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
伦敦 ，2019年8月23日 (星期五)：和黄中国医药科技有限公司 (简称“和黄医药”或“Chi-Med”) (AIM/Nasdaq: HCM) 在中国启动了一项HMPL-523治疗免疫性血小板减少性紫癜(“ITP”)患者的I期临床试验。HMPL-523是和黄医药自主研发的新型脾酪氨酸激酶 (“Syk”)抑制剂。ITP是一种导致出血风险增加的自身免疫疾病。首位受试者已于2019年8月12日在中国接受给药治疗。
本研究是一项随机、双盲、安慰剂对照Ib期临床试验，考察HMPL-523在ITP成年患者中的安全性、耐受性、药代动力学和初步疗效。该研究主要终点指标是出现不良事件的患者数目。次要终点指标是最大血药浓度 (Cmax)、选定时间间隔内血药浓度时间曲线下面积 (AUC0-t)，和第8周临床缓解率。该试验包括一个剂量递增阶段和一个剂量扩展阶段，将招募约50至60名患者。该研究额外详情可登陆clinicaltrials.gov，检索注册号 NCT03951623查看。
本项研究补充了正在澳大利亚 (clinicaltrials.gov，检索注册号：NCT02503033) 和中国 (clinicaltrials.gov，检索注册号：NCT02857998 及NCT03483948) 进行的HMPL-523Ib期剂量扩展临床试验，涉及广泛的血液肿瘤。这些肿瘤包括急性髓细胞白血病、慢性淋巴细胞白血病/小淋巴细胞淋巴瘤、套细胞淋巴瘤、滤泡性淋巴瘤、边缘区淋巴瘤、弥漫性大B细胞淋巴瘤和华氏巨球蛋白血症。关于复发性或难治性B细胞淋巴瘤患者中开展的HMPL-523中国I期临床试验的剂量递增阶段初步结果已于2018年发布。1 此外，一项在澳大利亚健康志愿者中开展的I期剂量递增临床试验亦已完成，表明HMPL-523的总体耐受性良好 (clinicaltrials.gov，检索注册号：NCT02105129)。
HMPL-523是一种新型的强效且高选择性的小分子靶向脾酪氨酸激酶 (Syk) 的口服抑制剂。Syk作为B细胞信号传导通路中的一个关键蛋白，是多种亚型的B细胞淋巴瘤及自身免疫疾病的成熟治疗靶点。
ITP是一种血小板减少性紫癜，表现为骨髓正常且无其他血小板减少原因的低血小板计数 (血小板减少)。其常见病征包括瘀点、紫癜和胃肠道和/或尿道粘膜出血等。2 ITP还与疲乏 (ITP成人中报告率多达39%) 和生活质量受损 (包括情感、功能和生育健康方面，以及工作或社交生活) 有关。3-7成人中的原发性ITP发生率为每年3.3/10万，发病率为9.5/10万。8
成人中的ITP是一种异质性疾病，即使接受现有最佳治疗，仍可持续数年，并且治愈率较低。尽管现时已有数种不同作用机制的治疗方法，但慢性疾病仍是一个难题。许多患者出现耐药性而容易复发。9 因此，目前仍有大量对现有治疗反应不佳的患者人群，急需一种新的治疗方法。
和黄中国医药科技有限公司 (Chi-Med，简称和黄医药) (AIM/Nasdaq：HCM) 是一家创新型生物医药公司，致力于药品的研究、开发、生产和销售。和记黄埔医药 (上海) 有限公司是Chi-Med的创新药研发平台，现有一支约440人的研发团队，专注于研发和商业开发治疗癌症和自身免疫性疾病的靶向创新药物和免疫疗法，目前共有8个抗癌类候选药物进入临床阶段，正在全球开展临床研究。Chi-Med的商业平台负责处方药和健康类消费品在中国的生产和营销,销售网络覆盖中国广大地区医院。
Chi-Med总部位于中国香港，在伦敦证券交易所 (AIM) 和美国纳斯达克全球精选市场均已上市。了解更多详情请访问：www.chi-med.com 。
本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对HMPL-523临床开发的预期、启动HMPL-523用作单药或联合疗法的临床研究计划、对此类研究是否能达到其主要或次要终点的预期，以及对此类研究完成时间和结果发布的预期。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：入组率、满足研究入选和排除标准的受试者的时间和可用性、临床方案或监管要求变更、非预期不良事件或安全性问题、候选药物HMPL-523（包括作为单药或联合治疗）达到研究的主要或次要终点的疗效、获得不同司法管辖区的监管批准、获得监管批准后获得上市许可、HMPL-523用于目标适应症的潜在市场和资金充足性等。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会和AIM提交的文件。无论是否出现新信息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含信息的义务。
投资者咨询 |
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媒体咨询 |
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任命保荐人 |
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| 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.
|
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| 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. |
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| 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 |