— Single-arm study in ~180 patients, with ORR as primary endpoint —

— Relapsed/refractory FL and MZL constitute approximately 25% of all NHL —

— HMPL-689 trials are also underway in these and other NHL subtypes in the U.S., Europe and China —

Hong Kong, Shanghai & Florham Park, NJ — Thursday, April 29, 2021: Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) has initiated a registration-intent Phase II clinical trial of HMPL‑689, its highly selective and potent PI3Kδ inhibitor, in China in patients with relapsed or refractory follicular lymphoma (“FL”) and marginal zone lymphoma (“MZL”), two subtypes non-Hodgkin’s lymphoma (“NHL”). The first patient was dosed today.

The clinical trial is a multi-center, single-arm, open-label clinical study to evaluate the efficacy and safety of HMPL-689 once a day oral monotherapy in approximately 100 patients with relapsed/refractory FL and approximately 80 patients with relapsed/refractory MZL. Relapsed/refractory is defined when a patient has not achieved response (complete response or partial response) after the latest line of systemic treatment, or has progressive disease or relapse after achieving response. The primary endpoint is objective response rate (“ORR”), with secondary endpoints including complete response rate (CRR), progression-free survival (PFS), time to response (TTR) and duration of response (DoR).  The trial is being conducted in over 35 sites in China.  More information will be available at clinicaltrials.gov, using identifier NCT04849351.

The initiation of the Phase II trial is based on the highly promising preliminary results from the Phase Ib expansion study ongoing in China, which show that HMPL-689 was well tolerated, exhibiting dose-proportional pharmacokinetics (“PK”), a manageable toxicity profile, and single-agent clinical activity in relapsed/refractory B-cell lymphoma patients. Additional details may be found at clinicaltrials.gov, using identifier NCT03128164.

About PI3Kδ and NHL

PI3Kδ (phosphoinositide 3-kinase delta) is a lipid kinase that controls the activation of several important signaling proteins. Upon an antigen binding to B-cell receptors, PI3Kδ can be activated through the Lyn and Syk signaling cascade. The abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hematological cancers, which represent approximately 85% of all NHL cases. Therefore, PI3Kδ is considered to be a promising target for drugs that aim to prevent or treat hematologic cancer.

FL accounts for approximately 17% of NHL and MZL accounts for approximately 8% of NHL. In the U.S., there were estimated 13,000 and 6,000 new cases of FL and MZL in 2020, respectively. In China, there were estimated 16,000 and 7,000 new cases of FL and MZL in 2020, respectively ^[1],[2],[3].

About HMPL-689

HMPL-689 is a novel, selective and potent oral inhibitor targeting the isoform PI3Kδ. HMPL-689’s PK properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, suggesting a low risk of drug accumulation and drug-to-drug interaction. Because of its high target selectivity and optimal PK profile, HMPL-689 has the potential to demonstrate an optimal benefit-risk profile in this class.

HUTCHMED has initiated an extensive, globally-focused clinical development pathway for HMPL-689. In addition to the currently Phase II trial and the supportive Phase I trial in China, HMPL-689 is also being evaluated in an ongoing Phase I/Ib study in the U.S. and Europe in patients with relapsed or refractory NHL.

HUTCHMED currently retains all rights to HMPL-689 worldwide.

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

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 HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of HMPL-689 for patients with FL, MZL and NHL, the further clinical development for HMPL-689, 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 HMPL-689, including as a combination therapy, 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-689 for a targeted indication, the sufficiency of funding and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. 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 HUTCHMED’s filings with the U.S. Securities and Exchange Commission and on AIM. HUTCHMED 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.

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[1] Source: NCCN^® – https://www.nccn.org

[2] Source: SEER – https://seer.cancer.gov/statfacts/html/follicular.html

[3] Source: GLOBOCAN https://gco.iarc.fr/

Hong Kong, Shanghai, & Florham Park, NJ: Wednesday, April 28, 2021: Hutchison China MediTech Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM) today announces that all ordinary resolutions and special resolutions put to its Annual General Meeting (“AGM”) held on April 28, 2021 were duly passed.  The poll results of the resolutions were as follows:

*  Percentages rounded to 4 decimal places

^# A vote withheld is not a vote in law and is not counted in the calculation of the proportion of the votes for and against a resolution.

