2017年10月31日：和黃醫藥今日宣佈在中國啟動呋喹替尼聯合紫杉醇（泰素® ）以晚期胃癌或胃食管結合部（GEJ）腺癌為適應症的關鍵性III期臨床研究，這項研究被命名為FRUTIGA 。呋喹替尼是一種高選擇性強效口服血管內皮生長因子受體（VEGFR）1，2及3的抑製劑。這項隨機雙盲安慰劑對照的多中心臨床研究受試者為既往接受一線標準化療後進展的晚期胃癌患者。晚期胃癌的治療，尤其在亞洲人群中，目前尚存在著巨大的未獲滿足的醫療需求。對於既往接受5-氟尿嘧啶（5-FU）和含鉑雙藥組合化療失敗的患者，可供選擇的治療方案非常有限。中國每年胃癌發病數約為679,100例，死亡數約為498,000例。
“ 呋喹替尼可以高選擇性地抑制VEGFR 1，2及3，展現出了良好的與化療聯合的潛力，這種聯合療法是針對晚期胃癌的一種創新性的嘗試。”和黃中國醫藥科技有限公司首席執行官賀雋先生表示，“目前呋喹替尼以三線結直腸癌（CRC）為適應症的新藥上市申請（NDA）正在審評中，以三線非小細胞肺癌為適應症的III期臨床研究也將要完成入組。我們非常高興地看到，呋喹替尼以二線胃癌為適應症的臨床研究也進入了最後的階段。胃癌的二線治療涉及到的病患人數非常多，中國的胃癌患者對新的二線治療方案的需求極其急迫。”
FRUTIGA研究是一項隨機雙盲III期臨床試驗，旨在評估呋喹替尼聯合紫杉醇對比紫杉醇單藥化療治療二線晚期胃癌或GEJ腺癌的療效和安全性。研究計劃納入500名患者，目標受試者為經組織學或細胞學確診為晚期胃癌或GEJ腺癌，且對含有鉑類和氟尿嘧啶的一線標準化療無應答的患者。受試者將以1:1的比例接受呋喹替尼聯合紫杉醇或安慰劑聯合紫杉醇的治療，並根據胃癌vs. GEJ腺癌和ECOG 評分等因素進行分層。這項研究的安全性和療效數據將由獨立的數據監察委員會（IDMC）進行評審。
研究的主要療效終點為總生存期（OS）。次要療效終點包括無進展生存期（PFS，依據RECIST 1.1 進行評估）、客觀緩解率（ORR）、疾病控制率（DCR）、疾病緩解時間和生存質量評分（依據EORTC QLQ-C30，3.0版進行評估）。研究也將探索與呋喹替尼抗腫瘤活性相關的生物標誌物。
該研究詳情可登陸clinicaltrials.gov，檢索NCT03223376查看。
呋喹替尼聯合紫杉醇（泰素® ）以二線晚期胃癌為適應症的多中心開放標籤Ib期劑量探索/ 劑量擴展臨床試驗（clinicaltrials.gov註冊號NCT02415023）的研究結果為FRUTIGA的開展提供了基礎。該項Ib期臨床試驗的研究結果已在2017年1月召開的美國臨床腫瘤學會胃腸道腫瘤論壇上公佈。該項Ib期研究共入組32名受試者，其中可進行療效評估的有28名，ORR 為36%，DCR 為68%。在呋喹替尼的II期臨床試驗推薦劑量（RP2D）下，50%的患者PFS≥16週，50%的患者OS≥7個月。聯合方案在RP2D下的耐受性與預期一致，常見的與治療相關的3 級及以上不良事件（AEs）包括中性粒細胞減少（41%）、白細胞減少（28 %）、血紅蛋白下降（6%）和手足綜合徵（6%）。
根據Frost & Sullivan公司的估計，全球每年新增胃癌病例數約為1百萬。2015年中國新增胃癌病例數約佔全球新增胃癌病例數的44%。根據全國腫瘤登記中心估計，2015年中國胃癌發病數約為679,100例，死亡數約為498,000例。
胃癌引起的死亡病例數在各項癌症中排名第三。胃癌在確診時常常已經發展到晚期階段，預後較差，中位OS不超過12個月。雖然在中國已有在研的胃癌靶向療法，化療仍是胃癌治療的主要手段，但化療帶來的生存獲益較為有限。因此，目前亟需針對胃癌的新型靶向治療選擇。
