HUTCHMED Announces NMPA Conditional Approval for TAZVERIK® (tazemetostat) for the Treatment of Relapsed or Refractory Follicular Lymphoma [Yahoo! Finance]
HUTCHMED (China) Limited - American Depositary Shares (HCM)
NASDAQ:AMEX Investor Relations:
chi-med.com/investors/information-for-shareholders
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Source: Yahoo! Finance
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 21, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:?HCM; HKEX:?13) today announces that the New Drug Application (“NDA”) for TAZVERIK ® (tazemetostat) has been granted conditional approval in China for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) with EZH2 mutation who have received at least two prior systemic therapies. This approval follows the priority review status by the National Medical Products Administration (“NMPA”) and marks the first nationwide regulatory approval for TAZVERIK ® in China. The conditional approval by the NMPA was supported by results from a multicenter, open-label, Phase II bridging study in China, and clinical studies conducted by Epizyme, Inc. (“Epizyme”), an Ipsen company, outside China. The primary objective of the bridging study is to evaluate the objective response rate (“ORR”) of TAZVERIK ® for the treatment of patien
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HCM
Sec Filings
- 12/17/25 - Form 6-K
- 12/8/25 - Form 6-K
- 11/28/25 - Form 6-K
- HCM's page on the SEC website