，预后较差，中位OS不超过12个月。虽然在中国已有在研的胃癌靶向疗法，化疗仍是胃癌治疗的主要手段，但化疗带来的生存获益较为有限。因此，目前亟需针对胃癌的新型靶向治疗选择。
呋喹替尼（HMPL-013）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。呋喹替尼良好的耐受性以及无药物间相互作用的特性，为其与其他癌症疗法相联合提供了理论支持，例如当前正在进行的呋喹替尼联合化疗或其他靶向治疗的临床研究。
癌症进入到晚期，肿瘤会分泌大量VEGFR的配体蛋白-血管内皮生长因子(VEGF)，以促进肿瘤组织周围形成大量的血管（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，而呋喹替尼可以抑制VEGF/VEGFR通路。对VEGF/VEGFR相关通路的抑制可以阻断肿瘤新生血管形成，从而成为防止肿瘤增长和入侵的一种重要的治疗策略。
目前呋喹替尼由和黄医药和礼来在中国范围内合作开发。
2017年6月，中国食品药品监督管理总局（CFDA）受理呋喹替尼以晚期结直肠癌为适应症的新药上市申请；2017年9月，CFDA公布因呋喹替尼具有明显临床价值而授予其优先审评的资格。FRESCO研究的成功为呋喹替尼的新药上市申请提供了有力的数据支持。FRESCO研究是一项在中国完成的III期关键性注册研究，共计纳入416名CRC患者，研究结果于2017年6月5日在美国临床肿瘤学会年会上以口头报告的形式公布（clinicaltrials.gov 注册号 NCT02314819）。
除FRUTIGA和FRESCO两项III期临床研究以外，呋喹替尼以非小细胞肺癌（NSCLC）为适应症的III期关键性临床试验FALUCA（clinicaltrials.gov 注册号 NCT02691299）目前也正在中国展开；另有一项II期临床试验也正在进行中，该试验以呋喹替尼联合易瑞沙®（吉非替尼）作为一线疗法，治疗晚期或转移性NSCLC（clinicaltrials.gov 注册号 NCT02976116）。呋喹替尼在美国的数项新研究（clinicaltrials.gov 注册号 NCT03251378)，以及与其他抗肿瘤药物联合用药的多项探索性研究正在计划中。
London: Monday, October 30, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announced today the closing of its underwritten public offering of American Depositary Shares (“ADSs”) on the Nasdaq Global Select Market, previously announced by Chi-Med on October 24, 2017, October 25, 2017 and October 27, 2017 at a price of US$26.50 per ADS (“Offering”), raising gross proceeds of approximately US$301.3 million (before deducting underwriting discounts, commissions and offering expenses).
BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon (UK) Limited and CITIC CLSA are acting as co-managers for the Offering.
Chi-Med further hereby gives notice that no stabilisation (within the meaning of Article 3.2(d) of the Market Abuse Regulation 596/2014) was undertaken by Deutsche Bank as stabilising manager in relation to the Offering of the ADSs.
The 5,684,905 new ordinary shares being issued by Chi-Med pursuant to the Offering (“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 has been made to the London Stock Exchange for 4,943,396 new ordinary shares to be admitted to the AIM market operated by the London Stock Exchange (“First Admission”). It is expected that First Admission will become effective at 8:00 a.m. on October 31, 2017.
Application has been made to the London Stock Exchange for 741,509 new ordinary shares to be admitted to the AIM market operated by the London Stock Exchange (“Second Admission”). It is expected that Second Admission will become effective at 8:00 a.m. on November 2, 2017.
Following admission of the 5,684,905 New Shares to trading on AIM, the issued share capital of Chi-Med will consist of 66,435,037 ordinary shares of US$1.00 each, with each share carrying one right to vote and with no shares held in treasury. This figure of 66,435,037 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 66,435,037 ordinary shares would be equivalent to 66,435,037 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 132,870,074 ADSs (each equating to one-half of one ordinary share) which are traded on Nasdaq.
This announcement does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The ADSs described above are being offered by Chi-Med pursuant to a shelf registration statement on Form F-3 (including a base prospectus) filed by Chi-Med with the United States Securities and Exchange Commission (“SEC”) that became automatically effective on April 3, 2017. A prospectus supplement and an accompanying prospectus related to the Offering has been filed with the SEC. This prospectus supplement, the accompanying prospectus and any documents incorporated therein are available on the website of the SEC at www.sec.gov.
No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.
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 distribution of this announcement into jurisdictions other than the UK may be restricted by law. Persons into whose possession this announcement come should inform themselves about and observe any such restrictions.
