HUTCHMED Announces NDA Acceptance in China for Tazemetostat for the Treatment of Relapsed or Refractory Follicular Lymphoma with Priority Review Status

Hong Kong, Shanghai & Florham Park, NJ — Thursday, July 4, 2024: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application (“NDA”) for tazemetostat for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) has been accepted for review and granted Priority Review by the China National Medical Products Administration (“NMPA”).

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

This China NDA is supported by results from a multicenter, open-label, Phase II bridging study in China, and clinical studies conducted by Epizyme outside China.

Tazemetostat was approved for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (Hainan Pilot Zone) in May 2022, 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. Tazemetostat was approved in the Macau Special Administrative Region (“SAR”) in March 2023 and in the Hong Kong SAR in May 2024.

About Follicular Lymphoma

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.[i]^,[ii]^,[iii]

About Tazemetostat Clinical Development in China

Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, an Ipsen company. HUTCHMED entered into a strategic collaboration to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.

42 patients were enrolled in the Phase II bridging study in China. The primary objective was to evaluate the objective response rate (“ORR”) of tazemetostat for the treatment of patients with R/R FL whose disease harbor EZH2 mutations. The secondary objectives included duration of response (“DoR”), progression-free survival (PFS), overall survival (OS), safety and pharmacokinetics of tazemetostat for the treatment of R/R FL patients whose disease do or do not harbor EZH2 mutations. Results of the study will be submitted for presentation at an upcoming medical conference (NCT05467943).

HUTCHMED is participating in Ipsen’s SYMPHONY-1 study, leading it in China. This is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase Ib/III study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with rituximab and lenalidomide (R²) in patients with R/R FL after at least one prior line of therapy (NCT04224493).

About Tazemetostat approval in the United States

Tazemetostat is a methyltransferase inhibitor indicated in the United States for the treatment of:

·   Adults and pediatric patients aged 16 years and older with metastatic or locally advanced ES not eligible for complete resection.

·   Adult patients with R/R FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.

·   Adult patients with R/R FL who have no satisfactory alternative treatment options.

·   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.

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.

Please see the U.S. Full Prescribing Information for TAZVERIK^® (tazemetostat).

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

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

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 medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

[i] Source: NCCN – https://www.nccn.org

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

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