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百利天恒首款抗体放射性核素偶联药物获临床试验许可
Zhong Zheng Wang· 2025-10-09 06:11
Core Viewpoint - The approval of the clinical trial application for the first antibody-radionuclide conjugate drug, Lutetium [177Lu]-BL-ARC001, by the National Medical Products Administration (NMPA) marks a significant advancement for the company in the field of nuclear medicine [1] Group 1: Product Development - Lutetium [177Lu]-BL-ARC001 is the company's first Class I innovative drug developed based on its proprietary HIRE-ARC platform [1] - The drug is intended for use in patients with locally advanced or metastatic solid tumors who have failed standard treatment or cannot access standard treatment [1] - The HIRE-ARC platform integrates antibody-mediated targeted delivery technology with the powerful tumor-killing ability of radionuclides, showcasing the company's commitment to innovative drug development [1] Group 2: Intellectual Property and Market Position - The drug represents a potential global first-in-class (First-in-class) ARC drug, highlighting the company's complete ownership of intellectual property rights [1] - The company plans to continue developing a series of ARC candidate innovative drugs based on the HIRE-ARC platform, indicating a strategic focus on expanding its product pipeline in the nuclear medicine sector [1]
百济神州专利案结案;*ST赛隆董事长、副总裁等辞职|医药早参
Mei Ri Jing Ji Xin Wen· 2025-10-08 23:12
Group 1 - Norin Pharma and Zenas BioPharma have reached a licensing agreement for the global development and commercialization rights of Obinutuzumab in multiple sclerosis and other non-oncology indications [1] - Zenas also acquired rights to two preclinical molecules, a novel oral IL-17 AA/AF inhibitor and a brain-penetrant oral TYK2 inhibitor [1] - This strategic collaboration aims to accelerate the clinical development of Obinutuzumab and maximize its clinical and commercial value globally, particularly in the field of multiple sclerosis [1] Group 2 - The board of *ST Sailong has received resignation letters from Chairman Chen Ke, Vice President and Secretary Zhang Xu, and Vice President Duan Daifeng [2] - Chen Ke and Zhang Xu will retain their positions as President and Secretary, respectively, while Duan Daifeng's resignation reflects a personal career development decision [2] - This "name resignation but actual retention" adjustment is common but may indicate potential strategic disagreements within the company [2] Group 3 - BeiGene announced that Pharmacyclics LLC has decided not to appeal the final written decision of the U.S. Patent and Trademark Office, leading to the voluntary withdrawal of the lawsuit [3] - The lawsuit was resolved without adverse effects on BeiGene, and the development and sales of Baiyueze® in the U.S. remain unaffected [3] - The resolution of this litigation does not pose significant negative impacts on the company's operations [3] Group 4 - BaiLi Tianheng's first antibody-drug conjugate (ARC) has received clinical trial approval from the National Medical Products Administration [4] - The drug, Lutetium [177Lu]-BL-ARC001 injection, is intended for patients with locally advanced or metastatic solid tumors who have failed standard treatments [4] - This therapy offers new hope for advanced solid tumor patients by precisely targeting and destroying tumor cells, showcasing a differentiated innovation path in the current ADC drug development landscape [4]