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation 596/2014.
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.
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 management’s goals and objectives. 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 SEC and on AIM. None of Chi-Med, BofA Merrill Lynch or Deutsche Bank Securities (in alphabetical order) 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.
No prospectus required for the purposes of the Prospectus Directive or admission document will be made available in connection with the matters contained in this announcement. For these purposes, the term “Prospectus Directive” means Directive 2003/71/EC (including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member States) and includes any relevant implementing measure in the Relevant Member State and the term “2010 PD Amending Directive” means Directive 2010/73/EU.
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 (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, or the Order, (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order or (iii) persons who fall within Article 43(2) of the Order to whom it may lawfully be communicated (all such persons together each being referred to as a “relevant person”). The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
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@citigatedewerogerson.com
Richard Gray / Andrew Potts
+44 (20) 7886 2500
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION
London: Friday, October 27, 2017: 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 October 24, 2017 and October 25, 2017 (the “Offering”), have given notice to Chi-Med that they are exercising, in full, their over-allotment option. The underwriters have elected to purchase an additional 1,483,018 ADSs at the Offering price of US$26.50 per ADS, raising approximately an additional US$39.3 million in gross proceeds for the Company and bringing the total gross proceeds of the Offering to approximately US$301.3 million. Closing of the Offering, including the over-allotment portion, is expected to occur on October 30, 2017. After the closing, the total number of ADSs sold by Chi-Med in the Offering will have increased to 11,369,810.
BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon and CITIC CLSA are acting as co-managers for the Offering.
The 741,509 new ordinary shares being issued by Chi-Med pursuant to the underwriters’ full 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 November 2, 2017.
This announcement does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The ADSs described above are being offered by Chi-Med pursuant to a shelf registration statement on Form F-3 (including a base prospectus) filed by Chi-Med with the United States Securities and Exchange Commission (“SEC”) that became automatically effective on April 3, 2017. A prospectus supplement and an accompanying prospectus related to the Offering has been filed with the SEC. This prospectus supplement, the accompanying prospectus and any documents incorporated therein are available on the website of the SEC at www.sec.gov.
No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.
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 distribution of this announcement into jurisdictions other than the UK may be restricted by law. Persons into whose possession this announcement come should inform themselves about and observe any such restrictions.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
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.
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 management’s goals and objectives. 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 SEC and on AIM. None of Chi-Med, BofA Merrill Lynch or Deutsche Bank Securities (in alphabetical order) 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.
No prospectus required for the purposes of the Prospectus Directive or admission document will be made available in connection with the matters contained in this announcement. For these purposes, the term “Prospectus Directive” means Directive 2003/71/EC (including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member States) and includes any relevant implementing measure in the Relevant Member State and the term “2010 PD Amending Directive” means Directive 2010/73/EU.
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 (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, or the Order, (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order or (iii) persons who fall within Article 43(2) of the Order to whom it may lawfully be communicated (all such persons together each being referred to as a “relevant person”). The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
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@citigatedewerogerson.com
Richard Gray / Andrew Potts
+44 (20) 7886 2500
London: Wednesday, October 25, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announced today the pricing of the underwritten public offering previously announced by Chi-Med on October 24, 2017. Chi-Med will issue and sell 9,886,792 American Depositary Shares (“ADSs”), each representing one-half of one ordinary share, par value US$1.00 each, of Chi-Med, at a price of US$26.50 per ADS on the Nasdaq Global Select Market (“Offering”), raising gross proceeds of approximately US$262 million (before deducting underwriting discounts, commissions and Offering expenses). Chi-Med has granted the underwriters a 30-day option to purchase up to 1,483,018 additional ADSs at the Offering price, less underwriting discounts and commissions. Closing of the Offering is expected to occur on or about October 30, 2017.
The net proceeds from the Offering are expected to be used to fund the on-going research and development of the Chi-Med Innovation Platform drug pipeline and for working capital and general corporate purposes.
BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon (UK) Limited and CITIC CLSA are acting as co-managers for the Offering.
The 4,943,396 new ordinary shares to be issued by Chi-Med pursuant to the Offering (“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 October 31, 2017.
Hutchison Healthcare Holdings Limited (“HHHL”), Chi-Med’s majority shareholder holding approximately 60.36% of Chi-Med’s share capital, is a related party of Chi-Med for the purposes of Rule 13 of the AIM Rules for Companies (“AIM Rules”) by virtue of its status as a substantial shareholder of Chi-Med. HHHL’s subscription for 3,431,210 ordinary shares in the form of 6,862,420 ADSs at the Offering price as part of the Offering is conditional upon Admission. The Directors consider, having consulted with Panmure Gordon (UK) Limited, nominated adviser of Chi-Med, that the terms of the Offering with HHHL are fair and reasonable in so far as shareholders of Chi-Med are concerned.
