Hutchmed closer to Chinese approval with sovleplenib

21 August 2023

Chinese biopharma Hutchmed (HKEX:13; AIM: HCM) has announced that the pivotal Phase III trial ESLIM-01 evaluating the investigational use of sovleplenib met its primary endpoint of durable response rate in adults with primary immune thrombocytopenia (ITP) in China.

Hutchmed is now planning a filing by the end of the year for sovleplenib in China, where it has been designated a Breakthrough Therapy.

The National Medical Products Administration of China (NMPA) granted the Breakthrough Therapy designation to sovleplenib for the indication studied in ESLIM-01 in January 2022.

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