3月起，中药将面临最严监管；中国生物制药与赛诺菲订立授权协议

Policy Developments - The State Administration for Market Regulation has revised the "Special Medical Purpose Formula Food Production License Review Guidelines (2026 Edition)," which includes 7 chapters and 43 articles, imposing strict requirements on production sites, equipment, processes, personnel management, and system management [1] - The guidelines adjust the production license variety details according to the 2025 version of special medical food standards and clarify environmental hygiene control and key equipment monitoring requirements based on the 2023 version of good manufacturing practices [1] Regulatory Changes - Starting March 1, the "Special Regulations on the Supervision of Traditional Chinese Medicine Production" will be implemented, prohibiting the external purchase of packaged traditional Chinese medicine pieces and mandating standardized labeling [2] - This regulation aims to address issues of quality in traditional Chinese medicine pieces, which have frequently been highlighted in inspections by various drug regulatory agencies [2] Drug and Device Approvals - Tuoxin Pharmaceutical's subsidiary has obtained NSF 173 GMP DI certification, indicating compliance with stringent quality and safety audits [3] - Newnow's subsidiary has received approval for clinical trials of SYS6053, a drug for patients with Type A hemophilia [4] - Anke Biological's investee company has been granted approval for clinical trials of PA3-17 injection for treating pediatric and adolescent relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma [5] - Sunshine Nuohuo has received approval for clinical trials of BTP4327, aimed at patients with uncontrolled hypertension [6] Capital Market Activities - Aidi Pharmaceutical plans to raise up to 1.277 billion yuan through a private placement, with over 60% of the funds allocated to HIV innovative drug projects [8] Major Industry Events - China National Pharmaceutical Group has signed an exclusive licensing agreement with Sanofi for the development, production, and commercialization of the JAK/ROCK inhibitor rovalpitinib, receiving an upfront payment of $135 million and potential milestone payments of up to $1.395 billion [9] - Gilead Sciences presented new data on the BIC/LEN single-tablet regimen for HIV treatment, showing effective maintenance of viral suppression in patients switching from other regimens [10][11] Licensing Agreements - Deciphera Pharmaceuticals has entered into a global exclusive licensing agreement with UCB for ATG-201, a CD19/CD3 bispecific T-cell engager, with an upfront payment of $60 million and potential milestone payments exceeding $1.1 billion [12] - Novo Nordisk's semaglutide injection for treating metabolic-associated steatotic liver disease is proposed for priority review by the National Medical Products Administration [14]