This announcement is being issued pursuant to and in accordance with Rule 135e under the United States Securities Act of 1933, as amended (“Securities Act”). This announcement does not constitute a prospectus and does not constitute an offer to sell or the solicitation of an offer to purchase or acquire, any of the Ordinary Shares or the ADSs or any other securities in the United States of America or any other jurisdiction. Securities may not be offered or sold in in the United States of America absent registration or an exemption from registration under the Securities Act. Any public offering of securities to be made in the United States of America will be made by means of a prospectus. Such prospectus will contain or incorporate by reference detailed information about Chi-Med and its management and financial statements. This announcement does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The ADSs described above are being offered by Chi-Med pursuant to a shelf registration statement on Form F-3 (including a base prospectus) filed by Chi-Med with the United States Securities and Exchange Commission (“SEC”) that became automatically effective on April 3, 2017. A prospectus supplement and an accompanying prospectus related to the Offering have been filed with the SEC. This prospectus supplement, the accompanying prospectus and any documents incorporated by reference therein are available on the website of the SEC at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering may be obtained from (i) BofA Merrill Lynch by mailing NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or emailing dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc. by mailing 60 Wall Street, New York, NY 10005, Attention: Prospectus Group or emailing prospectus.cpdg@db.com.
No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.
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 distribution of this announcement into jurisdictions other than the UK may be restricted by law. Persons into whose possession this announcement come should inform themselves about and observe any such restrictions.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
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.
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 management’s goals and objectives and the successful completion of the Offering. Forward-looking statements involve risks and uncertainties. More information about such risks and uncertainties is contained or incorporated by reference in the 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 Merrill Lynch or Deutsche Bank Securities Inc. (in alphabetical order) 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.
No prospectus required for the purposes of the Prospectus Directive or admission document will be made available in connection with the matters contained in this announcement. For these purposes , the term “Prospectus Directive” means Directive 2003/71/EC (including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member States) and includes any relevant implementing measure in the Relevant Member State and the term “2010 PD Amending Directive” means Directive 2010/73/EU.
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 (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, or the Order, (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order or (iii) persons who fall within Article 43(2) of the Order to whom it may lawfully be communicated (all such persons together each being referred to as a “relevant person”). The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
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
Richard Gray / Andrew Potts
+44 (20) 7886 2500
London: Wednesday, October 25, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announced today the pricing of the underwritten public offering previously announced by Chi-Med on October 24, 2017. Chi-Med will issue and sell 9,886,792 American Depositary Shares (“ADSs”), each representing one-half of one ordinary share, par value US$1.00 each, of Chi-Med, at a price of US$26.50 per ADS on the Nasdaq Global Select Market (“Offering”), raising gross proceeds of approximately US$262 million (before deducting underwriting discounts, commissions and Offering expenses). Chi-Med has granted the underwriters a 30-day option to purchase up to 1,483,018 additional ADSs at the Offering price, less underwriting discounts and commissions. Closing of the Offering is expected to occur on or about October 30, 2017.
The net proceeds from the Offering are expected to be used to fund the on-going research and development of the Chi-Med Innovation Platform drug pipeline and for working capital and general corporate purposes.
BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon (UK) Limited and CITIC CLSA are acting as co-managers for the Offering.
The 4,943,396 new ordinary shares to be issued by Chi-Med pursuant to the Offering (“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 October 31, 2017.
This announcement does not constitute a prospectus and does not constitute an offer to sell or the solicitation of an offer to purchase or acquire, any of the Ordinary Shares or the ADSs or any other securities in the United States of America or any other jurisdiction. Securities may not be offered or sold in in the United States of America absent registration or an exemption from registration under the Securities Act. Any public offering of securities to be made in the United States of America will be made by means of a prospectus. Such prospectus will contain or incorporate by reference detailed information about Chi-Med and its management and financial statements. This announcement does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The ADSs described above are being offered by Chi-Med pursuant to a shelf registration statement on Form F-3 (including a base prospectus) filed by Chi-Med with the United States Securities and Exchange Commission (“SEC”) that became automatically effective on April 3, 2017. A prospectus supplement and an accompanying prospectus related to the Offering have been filed with the SEC. The prospectus supplement, the accompanying prospectus and any documents incorporated by reference therein are available on the website of the SEC at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering may be obtained from (i) BofA Merrill Lynch by mailing NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or emailing dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc. by mailing 60 Wall Street, New York, NY 10005, Attention: Prospectus Group or emailing prospectus.cpdg@db.com.
