Hutchmed’s sovleplenib NDA accepted for priority review in China

The New Drug Application (NDA) for China-based Hutchmed’s (AIM; HKEX/HCM: 13) sovleplenib as a treatment of adult patients with primary immune thrombocytopenia (ITP) has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA).

Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (Syk), being developed for the treatment of hematological malignancies and immune diseases. The news pushed Hutchmed’s London-listed shares up 4.6% to 262.50 pence.

Hutchmed said the NDA is supported by data from ESLIM-01, a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy.