Sovleplenib - (China trial)

Nov. 04, 2026: HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) said the US FDA granted Orphan Drug Designation to sovleplenib, a selective oral spleen tyrosine kinase (Syk) inhibitor, for autoimmune hemolytic anemia (AIHA). The company said this is sovleplenib’s second FDA orphan designation, following primary immune thrombocytopenia (ITP) in October 2026.

The designation is a regulatory milestone that, if sovleplenib is approved for the designated indication, could provide 7 years of US market exclusivity, tax credits for qualified clinical trials, user fee waivers, and FDA regulatory guidance.

HUTCHMED also said New Drug Applications in China for sovleplenib in primary ITP and warm AIHA are under review by the National Medical Products Administration, supported by positive pivotal data from the ESLIM-01 trial in primary ITP and the ESLIM-02 trial in warm AIHA.