No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.
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.
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.
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 management’s goals and objectives and the successful completion of the Offering. Forward-looking statements involve risks and uncertainties. More information about such risks and uncertainties is contained or incorporated by reference in the 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 Merrill Lynch or Deutsche Bank Securities (in alphabetical order) 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.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
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
Richard Gray / Andrew Potts
+44 (20) 7886 2500
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION
London: Tuesday, October 24, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announced today that it intends to offer, subject to market and other conditions, US$262.0 million of American Depositary Shares (“ADSs”), each representing one-half of one ordinary share, par value US$1.00 each of Chi-Med (“Ordinary Shares”), on the Nasdaq Global Select Market (“Offering”). Chi-Med intends to grant the underwriters a 30-day option to purchase up to an aggregate of US$39.3 million of additional ADSs at the Offering price. There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or final terms of the Offering. The price for the Offering has not yet been determined.
The proceeds from the Offering, if completed, are expected to be used to fund the on-going research and development of the Chi-Med Innovation Platform drug pipeline and for working capital and general corporate purposes.
Details of the final terms of the Offering will be determined following the bookbuilding process.
The Directors intend that the Offering would be effected within existing allotment authorities and pre-emption disapplications granted pursuant to shareholder resolutions passed at Chi-Med’s annual general meeting held on April 27, 2017. The Offering would therefore not be conditional upon shareholder approval.
Hutchison Healthcare Holdings Limited (“HHHL”), Chi-Med’s majority shareholder holding approximately 60.36% of Chi-Med’s share capital, has given a non-binding indication of interest to purchase up to US$182.0 million in ADSs in the aggregate in the Offering on the same terms as other investors. As a substantial shareholder of Chi-Med, HHHL is a related party under the AIM Rules for Companies (“AIM Rules”). Participation in the Offering by HHHL would be expected to constitute a related party transaction for the purposes of Rule 13 of the AIM Rules. This would require the Directors to make a statement that, having consulted with Panmure Gordon (UK) Limited (nominated adviser of Chi-Med), they consider the terms of the relevant participation in the Offering by HHHL to be fair and reasonable insofar as shareholders of Chi-Med are concerned. Further details of any participation by HHHL in the Offering will be set out in the announcement to be made on the closing of the bookbuilding exercise.
BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon and CITIC CLSA are acting as co-managers for the potential Offering.
The ADSs described above are being offered by Chi-Med pursuant to a shelf registration statement on Form F-3 (including a base prospectus) filed by Chi-Med with the United States Securities and Exchange Commission (“SEC”) that became automatically effective on April 3, 2017. A preliminary prospectus supplement and an accompanying prospectus to this registration statement related to the Offering, an extract of which has been appended to this announcement, have been filed with the SEC. The preliminary prospectus supplement, the accompanying prospectus and any documents incorporated by reference therein are available on the website of the SEC at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering may be obtained from (i) BofA Merrill Lynch by mailing NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or emailing dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc. by mailing 60 Wall Street, New York, NY 10005, Attention: Prospectus Group or emailing prospectus.cpdg@db.com.
No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.
Shareholders and potential investors should note that the proposed Offering may or may not proceed and are accordingly advised to exercise caution when dealing in securities of Chi-Med.
References herein to this announcement includes the appendices to it.
This announcement is being issued pursuant to and in accordance with Rule 135e under the United States Securities Act of 1933, as amended (“Securities Act”). This announcement does not constitute a prospectus and does not constitute an offer to sell or the solicitation of an offer to purchase or acquire, any of the Ordinary Shares or ADSs or any other securities in the United States of America or any other jurisdiction. Securities may not be offered or sold in the United States of America absent registration or an exemption from registration under the Securities Act. Any public offering of securities to be made in the United States of America will be made by means of a prospectus. Such prospectus will contain or incorporate by reference detailed information about Chi-Med and its management and financial statements. This announcement does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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 distribution of this announcement into jurisdictions other than the UK may be restricted by law. Persons into whose possession this announcement come should inform themselves about and observe any such restrictions.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (“MAR”). In addition, market soundings (as defined in MAR) were taken in respect of the Offering with the result that certain persons became aware of inside information (as defined in MAR), as permitted by MAR. This inside information is set out in this announcement. Therefore, those persons that received inside information in a market sounding are no longer in possession of such inside information relating to Chi-Med and its securities.
