12月11日，石家庄四药集团发布公告，其申报的化学药第3类乙酰半胱氨酸注射液（25ml：5g）获国家药监局生产注册批件，并视同通过一致性评价，是国 截图来源：企业公告 乙酰半胱氨酸注射液原研为意大利的赞邦制药（Zambon Group），赞邦于2018年申请临床，并在中国完成I期和III期临床。该品种适用于急性对乙酰氨基酚 中毒解毒，用于预防或减轻其过量引起的肝脏损伤。据摩熵医药数据库显示，在2024年全终端医院市场乙酰半胱氨酸注射液的销售额近6亿元，2025年上半 年销售额超1亿元。 截图来源：摩熵医药全终端医院销售数据库 对于偌大的市场，此前曾有众多企业试图仿制。但由于参比规格和适应症在国内未上市，众多企业的仿制申请频频被驳回。目前，国内已有超30家药企的乙 酰半胱氨酸注射液仿制申请被驳回。 | 药品名称: 乙酰半胱氨酸注射液 × 审评结论:未被批准 × | | --- | 内第3家获批该品种的企业。 | | | | 药品名称 | 单方/复方 | 药品类型 | 剂型 | CDE企业名称 | 申请类型 | 注册类型 | 承办日期 | 状 | | --- | --- | --- | --- | --- | - ...

Core Viewpoint - The financial performance of Huiyu Pharmaceutical shows a significant increase in revenue and net profit, but the underlying growth is driven by non-recurring gains, indicating potential fragility in its financial health [2]. Group 1: Financial Performance - Huiyu Pharmaceutical reported a revenue of 1.09 billion yuan, representing a year-on-year increase of 18.05%, and a net profit of 325 million yuan, up 132.78% [2]. - After excluding non-recurring gains, the net profit was only 92 million yuan, reflecting a more modest year-on-year growth of 39.55% [2]. - The core profit driver was the fair value changes of financial assets, particularly a gain of 211 million yuan from the investment in a drug company, which constituted 64.9% of the net profit [2]. Group 2: International Expansion - The overseas business has become a significant growth engine, with foreign sales revenue reaching 166 million yuan, a year-on-year increase of 97.12% [3]. - The company obtained 101 new drug approvals, expanding its market coverage from 54 to 68 countries [3]. - However, overseas revenue only accounts for 15.2% of total revenue, and the reliance on low-margin generic drug exports poses challenges, including rising costs for EU GMP certification and currency fluctuations in emerging markets [3]. Group 3: Domestic Strategy - The domestic business has improved structurally through a strategy focused on high-barrier generics and first-to-market products, resulting in 17 new generic drug launches [4]. - Domestic sales revenue grew by 10.12% to 928 million yuan, supported by stable cash flow from 10 products that won national or provincial procurement bids [4]. - Despite this growth, the average annual price decline for generics exceeds 50% due to normalized bulk purchasing, raising questions about the sustainability of revenue growth [4].