Regulatory Developments - The National Medical Products Administration (NMPA) is seeking opinions on optimizing the review and approval process for innovative drug clinical trials, proposing a 30-day fast track for applications of traditional Chinese medicine, chemical drugs, and biological products classified as Category 1 innovative drugs [1] - The application must meet specific criteria, including being a key innovative drug supported by national policies, included in special programs for children's drugs or rare diseases, or part of global synchronized research [1] Company Announcements - Shanghai Aikobio announced that its new drug application for Aizhida (a combination capsule for ADHD) has been accepted by the NMPA and is included in the priority review process [1] - WuXi Biologics announced a placement of 82.94 million existing shares at HKD 26.60 per share, representing approximately 2.04% of its total issued share capital [2] - Jichuan Pharmaceutical disclosed that after a share transfer, Cao Fei and Cao Longxiang became the joint actual controllers of the company, holding a combined 56.07% of the total share capital [3] - Wuhan Dazhong Oral Medical Co., Ltd. has received IPO approval to list on the Hong Kong Stock Exchange, operating 92 dental clinics across Hubei and Hunan provinces [4][5] Market Dynamics - Three Leaf Clover Biotech announced the termination of its exclusive agreement with Guoguang Biotechnology due to significant market changes, ceasing the distribution of a seasonal flu vaccine in mainland China [6] - Sanofi has re-entered the flu vaccine market after receiving approval for its quadrivalent flu vaccine for the 2025-2026 season, following a previous suspension due to efficacy issues [6] - Zhejiang Province's government procurement center announced the results for flu vaccine procurement, with prices as low as 6 CNY per dose, marking a new low for flu vaccine bids [6] Safety Concerns - Sarepta Therapeutics reported a second death related to its DMD gene therapy Elevidys, leading to a suspension of the drug's supply for non-ambulatory patients [7] Regulatory Actions - The State Administration for Market Regulation imposed a total fine of 362 million CNY on several pharmaceutical companies for engaging in price-fixing agreements [8]

以下文章来源于健闻咨询 ，作者健闻咨询 健闻咨询 . 医疗行业跨界洞察 作者 | 一闻 来源 | 健闻咨询 导 语 ：《反垄断法》确定的"没收违法所得"的处罚方式实践中难以完全落实，药企参与垄断的 收益可能远远高于违法成本。 4月24日，仙琚制药发布2024年年度报告，其中提及：公司因涉嫌地塞米松磷酸钠原料药垄断案， 被天津市市场监督管理委员会罚没1.95亿元。 今年3月，也有一款临床短缺药涨价的背后原因，同样是药企的合谋垄断。 一城市的市场监督管理局开出罚单，指出有三家药企合谋推高甲硫酸新斯的明注射液（下称"新斯 的明"）销售价格，使得这款药的价格涨幅高达11~21倍。近期，三家药企被没收违法所得并处罚 款，合计约2.23亿元。 而在此案被查之前，新斯的明的经销商一度曾将药价上涨的原因归结为"原料药价格上涨"，甚至该 药还进入过《国家短缺药品清单》。直到2024年底，该药以不足一元每支的价格进入集采，价格泡 沫才破裂。 如今真相揭开，背后隐藏的其实是三家药企的垄断合谋。 一通电话，救命短缺药涨价20倍 新斯的明注射液的价格，近几年间经历了一轮过山车。 从2020年起，新斯的明突然涨价，以1ml：0.5mg的 ...