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.
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 management’s goals and objectives and a potential public Offering in the United States. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the possibility that the Offering will not be completed within a particular time frame, at a particular offering amount, or at all, including as a result of market or other factors. 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 Merrill Lynch or Deutsche Bank Securities (in alphabetical order) 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.
No prospectus required for the purposes of the Prospectus Directive or admission document will be made available in connection with the matters contained in this announcement. For these purposes, the term “Prospectus Directive” means Directive 2003/71/EC (including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member States) and includes any relevant implementing measure in the Relevant Member State and the term “2010 PD Amending Directive” means Directive 2010/73/EU.
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 (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, or the Order, (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order or (iii) persons who fall within Article 43(2) of the Order to whom it may lawfully be communicated (all such persons together each being referred to as a “relevant person”). The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
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
Richard Gray / Andrew Potts
+44 (20) 7886 2500
Appendix
Preliminary Prospectus Supplement and Accompanying Prospectus to Form F-3 Registration Statement
Please download the full announcement to view the appendix.
London: Tuesday, October 24, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announced today that it intends to offer, subject to market and other conditions, US$262.0 million of American Depositary Shares (“ADSs”), each representing one-half of one ordinary share, par value US$1.00 each of Chi‑Med (“Ordinary Shares”), on the Nasdaq Global Select Market (“Offering”). Chi-Med intends to grant the underwriters a 30-day option to purchase up to an aggregate of US$39.3 million of additional ADSs at the Offering price. There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or final terms of the Offering. The price for the Offering has not yet been determined.
The proceeds from the Offering, if completed, are expected to be used to fund the on-going research and development of the Chi-Med Innovation Platform drug pipeline and for working capital and general corporate purposes.
Details of the final terms of the Offering will be determined following the bookbuilding process.
The Directors intend that the Offering would be effected within existing allotment authorities and pre-emption disapplications granted pursuant to shareholder resolutions passed at Chi-Med’s annual general meeting held on April 27, 2017. The Offering would therefore not be conditional upon shareholder approval.
BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon and CITIC CLSA are acting as co-managers for the potential Offering.
The ADSs described above are being offered by Chi-Med pursuant to a shelf registration statement on Form F‑3 (including a base prospectus) filed by Chi-Med with the United States Securities and Exchange Commission (“SEC”) that became automatically effective on April 3, 2017. A preliminary prospectus supplement and an accompanying prospectus to this registration statement related to the Offering have been filed with the SEC. The preliminary prospectus supplement, the accompanying prospectus and any documents incorporated by reference therein are available on the website of the SEC at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering may be obtained from (i) BofA Merrill Lynch by mailing NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or emailing dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc. by mailing 60 Wall Street, New York, NY 10005, Attention: Prospectus Group or emailing prospectus.cpdg@db.com.
No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.
Shareholders and potential investors should note that the proposed Offering may or may not proceed and are accordingly advised to exercise caution when dealing in the securities of Chi-Med.
This announcement does not constitute a prospectus and does not constitute an offer to sell or the solicitation of an offer to purchase or acquire, any of the Ordinary Shares or ADSs or any other securities in the United States of America or any other jurisdiction. Securities may not be offered or sold in the United States of America absent registration or an exemption from registration under the Securities Act. Any public offering of securities to be made in the United States of America will be made by means of a prospectus. Such prospectus will contain or incorporate by reference detailed information about Chi-Med and its management and financial statements. This announcement does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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.
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.
