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2毛钱的仿制药暴雷,问题出在哪儿?
虎嗅APP· 2025-03-29 09:59
Core Viewpoint - The article discusses the impact of the recent drastic price cuts in the pharmaceutical industry, particularly focusing on the implications of the tenth batch of centralized procurement and the challenges faced by companies involved in the production of generic drugs [1][2]. Group 1: Centralized Procurement and Price Cuts - The tenth batch of centralized procurement has led to unprecedented price cuts, with some drugs like the injection of isopropyl phenol being bid at extremely low prices, raising concerns about quality and sustainability [2][4]. - The price of isopropyl phenol injection was bid at 0.22 yuan per unit, a 92.36% drop from the highest effective bid of 2.8805 yuan, highlighting the aggressive competition among 36 companies [4][5]. - The involvement of B-class pharmaceutical companies, which often outsource production and have minimal investment in R&D, has increased significantly, leading to a more competitive and potentially unstable market environment [10][11]. Group 2: Regulatory Challenges and Company Responses - Two companies, Haimeizhisun and Sichuan Taiji, faced penalties for failing to meet quality standards, resulting in an 18-month suspension from national procurement, indicating the regulatory scrutiny in the industry [2][3][4]. - The rapid increase in B-class companies, from 140 in January 2021 to 1172 by November 2023, reflects a shift in the industry where many companies prioritize low-cost production over quality assurance [10][11]. - The article notes that many B-class companies lack adequate quality management, leading to potential risks in drug production and compliance with regulatory standards [11][12]. Group 3: Market Dynamics and Competitive Pressures - The intense competition has forced companies to shorten drug development cycles, with some projects being completed in as little as 12 months, raising concerns about the thoroughness of research and development [18][19]. - Companies are increasingly focusing on cost control, with a shift towards using domestic raw materials to reduce expenses, reflecting the pressure to maintain profitability amid price cuts [21][22]. - The article highlights a trend where companies are reducing R&D budgets and personnel, leading to a decline in innovation and a potential long-term impact on the industry [22][23].
2毛钱的仿制药暴雷,最担心的事还是发生了
凤凰网财经· 2025-03-28 13:17
凤凰网《风暴眼》出品 文|玲子 2024 年底,北方一家制药公司的办公室里,几位研发、采购人员围坐一圈,在稿纸上、白板上疾笔写下一串串数字。 3 分钱 / 片的阿司匹林肠溶 片、 0.22 元 / 支的间苯三酚注射液,按照理论成本,无论换多少种计算方法,他们也算不出这个价格。此时,第十批集采的中标价刚刚出炉,整个 医药圈都骚动起来。 "至少需要五六毛!"有人把笔一搁,最后一轮演算,成本价最多还是只能压到这里。研发主管郭青沉思片刻,试图给出合理解释:"估计是为了打出 品牌"。马上有人附和:"如果企业技术很厉害,应该有更好的方式控制成本吧……" 郭青在仿制药研发领域摸爬滚打了七年,经手过 50 余个研发项目。他所在的公司曾参与集采竞标,有几款产品顺利中标。通常,他会遇到两三毛钱 的压价,觉得这在预期范围之内,规模效应带来的持续订单和利润,与暂时的让价相比,总是更有诱惑力的。但第十批集采的激烈厮杀,他却前所未 见。 而近期,就在第十批集采落地前夕,饱受争议的超低价中标药间苯三酚注射液忽然被曝出不符合要求,两家涉事药企遭同步重罚 —— 委托方四川海 梦智森生物制药有限公司(下称"海梦智森")与受托方太极集团四川太极制 ...