(Alliance News) - Hutchmed China Ltd on Monday said a Chinese watchdog has granted breakthrough therapy designation to amdizalisib for the treatment of relapsed or refractory follicular lymphoma.
The Hong Kong-based pharmaceutical company said the Center for Drug Evaluation of China's National Medical Products Administration 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.
Hutchmed China highlighted that drug candidates with breakthrough therapy designation may be considered for conditional approval and priority review when submitting a new drug application.
"There is a clear need for new therapies in this treatment setting, particularly with regard to specific toxicities and suboptimal efficacy with existing treatments across different lymphoma subtypes. We look forward to important clinical data on amdizalisib being presented at the ESMO Congress next week and are continuing to accelerate global development of this novel therapy," said Chief Executive Christian Hogg.
Hutchmed China shares were trading 3.0% higher in London on Monday at 583.00 pence each.
By Evelina Grecenko; evelinagrecenko@alliancenews.com
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Hutchmed (HCM)