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 management’s goals and objectives and a potential public Offering in the United States. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the possibility that the Offering will not be completed within a particular time frame, at a particular offering amount, or at all, including as a result of market or other factors. 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 Merrill Lynch or Deutsche Bank Securities (in alphabetical order) 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.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
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
Richard Gray / Andrew Potts
+44 (20) 7886 2500
–沃利替尼联合泰瑞莎®或易瑞沙®的临床研究数据于世界肺癌大会公布–
–新公布的数据有助于理解MET扩增的EGFR突变NSCLC的疾病进展过程和探索潜在的新一代治疗策略 –
2017年10月17日：和黄医药今日与阿斯利康（AstraZeneca）联合公布沃利替尼与泰瑞莎®（奥希替尼）或易瑞沙®（吉非替尼）联合的两项Ib/II期概念验证临床研究初步的安全性和临床抗肿瘤活性数据。这两项临床研究的目标受试者为MET基因扩增的表皮生长因子受体（EGFR）突变非小细胞肺癌（NSCLC）患者，受试者既往需接受过一线EGFR抑制剂治疗且治疗后疾病进展。在这两项研究中，沃利替尼（600mg，每天一次）联合泰瑞莎®（80mg，每天一次）或易瑞沙®（250mg，每天一次）均展现出了初步的抗肿瘤活性。沃利替尼是一种在研的高选择性间充质上皮转移因子（c-MET）受体酪氨酸激酶抑制剂。这两项研究的初步结果均以口头报告的形式公布于2017年10月15-18日在日本横滨举行的第18届世界肺癌大会（WCLC）上。
韩国首尔三星医疗中心血液和肿瘤学系的Myung-Ju Ahn教授表示：“肿瘤患者使用针对基因突变的靶向抗癌药物治疗后，经常会产生继发性耐药，导致疾病进展。这次我们在WCLC大会上公布的数据表明，针对出现MET基因突变的肺癌患者使用沃利替尼也许可以帮助克服耐药的问题。”
阿斯利康早期研发部的肿瘤学负责人Susan Galbraith博士表示：“我们致力于研发创新型药物以克服肿瘤耐药的关键驱动因素，并侧重探索有效的联合用药疗法。沃利替尼联合奥希替尼或吉非替尼临床研究的最新进展为我们携手和黄医药鼎力制定的战略措施提供了有力的支持。”
TATTON研究是一项Ib/II期概念验证临床试验，目标受试者为MET基因扩增的EGFR突变NSCLC患者，受试者的基因突变状态由各研究中心或中央实验室诊断。沃利替尼与泰瑞莎®联合疗法初步的安全性和抗肿瘤活性在这项研究中得到了评估。在接受治疗的66名受试者中，最常见的全因不良事件（AEs）包括恶心（44%）、呕吐（35%）、疲劳（30%）和食欲下降（30%），与已知的沃利替尼和泰瑞莎®联合疗法的安全性数据一致。
依据实体瘤疗效评价标准（RECIST 1.1），初步研究结果显示在既往接受过包括泰瑞莎®在内的第三代靶向T790M突变的EGFR抑制剂治疗的受试者中（n=30），有33%获得了部分缓解。在既往一线或二线EGFR抑制剂治疗后进展的受试者中，无T790M突变的患者（n=23）有61%获得部分缓解，T790M突变的患者（n=11）有55%获得了部分缓解。
中央实验室诊断为MET基因扩增的受试者中，有28%既往接受过靶向T790M突变的 EGFR抑制剂治疗的患者（n=25）获得了部分缓解。在既往一线或二线EGFR抑制剂治疗后进展的受试者中，无T790M突变的患者（n=15）有53%获得部分缓解，T790M突变的患者（n=7）有57%获得了部分缓解。
详细报告请点击www.chi-med.com/ph2-savo-plus-tagrisso-nsclc/。
另外一项在中国开展的Ib/II期概念验证试验的研究数据也被公布。这项研究对沃利替尼和易瑞沙®联合疗法进行了评估，目标受试者为既往接受EGFR抑制剂治疗后进展的MET基因扩增的EGFR突变晚期NSCLC患者，受试者的MET基因扩增状态由中央实验室诊断确定。在接受治疗的51名受试者中，最常见的全因不良事件（AEs）包括呕吐（39%）、丙氨酸氨基转移酶（ALT）升高（37%）、天冬氨酸氨基转移酶（AST）升高（35%）、恶心（35%）和皮疹（35%），与已知的沃利替尼和易瑞沙®联合疗法的安全性数据一致。
根据RECIST 1.1标准，31%的受试者获得了部分缓解，包括52%无T790M突变的患者（n=23）和9%T790M突变的患者（n=23）。
详细报告请点击http://www.chi-med.com/ph2-savolitinib-plus-iressa-nsclc/。
和黄中国医药科技有限公司首席执行官贺隽先生表示：“ 在经一线和二线酪氨酸激酶抑制剂治疗后出现疾病进展的EGFR突变NSCLC患者中，有相当一部分患者受到了MET基因扩增的影响。对于这种机制导致的难治性耐药，仍存在着很大的尚未满足的医疗需求。”
沃利替尼（AZD6094/HMPL-504）是一种有潜力成为同类首款的高选择性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，比如肾毒性等。
沃利替尼由和黄医药发现，目前由和黄医药与阿斯利康合作开发。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。
参考文献
[1] Ahn M-J 等. TATTON Ib期扩展队列研究：奥希替尼联合沃利替尼治疗既往EGFR-TKI进展的EGFR突变且MET扩增NSCLC.摘要号：8985. 口头报告，2017年10月15-18日， 世界肺癌大会2017，日本，横滨。
[2] Yang J-J等. 沃利替尼联合吉非替尼治疗EGFR突变且MET扩增的晚期NSCLC患者的Ib期研究. 摘要号：8995. 口头报告，2017年10月15-18日， 世界肺癌大会2017，日本，横滨
Jin-Ji Yang, Jian Fang, Y. Shu, J. Chang, G. Chen, J. He, W. Li, X. Liu, N. Yang, Caicun Zhou, J. Huang, L. Yang, A.A. Handzel, M.M. Frigault, G. Ahmed, C. Egile, S. Morgan, Yi-Long Wu
Venue: IASLC 18th World Conference on Lung Cancer
Session: OA 09 – EGFR TKI Resistance (ID 663)
Presenter: Jin-Ji Yang
Date: Tuesday, October 17, 2017
For a summary of the data presented, please see the company overview presentation.
