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HUTCHMED Announces NDA Acceptance For Tazemetostat In China - Quick Facts

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

HUTCHMED China (HCM) said the New Drug Application for tazemetostat for the treatment of adult patients with relapsed or refractory follicular lymphoma has been accepted for review and granted Priority Review by the China National Medical Products Administration. The 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 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.

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