London: Friday, August 30, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) hereby notifies the market that as at August 30, 2019, the issued share capital of Chi-Med consisted of 666,777,450 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 666,777,450 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 666,777,450 ordinary shares would be equivalent to 666,777,450 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 133,355,490 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 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.
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
Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
倫敦，2019年8月23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) 在中國啟動了一項HMPL-523治療免疫性血小板減少性紫癜 (「ITP」) 患者的I期臨床試驗。 HMPL-523是和黃醫藥自主研發的新型脾酪氨酸激酶 (「Syk」) 抑製劑。 ITP是一種導致出血風險增加的自身免疫疾病。首位受試者已於2019年8月12日在中國接受給藥治療。
本研究是一項隨機、雙盲、安慰劑對照Ib期臨床試驗，考察HMPL-523在ITP成年患者中的安全性、耐受性、藥代動力學和初步療效。該研究主要終點指標是出現不良事件的患者數目。次要終點指標是最大血藥濃度 (Cmax)、選定時間間隔內血藥濃度時間曲線下面積 (AUC0-t)，和第8週臨床緩解率。該試驗包括一個劑量遞增階段和一個劑量擴展階段，將招募約50至60名患者。該研究額外詳情可瀏覽clinicaltrials.gov，檢索註冊號NCT03951623查看。
本項研究補充了正在澳洲 (clinicaltrials.gov，檢索註冊號：NCT02503033) 和中國 (clinicaltrials.gov，檢索註冊號：NCT02857998 及NCT03483948) 進行的HMPL-523Ib期劑量擴展臨床試驗，涉及廣泛的血液腫瘤。這些腫瘤包括急性髓細胞白血病、慢性淋巴細胞白血病/小淋巴細胞淋巴瘤、套細胞淋巴瘤、濾泡性淋巴瘤、邊緣區淋巴瘤、瀰漫性大B細胞淋巴瘤和華氏巨球蛋白血症。關於復發性或難治性B細胞淋巴瘤患者中開展的HMPL-523中國I期臨床試驗的劑量遞增階段初步結果已於2018年發布。1 此外，一項在澳洲健康志願者中開展的I期劑量遞增臨床試驗亦已完成，表明HMPL-523的總體耐受性良好 (clinicaltrials.gov，檢索註冊號：NCT02105129)。
HMPL-523是一種新型的強效且高選擇性的小分子靶向脾酪氨酸激酶 (Syk) 的口服抑製劑。 Syk作為B細胞信號傳導通路中的一個關鍵蛋白，是多種亞型的B細胞淋巴瘤及自身免疫疾病的成熟治療靶點。
ITP是一种血小板減少性紫癜，表現為骨髓正常且無其他血小板減少原因的低血小板計數 (血小板減少)。其常見病徵包括瘀點、紫癜和胃腸道和/或尿道粘膜出血等。2 ITP還與疲乏 (ITP成人中報告率多達39%) 和生活質量受損 (包括情感、功能和生育健康方面，以及工作或社交生活) 有關。3-7成人中的原發性ITP發生率為每年3.3/10萬，發病率為9.5/10萬。8
成人中的ITP是一種異質性疾病，即使接受現有最佳治療，仍可持續數年，並且治愈率較低。儘管現時已有數種不同作用機制的治療方法，但慢性疾病仍是一個難題。許多患者出現耐藥性而容易復發。9 因此，目前仍有大量對現有治療反應不佳的患者人群，急需一種新的治療方法。
和黃中國醫藥科技有限公司（Chi-Med，簡稱和黃醫藥 ）（AIM/Nasdaq：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440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。
Chi-Med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HMPL-523臨床開發的預期、啟動HMPL-523用作單藥或聯合療法的臨床研究計劃、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布的預期。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：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HMPL- 523（包括作為單藥或聯合治療）達到研究的主要或次要終點的療效、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、HMPL-523用於目標適應症的潛在市場和資金充足性等。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 |
| NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) | ||||||
| 1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached: |
Hutchison China MediTech Limited; Legal Entity Identifier: 2138006X34YDQ6OBYE79 |
|||||
| 1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) | ||||||
| Non-UK issuer | X | |||||
| 2. Reason for the notification (please mark the appropriate box or boxes with an “X”) | ||||||
| An acquisition or disposal of voting rights | X | |||||
| An acquisition or disposal of financial instruments | ||||||
| An event changing the breakdown of voting rights | ||||||
| Other (please specify): | ||||||
| 3. Details of person subject to the notification obligation | ||||||
| Name | The Capital Group Companies, Inc. (“CGC”) | |||||
| City and country of registered office (if applicable) | Los Angeles, CA 90071, USA | |||||
| 4. Full name of shareholder(s) (if different from 3.) | ||||||
| Name | ||||||
| City and country of registered office (if applicable) | ||||||
| 5. Date on which the threshold was crossed or reached: | 15 August 2019 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | 16 August 2019 | |||||
| 7. Total positions of person(s) subject to the notification obligation | ||||||
| % of voting rights attached to shares (total of 8. A) | % of voting rights through financial instruments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights of issuer | |||
| Resulting situation on the date on which threshold was crossed or reached | 5.0357% | 0.0000% | 5.0357% | 666,577,450 | ||
