London: Friday, June 28, 2019: Hutchison China MediTech Limited (“Chi-Med” or the “Company”) (AIM/Nasdaq: HCM) announces the following blocklisting six monthly return:
| 1. | Name of applicant: | Hutchison China MediTech Limited | ||
| 2. | Name of scheme: | (a) | Share Option Scheme conditionally adopted by Hutchison China MediTech Limited in 2005 (“2005 HCML Share Option Scheme”) | |
| (b) | Share Option Scheme conditionally adopted by Hutchison China MediTech Limited in 2015 (“2015 HCML Share Option Scheme”) | |||
| 3. | Period of return: | From December 29, 2018 to June 28, 2019 | ||
| 4. | Balance under scheme from previous return: | (a) | 2005 HCML Share Option Scheme: 2,067,910 ordinary shares of US$0.1 each | |
| (b) |
2015 HCML Share Option Scheme: 23,130,970 ordinary shares of US$0.1 each Note: Chi-Med underwent a share subdivision which took effect on May 30, 2019 on the basis of 10 new ordinary shares of US$0.1 each for every existing ordinary share of US$1 each. For consistency, the balance of unallotted securities under the schemes from the previous return above have been adjusted to reflect the post-subdivision (i.e. current) share capital of the Company. |
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| 5. | The amount by which the block scheme has been increased, if the scheme has been increased since the date of the last return: | (a) | 2005 HCML Share Option Scheme: Nil | |
| (b) | 2015 HCML Share Option Scheme: Nil | |||
| 6. | Number of securities issued/allotted under scheme during period: | (a) | 2005 HCML Share Option Scheme: Nil | |
| (b) | 2015 HCML Share Option Scheme: Nil | |||
| 7. | Balance under scheme not yet issued/allotted at end of the period: | (a) | 2005 HCML Share Option Scheme: 2,067,910 ordinary shares of US$0.1 each | |
| (b) | 2015 HCML Share Option Scheme: 23,130,970 ordinary shares of US$0.1 each | |||
| 8. | Number and class of securities originally listed and the date of admission: | (i) | 2,560,606 ordinary shares of US$1 each admitted on June 26, 2007 | |
| (ii) | 1,000,000 ordinary shares of US$1 each admitted on June 20, 2016 | |||
| (iii) | 1,425,597 ordinary shares of US$1 each admitted on April 27, 2018 | |||
| (iv) | 25,198,880 ordinary shares of US$0.1 each admitted on June 17, 2019 (to replace the Company’s previous block admission schemes following the Company’s share subdivision which took effect on May 30, 2019) | |||
| 9. | Total number of securities in issue at the end of the period: | 666,577,450 ordinary shares of US$0.1 each | ||
| Name of contact: | Christian Hogg | |||
| Address of contact: | Level 18, The Metropolis Tower, 10 Metropolis Drive, Hung Hom, Kowloon, Hong Kong | |||
| Telephone number of contact: | +852 2121 8200 | |||
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.
CONTACTS
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
+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: June 28, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces the upsizing and pricing of the underwritten public secondary offering previously announced by Chi-Med on June 27, 2019. Hutchison Healthcare Holdings Limited (“HHHL”), the largest shareholder of Chi-Med and a subsidiary of CK Hutchison Holdings Limited (SEHK: 1), will sell 12,000,000 American Depositary Shares (“ADSs”), each representing five ordinary shares, par value US$0.10 each, of Chi-Med, at a price of US$24.00 per ADS (“Offering”), less underwriting discounts and commissions.
HHHL has granted the underwriter a 30-day option to purchase up to 1,800,000 additional ADSs at the Offering price, less underwriting discounts and commissions. Assuming the over-allotment option is not exercised, HHHL will own approximately 51.2% of Chi-Med’s share capital immediately following the Offering. Assuming full exercise of the over-allotment option, HHHL will own approximately 49.8% of Chi-Med’s share capital immediately following the Offering. Closing of the Offering is expected to occur on or about July 2, 2019, subject to customary closing conditions.
HHHL will receive all of the proceeds from the Offering. Morgan Stanley & Co. LLC is acting as sole underwriter for the Offering.
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 HHHL pursuant to a shelf registration statement on Form F-3 filed by Chi-Med with the United States Securities and Exchange Commission (“SEC”) that became automatically effective on April 3, 2017. A preliminary prospectus supplement related to the Offering has been filed with the SEC. A final prospectus supplement related to the Offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, electronic copies of the final prospectus supplement and the accompanying prospectus relating to the Offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014.
