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 Insights - Hangzhou Kang En Bei Pharmaceutical's application for the generic version of Finerenone has been accepted, with 30 companies currently competing for the first generic approval [1][7][10] - Finerenone, originally developed by Bayer, is used for treating type 2 diabetes-related chronic kidney disease (CKD) and heart failure, showing strong market performance with sales exceeding 410 million yuan in the first half of 2025, a 135.98% year-on-year increase [4][10] - The original patent for Finerenone is set to expire in February 2028, with 23 companies currently filing for a type 3 patent declaration, indicating they cannot market the product until the patent expires [10][13] Company Developments - Kang En Bei Pharmaceutical has successfully obtained approvals for over 50 products, with several being the first to pass consistency evaluations, including Sulfamethoxazole and Amisulpride solutions [16] - The competition for Finerenone has intensified, with 37 companies having completed bioequivalence (BE) trials and over 20 more currently conducting BE trials [13][16] Market Dynamics - The strong sales performance of Finerenone has attracted numerous domestic pharmaceutical companies to enter the market, leading to a competitive landscape [4][7] - The ongoing patent challenges and the competitive nature of the generic drug market suggest a dynamic environment for both original and generic manufacturers [10][13]

Core Viewpoint - Fudan Zhangjiang's application for the drug Ocaliva (Obeticholic Acid) has been rejected by the National Medical Products Administration due to safety concerns and lack of sufficient evidence to support its approval as a generic drug [1][4]. Group 1: Company Updates - Fudan Zhangjiang's subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., received a notification of non-approval for its drug application for Obeticholic Acid, which is intended for treating primary biliary cholangitis (PBC) [1]. - The company has invested approximately 125 million yuan in the development of Obeticholic Acid [1]. - The rejection of the drug application is not expected to have a significant impact on the company's current financial status [1]. Group 2: Industry Context - Obeticholic Acid, originally developed by Intercept Pharmaceuticals, was first approved by the FDA in May 2016 and subsequently received conditional approval in Europe [2]. - The global sales of Obeticholic Acid showed steady growth from 2016 to 2021, reaching approximately $363 million in 2021 before stabilizing around $300 million in subsequent years [2]. - Safety concerns regarding Obeticholic Acid have led to multiple warnings and restrictions, including its classification under a "black box warning" by the FDA due to reports of severe liver damage and increased risk of liver transplant and death [3]. - The European Medicines Agency recommended the withdrawal of Obeticholic Acid's marketing authorization in 2023, and Intercept Pharmaceuticals voluntarily withdrew the drug from the U.S. market in September 2023 [3]. - There are currently no approved Obeticholic Acid products in China, and the safety risks associated with the original drug have created uncertainty for domestic generic drug prospects [4]. - Other domestic companies, including Hengrui Medicine and Zai Lab, are also facing setbacks in their applications for Obeticholic Acid generics, with some projects being halted after significant investments [5].