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中国生物制药:TQ-B3234“选择性MEK1/2抑制剂”纳入突破性治疗药物程序
Zhi Tong Cai Jing· 2025-10-15 10:38
Core Viewpoint - China Biopharmaceutical (01177) has announced that its self-developed national class 1 new drug TQ-B3234 capsule, a selective MEK1/2 inhibitor, has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of symptomatic, unresectable neurofibromatosis type I (NF1) related adult plexiform neurofibromas [1] Group 1 - TQ-B3234 is a selective MEK1/2 inhibitor that targets the upstream regulatory factor of the extracellular signal-regulated kinase (ERK) pathway, which can inhibit tumor growth by suppressing the activity of the RAS-regulated RAF/MEK/ERK pathway [1] - The phase III registration clinical study for TQ-B3234 in treating adult plexiform neurofibromas has been approved by the CDE, aiming to confirm its efficacy and safety in a larger patient population to fill the domestic treatment gap [1] - The inclusion of TQ-B3234 in the BTD program will accelerate the drug's market launch process, potentially benefiting more patients sooner [1]