Myung-Ju Ahn, Ji-Youn Han, Lecia V Sequist, Byoung Chul Cho, J.S. Lee, Sang-We Kim, W. Su, C. Tsai, James Chih-Hsin Yang, Helena Yu, L. Horn, K. Lee, V. Haddad, M.M. Frigault, G. Ahmed, L. Yang, D. Ghiorghiu, Geoffrey R. Oxnard
Venue: IASLC 18th World Conference on Lung Cancer
Session: OA 09 – EGFR TKI Resistance (ID 663)
Presenter: Myung-Ju Ahn
Date: Tuesday, October 17, 2017
For a summary of the data presented, please see the company overview presentation.
– 呋喹替尼联合易瑞沙®（吉非替尼）展现出良好的疗效和安全性 –
–进一步证实呋喹替尼因其高选择性和出众的安全性而具有与其他癌症疗法相联合的巨大潜力–
2017年10月16日：和黄医药今日公布呋喹替尼和易瑞沙®联合疗法的初步临床疗效、安全性和耐受性数据。呋喹替尼是一种在研的高选择性血管内皮生长因子受体（VEGFR）抑制剂。公布的数据来自于一项II期概念验证临床试验，目标受试者为表皮生长因子受体（EGFR）突变（EGFRm）的非小细胞肺癌（NSCLC）患者，这项研究目前仍在进行中。这项II期概念验证试验首次对呋喹替尼和另一种酪氨酸激酶抑制剂的联合疗法进行了评估，初步结果显示联合疗法的疗效令人鼓舞且安全性良好。这些数据公布于2017年10月15-18日在日本横滨举行的国际肺癌研究协会第18届世界肺癌大会（WCLC）上[1]。
“呋喹替尼单药治疗的疗效在结直肠癌中已经得到确证。现在，呋喹替尼在创新型联合疗法中也展现出了良好的疗效和耐受性，这要归功于呋喹替尼的高选择性、无脱靶毒性、亦无药物间相互作用的特性，”和黄中国医药科技有限公司首席执行官贺隽先生表示。“今年1月，我们公布了呋喹替尼联合化疗药物泰素®（紫杉醇）以胃癌为适应症的I/II期临床研究的初步的耐受性和疗效。现在，呋喹替尼和易瑞沙®联合疗法的早期数据也进一步证实了我们长期以来一直坚持并致力于研发高选择性和最优化的候选药物的战略。”
这项研究旨在评估呋喹替尼（4-5mg，每天一次，服药三周/停药一周）联合易瑞沙®（250mg，每天一次）在中国作为一线疗法治疗EGFR突变的晚期NSCLC患者的疗效和安全性。在入组的26名受试者中，治疗过程中最常见的不良事件（AEs）包括天冬氨酸氨基转移酶（AST）升高（54%）、丙氨酸氨基转移酶（ALT）升高（46%）、总胆红素（DBiL）升高（39%）、促甲状腺激素（TSH）升高（39%）和皮疹（35%）。共有8名受试者出现3级不良事件（31%），包括ALT升高（19%）、AST升高（4%）、蛋白尿（4%）和高血压（4%），未出现严重不良事件或致死不良事件。
初步结果显示，在17例可评估疗效的受试者中，总缓解率（ORR）为76%（13/17），疾病控制率（DCR）达到100%（17/17）。另外，还有4例部分缓解在数据截止时未得到确认。
详细报告请点击www.chi-med.com/wclc-fruq-iressa-combo-nsclc/。
呋喹替尼（HMPL-013）是一种高选择性小分子候选药物，经研究证实，通过一日一次的口服剂量即可有效地抑制血管内皮生长因子受体（VEGFR），且并未显示出脱靶毒性。呋喹替尼良好的耐受性和清晰的药物间相互作用，为其与其他癌症疗法相联合提供了理论支持，例如当前正在进行的呋喹替尼联合化疗或其他靶向治疗的临床研究。 VEGF和VEGFR在肿瘤血管生成过程中起着至关重要的作用。
呋喹替尼目前由和黄医药和礼来（Lilly）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了呋喹替尼以结直肠癌为适应症的FRESCO研究的关键结果。此外，呋喹替尼以NSCLC为适应症的III期关键性临床试验FALUCA目前也正在中国展开；另有一项II期临床试验也正在进行中，该试验以呋喹替尼联合易瑞沙®作为一线疗法，治疗晚期或转移性NSCLC。呋喹替尼与紫杉醇联合治疗胃癌的中国III期临床研究，在美国的数项新研究，以及与其他抗肿瘤药物联合用药的多项探索性研究也正在计划中，很快将逐渐展开。
