Group 1: Regulatory Actions - Shanghai Municipal Drug Administration reported six typical cases of violations in the pharmaceutical and medical device sectors, emphasizing strict enforcement of drug safety regulations [1] - Cases included unauthorized retail of drugs, non-compliance with quality management standards, and unlicensed activities related to medical devices [1] Group 2: Healthcare Financing Innovations - The National Healthcare Security Administration announced that Jiangxi province has implemented a direct settlement model for medical payments, reducing the payment cycle from 180 days to 30 days, significantly improving cash flow for pharmaceutical companies [2] - As of July 2025, Jiangxi's healthcare departments have directly settled payments with pharmaceutical companies totaling approximately 296.42 billion yuan, with 99.73 billion yuan settled in 2025 alone [2] Group 3: Drug Approvals - The FDA approved two biosimilars developed by Fuhong Hanlin for the treatment of osteoporosis, targeting specific patient populations [3] - Zai Lab received approval for TIVDAK (维替索妥尤单抗) in Hong Kong for treating recurrent or metastatic cervical cancer in adults [4] - Hansoh Pharmaceutical announced the approval of a second indication for its drug, Yina Li (伊奈利珠单抗), for adult patients with IgG4-related disease [5] Group 4: Capital Market Activities - Nanwei Medical reported a cumulative buyback of approximately 110,000 shares, representing 0.0585% of its total share capital, with a total expenditure of about 9.6 million yuan [6] - Olin Bio announced the termination of a 175 million yuan private placement due to current market conditions, stating that it would not adversely affect its operations [7][8] Group 5: Strategic Collaborations - Koyi Pharmaceuticals entered into an exclusive licensing agreement with RADIANCE Biopharma for its first-in-class dual antibody ADC drug, KY-0301, with potential milestone payments totaling up to 1.5 billion USD [8][9]

Core Viewpoint - Hansoh Pharmaceutical (03692) announced that its innovative drug, XinYue (Inalizumab injection), received a drug registration certificate from the National Medical Products Administration (NMPA) of China on August 26, 2025, for an additional indication: treatment of adult patients with Immunoglobulin G4-related disease (IgG4-RD) [1] Group 1 - XinYue is a targeted CD19B cell-depleting antibody [1] - The product was licensed in 2019 through an agreement with VielaBio for exclusive development and commercialization rights in mainland China, Hong Kong, and Macau [1] - In March 2022, XinYue was approved by NMPA for marketing in China for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD) [1] Group 2 - In January 2023, XinYue was included in the National Basic Medical Insurance Drug List for the first time [1] - The additional indication for IgG4-RD was prioritized for review and approval on February 8, 2025 [1]

Core Viewpoint - Hansoh Pharmaceutical (03692) announced that its innovative drug, XinYue (Inalizumab injection), received a drug registration certificate from the National Medical Products Administration (NMPA) of China on August 26, 2025, approving an additional indication for adult patients with Immunoglobulin G4-related disease (IgG4-RD) [1] Group 1 - The drug XinYue has now been approved for a second indication, expanding its therapeutic applications [1] - The new indication was included in the NMPA's priority review and approval process on February 8, 2025 [1]