石家庄四药获批“乙酰半胱氨酸注射液”，呼吸药赛道再添竞争者，超6亿市场格局生变！

Core Viewpoint - Shijiazhuang Fourth Pharmaceutical Group has received production registration approval from the National Medical Products Administration for its acetylcysteine injection (25ml: 5g), marking it as the third company in China to obtain approval for this product [1][2][13]. Group 1: Product Approval and Market Potential - The acetylcysteine injection is originally developed by Zambon Group from Italy, which completed clinical trials in China in 2018 [4]. - The product is indicated for the treatment of acute acetaminophen poisoning and is expected to generate sales of nearly 600 million yuan in the hospital market by 2024, with over 100 million yuan in sales anticipated in the first half of 2025 [4][5]. - Over 30 companies have had their applications for acetylcysteine injection rejected due to the lack of domestic reference specifications and indications [7]. Group 2: Competitive Landscape - Since the original product was approved in May 2023, 70 companies have submitted applications for generic versions, indicating a highly competitive market for acetylcysteine injection [11]. - The approval of Shijiazhuang Fourth Pharmaceutical Group's product adds to the competitive landscape, following approvals from Sichuan Huiyu Pharmaceutical and Sichuan Haimengzhisen Biological Pharmaceutical [13]. Group 3: Company Innovation and Growth - Shijiazhuang Fourth Pharmaceutical Group has focused on innovation-driven high-quality development, with 164 products and 215 specifications passing consistency evaluations, enhancing its market position [16]. - The company has had over 50 products approved and evaluated this year, including several first-to-market products [16].