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]
三叶草生物与国光生技终止合作；市场监管总局指导查办一起医药领域重大典型垄断案件丨21健讯Daily
2 1 Shi Ji Jing Ji Bao Dao·2025-06-17 00:57