Hutchmed (China) Ltd. said the Center for Drug Evaluation of China's National Medical Products Administration has granted breakthrough therapy designation to HMPL-523, a spleen tyrosine kinase inhibitor, for the treatment of chronic adult primary immune thrombocytopenia patients who have received at least one prior therapy.
Hutchmed said that with breakthrough designation, it believes it can accelerate the development of HMPL-523 in China.
The company said the designation is supported by results from a Phase Ib study of HMPL-523. The data also supported the initiation of a Phase III trial, ESLIM-01, in China of HMPL-523 in adult patients with ITP in October. About 180 patients are expected to be enrolled.
The company said the NMPA grants breakthrough therapy designation 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 breakthrough therapy designation may be considered for conditional approval and priority review when submitting a New Drug Application.