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Hutchmed Gets BTD In China For HMPL-523 To Treat Primary Immune Thrombocytopenia

Hutchmed Limited (HCM) said Wednesday that the Center for Drug Evaluation of China's National Medical Products Administration or NMPA has granted Breakthrough Therapy Designation or BTD to HMPL-523.

HMPL-523 is 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.

NMPA has granted 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).

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.

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