| Position of previous notification (if applicable) | N/A | N/A | N/A | |||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reached | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of sharesISIN code (if possible) |
Number of voting rights | % of voting rights | |||||||
|
Direct (Art 9 of Directive 2004/109/EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/109/EC) (DTR5.2.1) |
Direct (Art 9 of Directive 2004/109/EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/109/EC) (DTR5.2.1) |
||||||
| ORD USD0.10 (KYG4672N1198) |
2,651,060 | 0.3977% | |||||||
| SPON ADS (US44842L1035) |
30,915,775 | 4.6380% | |||||||
| SUBTOTAL 8. A | 33,566,835 | 5.0357% | |||||||
| B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a)) | |||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights | |||
| N/A | |||||||
| SUBTOTAL 8. B 1 | |||||||
| B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b)) | |||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Period xi |
Physical or cash settlementxii |
Number of voting rights | % of voting rights | ||
| N/A | |||||||
| SUBTOTAL 8.B.2 | |||||||
| 9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) | ||||
| Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer | ||||
| Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) |
X | |||
| Name | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
|
The Capital Group Companies, Inc. Holdings by CG Management companies are set out below: |
5.0357% | 0.0000% | 5.0357% | |
| • Capital Bank & Trust Company2 | ||||
| • Capital International, Inc.1 | ||||
| • Capital International Limited1 | ||||
| • Capital International Sàrl1 | ||||
| • Capital Research and Management Company2 | ||||
|
1Indirect subsidiaries of Capital Research and Management Company. 2Subsidiary of The Capital Group Companies, Inc.
|
||||
| 10. In case of proxy voting, please identify: | ||||
| Name of the proxy holder | ||||
| The number and % of voting rights held | ||||
| The date until which the voting rights will be held | ||||
| 11. Additional information | ||||
|
The Capital Group Companies, Inc. (“CGC”) is the parent company of Capital Research and Management Company (“CRMC”) and Capital Bank & Trust Company (“CB&T”). CRMC is a U.S.-based investment management company that serves as investment manager to the American Funds family of mutual funds, other pooled investment vehicles, as well as individual and institutional clients. CRMC and its investment manager affiliates manage equity assets for various investment companies through three divisions, Capital Research Global Investors, Capital International Investors and Capital World Investors. CRMC is the parent company of Capital Group International, Inc. (“CGII”), which in turn is the parent company of four investment management companies (“CGII management companies”): Capital International, Inc., Capital International Limited, Capital International Sàrl and Capital International K.K. CGII management companies and CB&T primarily serve as investment managers to institutional and high net worth clients. CB&T is a U.S.-based investment management company that is a registered investment adviser and an affiliated federally chartered bank. Neither CGC nor any of its affiliates own shares of your company for its own account. Rather, the shares reported on this Notification are owned by accounts under the discretionary investment management of one or more of the investment management companies described above. |
||||
| Place of completion | Los Angeles, CA, USA |
| Date of completion | 16 August 2019 |
| Corporate Information | |
| Contents | 1 |
| Financial Highlights | 2 |
| Operating Highlights | 3 |
| Chairman’s Statement6 | 6 |
| Financial Review | 7 |
| Operations Review Innovation Platform Commercial Platform |
9 9 19 |
| Condensed Consolidated Balance Sheets | 24 |
| Condensed Consolidated Statements of Operations | 25 |
| Condensed Consolidated Statements of Comprehensive Loss | 26 |
| Condensed Consolidated Statements of Changes in Shareholders’ Equity | 27 |
| Condensed Consolidated Statements of Cash Flows | 28 |
| Notes to Unaudited Condensed Consolidated Financial Statements | 29 |
| Information For Shareholders | 54 |