From GlobeNewswire:

The New Drug Application (NDA) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (ITP) has been approved for priority review in China, following its Breakthrough Therapy designation. The NDA is supported by the successful Phase III ESLIM-01 trial in China, with full results to be published soon. Sovleplenib has shown a clinically meaningful and statistically significant increase in durable response rate for ITP patients who have received at least one prior therapy. HUTCHMED aimed to address the significant need for new therapies in adult primary ITP, as existing treatments are limited. Sovleplenib is a novel, selective Syk inhibitor designed for daily oral administration. Ongoing clinical investigations will evaluate the safety and efficacy of sovleplenib, and HUTCHMED currently holds worldwide rights to the drug. The incident of primary ITP in adults is 3.3/100,000 adults per year with a prevalence of 9.5 per 100,000 adults. Based on this prevalence rate, approximately 110,000 patients are estimated to be living with primary ITP in China, in addition to 56,000 patients in the U.S., Germany, France, Italy, Spain, UK, and Japan.9 Adult ITP is a potentially chronic condition that doesn’t typically respond well to treatments. Many patients develop resistance to treatment and thereby are prone to relapse. As platelet destruction in ITP is mediated by Syk-dependent phagocytosis of FcγR-bound platelets, Syk inhibition represents a promising approach to management of ITP. HUTCHMED has undertaken steps to bring the cancer drug candidates from in-house discovery to patients worldwide since its inception, and has focused on the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.



Read more: HUTCHMED Announces NDA Acceptance in China for Sovleplenib