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.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). 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 plans and objectives. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the possibility that the closing conditions for the Offering will not be satisfied. 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, HHHL or Morgan Stanley & Co. LLC undertakes any obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
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 (as amended) and includes any relevant implementing measure in the Member State of the European Economic Area concerned.
In any Member State of the European Economic Area, this announcement is only addressed to and directed at persons who are “Qualified Investors” within the meaning of Article 2(1)(e) of the Prospectus Directive. The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with Qualified Investors. This announcement should not be acted upon or relied upon in any Member State of the European Economic Area by persons who are not Qualified Investors.
This communication, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of s21 Financial Services and Markets Act 2000 as amended) in connection with the securities which are the subject of the Offering described in this announcement or otherwise, is being directed only at persons who (i) are outside the United Kingdom or (ii) have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) are persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000) in connection with the issue or sale of any securities may otherwise lawfully be communicated or caused to be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). This announcement is directed only at relevant persons and must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.
In connection with the Offering, the underwriter or its affiliates may conduct stabilization activities with respect to the ADSs on Nasdaq, in the over-the-counter market or otherwise, to support the market price of the ADSs at a higher level than that which might otherwise prevail in the open market, in compliance with all applicable laws and regulations, including Regulation M under the U.S. Securities Exchange Act of 1934, as amended. These activities may include short sales, stabilizing transactions and purchases of ordinary shares or ADSs to cover positions created by short sales. Any stabilization action may begin on the date of adequate public disclosure of the final price of the ADSs to be sold pursuant to the Offering and, if begun, may be ended at any time but must end no later than 30 calendar days thereafter (the “Stabilization Period”). However, there is no obligation on the underwriter (or any person acting for it) to conduct any such stabilizing activities, and the stabilization activities may be discontinued at any time.
In connection with the Offering, the underwriter may, for stabilization purposes, over-allocate ADSs up to a maximum of 15% of the total number of ADSs comprised in the Offering. For the purposes of allowing it to cover short positions resulting from any such over-allotments and/or from sales of ADSs effected by it during the Stabilization Period, the underwriter has entered into over-allotment arrangements pursuant to which the underwriter may purchase or procure purchasers for additional ADSs up to a maximum of 15% of the total number of ADSs comprised in the Offering (the “Over-allotment ADSs”) at the Offering price. The over-allotment arrangements will be exercisable in whole or in part, upon notice by the underwriter, at any time on or before the 30th calendar day after pricing. Any Over-allotment ADSs made available pursuant to the over-allotment arrangements will be sold on the same terms and conditions as the ADSs being offered pursuant to the Offering and will rank pari passu in all respects with, and form a single class with, the other ADSs.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
+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: June 27, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces that Hutchison Healthcare Holdings Limited (“HHHL”), the largest shareholder of Chi-Med and a subsidiary of CK Hutchison Holdings Limited (SEHK: 1), intends to offer 8,500,000 American Depositary Shares (“ADSs”), each representing five ordinary shares (“Ordinary Shares”), par value US$0.10 each of Chi-Med (“Offering”).
HHHL has granted the underwriter a 30-day option to purchase up to 1,275,000 additional ADSs at the Offering price, less underwriting discounts and commissions. Assuming the over-allotment option is not exercised, HHHL will own approximately 53.8% of Chi-Med’s share capital immediately following the Offering. Assuming full exercise of the over-allotment option, HHHL will own approximately 52.8% of Chi-Med’s share capital immediately following the Offering.
HHHL will receive all of the proceeds from the Offering. Morgan Stanley & Co. LLC is acting as sole underwriter for the Offering.
The ADSs described above are being offered by HHHL pursuant to a shelf registration statement on Form F-3 filed by Chi-Med with the United States Securities and Exchange Commission (“SEC”) that became automatically effective on April 3, 2017. A preliminary prospectus supplement related to the Offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014.
In connection with the Offering, Chi-Med, its officers and directors and the selling shareholder have agreed to a 90-day lock-up on sales or transfers of Ordinary Shares, ADSs or equity-linked securities. Chi-Med remains committed to its previously announced proposed listing of its Shares on The Stock Exchange of Hong Kong (“SEHK”) and a potential concurrent global offering of its Ordinary Shares which Chi-Med may pursue following the expiration of such lock-up period. Chi-Med’s listing application and potential concurrent global offering are subject to, among other things, the final approval of the SEHK, the final decision of the Chi-Med board of directors, market conditions and other factors. Accordingly, Chi-Med’s shareholders and potential investors should be aware that there is no assurance that the listing and the potential concurrent global offering will take place or as to when it may take place. Chi-Med will provide a further update on the timing as appropriate.
