Core Viewpoint - Shanghai Pharmaceuticals has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Acetate Eslicarbazepine Tablets, which are used to treat partial seizures in patients aged 4 and above [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., is responsible for the ANDA application and has invested approximately RMB 15.9371 million in the research and development of this drug [1] - The drug was originally developed by Bial-Portela, Eisai, and Dainippon Sumitomo and was first launched in the U.S. in 2013 [1] - The ANDA application was submitted in January 2018, with temporary approval granted in June 2020, leading to the recent final approval [1] Industry Summary - The approval of Acetate Eslicarbazepine Tablets represents a significant milestone in the generic pharmaceutical market, particularly for epilepsy treatments [1] - The drug's approval may enhance competition in the market for epilepsy medications, potentially impacting pricing and availability for patients [1]

Core Viewpoint - Shanghai Pharmaceuticals has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Oxcarbazepine Tablets, marking a significant milestone for the company in the U.S. market [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has successfully obtained final approval for the ANDA of Oxcarbazepine Tablets [1] - The drug is indicated for the treatment of partial seizures in patients aged 4 years and older, originally developed by Bial-Portela, Eisai, and Dainippon Sumitomo [1] - The ANDA application was submitted to the U.S. FDA in January 2018, with temporary approval granted in June 2020 for four specifications, leading to the recent final approval [1] - The company has invested approximately RMB 15.9371 million in research and development for this drug [1]

Core Viewpoint - Shanghai Pharmaceuticals has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Acetate Eslicarbazepine Tablets, which are used to treat partial seizures in patients aged 4 and above [1] Company Summary - The product was initially developed by Bial-Portela, Eisai, and Dainippon Sumitomo and was first launched in the U.S. in 2013 [1] - Shanghai Pharmaceuticals submitted the ANDA to the U.S. FDA in January 2018 and received temporary approval for four specifications in June 2020 [1] - The company has invested approximately RMB 15.9371 million in research and development for this product as of the announcement date [1]

Core Viewpoint - Shanghai Pharmaceuticals has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Acetate Eslicarbazepine Tablets, allowing the product to be marketed in the United States [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., is the entity that received the FDA notification regarding the approval [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., received notification from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for Eslicarbazepine Acetate Tablets has been approved for marketing [1] Group 1 - The approved drug, Eslicarbazepine Acetate Tablets, is indicated for the treatment of partial-onset seizures in patients aged 4 years and older [1]

Core 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]