Apeloa Pharmaceutical Co.,Ltd. (000739.SZ) has announced that its wholly-owned subsidiary, Zhejiang Apeloa Jutai Pharmaceutical Co., Ltd. ("Jutai Pharma"), has received notification from the U.S. Food and Drug Administration (FDA) regarding its Abbreviated New Drug Application (ANDA) for Brivaracetam Tablets. The submission, filed with the U.S. FDA, has now obtained official approval, marking a key regulatory milestone for the company.

Brivaracetam is a novel anti-epileptic drug and a second-generation derivative of levetiracetam, primarily indicated for the treatment of partial-onset seizures and related epilepsy types. According to relevant market data, sales of Brivaracetam Tablets in the U.S. market are projected to reach approximately $823 million in 2025, underscoring the significant commercial potential of this approval.

This approval strengthens Apeloa Pharmaceutical Co.,Ltd.'s foothold in the global central nervous system therapeutic segment, paving the way for the company to introduce the product to the U.S. market and expand its international generic drug portfolio.