London: Tuesday, December 31, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) hereby notifies the market that as at December 31, 2019, the issued share capital of Chi-Med consisted of 666,906,450 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury.
The above figure of 666,906,450 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 Rules and Transparency Rules.
For illustrative purposes only, the 666,906,450 ordinary shares would be equivalent to 666,906,450 CREST depositary interests (each equating to one ordinary share) which are traded on AIM or, if the CREST depositary interests were converted in their entirety, equivalent to 133,381,290 American depositary shares (each equating to five ordinary shares) which are traded on Nasdaq.
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 490 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.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. For more information, please visit: www.chi-med.com.
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
Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
London: Tuesday, December 31, 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 June 29, 2019 to December 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 | |||
| 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: 329,000 | |
| (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: 1,738,910 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:
|
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: | 666,906,450 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 490 scientists and staff focusing on discovering, developing and commercializing targeted therapeutics 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.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. For more information, please visit: www.chi-med.com.
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
Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
倫敦：2019年12月20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」） （AIM/Nasdaq: HCM） 今天宣佈中國國家藥品監督管理局（「國家藥監局」）藥品審評中心將索凡替尼用於非胰腺神經內分泌瘤患者的新藥上市申請納入優先審評。
「索凡替尼是我們第二款被納入國家藥監局優先審評的藥物。」和黃醫藥首席執行官賀雋（Christian Hogg）表示，「我們正與國家藥監局就索凡替尼用於非胰腺神經內分泌瘤治療的新藥上市申請密切溝通。目前非胰腺神經內分泌瘤的治療選擇非常有限。索凡替尼被納入優先審評，將為把這款創新藥帶向患者邁出積極的一步。」
2019年11月，國家藥監局受理了索凡替尼用於治療非胰腺神經內分泌瘤的新藥上市申請。此外，美國食品藥品監督管理局（FDA）亦授予索凡替尼孤兒藥資格，用於胰腺神經內分泌瘤的治療。
索凡替尼（surufatinib，亦稱HMPL-012或sulfatinib）是由和黃醫藥自主研發的一種新型的口服酪氨酸激酶抑制劑，具有抗血管生成和免疫調節雙重活性。索凡替尼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）以阻斷腫瘤血管生成，並可抑制集落刺激因子-1受體（CSF-1R），通過調節腫瘤相關巨噬細胞，促進機體對腫瘤細胞的免疫應答。因為具有抗腫瘤血管生成和免疫調節的雙重機制，索凡替尼可能非常適合與其他免疫療法聯合使用。目前，索凡替尼正在美國開展多項概念驗證研究，同時正在中國開展多項後期臨床試驗及概念驗證研究。
據Frost & Sullivan公司估計， 中國抗血管生成血管內皮生長因子受體（VEGF/VEGFR）抑制劑的市場已從2015年的5億美元增長至2019年的超過15億美元，預計到2026年將達到50億美元。
和黃醫藥目前擁有索凡替尼在全球範圍內的所有權利。
中國非胰腺神經內分泌瘤研究：2015年，和黃醫藥啟動了SANET-ep研究，這是一項關於索凡替尼以晚期非胰腺神經內分泌瘤為適應症的中國III 期臨床試驗，而這些患者目前尚無有效治療方法。 2019年6月，該研究獨立數據監察委員會（IDMC）評估認為，共198名患者參與的中期分析成功達到無進展生存期（「PFS」）這一預設主要療效終點並提前終止研究。 2019年11月，索凡替尼的新藥上市申請獲國家藥監局受理。
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2020年上半年開展一項中期分析，並在2020年完成患者入組工作（clinicaltrials.gov 註冊號NCT02589821）。
美國與歐洲神經內分泌瘤研究：由於索凡替尼以神經內分泌瘤為適應症的II期及III期中國臨床試驗數據令人鼓舞（clinicaltrials.gov 註冊號NCT02267967），且美國Ib期臨床試驗進展順利 （clinicaltrials.gov 註冊號NCT02549937），和黃醫藥計劃在美國開展索凡替尼在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總生存率（OS）（clinicaltrials.gov 註冊號NCT03873532）。
免疫聯合療法：2018年11月及2019年9月，和黃醫藥達成了數個合作協議，以評估索凡替尼聯合PD-1單克隆抗體的安全性、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，及與信達生物製藥在全球共同開發達伯舒®聯合療法的合作協議。拓益®及達伯舒®均已在中國獲批。
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例。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67,600例神經內分泌瘤新診斷病例。按照中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300,000名神經內分泌瘤患者 。據估計在中國患有神經內分泌瘤的患者中約有八成是非胰腺神經內分泌瘤患者。
和黃中國醫藥科技有限公司（簡稱 「和黃醫藥」或 「Chi-Med」）（AIM/納斯達克：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）有限公司是和黃醫藥的創新藥研發平台，現有一支約490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。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，銷售網絡覆蓋中國廣大地區醫院。
和黃醫藥總部位於中國香港，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。了解更多詳情請瀏覽：www.chi-med.com。
本新聞稿包含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，包括對索凡替尼的新藥上市申請是否獲批及是否在中國上市以治療非胰腺神經內分泌瘤的預期、索凡替尼針對非胰腺神經內分泌瘤、胰腺神經內分泌瘤及其他適應症的進一步臨床研究計劃、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佈的預期。前瞻性陳述涉及風險和不確定性。此類風險和不確定性包括下列假設：支持索凡替尼獲批用於在中國治療非胰腺神經內分泌瘤的新藥上市申請的數據充足性、在中國優先審評中及美國和歐洲等其他地區獲得快速審批的潛力、索凡替尼的安全性、索凡替尼成為治療非胰腺神經內分泌瘤患者治療新標準的潛力、實現及完成索凡替尼進一步臨床開發計劃的能力、在中國或其他地區推出上市的可能性及上市時間等。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佈當日有效。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和AIM提交的文件。無論是否出現新信息、未來事件或情況或其他因素，和黃醫藥均不承擔更新或修訂本新聞稿所含信息的義務。
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 |
|
| 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: Thursday, December 12, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces that on December 11, 2019, it granted share options under the Share Option Scheme conditionally adopted by Chi-Med at its Annual General Meeting in 2015 (the “2015 HCML Share Option Scheme”).
Chi-Med granted 400,000 share options under its 2015 HCML Share Option Scheme to an employee to subscribe for Ordinary Shares subject to the acceptance of the grantee. Details of such share options granted prescribed are as follows:
| Date of grant | : | December 11, 2019 |
| Exercise price of share options granted | : | GBP3.592 per Ordinary Share |
| Number of share options granted | : | 400,000 (each share option shall entitle the holder thereof to subscribe for one Ordinary Share) |
| Closing market price of Ordinary Shares on the date of grant | : | GBP3.400 per Ordinary Share |
| Validity period of the share options | : | From December 11, 2019 to December 10, 2029 |
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 490 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.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. For more information, please visit: www.chi-med.com.
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
+852 2121 8200
Annie Cheng, Vice President
+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
Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500