The change of name will be effective once the Register of Companies has issued a certificate of incorporation on change of name.

As at the date of the AGM, the number of issued shares of HUTCHMED was 744,515,660, which was the total number of shares entitling the holders to attend and vote on the ordinary resolutions and special resolutions proposed at the AGM.

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company.  It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Hong Kong, Shanghai & Florham Park, NJ: Friday, April 23, 2021: Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) announces that the non-performance based awards granted under the Long Term Incentive Plan (“LTIP”) on April 20, 2020 to the following persons discharging managerial responsibilities were vested on April 20, 2021:-

Notes:

1. Similar to the arrangement for his Director’s fees, these ADSs were not received by Mr Simon To, but were received by or for the account of his employer, Hutchison Whampoa (China) Limited.
2. Similar to the arrangement for her Director’s fees, these ADSs were not received by Ms Edith Shih, but were received by or for the account of her employer, Hutchison International Limited.

The notifications set out below are provided in accordance with the requirements of the EU Market Abuse Regulation.

(a) Dr Dan Eldar

(b) Mr Paul Carter

(c) Dr Karen Ferrante

(d) Mr Graeme Jack

(e) Professor Tony Mok

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company.  It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

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 HUTCHMED’s filings with the U.S. Securities and Exchange Commission and on AIM.  HUTCHMED 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.

CONTACTS

Hong Kong, Shanghai, & Florham Park, NJ: Wednesday, April 14, 2021:  Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) was notified that CK Hutchison Holdings Limited (“CK Hutchison”) shareholding^[1] in HUTCHMED remains unchanged, at 332,478,770 ordinary shares of par value US$0.10 each in the capital of HUTCHMED (“Shares”).

Each American Depositary Share (“ADS”) represents five Shares.  As announced on April 8, 2021, HUTCHMED issued a total of 16,393,445 Shares (equivalent to 3,278,689 ADSs) to funds affiliated with Baring Private Equity Asia.  HUTCHMED was notified on April 14, 2021 that this issuance diluted CK Hutchison’s holding^[1] to 44.66 per cent of the total number of voting rights of HUTCHMED.  The date on which the notification threshold was crossed was April 14, 2021.

^[1] Held through CK Hutchison’s indirect wholly-owned subsidiary Hutchison Healthcare Holdings Limited.

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company.  It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

CONTACTS

Presenter/Authors: Yongfeng Yu, Yongxin Ren, Jian Fang, Lejie Cao, Zongan Liang, Qisen Guo, Sen Han, Zimei Ji, Ye Wang, Yulan Sun, Yuan Chen, Xingya Li, Hua Xu, Jianying Zhou, Liyan Jiang, Ying Cheng, Zhigang Han, Jianhua Shi, Gongyan Chen, Rui Ma, Yun Fan, Sanyuan Sun, Longxian Jiao, Xiaoyun Jia, Linfang Wang, Puhan Lu, Jing Li, Qian Xu, Xian Luo, Weiguo Su, Shun Lu.

Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China, Hutchison MediPharma Limited, Shanghai, China, Peking University Cancer Hospital & Institute, Beijing, China, Anhui Provincial Hospital,The First Affiliated Hospital of USTC, Hefei, China, West China Hospital of Sichuan University, Chengdu, China, Shandong Cancer Hospital Affiliated to Shandong University, Jinan, China, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China, The First Affiliated Hospital of Zhengzhou University,, Zhengzhou, China, The Second Affiliated Hospital of Nanchang University, Nanchang, China, The First Affiliated Hospital of Zhejiang University, Hangzhou, China, Shanghai Chest Hospital,Shanghai JiaoTong University, Shanghai, China, Jilin Cancer Hospital, Changchun, China, The Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, China, Linyi Cancer Hospital, Linyi, China, Cancer Hospital of Harbin Medical University, Harbin, China, Liaoning Cancer Hospital, Shenyang, China, Zhejiang Cancer Hospital, Hangzhou, China, Xuzhou Central Hospital, Xuzhou, China

Abstract

Background: Savolitinib is a potent and selective MET tyrosine kinase inhibitor. It demonstrated clinical efficacy and a manageable safety profile in Chinese NSCLC pts with METex14 alterations in a phase 2 study (NCT028997479). Here, we report the post-hoc ctDNA analysis of METex14 at baseline and clearance upon treatment and the association of these findings with clinical outcome. In addition, concurrent gene alterations in ctDNA samples from the patients treated with savolitinib and impact on clinical efficacy is explored.