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.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014. 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.
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including management’s plans and objectives. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the possibility that the closing conditions for the Offering will not be satisfied. More information about such risks and uncertainties is contained or incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus related to the Offering filed with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the SEC and on AIM. None of Chi-Med, HHHL or Morgan Stanley & Co. LLC undertakes any obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Important Notice
No prospectus required for the purposes of 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 (as amended) and includes any relevant implementing measure in the Member State of the European Economic Area concerned.
In any Member State of the European Economic Area, this announcement is only addressed to and directed at persons who are “Qualified Investors” within the meaning of Article 2(1)(e) of the Prospectus Directive. The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with Qualified Investors. This announcement should not be acted upon or relied upon in any Member State of the European Economic Area by persons who are not Qualified Investors.
This communication, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of s21 Financial Services and Markets Act 2000 as amended) in connection with the securities which are the subject of the Offering described in this announcement or otherwise, is being directed only at persons who (i) are outside the United Kingdom or (ii) have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) are persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000) in connection with the issue or sale of any securities may otherwise lawfully be communicated or caused to be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). This announcement is directed only at relevant persons and must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.
In connection with the Offering, the underwriter or its affiliates may conduct stabilization activities with respect to the ADSs on Nasdaq, in the over-the-counter market or otherwise, to support the market price of the ADSs at a higher level than that which might otherwise prevail in the open market, in compliance with all applicable laws and regulations, including Regulation M under the U.S. Securities Exchange Act of 1934, as amended. These activities may include short sales, stabilizing transactions and purchases of ordinary shares or ADSs to cover positions created by short sales. Any stabilization action may begin on the date of adequate public disclosure of the final price of the ADSs to be sold pursuant to the Offering and, if begun, may be ended at any time but must end no later than 30 calendar days thereafter (the “Stabilization Period”). However, there is no obligation on the underwriter (or any person acting for it) to conduct any such stabilizing activities, and the stabilization activities may be discontinued at any time.