呋喹替尼（HMPL-013）是一種新型的高選擇性小分子候選藥物。臨床研究證實：通過一日一次的口服劑量即可有效的抑制血管內皮生長因子受體（VEGFR），且脫靶毒性低於其他靶向療法。呋喹替尼良好的耐受性以及無藥物間相互作用的特性，為其與其他癌症療法相聯合提供了理論支持，例如當前正在進行的呋喹替尼聯合化療或其他靶向治療的臨床研究。
癌症進入到晚期，腫瘤會分泌大量VEGFR的配體蛋白-血管內皮生長因子(VEGF)，以促進腫瘤組織周圍形成大量的血管（血管生成），為腫瘤細胞的生長提供更多的血流、氧氣和營養。VEGF和其受體VEGFR在腫瘤的血管生成中起到了至關重要的作用，而呋喹替尼可以抑制VEGF/VEGFR通路。對VEGF/VEGFR相關通路的抑制可以阻斷腫瘤新生血管形成，從而成為防止腫瘤增長和入侵的一種重要的治療策略。
目前呋喹替尼由和黃醫藥和禮來在中國范圍內合作開發。
2017年6月，中國食品藥品監督管理總局（CFDA）受理呋喹替尼以晚期結直腸癌為適應症的新藥上市申請；2017年9月，CFDA公佈因呋喹替尼具有明顯臨床價值而授予其優先審評的資格。FRESCO研究的成功為呋喹替尼的新藥上市申請提供了有力的數據支持。FRESCO研究是一項在中國完成的III期關鍵性註冊研究，共計納入416名CRC患者，研究結果於2017年6月5日在美國臨床腫瘤學會年會上以口頭報告的形式公佈（clinicaltrials.gov註冊號NCT02314819）。
除FRUTIGA和FRESCO兩項III期臨床研究以外，呋喹替尼以非小細胞肺癌（NSCLC）為適應症的III期關鍵性臨床試驗FALUCA（clinicaltrials.gov註冊號NCT02691299）目前也正在中國展開；另有一項II期臨床試驗也正在進行中，該試驗以呋喹替尼聯合易瑞沙® （吉非替尼）作為一線療法，治療晚期或轉移性NSCLC（clinicaltrials.gov註冊號NCT02976116）。呋喹替尼在美國的數項新研究（clinicaltrials.gov註冊號NCT03251378 )，以及與其他抗腫瘤藥物聯合用藥的多項探索性研究正在計劃中。
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
– 沃利替尼聯合泰瑞莎® 或易瑞沙® 的臨床研究數據於世界肺癌大會公佈–
–新公佈的數據有助於理解MET 擴增的EGFR突變NSCLC的疾病進展過程和探索潛在的新一代治療策略–
2017年10月17日：和黃醫藥今日與阿斯利康（AstraZeneca）聯合公佈沃利替尼與泰瑞莎® （奧希替尼）或易瑞沙® （吉非替尼）聯合的兩項Ib /II期概念驗證臨床研究初步的安全性和臨床抗腫瘤活性數據。這兩項臨床研究的目標受試者為MET基因擴增的表皮生長因子受體（EGFR）突變非小細胞肺癌（NSCLC）患者，受試者既往需接受過一線EGFR抑制劑治療且治療後疾病進展。在這兩項研究中，沃利替尼（600mg，每天一次）聯合泰瑞莎® （80mg，每天一次）或易瑞沙® （250mg，每天一次）均展現出了初步的抗腫瘤活性。沃利替尼是一種在研的高選擇性間充質上皮轉移因子（c-MET）受體酪氨酸激酶抑製劑。這兩項研究的初步結果均以口頭報告的形式公佈於2017年10月15-18日在日本橫濱舉行的第18屆世界肺癌大會（WCLC）上。
韓國首爾三星醫療中心血液和腫瘤學系的Myung-Ju Ahn 教授表示：“ 腫瘤患者使用針對基因突變的靶向抗癌藥物治療後，經常會產生繼發性耐藥，導致疾病進展。這次我們在WCLC大會上公佈的數據表明，針對出現MET基因突變的肺癌患者使用沃利替尼也許可以幫助克服耐藥的問題。”
阿斯利康早期研發部的腫瘤學負責人Susan Galbraith博士表示：“我們致力於研發創新型藥物以克服腫瘤耐藥的關鍵驅動因素，並側重探索有效的聯合用藥療法。沃利替尼聯合奧希替尼或吉非替尼臨床研究的最新進展為我們攜手和黃醫藥鼎力製定的戰略措施提供了有力的支持。”
