Acetylcysteine

来源：趣学术 作者：颜陆荣 三天内，43个仿制药上市申请，全被退审。 4月20日到4月22日，国家药监局接连发布3批通知，共计43个仿制药收到了通知件。 对于药品申请上市来说，收到通知件一般来说意味着这些药品的上市申请没有通过，或者是企业因预判无法过审而主动撤回上市申请。 而未通过品种名单中，利伐沙班、乙酰半胱氨酸片、阿卡波糖片等，大多是一些常见品种，有行业内人士评论，研发难度并非巨大。退审名单中的申报企业也包含不少医药行业知名厂家。 其实信号早已传来，早在2025年12月，就出现过上百个文号被否的场景。这次国家药监局再一次大规模退回仿制药申请，有行业人士分析，这是在反内卷情况下，医药行业产业仿制审批质量的进一步升级。 01 仿制药审批退审率，飙升至40% 根据国家药监局的公开消息，4月20日，38个审批文号被退回，其中有34个是仿制药。4月21日，9个审批文号被退回，6个是仿制药。4月22日，7个审批文号被退回，3个是仿制药。 从治疗领域看，涵盖的范围主要是心血管、呼吸系统、抗感染、肿瘤等。从具体品种来看，包括昂丹司琼口崩片、盐酸多西环素片、利伐沙班口崩片、二甲双胍恩格列净片等常见品种。 值得注意的是，此次退审名单中并非只有中小药企“折戟”，国内多家头部药企也赫然在列。江苏豪森的普拉曲沙注射液，浙江华海的卡维地洛片、富马酸二甲酯肠溶胶囊，湖南科伦的佩玛贝特片，上药信谊的环索奈德吸入气雾剂，石药的利奈唑胺干混悬剂，统统被否。 通知件送达，意味着CDE对这个申请已经有了明确的结论。至于具体是什么原因，从目前公布的情况中看不到。但有一个事实是确定的：仿制药审批通过的门槛，正在提高。 在2025年12月，国家药监局就发布了136个仿制药通知件送达信息，也就是退审信息。而根据统计，2025年上半年审批被否的仿制药也才134个。还有数据显示，此前仿制药行业平均退审率维持在10%-15%，而2025年Q4这一比例已飙升至40%，意味着每10个申报品种中就有4个折戟沉沙。 各项数据都显示，仿制药的审批是越来越严格了。过去十年，中国仿制药的核心逻辑是，只要敢申报、愿跟跑，总有机会拿批文。但如今，这条路正在被悄然关闭，越来越多的企业面临“直接出局”。 02 药品上市申请，质量门槛提高 退审量的激增，背后是两大征求意见稿构建的“质量防火墙”。2025年12月3日，国家药品监督管理局药品审评中心组织起草的《化学仿制药药学研究重大缺陷（试行）（征求意见稿）》和《化学仿制药生物等效性研究重大缺陷（试行）（征求意见稿）》对外发布。 在《化学仿制药药学研究重大缺陷（试行）（征求意见稿）》中，对于存在重大缺陷的申请，不再要求申请人补充资料，直接基于已有申报资料作出不予批准的决定，彻底堵死了部分企业“先申报、后补资料”的侥幸心理。 生物等效性研究是仿制药获批的核心前提，直接关系到仿制药与原研药的疗效一致性。此次发布的《化学仿制药生物等效性研究重大缺陷（试行）（征求意见稿）》，就直指BE（生物等效性）研究的硬伤——即便统计结果达标，若存在设计缺陷或质量问题，研究结果仍不被认可。 这两份文件首次以“负面清单”形式，明确了仿制药研发中不可触碰的红线，将审评标准从“完成即可”推向“质量可信”。另外，《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》中也提到，要优化仿制药审评、核查工作机制，基于产品风险加大批准前动态检查力度，促进仿制药质量提升。 除了质量层面的硬伤，低水平重复申报或许也是此次退审的重要推手。2025年7月，首都医科大学国家医疗保障研究院院长助理兼价格招采室主任蒋昌松在接受《中国医疗保险》杂志采访时就提到，我国仿制药企业数量非常多，同质化竞争严重，建议药监部门在审评审批环节对同质化品种强化风险提示。 过去十年，中国仿制药行业只要企业敢申报、愿投入，即便只是简单复制原研药工艺，也有机会获得批文。这导致大量企业扎堆布局热门品种，形成恶性内卷。从此次被退审的43个仿制药来看，左氧氟沙星氯化钠注射液已有49个批准文号，盐酸莫西沙星氯化钠注射液有39个批准文号，硫酸氢氯吡格雷片目前也已有28个批准文号。 哪个赛道热门就去哪个赛道，哪个药卖得好就去仿制哪个药。现在这种套路已经走不长远了，换个思路想，现在对于创新药，官方都明确表态不支持“内卷式创新”“换汤不换药的创新”，更别提仿制药了。 附：被退审仿制药名单 各位思齐会员朋友，思齐圈针对5.1新规策划了“合规新生态”系列讲座，第三期“重构医药营销合规新格局”将于4月29日19:00-20:00在“思齐圈”APP和“思齐会长Clark”视频号同步直播，感兴趣的思齐小伙伴们，现在就可以预报名~ 长按下方二维码 扫码立即报名

TORONTO, April 23, 2026 /PRNewswire/ - Apotex, the largest Canadian based pharmaceutical company, and Cumberland Pharmaceuticals Inc. ("Cumberland"), a U.S. based specialty pharmaceutical company, today announced that they have entered into a strategic transaction to integrate Cumberland's U.S. branded businesses into Apotex (the "Transaction"). Under the terms of the agreement, Apotex will add a portfolio of branded medicines to its US business. The Transaction is expected to significantly expand Apotex's U.S. specialty and hospital focused business with a diversified basket of products across acute care, oncology, infectious disease, and