2 1 Shi Ji Jing Ji Bao Dao·2025-11-18 01:26Policy Developments - The National Medical Products Administration (NMPA) has released new guidelines to streamline the registration process for new functional cosmetics, implementing an immediate review system [1] - The guidelines encourage the launch of international cosmetic products in China without the need for overseas sales proof and support the development of products targeting the elderly population [1] Drug and Device Approvals - Heng Rui Medicine has received clinical trial approval for Fumaric Acid Teglutik Injection, which is set to be the first domestically developed Class 1 opioid analgesic in China, expected to be approved for market in January 2024 [2] - Heng Rui Medicine also announced the approval for clinical trials of HRS-6209 capsules, a selective CDK4 inhibitor for advanced solid tumors, and HRS-2189 tablets, a KAT6 inhibitor for advanced malignancies, both of which have no similar products approved domestically or internationally [3] - Fuhong Hanlin's HLX11 (Pertuzumab) has been approved by the FDA for HER2-positive breast cancer treatment, marking it as the first interchangeable biosimilar for cancer treatment approved in the U.S. [4] Capital Markets - SenseTime Medical has initiated a Series A financing round, with post-investment valuation exceeding 3 billion yuan, following a recent strategic financing round [5] - Yabao Pharmaceutical plans to sell 62% of its stake in Taiyuan Pharmaceutical for approximately 87.19 million yuan, resulting in a significant change in ownership structure [6] Industry Developments - Kangfang Biotech has received approval for clinical trials of its dual-specific antibody new drug AK152 for Alzheimer's disease, marking a significant advancement in the treatment of this condition [7][8]