TATTON研究是一項Ib /II期概念驗證臨床試驗，目標受試者為MET基因擴增的EGFR突變NSCLC患者，受試者的基因突變狀態由各研究中心或中央實驗室診斷。沃利替尼與泰瑞莎® 聯合療法初步的安全性和抗腫瘤活性在這項研究中得到了評估。在接受治療的66名受試者中，最常見的全因不良事件（AEs）包括噁心（44%）、嘔吐（35%）、疲勞（30%）和食慾下降（30%） ，與已知的沃利替尼和泰瑞莎® 聯合療法的安全性數據一致。
依據實體瘤療效評價標準（RECIST 1.1），初步研究結果顯示在既往接受過包括泰瑞莎® 在內的第三代靶向T790M突變的EGFR抑製劑治療的受試者中（n=30），有33% 獲得了部分緩解。在既往一線或二線EGFR抑製劑治療後進展的受試者中，無T790M突變的患者（n=23）有61% 獲得部分緩解，T790M突變的患者（n=11 ）有55% 獲得了部分緩解。
中央實驗室診斷為MET基因擴增的受試者中，有28%既往接受過靶向T790M突變的EGFR抑製劑治療的患者（n=25）獲得了部分緩解。在既往一線或二線EGFR抑製劑治療後進展的受試者中，無T790M突變的患者（n=15）有53% 獲得部分緩解，T790M突變的患者（n=7 ）有57% 獲得了部分緩解。
詳細報告請點擊www.chi-med.com/ph2-savo-plus-tagrisso-nsclc/。
另外一項在中國開展的Ib /II期概念驗證試驗的研究數據也被公佈。這項研究對沃利替尼和易瑞沙® 聯合療法進行了評估，目標受試者為既往接受EGFR抑製劑治療後進展的MET基因擴增的EGFR突變晚期NSCLC患者，受試者的MET基因擴增狀態由中央實驗室診斷確定。在接受治療的51名受試者中，最常見的全因不良事件（AEs）包括嘔吐（39%）、丙氨酸氨基轉移酶（ALT）升高（37%）、天冬氨酸氨基轉移酶（AST）升高（35%）、噁心（35%）和皮疹（35%），與已知的沃利替尼和易瑞沙® 聯合療法的安全性數據一致。
根據RECIST 1.1 標準，31%的受試者獲得了部分緩解，包括52%無T790M突變的患者（n=23）和9%T790M突變的患者（n=23）。
詳細報告請點擊http://www.chi-med.com/ph2-savolitinib-plus-iressa-nsclc/。
和黃中國醫藥科技有限公司首席執行官賀雋先生表示：“在經一線和二線酪氨酸激酶抑製劑治療後出現疾病進展的EGFR突變NSCLC患者中，有相當一部分患者受到了MET基因擴增的影響。對於這種機制導致的難治性耐藥，仍存在著很大的尚未滿足的醫療需求。”
沃利替尼（AZD6094/HMPL-504）是一種有潛力成為同類首款的高選擇性c-MET（也被稱作間充質上皮轉移因子）受體酪氨酸激酶抑製劑。研究發現這種酪氨酸激酶在多種實體瘤中表現異常。沃利替尼作為一種強效的高選擇性口服抑製劑，旨在克服第一代c-Met抑製劑在臨床研究中出現的問題，比如腎毒性等。
沃利替尼由和黃醫藥發現，目前由和黃醫藥與阿斯利康合作開發。目前，雙方正在全球展開沃利替尼以多種腫瘤類型為適應症的臨床研究，包括腎癌，肺癌和胃癌，沃利替尼作為單一療法或與其他靶向和免疫治療藥物聯合治療。
參考文獻
[1] Ahn MJ 等. TATTON Ib 期擴展隊列研究：奧希替尼聯合沃利替尼治療既往EGFR-TKI 進展的EGFR 突變且MET 擴增NSCLC. 摘要號：8985. 口頭報告，2017 年10 月15-18 日，世界肺癌大會2017，日本，橫濱。
[2] Yang J- J 等. 沃利替尼聯合吉非替尼治療EGFR 突變且MET 擴增的晚期NSCLC 患者的Ib 期研究. 摘要號：8995. 口頭報告，2017 年10 月15-18 日，世界肺癌大會2017，日本，橫濱
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.