In connection with the Offering, the underwriter may, for stabilization purposes, over-allocate ADSs up to a maximum of 15% of the total number of ADSs comprised in the Offering. For the purposes of allowing it to cover short positions resulting from any such over-allotments and/or from sales of ADSs effected by it during the Stabilization Period, the underwriter has entered into over-allotment arrangements pursuant to which the underwriter may purchase or procure purchasers for additional ADSs up to a maximum of 15% of the total number of ADSs comprised in the Offering (the “Over-allotment ADSs”) at the Offering price. The over-allotment arrangements will be exercisable in whole or in part, upon notice by the underwriter, at any time on or before the 30th calendar day after pricing. Any Over-allotment ADSs made available pursuant to the over-allotment arrangements will be sold on the same terms and conditions as the ADSs being offered pursuant to the Offering and will rank pari passu in all respects with, and form a single class with, the other ADSs.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
香港：2019 年6 月14 日，星期五：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）今日宣布索凡替尼以晚期非胰腺神經內分泌瘤為適應症的III 期關鍵性研究SANET-ep 預設的中期分析已由該研究獨立數據監察委員會（IDMC）完成。
該研究已經成功達到無進展生存期（PFS）這一預設主要療效終點，因此IDMC 決定提前終止研究。和黃醫藥將與中國國家藥品監督管理局（NMPA）進行提交新藥上市申請（NDA）前的會議，以進一步討論索凡替尼就該適應症提交新藥上市申請的準備工作，並計劃於近期的學術會議上提交SANET-ep 研究結果。
SANET-ep 是一項中國III 期臨床試驗，入組人群為目前尚無有效治療的低級別或中級別晚期非胰腺神經內分泌瘤患者。在該研究中，患者以2：1 的比例隨機接受每天口服一次300 mg 索凡替尼或安慰劑治療，28 天為一個治療週期。該研究的主要終點為PFS，次要終點包括客觀緩解率（ORR）、疾病控制率（DCR）、到達疾病緩解的時間（TTR）、緩解持續時間（DoR）、總生存期（OS）、安全性及耐受性。該研究詳情可登陸clinicaltrials.gov，檢索NCT02588170 查看。
神經內分泌瘤（NET）起源於與神經系統相互作用的細胞或產生激素的腺體。神經內分泌瘤可起源於體內很多部位，最常見於消化道或肺部，可為良性或惡性腫瘤。按照起源，神經內分泌瘤通常分為胰腺神經內分泌瘤和非胰腺神經內分泌瘤。獲批的靶向治療包括索坦®（蘋果酸舒尼替尼）和飛尼妥®（依維莫司），用於治療胰腺神經內分泌瘤或高度分化的非功能性胃腸道或肺神經內分泌瘤。
據Frost & Sullivan 公司估計，2018 年美國神經內分泌瘤新診斷病例為19,000 宗。值得關注的是，與其他腫瘤相比，神經內分泌瘤患者的生存期相對較長，因此，雖然神經內分泌瘤發病率相對不高，但患者人群相對較大。此外，據估計2018 年美國神經內分泌瘤患者約141,000 名，其中約有超九成，即132,000 名患者，為非胰腺神經內分泌瘤患者。
在中國，2018 年約有65,600 宗神經內分泌瘤新診斷病例。按照美國的發病率與流行率比例（incidence to prevalence ratio）估算，中國總共或有高達490,000 名神經內分泌瘤患者。
索凡替尼（亦稱為HMPL-012）是一種新型的口服抗血管生成-免疫逃逸激酶抑製劑，可通過抑制血管內皮生長因子受體（VEGFR）和成纖維細胞生長因子受體（FGFR ）來抑制血管生成，索凡替尼也可抑制集落刺激因子-1 受體（CSF-1R），通過抑制CSF-1R 可調節腫瘤相關巨噬細胞，促進機體對腫瘤細胞的免疫應答。因為具有這種同時抑制腫瘤血管生成和免疫逃逸的作用機制，索凡替尼可能非常適合與其他免疫療法聯用。索凡替尼目前正在美國和中國開展多項概念驗證研究，並有多項後期臨床試驗正在中國進行。
我們目前擁有索凡替尼在全球範圍內的所有權利。
中國胰腺神經內分泌瘤研究：2016 年，和黃醫藥在中國啟動了一項關鍵性III 期註冊研究SANET-p，入組患者為低級別或中級別晚期胰腺神經內分泌瘤患者。主要研究終點為PFS。和黃醫藥計劃於2019年年底開展一項中期分析，並在2020 年完成患者入組工作（clinicaltrials.gov 註冊號NCT02589821）。
美國與歐洲胰腺神經內分泌瘤研究：由於索凡替尼以胰腺NET 為適應症的II 期中國臨床試驗數據令人鼓舞（clinicaltrials.gov 註冊號NCT02267967），且美國Ib/II 期臨床試驗進展順利，和黃醫藥決定將計劃開展索凡替尼在胰腺神經內分泌瘤患者中的註冊性研究。
中國膽道癌研究：2019 年3 月，和黃醫藥啟動了一項IIb/III 期臨床試驗，旨在對比索凡替尼和卡培他濱治療一線化療失敗晚期膽道癌患者的療效和安全性。該研究的主要終點為OS（clinicaltrials.gov 註冊號NCT03873532）
免疫聯合療法： 2018 年11 月，和黃醫藥達成了數個合作協議，以評估索凡替尼聯合免疫檢查點抑製劑的安全性、耐受性和療效。其中包括與上海君實生物醫藥科技股份有限公司在全球共同開發索凡替尼與拓益®聯合療法的合作協議。拓益®為上海君實生物醫藥科技股份有限公司研發的一種PD-1 單克隆抗體，已於 2018年年底在中國獲批。
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）是一家創新型生物醫藥公司，致力於藥品的研究、開發、生產和銷售。和記黃埔醫藥（上海）有限公司是Chi-Med 的創新藥研發平台，現有一支約420人的研發團隊，專注於研發和商業開發治療癌症和自身免疫性疾病的靶向創新藥物和免疫療法，目前共有8 個抗癌類候選藥物進入臨床階段，正在全球開展臨床研究。 Chi-Med 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，銷售網絡覆蓋中國廣大地區醫院。總部位於中國香港，在倫敦證券交易所（AIM）和美國納斯達克全球精選市場均已上市，由長江和記實業有限公司（SEHK：1）持有多數股權。了解更多詳情請瀏覽：www.chi-med.com
