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
London: Friday, August 23, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated a Phase I study of HMPL-523, its novel spleen tyrosine kinase (“Syk”) inhibitor, in patients with immune thrombocytopenia (“ITP”), an autoimmune disorder that can lead to increased risk of bleeding. The first ITP patient was dosed on August 12, 2019 in China.
The study is a randomized, double-blinded, placebo-controlled Phase Ib clinical trial investigating the safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-523 in adult patients with ITP. The primary endpoint is the number of patients with any adverse event. The secondary endpoints are maximum plasma concentration (Cmax), area under the concentration-time curve in a selected time interval (AUC0-t), and rate of clinical remission at week 8. The trial is comprised of a dose escalation stage and a dose expansion stage. Approximately 50 to 60 patients will be enrolled. Additional details may be found at clinicaltrials.gov, using identifier NCT03951623.
This study complements the ongoing Phase Ib dose expansion program of HMPL-523 in Australia (clinicaltrials.gov identifier: NCT02503033) and China (clinicaltrials.gov identifiers: NCT02857998 and NCT03483948) addressing a broad range of hematological cancers. These cancers include acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma and Waldenstrom’s macroglobulinemia. Preliminary results of the dose escalation stage in a Phase I study in China of HMPL-523 in patients with relapsed or refractory B-cell lymphomas were presented in 2018.1 A Phase I dose escalation study in Australia in healthy volunteers was also completed, showing that HMPL-523 was generally well tolerated (clinicaltrials.gov identifier: NCT02105129).
HMPL-523 is a novel, highly selective and potent small molecule inhibitor for oral administration targeting spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor signaling and is an established therapeutic target in multiple subtypes of B-cell lymphomas and autoimmune disorders.
ITP is a type of thrombocytopenic defined as isolated low platelet count (thrombocytopenia) with normal bone marrow and the absence of other causes of thrombocytopenia. Patients with ITP exhibit symptoms of petechiae, purpura, and gastrointestinal and/or urinary mucosal tract bleeding.2 ITP is also associated with fatigue (reported in up to 39% of adults with ITP) and impaired quality of life, across domains of emotional, functional and reproductive health, and work or social life.3-7 The incidence of primary ITP in adults is 3.3/100,000 adults per year with a prevalence of 9.5 per 100,000 adults.8
Adult ITP is a heterogeneous disease that can persist for years, even with best available care, and treatments are infrequently curative. Despite availability of several treatments with differing mechanisms of action, chronicity of disease continues to be a problem. Many patients develop resistance to treatment and thereby are prone to relapse.9 Thus, there remains a significant population of patients who have limited sensitivity to currently available agents and are in need of a new approach to treatment.
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.
This press release 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 its expectations for the clinical development of HMPL-523, plans to initiate clinical studies for HMPL-523 as a monotherapy or in combinations, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate HMPL-523 as a monotherapy or in combinations to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of HMPL-523 for a targeted indication and the sufficiency of funding. 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 press release, 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
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 |
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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 Statement | 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 |