HUTCHMED (00013.HK): Sovleplenib Wins FDA Orphan Drug Status for Primary ITP

NewTimeSpace News: On 29 October 2026, HUTCHMED (China) Limited (stock code: 13) published a voluntary announcement that sovleplenib has been granted orphan drug designation by the US Food and Drug Administration for the treatment of primary immune thrombocytopenia.

Sovleplenib is a novel, highly selective oral spleen tyrosine kinase (Syk) inhibitor, and immune thrombocytopenia is an autoimmune disease that increases the risk of bleeding. The FDA's orphan drug programme grants designation to drugs and biologics intended for rare diseases or conditions affecting fewer than 200,000 people in the United States; a designated drug, if approved for the indication, is eligible for seven years of US market exclusivity from approval, tax credits for qualifying clinical trials, exemption from Prescription Drug User Fee Act fees and FDA regulatory guidance during development.

In China, two new drug applications for sovleplenib—for primary immune thrombocytopenia and for warm antibody autoimmune haemolytic anaemia—are under review by the National Medical Products Administration, based on positive data from the pivotal ESLIM-01 and ESLIM-02 studies. The announcement cited an estimated adult primary ITP incidence of 3.3 per 100,000 adults per year and a prevalence of 9.5 per 100,000, implying about 110,000 patients in China.