奥贝胆酸
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创新药临床试验审评审批增设30日通道;奥贝胆酸将在美国撤市
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-15 00:48
Policy Developments - Fujian Province aims to lead breakthroughs in health and new pharmaceuticals, establishing a future industry pilot zone by promoting green low-carbon industries and developing strategic emerging industry clusters [2] Clinical Trials and Approvals - The National Medical Products Administration (NMPA) has introduced a 30-day review channel for innovative drug clinical trial applications, supporting key national R&D products and encouraging global early-stage and international multi-center clinical trials [3] - Kangning Jereh Pharmaceutical's new drug application for KN026 has been accepted by the NMPA, showing significant clinical efficacy in treating HER2-positive gastric cancer compared to existing standard treatments [5] - AstraZeneca's oral granules of Semeplakin have been approved for pediatric patients aged 1 year and older with symptomatic, unresectable neurofibromatosis type 1-related plexiform neurofibromas [6] Capital Market Activities - Qianjin Pharmaceutical has received approval from the China Securities Regulatory Commission to issue shares for the acquisition of stakes in two pharmaceutical companies, with a total share issuance of 51.44 million shares [8] - Tianchen Medical plans to use up to 200 million yuan of idle fundraising for cash management, investing in safe, liquid, and principal-protected financial products [9] - Lianhuan Pharmaceutical's wholly-owned subsidiary intends to purchase assets from its controlling shareholder for a transaction price of 74.5 million yuan [10] Industry Events - Alfasigma's subsidiary has voluntarily withdrawn Ocaliva from the U.S. market for the treatment of primary biliary cholangitis, following FDA requirements, and has paused all related clinical trials [12]