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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
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
news flash· 2025-06-15 23:03
Core Viewpoint - The company announced the termination of its exclusive agreement with Guoguang Biotech, effective June 30, 2025, which will result in the cessation of distribution of the quadrivalent seasonal influenza vaccine in mainland China. The board believes this termination will not have a significant adverse impact on the group's operations, as it will continue to advance the research and development of its proprietary respiratory syncytial virus (RSV) candidate vaccine SCB-1019 [1] Group 1 - The exclusive agreement with Guoguang Biotech will end on June 30, 2025 [1] - The company will no longer distribute the quadrivalent seasonal influenza vaccine in mainland China after the agreement termination [1] - The board of directors believes that the termination will not significantly adversely affect the group's operations [1] Group 2 - The company will continue to pursue the research and development of its proprietary RSV candidate vaccine SCB-1019 [1]