INNOCARE(09969.HK): NDA of Orelabrutinib for ITP Accepted by NMPA

NewTimeSpace News: Innocare Pharma Limited (09969.HK) issued a voluntary announcement on May 28, 2026. It disclosed that the NDA for orelabrutinib, a BTK inhibitor, has been accepted by the Center for Drug Evaluation, NMPA, for use in patients with primary immune thrombocytopenia (ITP).
This indication expands orelabrutinib’s application from hematological malignancies to autoimmune diseases. Featuring high target selectivity and a favorable safety profile, orelabrutinib is poised to be a preferred BTK inhibitor for ITP treatment. As of the announcement date, no BTK inhibitor has been approved for ITP in China.
Also known as immune thrombocytopenic purpura, ITP is an acquired immune-mediated disorder characterized by a low platelet count in peripheral blood, which raises the risks of bruising and bleeding. Globally, there are over 200,000 new ITP cases each year, including around 60,000 new cases in China, reflecting substantial unmet medical needs.
Orelabrutinib has demonstrated promising efficacy and safety in the field of autoimmune diseases. Apart from ITP, registrational Phase III clinical trials of orelabrutinib for systemic lupus erythematosus (SLE), primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) are ongoing across China and the rest of the world.

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