Hutchmed (HCM) said Wednesday that China's National Medical Products Administration accepted the new drug application and granted priority review for sovleplenib to potentially treat warm antibody autoimmune hemolytic anemia.

The company said its application was supported by data from a phase 2/3 study in China. In January, the phase 3 part of the trial met its primary endpoint of durable hemoglobin response rate within weeks 5 to 24 of treatment, the company added.

The Chinese regulator also granted breakthrough therapy designation for sovleplenib in warm antibody autoimmune hemolytic anemia in March, Hutchmed said.

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