抗体放射性核素偶联物
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百利天恒首款抗体放射性核素偶联药物获批临床试验许可
Zheng Quan Ri Bao Wang· 2025-10-09 11:44
Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for the clinical trial of its innovative drug, Lu-177-BL-ARC001 injection, marking a significant milestone in the development of its first-in-class antibody-radionuclide conjugate (ARC) drug [1] Group 1 - The clinical trial approval for BL-ARC001 represents the company's first I-class innovative drug in the ARC field [1] - BL-ARC001 is expected to demonstrate stronger target specificity and higher tumor accumulation compared to traditional radionuclide conjugates, potentially showing better resistance to drug resistance [1] - The approval of the clinical trial application indicates a significant step forward for the company in the field of nuclear medicine research [1]
百利天恒(688506.SH):BL-ARC001用于在晚期实体瘤治疗获得临床试验批准通知书
Ge Long Hui A P P· 2025-10-08 10:36
Core Viewpoint - The company, BaiLi TianHeng (688506.SH), has received formal approval from the National Medical Products Administration (NMPA) for the clinical trial of its innovative drug, Lutetium-177-BL-ARC001 injection (referred to as "BL-ARC001") [1] Group 1: Clinical Trial Approval - The clinical trial for BL-ARC001 has been approved for late-stage solid tumors, meeting the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1] - BL-ARC001 is the company's first Class I innovative drug in the field of antibody-radionuclide conjugates (ARC) and is a potential first-in-class ARC drug with fully independent intellectual property rights [1] Group 2: Drug Characteristics - BL-ARC001 utilizes antibody-mediated precise targeted delivery technology and the powerful tumor-killing ability of radionuclides, offering stronger target specificity and higher tumor enrichment compared to traditional radionuclide conjugated drugs [1] - The drug is expected to demonstrate better resistance to drug resistance [1]
百利天恒:BL-ARC001用于在晚期实体瘤治疗获得临床试验批准通
Zhi Tong Cai Jing· 2025-10-08 09:33
Core Viewpoint - The company, Baile Tianheng, has received formal approval from the National Medical Products Administration (NMPA) for the clinical trial of its innovative drug, BL-ARC001, marking a significant milestone in its development of antibody-radiolabeled conjugates [1] Group 1: Product Development - BL-ARC001 is the company's first Class I innovative drug in the field of antibody-radiolabeled conjugates (ARC) [1] - The drug is positioned as a potential first-in-class ARC product with fully independent intellectual property rights [1] - BL-ARC001 utilizes antibody-mediated targeted delivery technology combined with the powerful tumor-killing ability of radioactive nuclides, offering stronger target specificity and higher tumor accumulation compared to traditional radiolabeled conjugates [1] Group 2: Market Potential - The approval of BL-ARC001's clinical trial is expected to enhance the company's competitive edge in the ARC market [1] - The drug is anticipated to demonstrate better resistance to drug tolerance, which could improve treatment outcomes for patients [1]
百利天恒(688506.SH):BL-ARC001用于在晚期实体瘤治疗获得临床试验批准通
智通财经网· 2025-10-08 09:30
Core Viewpoint - The company, Baillie Tianheng (688506.SH), has received formal approval from the National Medical Products Administration (NMPA) for the clinical trial of its innovative drug, BL-ARC001, marking a significant milestone in its development of antibody-radiolabeled conjugates [1] Group 1: Drug Development - BL-ARC001 is the company's first Class I innovative drug in the field of antibody-radiolabeled conjugates (ARC) [1] - The drug is positioned as a potential first-in-class ARC product with fully independent intellectual property rights [1] - BL-ARC001 utilizes antibody-mediated targeted delivery technology combined with the powerful tumor-killing ability of radioactive nuclides, offering stronger target specificity and higher tumor accumulation compared to traditional radiolabeled conjugates [1] Group 2: Market Potential - The drug is expected to demonstrate better resistance to drug resistance, which is a significant advantage in cancer treatment [1]