易瑞沙®商标为阿斯利康公司所有。泰素®商标为百时美施贵宝公司所有。
参考文献
[1] 陆舜 等. 呋喹替尼联合吉非替尼用于EGFR突变晚期NSCLC的II期研究结果. 摘要号：10907. 口头报告, 2017年10月15-18日， 世界肺癌大会2017，日本，横滨。
Shun Lu, Jianying Zhou, Xiaomin Niu, Mo Chen, Hongyan Yin, Ye Hua, Weiguo Su
Venue: IASLC 18th World Conference on Lung Cancer
Session: JCSE 01 – Joint IASLC / CSCO / CAALC Session: Immunotherapy for Management of Lung Cancer: Ongoing Research from East and West (ID 630)
Presenter: J Zhou
Date: Sunday, October 15, 2017
For a summary of the data presented, please see the company overview presentation.
2017年10月12日：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/伦敦证交所：HCM）今日宣布任命莫树锦（Tony Mok）教授担任公司独立非执行董事，同时担任科学委员会委员。这项任命自2017年10月12日起生效。
莫树锦教授有着30余年丰富的临床肿瘤研究经验，研究重点集中在肺癌生物标志物和肺癌分子靶向治疗等相关领域。他现任香港中文大学李树芬医学基金肿瘤学教授、肿瘤学系系主任，也是肺癌研究协作组的共同建立者之一。他主导了多项重要的国际临床研究，包括IPASS、FASTACT 2、IMPRESS和PROFILE 1014等，这些研究为当今晚期肺癌治疗标准的建立提供了有力的医学证据支持。
莫树锦教授在包括《新英格兰医学杂志》（NEJM）、《科学》、《柳叶刀》和《临床肿瘤学杂志》（JCO）等众多国际顶尖同行评审期刊上发表了200余篇文章，也多次应邀参与教科书与评述性文章的撰写。他是美国临床肿瘤学会（ASCO）国际事务委员会前任主席、ASCO学术发表委员会成员和中国临床肿瘤学会（CSCO）副理事长。
莫树锦教授与中国大陆肿瘤学界联系紧密，他同时担任广东省人民医院荣誉教授、北京大学肿瘤学系客座教授、上海交通大学访问教授和四川大学华西临床医学院/华西医院客座教授等多项职务。
莫树锦教授在加拿大阿尔伯塔大学获得医学学士和医学博士学位。他也是加拿大皇家内科及外科医师学院、香港内科医学院、香港医学专科学院、爱丁堡皇家内科医学院和美国临床肿瘤学会的会员。
莫树锦教授现任善觅有限公司董事会董事、中国肺癌研究基金会理事、国际肺癌研究协会（IASLC）理事和香港肿瘤治疗学会主席。
莫树锦教授目前持有10,002股和黄中国医药科技的美国存托凭证（每存托凭证相当于0.5普通股），约相当于和黄中国医药科技已发行股本的0.008%。依据英国《另类投资市场企业规则》第17条和附表2（g），除以上信息外，关于莫树锦教授的任命没有其他需要披露的信息。
和黄医药董事长杜志强先生表示：“我们衷心地欢迎莫树锦教授加入公司董事会。他在临床肿瘤学尤其是肺癌领域的卓越建树和丰富经验将使公司获益良多。”
和黄医药是一家创新型生物医药公司，致力于研究、开发、生产和销售药品和健康类产品。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，专注于为全球病患研发治疗癌症和自身免疫性疾病的创新药物。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。
和黄医药由长江和记实业有限公司（SEHK：0001）持有多数股权。了解更多详情请访问：www.chi-med.com。