– 呋喹替尼聯合易瑞沙® （吉非替尼）展現出良好的療效和安全性–
– 進一步證實呋喹替尼因其高選擇性和出眾的安全性而具有與其他癌症療法相聯合的巨大潛力–
2017年10月16日：和黃醫藥今日公佈呋喹替尼和易瑞沙® 聯合療法的初步臨床療效、安全性和耐受性數據。呋喹替尼是一種在研的高選擇性血管內皮生長因子受體（VEGFR）抑製劑。公佈的數據來自於一項II期概念驗證臨床試驗，目標受試者為表皮生長因子受體（EGFR）突變（EGFRm ）的非小細胞肺癌（NSCLC）患者，這項研究目前仍在進行中。這項II期概念驗證試驗首次對呋喹替尼和另一種酪氨酸激酶抑製劑的聯合療法進行了評估，初步結果顯示聯合療法的療效令人鼓舞且安全性良好。這些數據公佈於2017年10月15-18日在日本橫濱舉行的國際肺癌研究協會第18屆世界肺癌大會（WCLC）上[1]。
“ 呋喹替尼單藥治療的療效在結直腸癌中已經得到確證。現在，呋喹替尼在創新型聯合療法中也展現出了良好的療效和耐受性，這要歸功於呋喹替尼的高選擇性、無脫靶毒性、亦無藥物間相互作用的特性，”和黃中國醫藥科技有限公司首席執行官賀雋先生表示。“今年1月，我們公佈了呋喹替尼聯合化療藥物泰素® （紫杉醇）以胃癌為適應症的I/II期臨床研究的初步的耐受性和療效。現在，呋喹替尼和易瑞沙® 聯合療法的早期數據也進一步證實了我們長期以來一直堅持並致力於研發高選擇性和最優化的候選藥物的戰略。”
這項研究旨在評估呋喹替尼（4-5mg，每天一次，服藥三週/停藥一周）聯合易瑞沙® （250mg，每天一次）在中國作為一線療法治療EGFR突變的晚期NSCLC患者的療效和安全性。在入組的26名受試者中，治療過程中最常見的不良事件（AEs）包括天冬氨酸氨基轉移酶（AST）升高（54%）、丙氨酸氨基轉移酶（ALT）升高（46%）、總膽紅素（DBiL ）升高（39%）、促甲狀腺激素（TSH）升高（39%）和皮疹（35%）。共有8名受試者出現3 級不良事件（31%），包括ALT升高（19%）、AST升高（4%）、蛋白尿（4%）和高血壓（4%），未出現嚴重不良事件或致死不良事件。
初步結果顯示，在17例可評估療效的受試者中，總緩解率（ORR）為76%（13/17），疾病控制率（DCR）達到100%（17/17） 。另外，還有4例部分緩解在數據截止時未得到確認。
詳細報告請點擊www.chi-med.com/wclc-fruq-iressa-combo-nsclc/。
呋喹替尼（HMPL-013）是一種高選擇性小分子候選藥物，經研究證實，通過一日一次的口服劑量即可有效地抑制血管內皮生長因子受體（VEGFR） ，且並未顯示出脫靶毒性。呋喹替尼良好的耐受性和清晰的藥物間相互作用，為其與其他癌症療法相聯合提供了理論支持，例如當前正在進行的呋喹替尼聯合化療或其他靶向治療的臨床研究。VEGF和VEGFR在腫瘤血管生成過程中起著至關重要的作用。
呋喹替尼目前由和黃醫藥和禮來（Lilly）在中國范圍內合作開發。2017年3月3日，合作的雙方共同宣布了呋喹替尼以結直腸癌為適應症的FRESCO研究的關鍵結果。此外，呋喹替尼以NSCLC 為適應症的III期關鍵性臨床試驗FALUCA目前也正在中國展開；另有一項II期臨床試驗也正在進行中，該試驗以呋喹替尼聯合易瑞沙® 作為一線療法，治療晚期或轉移性NSCLC。呋喹替尼與紫杉醇聯合治療胃癌的中國III期臨床研究，在美國的數項新研究，以及與其他抗腫瘤藥物聯合用藥的多項探索性研究也正在計劃中，很快將逐漸展開。
