Hainan Poly Pharm Secures Tentative FDA Approval for Generic Version of UCB’s Briviact

Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received tentative marketing approval from the US Food and Drug Administration (FDA) for its generic version of Belgium-based UCB’s Briviact (brivaracetam). Briviact is recognized as a selective high-affinity synaptic vesicle protein 2A (SV2A) ligand, demonstrating its capacity to elicit anti-epileptic effects across various preclinical models and clinical studies. The drug obtained marketing approval in both the European Union and the United States in 2016 but has yet to be approved in China. The patent for Briviact remains in effect until February 21, 2026, with no generic versions approved in the US to date.- Flcube.com