本公告包含1995 年《美國私人證券訴訟改革法案》「安全港」條款中定義的前瞻性陳述。這些前瞻性陳述反映了和黃醫藥目前對未來事件的預期，包括對索凡替尼臨床開發的預期、啟動索凡替尼臨床研究的計劃、對此類研究是否能達到其主要或次要終點的預期以及對此類研究完成時間和結果發布的預期。前瞻性陳述涉及風險和不確定性。此外，此類風險和不確定性包括下列假設：入組率、滿足研究入选和排除標準的受試者的時間和可用性、臨床方案或監管要求變更、非預期不良事件或安全性問題、候選藥物索凡替尼的療效（包括作為聯合治療）、達到研究的主要或次要終點、獲得不同司法管轄區的監管批准、獲得監管批准後獲得上市許可、索凡替尼用於目標適應症的潛在市場和資金充足性。此外，由於一些研究需使用拓益®和HX008 與索凡替尼作為聯合治療，因此，此類風險和不確定性包括有關拓益®和HX008 的安全性、療效、供應和持續監管批准的假設。提醒當前和潛在投資者請勿過度依賴這些前瞻性陳述，這些陳述僅在截至本新聞稿發布當日有效。有關這些風險和其他風險的進一步討論，請查閱和黃醫藥向美國證券交易委員會提交的文件和AIM。無論是否出現新信息、未來事件或情況或其他方面，和黃醫藥均不承擔更新或修訂本公告所含信息的義務。
本新聞稿載有依法規（EU）No 596/2014第7條所披露的內幕消息。
聯繫方式
投資者諮詢 |
|
| 李健鴻，資深副總裁 | +852 2121 8200 |
| 鄭嘉惠，副總裁 | +1 (973) 567 3786 |
| David Dible, Citigate Dewe Rogerson |
+44 7967 566 919 （手機)）david.dible@citigatedewerogerson.com |
| Xuan Yang, Solebury Trout |
+1 (415) 971 9412（手機） xyang@troutgroup.com |
媒體諮詢 |
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| 英國及歐洲 – | |
| Anthony Carlisle, Citigate Dewe Rogerson | +44 7973 611 888（手機） anthony.carlisle@cdrconsultancy.co.uk |
| 美洲 — | |
| Brad Miles, Solebury Trout | +1 (917) 570 7340（手機） bmiles@troutgroup.com |
| 中國香港及亞洲其他地區 （不含中國大陸地區） – | |
| 盧志倫, 博然思維集團 | +852 9850 5033（手機） jlo@brunswickgroup.com |
| 周怡, 博然思維集團 | +852 9783 6894（手機） yzhou@brunswickgroup.com |
| 中國大陸地區 – | |
| 沈雁翎, 愛德曼公關公司 | +86 136 7179 1029 （手機） sam.shen@edelman.com |
任命保薦人 |
|
| Andrew Potts, Panmure Gordon (UK) Limited | +44 (20) 7886 2500 |
London: Wednesday, June 12, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that the following applications have been made to the London Stock Exchange plc for the block admission of ordinary shares, par value of US$0.10 each (“Ordinary Shares”) to be admitted to trading on AIM:
When issued, these Ordinary Shares will be credited as fully paid and will rank pari passu with the existing Ordinary Shares in issue.
The sole reason for the above block admission applications is to replace the Company’s previous block admission schemes following the Company’s recent share subdivision which took effect on May 30, 2019.
As at the date of this announcement, the issued share capital of Chi-Med consists of 666,577,450 Ordinary Shares, with each share carrying one right to vote and with no shares held in treasury. This figure of 666,577,450 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, Chi-Med under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules. For illustrative purposes only, the 666,577,450 Ordinary Shares would be equivalent to 666,577,450 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 133,315,490 ADSs (each equating to five Ordinary Shares) which are traded on the NASDAQ Global Select Market.
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 420 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.
Forward Looking Statements
This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
London: Thursday, June 6, 2019: Hutchison China MediTech Limited (“Chi-Med” or the “Company”) (AIM/Nasdaq: HCM) today filed the Post Hearing Information Pack (the “PHIP”) with the Stock Exchange of Hong Kong Limited (“SEHK”) in connection with a proposed listing of its ordinary shares on the Main Board of the SEHK (the “Listing”) and concurrent global offering of ordinary shares (the “Offering”) as previously announced on April 15, 2019. The PHIP contains unaudited condensed consolidated interim financial information as of and for the three months ended March 31, 2018 and 2019 and certain updates regarding the Company’s business and financial information which are available for viewing at https://www.rns-pdf.londonstockexchange.com/rns/3500B_1-2019-6-6.pdf .
