迈入麻精药市场，注入成长新动能。氢溴酸依他佐辛注射液是一种中枢性镇痛药（尤其是癌痛及手术后 疼痛），通过与κ－阿片受体结合抑制痛觉传导。目前国内镇痛药物主要包括地佐辛、喷他佐辛、纳布 啡和布托啡诺等，2023 年国内重点样本医院中镇痛药物（镇痛药物包含了麻醉用镇痛药物与止痛药） 销售规模约190 亿元，空间广阔，且因严格管制的原因具有高进入壁垒。本次获批是公司首个麻精类药 品获批上市，标志着公司进入麻精类药品领域，也标志着公司成功实现了首个管制类药品从研发到生产 再到销售的全链条打通。新市场、新领域、新产品将为公司发展持续注入新动能。 事件：公司发布《关于获得药品注册证书的公告》，披露其全资子公司合肥亿帆生物制药有限公司于 2025 年4月8日收到国家药品监督管理局核准签发的氢溴酸依他佐辛注射液《药品注册证书》。 公司氢溴酸依他佐辛注射液获批上市。氢溴酸依他佐辛注射液是由公司全资子公司合肥亿帆生物制药有 限公司自主研发并生产的麻精类药物。公司于2023 年6 月向CDE 递交了药品上市许可申请，同年7月获 得受理，后于2023 年9 月收到NMPA 签发的《麻醉药品和精神药品试验研究立项批件》，最终于2025 ...

Core Viewpoint - Yifan Pharmaceutical has received the drug registration certificate for Hydrochloride Etizolam Injection, marking its entry into the controlled substance market and enhancing its product portfolio [1][4]. Group 1: Drug Registration Information - The drug name is Hydrochloride Etizolam Injection, classified as a chemical drug of category 3 [2][3]. - The approval conclusion states that the product meets the requirements for drug registration according to Chinese regulations [1][2]. - The drug registration certificate was issued on April 8, 2025, with a validity period until March 31, 2030 [3]. Group 2: Product Overview - Hydrochloride Etizolam Injection is indicated for pain relief, particularly for cancer pain and postoperative pain [2]. - The company submitted the drug application in June 2023, received acceptance in July 2023, and obtained the research approval for controlled substances in September 2023 [2]. - The product is the first of its kind in China to pass the consistency evaluation for generic drugs [2]. Group 3: Market and Financial Impact - The domestic sales of Hydrochloride Etizolam Injection reached 128 million yuan in 2023 [2]. - The company has invested approximately 10.02 million yuan in the research and development of this product [2]. - The approval of this product is expected to positively impact the company's performance and enhance its competitiveness in the pharmaceutical sector [4].

亿帆医药（002019）公告，全资子公司合肥亿帆生物制药有限公司于2025年4月8日收到国家药品监督管 理局核准签发的氢溴酸依他佐辛注射液《药品注册证书》。氢溴酸依他佐辛注射液用于镇痛，尤其是癌 痛及手术后疼痛。公司于2023年6月递交了药品上市许可申请，于2023年7月获得受理。截至报告披露 日，公司是中国首家通过仿制药一致性评价的企业。2023年国内销售额为1.28亿元，公司对其研发投入 约1002.06万元。 ...