HCM HUTCHMED China Limited

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 6-K

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REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE

SECURITIES EXCHANGE ACT OF 1934

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For the Month of September 2023

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Commission File Number: 001-37710

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HUTCHMED (CHINA) LIMITED

(Translation of registrant’s name into English)

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48th Floor, Cheung Kong Center, 2 Queen’s Road Central, Hong Kong

(Address of principal executive offices)

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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

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Form 20-F  ⌧             Form 40-F  ◻

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HUTCHMED (CHINA) LIMITED

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Form 6-K

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EXHIBIT INDEX

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2

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SIGNATURE

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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

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Date: September 12, 2023

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Exhibit 99.1

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Press Release

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HUTCHMED Completes Patient Enrollment of a Bridging Study of Tazemetostat in Patients with Relapsed/Refractory Follicular Lymphoma in China

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Hong Kong, Shanghai & Florham Park, NJ — Tuesday, September 12, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it has completed patient enrollment of a bridging study of tazemetostat in China.

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The bridging study is a multicenter, open-label, Phase II study to evaluate the efficacy, safety and pharmacokinetics of tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma (“R/R FL”). The primary objective is to evaluate the objective response rate (“ORR”) of tazemetostat for the treatment of patients with R/R FL whose disease harbor EZH2¹ mutations (Cohort 1). The secondary objectives included duration of response (“DoR”), progression-free survival (PFS), and overall survival (OS) of tazemetostat for the treatment of R/R FL patients whose disease do or do not harbor EZH2 mutations (Cohort 2), as well as to evaluate the safety and pharmacokinetics. The lead principal investigator is Dr Junning Cao of Shanghai Fudan University Cancer Center. A total of 42 patients were enrolled. Additional details may be found at clinicaltrials.gov, using identifier NCT05467943.

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Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, Inc. (“Epizyme”), an Ipsen company. It is approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of certain patients with advanced epithelioid sarcoma (“ES”) and certain patients with R/R FL under the FDA accelerated approval granted in January and June 2020, respectively. HUTCHMED entered into a strategic collaboration to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.

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In May 2022, tazemetostat was approved by the Health Commission and Medical Products Administration of Hainan Province of China to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (“Hainan Pilot Zone”), under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with ES and FL consistent with the label as approved by the FDA.

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In March 2023, tazemetostat was approved and launched in Macau. A market authorization application has been under review in Hong Kong since December 2022.

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Tazemetostat was included in the Chinese Society of Clinical Oncology (CSCO) guidelines for ES in 2022 and for FL in 2023.

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About FL and ES

FL is a subtype of non-Hodgkin’s lymphoma (“NHL”). FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively. ^2,3,4

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ES is a rare, slow-growing type of soft tissue cancer. Radical tumor resection is the primary treatment for patients with ES. However, ES is known for its high propensity for locoregional recurrence and distant metastases. The survival of patients with ES is often unsatisfactory with very limited treatment options.⁵

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About TAZVERIK^® (tazemetostat)

TAZVERIK^® is a methyltransferase inhibitor indicated in the United States for the treatment of:

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These indications are approved under accelerated approval by the U.S. FDA based on ORR and DoR. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

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The most common (≥20%) adverse reactions in patients with ES are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with FL are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

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View the U.S. Full Prescribing Information here:

https://www.ipsen.com/websites/Ipsen_Online/wp-content/uploads/sites/9/2022/11/03075215/TAZ-US-000213_TAZVERIK-US-PI-1.pdf

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TAZVERIK^® is approved in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive FL (only when standard treatment is not applicable).  

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TAZVERIK^® is a registered trademark of Epizyme Inc., an Ipsen company.

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About Tazemetostat Clinical Development in China

HUTCHMED and Ipsen are developing tazemetostat in various hematological and solid tumors in Greater China. We are participating in Ipsen’s SYMPHONY-1 (EZH-302) study, leading it in China. We also initiated a Phase ІІ study in combination with our phosphoinositide 3-kinase delta (PІ3Kδ) inhibitor amdizalisib in patients with R/R FL in February 2023. We are generally responsible for funding all clinical trials of tazemetostat in China, including the portion of global trials conducted there.

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SYMPHONY-1 (EZH-302) is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase 1b/3 study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with rituximab + lenalidomide (R²) in patients with R/R FL after at least one prior line of therapy (clinicaltrials.gov identifier: NCT04224493).

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China combination study in R/R FL is an open-label, Phase ІІ study in approximately 140 patients to evaluate the safety, tolerability and preliminary anti-tumor efficacy of tazemetostat in combination with amdizalisib in patients with R/R lymphoma. The first patient was dosed in February 2023 (clinicaltrials.gov identifier: NCT05713110).

