Xin Lang Cai Jing·2025-11-10 07:38Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Pharmaceuticals Holding Co., Ltd., received notification from the U.S. FDA that its abbreviated new drug application for Eslicarbazepine Acetate Tablets has been approved for marketing [1] Group 1: Drug Approval and Market Potential - The drug is indicated for the treatment of partial seizures in patients aged 4 years and older, and it was originally launched in the U.S. in 2013 [1] - The application was submitted in January 2018 and received temporary approval in June 2020 [1] - The company has invested approximately 15.9371 million yuan in research and development for this drug [1] - The projected sales for both the original and generic versions of the drug in the U.S. for 2024 are approximately 382 million USD [1] Group 2: Export Business Uncertainty - There is uncertainty regarding the company's formulation export business [1]