易瑞沙® 商標為阿斯利康公司所有。泰素® 商標為百時美施貴寶公司所有。
參考文獻
[1] 陸舜等. 呋喹替尼聯合吉非替尼用於EGFR 突變晚期NSCLC 的II 期研究結果. 摘要號：10907. 口頭報告, 2017 年10 月15-18 日，世界肺癌大會2017 ，日本，橫濱。
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：和黃中國醫藥科技有限公司（簡稱“ 和黃醫藥 ”或“Chi-Med”）（納斯達克/倫敦證交所：HCM）今日宣布任命莫樹錦（Tony Mok ）教授擔任公司獨立非執行董事，同時擔任科學委員會委員。這項任命自2017 年10 月12 日起生效。
莫樹錦教授有著30餘年豐富的臨床腫瘤研究經驗，研究重點集中在肺癌生物標誌物和肺癌分子靶向治療等相關領域。他現任香港中文大學李樹芬醫學基金腫瘤學教授、腫瘤學系系主任，也是肺癌研究協作組的共同建立者之一。他主導了多項重要的國際臨床研究，包括IPASS、FASTACT 2、IMPRESS和PROFILE 1014等，這些研究為當今晚期肺癌治療標準的建立提供了有力的醫學證據支持。
莫樹錦教授在包括《新英格蘭醫學雜誌》（NEJM）、《科學》、《柳葉刀》和《臨床腫瘤學雜誌》（JCO）等眾多國際頂尖同行評審期刊上發表了200餘篇文章，也多次應邀參與教科書與評述性文章的撰寫。他是美國臨床腫瘤學會（ASCO）國際事務委員會前任主席、ASCO學術發表委員會成員和中國臨床腫瘤學會（CSCO）副理事長。
莫樹錦教授與中國大陸腫瘤學界聯繫緊密，他同時擔任廣東省人民醫院榮譽教授、北京大學腫瘤學系客座教授、上海交通大學訪問教授和四川大學華西臨床醫學院/ 華西醫院客座教授等多項職務。
莫樹錦教授在加拿大阿爾伯塔大學獲得醫學學士和醫學博士學位。他也是加拿大皇家內科及外科醫師學院、香港內科醫學院、香港醫學專科學院、愛丁堡皇家內科醫學院和美國臨床腫瘤學會的會員。
莫樹錦教授現任善覓有限公司董事會董事、中國肺癌研究基金會理事、國際肺癌研究協會（IASLC）理事和香港腫瘤治療學會主席。
莫樹錦教授目前持有10,002股和黃中國醫藥科技的美國存託憑證（每存託憑證相當於0.5普通股），約相當於和黃中國醫藥科技已發行股本的0.008% 。依據英國《另類投資市場企業規則》第17條和附表2（g），除以上信息外，關於莫樹錦教授的任命沒有其他需要披露的信息。
和黃醫藥董事長杜志強先生表示：“我們衷心地歡迎莫樹錦教授加入公司董事會。他在臨床腫瘤學尤其是肺癌領域的卓越建樹和豐富經驗將使公司獲益良多。”
和黃醫藥是一家創新型生物醫藥公司，致力於研究、開發、生產和銷售藥品和健康類產品。和記黃埔醫藥（上海）有限公司是和黃醫藥的創新藥研發平台，專注於為全球病患研發治療癌症和自身免疫性疾病的創新藥物。和黃醫藥的商業平台負責處方藥和健康類消費品在中國的生產和營銷。
和黃醫藥由長江和記實業有限公司（SEHK：0001）持有多數股權。了解更多詳情請訪問：www.chi-med.com。