Policy Developments - The "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies" were officially published, emphasizing the balance between innovation and safety in the biomedical sector [2] - The National Healthcare Security Administration has issued a draft for "Basic Medical Insurance Registration Service Specifications," mandating that registration for individuals or units must not exceed five working days [3] Industry News - The National Healthcare Security Administration is conducting a special investigation into "dual pricing" practices at designated retail pharmacies, which discriminate between insured and uninsured patients [4] - Keren Biotechnology's TROP2 ADC has received approval for second-line treatment of EGFR mutation NSCLC, marking a significant advancement for the company's core product [6] - Beijing Norsland Biotechnology Co., Ltd. plans to issue H-shares and apply for listing on the Hong Kong Stock Exchange to enhance its international presence and raise funds for long-term development [8] - The National Medical Products Administration has reclassified Dangshen Granules and Regulating Menstrual Blood Capsules from prescription to over-the-counter drugs [10] - KingMed Diagnostics, Tencent, and Guangzhou Medical University First Affiliated Hospital announced a collaboration to develop a multimodal model for pathological genetics using AI [11] Company Updates - Kangtai Medical received a warning letter from the FDA regarding non-compliance with medical device quality system regulations, which could prevent its products from entering the U.S. market until issues are resolved [14] - Warner Pharmaceuticals has voluntarily withdrawn its drug registration application for Arolol Hydrochloride Tablets, which will not significantly impact the company's current or future operations [15]