gastroenterology. Closing of the Transaction is subject to, among other things, the required approval of Cumberland's shareholders. "This Transaction will strengthen our ability to support patients in some of the most critical moments of their care journey," said Jeff Watson, President & CEO of Apotex. "As a Force for Health, we are committed to improving access to high-quality medicines and ensuring that patients, families, and clinicians have the specialty treatments they rely on. Integrating Cumberland's branded commercial business into the Apotex family will enhance our ability to deliver a meaningful health impact for patients across the United States." The portfolio includes well-established brands such as Kristalose®, Caldolor®, Sancuso®, Vibativ®, Acetadote®, Vaprisol®, and Talicia®, which are prescribed across hospitals, oncology, infectious disease, and gastroenterology settings. These differentiated products benefit from strong clinical data and offer opportunities for continued commercial growth and optimization under Apotex's ownership. The portfolio of brands is an excellent strategic fit for Apotex enabling it to bolster its longstanding relationships with institutional customers and providing an opportunity to grow its position in the institutional channel. "With this Transaction, we intend to expand our U.S. commercial footprint in hospital and specialty care" said Christine Baeder, President of U.S. and LATAM. "Most importantly, we believe this Transaction will strengthen our ability to support physicians and the patients they serve. By enhancing awareness, improving access, and ensuring continuity of supply, we continue to act as a Force for Health in every community we reach." "We believe the integration of these products into Apotex creates more critical mass to better support patient care," said A.J. Kazimi, Chief Executive Officer at Cumberland. "We look forward to working with Apotex to ensure a smooth and successful transition that will expand access for patients who can benefit from our medicines." Raymond James is acting as financial advisor to Apotex in connection with the Transaction. About Apotex Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. Learn more at About Cumberland Pharmaceuticals Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee. The company is focused on providing unique products that improve the quality of patient care. Cumberland currently distributes a portfolio of FDA-approved specialty brands. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis. For more information see SOURCE Apotex Inc. 21% more press release views with Request a Demo