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About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) 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. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/​immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

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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 TAZVERIK^® for the treatment of patients with ES or FL, the further clinical development of TAZVERIK^® in this and other indications, risks associated with the use of TAZVERIK^® in the Hainan Pilot Zone and Macau, including that it could be discontinued in the future for a variety of reasons, the risk that ongoing or future clinical trials conducted by HUTCHMED for TAZVERIK^® may not meet their primary or secondary endpoints or will warrant meetings with regulatory authorities, submissions for regulatory approval or review by governmental authorities under the accelerated approval process and 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 regulatory approvals, including accelerated approval, to conduct trials or to market products (including to continue offering TAZVERIK^® in the Hainan Pilot Zone, Macau or elsewhere in China, Hong Kong and Taiwan), its expectations that preclinical studies or earlier clinical studies are predictive of the results of future trials, such as the ongoing confirmatory trials, the safety profile of TAZVERIK^®, the potential for TAZVERIK^® to become a new standard of care for ES or FL patients, HUTCHMED’s and Epizyme’s ability to implement and complete its further clinical development plans for TAZVERIK^®, the potential commercial launch of TAZVERIK^® in China and other jurisdictions in the approved indications, the sufficiency of each company's cash resources to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the timing of these events, and the impact of COVID-19 on HUTCHMED’s business, results of operations and financial condition and on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of other drug candidates as combination therapeutics with TAZVERIK^®, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and regulatory approval of such drug candidates. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. HUTCHMED anticipates that subsequent events and developments may cause its views to change; however, HUTCHMED does not undertake any 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. For a further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and with The Stock Exchange of Hong Kong Limited.

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CONTACTS

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¹ EZH2 = Enhancer of Zeste Homolog 2

² Source: NCCN^® – https://www.nccn.org

³ Source: SEER – https://seer.cancer.gov/statfacts/html/follicular.html

⁴ Source: GLOBOCAN https://gco.iarc.fr/

⁵ Sobanko JF, Meijer L, Nigra TP. Epithelioid sarcoma: a review and update. J Clin Aesthet Dermatol. 2009;2(5):49-54.

Exhibit 99.2

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Press Release

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HUTCHMED Highlights Presentation of Results from the Phase IIIb Trial of Savolitinib at the 2023 World Conference of Lung Cancer

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Hong Kong, Shanghai & Florham Park, NJ — Tuesday, September 12, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX: 13) today announces that results from the confirmatory Phase IIIb clinical trial of savolitinib in patients with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration non-small cell lung cancer (“NSCLC”), were presented during the  IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (“WCLC”), which took place from September 9 to 12, 2023 in Singapore.

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Here we reported initial efficacy and safety data from the first-line cohort of a confirmatory Phase IIIb trial conducted in China of savolitinib as a monotherapy in patients with NSCLC MET exon 14 skipping alterations (NCT04923945).  At data cut-off date of April 30, 2023, among the 84 patients in the tumor response evaluable set (TRES), objective response rate (ORR) was 60.7% (95% Confidence Interval (“CI”): 49.5% to 71.2%) and disease control rate (DCR) was 95.2% (95% CI: 88.3% to 98.7%), as assessed by an independent review committee.  At median follow-up of 11.1 months, median progression free survival (mPFS) was 13.8 months (95% CI: 9.7 months to not reached).  Median duration of response (DoR) and overall survival (OS) have not been reached.  No new safety signals were observed.  

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The other cohort of this confirmatory trial was fully enrolled in H1 2023 and included patients who received prior treatments. The trial follows the June 2021 approval of savolitinib as a monotherapy in this indication from China’s National Medical Products Administration (NMPA), which was based on positive results from a Phase II trial (NCT02897479). This confirmatory trial enrolled a more representative proportion of the different NSCLC subtypes, which may confer different prognostic outcomes.

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More than a third of the world’s lung cancer patients are in China and, among those with NSCLC globally, approximately 2-3% have tumors with MET exon 14 skipping alterations. Savolitinib was launched and is marketed under the brand name ORPATHYS^® by our partner, AstraZeneca for this patient population, representing the first selective MET inhibitor approved in China.

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A Quantitative Continuous Scoring (QCS) algorithm is being developed as an automated methodology to identify patients who are most likely to respond to treatment.  This e-poster showcased the application of this method based on information collected in the Phase II SAVANNAH study.  The global Phase III study SAFFRON will serve as an additional independent validation cohort.  

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About Savolitinib (ORPATHYS^® in China)

Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

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Savolitinib is marketed in China under the brand name ORPATHYS^® for the treatment of patients with non-small cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney and gastric cancers, as a single treatment and in combination with other medicines. Starting on March 1, 2023, ORPATHYS^® was included in the National Reimbursement Drug List (NRDL) for the treatment of locally advanced or metastatic NSCLC adult patients with MET exon 14-skipping alterations who have progressed after or unable to tolerate platinum-based chemotherapy.

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In 2011, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize savolitinib. Joint development of savolitinib in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib are recognized by AstraZeneca.

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About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) 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. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

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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 savolitinib, the further clinical develop­ment for savolitinib, its expectations as to whether any studies on savolitinib 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 and the 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 savolitinib, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of savolitinib for a targeted indication; the sufficiency of funding; and the impact of COVID-19 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, The Stock Exchange of Hong Kong Limited 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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CONTACTS

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