Ezharmia(valemetostattosilate)

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恒瑞医药:泽美妥司他片获得药品注册批准,是中国首个自主研发的EZH2抑制剂
Ge Long Hui· 2025-09-01 09:29
Core Viewpoint - Heng Rui Medicine has received conditional approval from the National Medical Products Administration for its self-developed innovative drug, SHR2554 tablets, which is the first EZH2 inhibitor independently developed in China, aimed at adult patients with relapsed or refractory peripheral T-cell lymphoma who have received at least one line of systemic therapy [1] Group 1: Product Development - SHR2554 tablets are a new, highly efficient, and selective oral EZH2 inhibitor developed by the company [1] - The drug is positioned to address a significant unmet medical need in the treatment of R/RPTCL [1] Group 2: Market Context - The approval of SHR2554 follows the earlier approvals of similar drugs, such as Tazverik by Epizyme in the US and Ezharmia by Daiichi Sankyo in Japan, indicating a growing market for EZH2 inhibitors [1] - Tazverik is projected to have global sales of approximately $51 million in 2024, highlighting the commercial potential for EZH2 inhibitors [1] Group 3: Investment and R&D - The cumulative R&D investment for the SHR2554 project has reached approximately 213 million yuan [1]
恒瑞医药(600276.SH):泽美妥司他片获得药品注册批准,是中国首个自主研发的EZH2抑制剂
Ge Long Hui A P P· 2025-09-01 09:04
Core Viewpoint - Heng Rui Medicine has received conditional approval from the National Medical Products Administration for its self-developed innovative drug, SHR2554 tablets, for adult patients with relapsed or refractory peripheral T-cell lymphoma who have received at least one line of systemic therapy [1] Group 1: Product Development - SHR2554 tablets are the first self-developed EZH2 inhibitor in China [1] - The drug is a new, efficient, and selective oral EZH2 inhibitor [1] - The total R&D investment for the SHR2554 project has reached approximately 213 million yuan [1] Group 2: Market Context - In January 2020, the U.S. FDA approved the oral EZH2 inhibitor Tazverik (tazemetostat) developed by Epizyme [1] - In August 2021, Hutchison China MediTech obtained the development and commercialization rights for tazemetostat in Greater China [1] - Tazverik's global sales are projected to be approximately 51 million USD in 2024 according to EvaluatePharma [1]