12月31日，亿帆医药（002019）通过官方微信公众号披露核心经营数据，公司核心创新药亿立舒2025年 国内外累计发货量突破50万支，同比增幅超80%，放量趋势显著。其中，国内市场发货规模预计达到销 售里程碑条款的会计确认阈值，有望将对公司当期业绩形成实质性提振；海外市场方面，美国终端定价 达4600美元/支，发货量超4.6万支，国际化布局成效凸显。与此同时，公司另一款创新药易尼康同样表 现亮眼，2025年累计发货量实现同比超200%的高速增长，创新药管线多点开花的格局逐步成型。 2025年是中国创新药企全球化突围的关键之年，对外授权（BD）交易市场迎来爆发式增长，全年对外 授权总金额突破1000亿美元，首付款规模达81亿美元，印证中国创新药的全球临床价值与商业化潜力获 得国际市场高度认可，更成为中国医药产业从规模扩张的医药大国向创新驱动的医药强国加速转型的核 心注脚。 为统筹推进各事业部产品交易执行、跨境商务谈判、联盟生态管理及全球化与区域市场拓展等核心职 能，亿帆医药于2025年上半年正式组建全球BD中心。全球BD中心通过重塑BD业务定位、整合内外部 资源，强化战略合作纽带，旨在为亿帆医药持续引入高价值 ...

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].

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].

Core Viewpoint - Yifan Pharmaceutical (002019) has received approval for its drug, Hydrobromide Etizolam Injection, from the National Medical Products Administration, marking a significant milestone in its product development and market entry [1] Group 1: Product Approval and Market Entry - The company's wholly-owned subsidiary, Hefei Yifan Biopharmaceutical Co., Ltd., received the drug registration certificate for Hydrobromide Etizolam Injection on April 8, 2025 [1] - The drug is indicated for pain relief, particularly for cancer pain and postoperative pain [1] - Yifan Pharmaceutical submitted the drug marketing application in June 2023 and received acceptance in July 2023 [1] Group 2: Market Position and Financials - As of the report date, the company is the first in China to pass the consistency evaluation for generic drugs [1] - The domestic sales revenue for 2023 reached 128 million yuan [1] - The company invested approximately 10.02 million yuan in research and development [1]