TQ-B3234 Capsules, a “selective MEK1/2 inhibitor,” receives Breakthrough Therapy Designation
October 16, 2025
Source: drugdu
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On October 15, Sino Biopharmaceutical (01177) issued an announcement, announcing that the national Class 1 new drug TQ-B3234 capsules, a "selective MEK1/2 inhibitor" developed by it, has been included in the breakthrough therapy drug program by the Drug Review Center of the China National Medical Products Administration for the treatment of symptomatic, inoperable neurofibromatosis type 1 (NF1)-related adult plexiform neurofibromas.
According to Phase I clinical trial results presented at the 2025 American Society of Clinical Oncology Annual Meeting, TQ-B3234 demonstrated significant activity against NF1-related plexiform neurofibromas, with 96.7% of NF1-PN subjects experiencing tumor shrinkage and 36.7% achieving partial remission. In an exploratory analysis, 100% of cNF patients experienced tumor shrinkage, with the largest reduction reaching 85.2%.
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