安科生物：参股公司创新药PA3-17注射液纳入拟突破性治疗品种

Core Viewpoint - Anke Biotech's PA3-17 injection has been included in the list of proposed breakthrough therapy products by the National Medical Products Administration (NMPA), marking a significant advancement in the treatment of adult relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) [1][2] Group 1: Product Development - PA3-17 injection is the first CAR-T therapy targeting T-cell blood tumors in China and is globally leading in this category [1] - The drug has completed Phase I clinical trials and received the Clinical Trial Approval Notification in August 2021 [1] - The objective response rate (ORR) of PA3-17 injection is reported to be 84.6%, significantly outperforming existing therapies [2] Group 2: Technical Innovations - PA3-17 injection overcomes the "self-harm" barrier in T-cell tumors by targeting the CD7 antigen, which allows it to avoid attacking its own CD7-positive T-cells [2] - The product utilizes non-gene editing technology to retain CD7 protein within T-cells, minimizing off-target risks associated with traditional gene editing [2] - The fully automated closed production process reduces contamination risks and ensures product consistency [2] Group 3: Market Implications - The inclusion of PA3-17 injection in the breakthrough therapy category is expected to accelerate its market approval process and enhance its competitive position globally [2] - This development lays a solid foundation for Chinese original cell therapies to enter international markets, positioning China favorably in global competition [2]