Humanwell Healthcare gets tentative FDA nod for epilepsy drug

Humanwell Healthcare Group Co., Ltd. announced that its subsidiary, Wuhan Humanwell Pharmaceutical Co., Ltd., received U.S. FDA tentative approval for its Oxcarbazepine Extended-Release Tablets, used to treat partial-onset seizures in patients aged six and older. The Abbreviated New Drug Application (ANDA) was granted tentatively because the innovator drug, "OXTELLAR XR," remains under patent protection.

The cumulative research and development investment for this product totals approximately RMB 1,500 million. According to IQVIA data, the U.S. market for Oxcarbazepine Extended-Release Tablets had total sales of approximately $216 million in 2024. The innovator, Supernus Pharmaceuticals, Inc., holds patents until April 13, 2027. Upon patent expiration and final FDA approval, Humanwell will be able to market the product in the U.S.

This tentative approval confirms the product's safety and efficacy. However, the company emphasized that its U.S. generic drug business is susceptible to policy, market, and exchange rate fluctuations, urging investors to exercise caution.