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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
每经记者|陈星 每经编辑|董兴生 NO.2 *ST赛隆董事长等辞职 *ST赛隆公告,公司董事会于近日收到公司董事长兼总裁陈科、副总裁兼董事会秘书张旭、副总裁段代 风的书面辞职报告。因工作调整原因,陈科和张旭将继续分别担任公司总裁、董事会秘书等职务。因个 人职业发展规划原因,段代风辞职后将不在公司担任任何职务。 点评:董事长陈科与董秘张旭保留原有经营层职位,此举或为满足公司治理要求。而副总裁段代风的彻 底离职则反映真实人事变动。这种"名退实留"的调整虽属常见操作,但仍需关注其是否伴随战略分歧。 NO.3 百济神州专利案结案 10月8日晚间,百济神州发布关于公司涉及诉讼的进展公告,Pharmacyclics LLC公司(申诉方)决定不 对美国专利商标局的最终书面决定提起上诉。申诉方和被申诉方(百济神州及全资子公司)于2025年9 月30日(美国时间)向美国特拉华州地方法院提交一份共同协议,自愿撤回诉讼案件,案件已做出终局 处理。 点评:作为被申诉方的百济神州在本次诉讼中并未受到不利影响,百悦泽®在美国的研发和销售未受到 影响,且未对公司的生产经营产生重大不利影响。 | 2025年10月9日 星期四 | NO.1 ...