HWHG(SH:600079) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-09-20 00:38Core Points - The company announced that its subsidiary, Wuhan Renfulikang Pharmaceutical Co., Ltd., received a tentative approval from the FDA for Oxcarbazepine Extended-Release Tablets [1][2] - The product is intended for the treatment of partial seizures in patients aged 6 and above [1] - The ANDA application was submitted in 2024, with a total R&D investment of approximately 15 million RMB [1] - The total sales for Oxcarbazepine Extended-Release Tablets in the U.S. market is estimated to be around $216 million in 2024 [1] Regulatory and Market Context - The ANDA approval is tentative due to the original drug "OXTELLAR XR" being under patent protection until April 13, 2027 [2] - The product must receive final FDA approval after the patent expires before it can be marketed in the U.S. [2] - Other companies, including APOTEX and AJANTA PHARMA LTD, have received formal approvals, while several others have tentative approvals [1][2]