Methods: Plasma samples were prospectively collected pre-dose and at tumor assessment visits, until disease progression or end of treatment. MET and other somatic gene alterations in the ctDNA samples were detected by next generation sequencing (425-gene panel, Geneseeq).

Results: Sixty-six pts provided baseline plasma samples, of which METex14 ctDNA was detectable in 46 (70%) and undetectable in the remaining 20 pts (30%). Among the 46 ctDNA detectable pts, 19 were pulmonary sarcomatoid carcinoma (19/22, 86%) and 27 were other NSCLC (27/44, 61%), respectively. Of the 46 baseline-detectable pts, 24 were clearance evaluable and 22 had no qualified post baseline samples for clearance evaluation. Of the 24 clearance evaluable pts, 14 achieved ctDNA clearance (undetectable) with a median time to clearance of 1.4 months of treatment (Min 1.4 m, Max 4.2 m). The PFS and OS were compared for pts based on their METex14 ctDNA status at baseline and upon treatment. As shown in the table, METex14 baseline undetectable or clearance pts demonstrated significantly longer mPFS and mOS. Furthermore, in 21 pts with analyzable ctDNA samples at baseline and at disease progression, additional gene alterations were observed such as KRAS, NRAS, BRAF, PIK3CA as well as secondary MET mutations and FGF19 amplification in 12 pts (57%). These alterations might be associated with treatment resistance.

Conclusions: The results suggest that ctDNA METex14 undetectable at baseline or clearance upon savolitinib treatment may define favorable treatment outcome. Confirmation of this finding and the predictive value of the ctDNA with larger sample size is desirable.

CI, confidence interval; HR, hazard ratio; NC, non-calculable

Disclosures:

Y. Yu: None. Y. Ren: ; Hutchison MediPharma Limited.. J. Fang: None. L. Cao: None. Z. Liang: None. Q. Guo: None. S. Han: None. Z. Ji: None. Y. Wang: None. Y. Sun: None. Y. Chen: None. X. Li: None. H. Xu: None. J. Zhou: None. L. Jiang: None. Y. Cheng: None. Z. Han: None. J. Shi: None. G. Chen: None. R. Ma: None. Y. Fan: None. S. Sun: None. L. Jiao: ; Hutchison MediPharma Limited. X. Jia: ; Hutchison MediPharma Limited. L. Wang: ; Hutchison MediPharma Limited. P. Lu: ; Hutchison MediPharma Limited. J. Li: ; Hutchison MediPharma Limited. Q. Xu: ; Hutchison MediPharma Limited. X. Luo: ; Hutchison MediPharma Limited. W. Su: ; Hutchison MediPharma Limited. S. Lu: ; Hutchison MediPharma. ; Astra Zeneca. ; BMS. ; Heng Rui. ; Beigene. ; Hansoh. ; Roche. ; Pfizer. ; BoehringerIngelheim. ; Simcere. ; Zai Lab. ; GenomiCare. ; Yuhan Corporation. ; PrIME Oncology. ; Menarini.

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

Hong Kong, Shanghai & Florham Park, NJ — Thursday, April 8, 2021: Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) today announces that it has entered into a definitive agreement for the issuance of US$100 million of shares at a price equivalent to US$30.5 per American Depositary Share (“ADS”) via a private placement to funds affiliated with Baring Private Equity Asia (“BPEA”).

