China Breakthrough status for amdizalisib in follicular lymphoma

13 September 2021

Shares of Chinese biotech Hutchmed (Nasdaq: HCM) were up 3.2% higher in London trading on Monday at 584.16 pence each, after it revealed that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) to amdizalisib (HMPL-689), a highly selective and potent PI3Kδ inhibitor, for the treatment of relapsed or refractory follicular lymphoma (FL), a subtype of non-Hodgkin’s lymphoma (NHL).

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). This indicates that the development and review of amdizalisib for relapsed or refractory FL may be expedited, to address patients' unmet needs more quickly.

Clear need for new therapies

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