Sinotherapeutics (SH:688247) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-10-21 10:42Core Viewpoint - Shanghai Xuantai Pharmaceutical Technology Co., Ltd. has received Tentative Approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Sitagliptin Metformin Extended-Release Tablets, indicating that the product meets all generic drug review requirements [1][2]. Group 1: Drug Information - Drug Name: Sitagliptin Metformin Extended-Release Tablets [1] - ANDA Number: 212869 [1] - Dosage Form: Tablet [1] - Specifications: 50/500mg, 50/1000mg [1] - Initial Approval: The drug was developed by Merck Sharp & Dohme and was approved in the U.S. in February 2012 for improving blood sugar control in adults with type 2 diabetes [1]. - Market Inclusion: The product will be included in the national medical insurance directory in 2024 and has already been commercialized in the domestic market [1]. - Patent Status: The fixed-dose combination formulation is still under patent protection, with only the original product available in the U.S. market [1]. - Market Potential: The sales of the original product in the U.S. are expected to exceed $1.7 billion in 2024 [1]. Group 2: Company Impact - Tentative Approval Significance: The Tentative Approval from the FDA is a positive step for the company, allowing it to expand its sales scale in the U.S. market and enrich its product portfolio [2]. - Future Steps: The company will actively pursue the final approval from the FDA to gain the qualification for marketing the product in the U.S. [2]. - Sales Uncertainty: The specific sales performance may be influenced by various factors such as market conditions and channel expansion, leading to uncertainty in the company's short-term operational performance [2].