Mr. Christian Hogg, Chief Executive Officer of HUTCHMED, said, “We expect significant growth of our business this year as we look to accelerate our oncology revenues from ELUNATE^®, SULANDA^® and the potential upcoming approval of savolitinib, likely to be a first-in-class selective c-MET inhibitor in China.  We are rapidly expanding global development of our ten oncology assets, all of which were discovered in-house at HUTCHMED, and are planning to initiate 8-10 registration and registration-intent studies in 2021.  This is the right time to welcome BPEA to our existing shareholder base, a firm with a long history of supporting innovative globally-focused businesses.  We look forward to partnering with BPEA in the next stage of our development.”

Mr. Jean Eric Salata, Chief Executive Officer and Founding Partner of BPEA, said, “With this strategic investment, BPEA is demonstrating our long-term commitment to HUTCHMED, an emerging biopharma leader in Asia.  The healthcare sector in China is a core area of investment focus for BPEA.  HUTCHMED is developing and delivering highly differentiated oncology therapies to patients around the world and we look forward to working with the CEO and management team to support the company’s innovation and global growth aspirations”.

Founded in 1997, BPEA is one of the largest and most established independent private equity firms in Asia with approximately $23 billion of assets under management.  BPEA has a well-established track record investing in the healthcare sector with a diverse portfolio across different verticals, providing strategic capital to and working closely with industry leaders to grow their businesses over the long-term.

HUTCHMED will receive all proceeds from this private placement of the equivalent of 3,278,689 ADSs, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally.

Description of Share Capital and Securities Regulation

HUTCHMED has agreed to issue 16,393,445 ordinary shares, par value US$0.10 each (the “Shares”), pursuant to the private placement.  The Shares will, when issued, be fully paid and will rank pari passu in all respects with the existing ordinary shares of HUTCHMED.  Each ADS represents five Shares.

The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.  Subject to certain conditions, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Shares sold in the private placement to facilitate future resales by BPEA.  Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

This announcement, including any information included or incorporated by reference in this announcement, is for information purposes only and shall not constitute nor form part of, and should not be construed as, an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.  No public offering of the securities referred to in this announcement is being made in the United States or elsewhere.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).

Admission to the London Stock Exchange AIM market and Shares Outstanding After Completion

Application will be made for the Shares to be admitted to the AIM market operated by the London Stock Exchange (“Admission”).  It is expected that Admission will become effective at 8:00 a.m. BST on April 14, 2021.

Following admission of the Shares to trading on AIM, the issued share capital of HUTCHMED will consist of 744,515,660 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury.  The figure of 744,515,660 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, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

For illustrative purposes only, if the 744,515,660 ordinary shares were converted in their entirety, they would be equivalent to 148,903,132 Nasdaq-traded ADSs (each equating to five ordinary shares).

About Baring Private Equity Asia

Baring Private Equity Asia (BPEA) is one of the largest and most established private alternative investment firms in Asia, with US$23 billion of assets under management.  The firm manages a private equity investment program, sponsoring buyouts and providing growth capital to companies for expansion or acquisitions with a particular focus on the Asia Pacific region, as well as investing in companies globally that can benefit from further expansion into the Asia Pacific region.  BPEA also manages dedicated funds focused on private real estate and private credit.  The firm has a 24-year history and 195+ employees located across offices in Hong Kong, China, India, Japan, Singapore, Australia, and the US.  BPEA currently has over 39 portfolio companies active in Asia with a total of 230,000 employees and sales of approximately US$32 billion.  For more information, please visit www.bpeasia.com.

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases.  It has advanced ten cancer drug candidates from discovery into clinical studies around the world and has extensive commercial infrastructure in its home market of China.  For more information, please visit: www.hutch-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 HUTCHMED’s current expectations regarding future events, including its expectations regarding the use of proceeds from the transaction as well as HUTCHMED’s clinical development and regulatory plans for its drug candidates and HUTCHMED’s overall business strategy.  Forward-looking statements involve risks and uncertainties.  Such risks and uncertainties include, among other things, assumptions regarding the funding necessary for HUTCHMED’s future clinical development plans, 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 timing and ability of HUTCHMED to raise additional funding as needed for continued operations, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions.  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 HUTCHMED’s filings with the U.S. Securities and Exchange Commission and on AIM.  HUTCHMED 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.

CONTACTS