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 420 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). 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. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks and uncertainties related to completion of the SEHK’s review of Chi-Med’s listing application and completion of the Offering (including the terms of the Offering), market conditions, the satisfaction of customary closing conditions related to the Offering, whether and the degree to which Chi-Med will continue to benefit from CKHH’s support, and Chi-Med’s ability to progress the development of its drug candidates and successfully commercialize them. More information about the risks and uncertainties faced by Chi-Med will be contained or incorporated by reference in the preliminary prospectus filed with the SEHK and preliminary prospectus supplement filed with the SEC, in each case related to the Offering, when completed. 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 SEHK, SEC and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
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, American depositary shares or any other securities of the Company in the United States or any other jurisdiction. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act. Any public offering of securities to be made in the United States will be made by means of a prospectus. Such prospectus may be obtained from the Company and will contain or incorporate by reference detailed information about the Company, its management and financial statements.
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.
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 United Kingdom may be restricted by law. Persons into whose possession this announcement come should inform themselves about and observe any such restrictions.
In connection with the Offering, the price of the Shares may be stabilized in accordance with the Securities and Futures (Price Stabilizing) Rules (Chapter 571W of the Laws of Hong Kong) and Regulation M under the U.S. Exchange Act of 1934, as amended. Details of any intended stabilization and how it will be regulated under the Securities and Futures Ordinance (Chapter 571 of the Laws of Hong Kong) will be contained in the Company’s Hong Kong prospectus, which will be issued in Hong Kong in connection with the Hong Kong public offering of the Shares if the Offering proceeds.
In any European Economic Area Member State that has implemented the Prospectus Directive, this announcement is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Directive. The term “Prospectus Directive” means Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant Member State), together with any relevant implementing measure in the relevant Member State.
This announcement, insofar as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the potential offering described in this announcement or otherwise, is being directed only at (i) persons who are outside the United Kingdom or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (iii) persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). Any person who is not a relevant person should not act or rely on this announcement or any of its contents.
This announcement shall not be deemed as public invitation or inducement to enter into investment activity, nor shall the publication of this announcement be deemed as offering securities consultation-related services in the PRC (for the purpose of this announcement only, excluding Hong Kong, Macau and Taiwan). The securities which are the subject of the potential offering described in this announcement may not be offered or sold, and will not be offered or sold to any person for re-offering or resale, directly or indirectly, to any resident of the PRC except pursuant to applicable laws and regulations of the PRC.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
Jianming Xu, Jie Li, Chunmei Bai, Nong Xu, Zhiwei Zhou, Zhiping Li, Caicun Zhou, Ru Jia, Ming Lu, Yuejuan Cheng, Chenyu Mao, Wei Wang, Ke Cheng, Chunxia Su, Ye Hua, Chuan Qi, Jing Li, Wei Wang, Ke Li, Qiaoling Sun, Yongxin Ren, and Weiguo Su
Journal: Clinical Cancer Research June 2019
DOI: 10.1158/1078-0432.CCR-18-2994
PubMed: 30833272
Purpose: No anti-angiogenic treatment is yet approved for extrapancreatic neuroendocrine tumors (NETs). Surufatinib (HMPL-012, previously named sulfatinib) is a small molecule inhibitor targeting vascular endothelial growth factor receptors, fibroblast growth factor receptor 1 and colony stimulating factor 1 receptor. We conducted a single-arm phase Ib/II study of surufatinib in advanced NETs.
Experimental Design: Patients with histologically well-differentiated, low or intermittent grade, inoperable or metastatic NETs were enrolled into a pancreatic or extrapancreatic NETs cohort. Patients were treated with surufatinib 300 mg orally, once daily. The primary endpoints were safety and objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (version 1.1).
Results: Of the 81 patients enrolled, 42 had pancreatic NETs, and 39 had extrapancreatic NETs. Most patients had radiological progression within one year prior to enrollment (32 patients in each cohort). In the pancreatic and extrapancreatic NETs cohorts, ORRs were 19% (95% CI 9-34) and 15% (95% CI 6-31), disease control rates were 91% (95% CI 77-97) and 92% (95% CI 79-98), and median progression-free survival was 21.2 months (95% CI 15.9-24.8) and 13.4 months (95% CI 7.6-19.3), respectively. The most common grade ≥3 treatment-related adverse events were hypertension (33%), proteinuria (12%) hyperuricemia (10%), hypertriglyceridemia and diarrhea (6% for each), and increased alanine aminotransferase (5%).
Conclusions: Surufatinib showed encouraging anti-tumor activity and manageable toxicities in patients with advanced NETs. Two ongoing phase III studies, validating the efficacy of surufatinib in patients with NETs, will contribute to the clinical evidence.