Breakthrough status in China for Hutchmed's HMPL-523 for thrombocytopenia

Chinese biotech Hutchmed (Nasdaq: HCM) today announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) to HMPL-523, a novel, investigational spleen tyrosine kinase (Syk) inhibitor, for the treatment of chronic adult primary immune thrombocytopenia (ITP) patients who have received at least one prior therapy.

The NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. Drug candidates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application (NDA).

Christian Hogg, chief executive of Hutchmed, said: “ITP is an autoimmune bleeding disorder that can often be serious and can have a significant, multifaceted impact on patients’ health and quality of life. The granting of BTD to HMPL-523 in ITP highlights the unmet need in this treatment setting and the promising clinical value of this novel oral Syk inhibitor. With this designation, we are hopeful that can accelerate the development of HMPL-523 in China.”