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亿帆医药(002019):新品获批上市 迈入麻精药新领域
Xin Lang Cai Jing· 2025-04-11 00:29
Core Viewpoint - The company has received approval for its hydrobromide etizolam injection, marking its entry into the controlled substance market and indicating a successful transition from R&D to production and sales [1][2]. Group 1: Product Approval - The company's wholly-owned subsidiary, Hefei Yifan Biopharmaceutical Co., Ltd., received the drug registration certificate for hydrobromide etizolam injection from the National Medical Products Administration (NMPA) on April 8, 2025 [1]. - The drug was developed and produced independently by the subsidiary and is classified as a Class 3 chemical drug, which is equivalent to passing the consistency evaluation [1]. - Currently, only one other company in China has received approval for hydrobromide etizolam injection, while another is in the review stage for generic drug production [1]. Group 2: Market Potential - Hydrobromide etizolam injection is a central analgesic, particularly effective for cancer pain and postoperative pain, and works by binding to kappa-opioid receptors to inhibit pain transmission [2]. - The domestic market for analgesics, including anesthetic analgesics and pain relievers, had a sales scale of approximately 19 billion yuan in 2023, indicating significant growth potential [2]. - The approval of this drug represents the company's first entry into the controlled substance market, providing new growth momentum through new markets, fields, and products [2]. Group 3: Earnings Forecast - The company's earnings per share (EPS) are projected to be 0.33 yuan, 0.51 yuan, and 0.64 yuan for the years 2024, 2025, and 2026, respectively [3].