SINO BIOPHARM (01177): TQ-B3234 「Selective MEK1/2 Inhibitor」 Included in Breakthrough Therapy Designation Program

Stock News
10/15

SINO BIOPHARM (01177) has announced that its independently 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 China's National Medical Products Administration. This designation is for the treatment of adult plexiform neurofibromas associated with Neurofibromatosis Type 1 (NF1) that are symptomatic and not amenable to surgical intervention. TQ-B3234 functions as a selective MEK1/2 inhibitor. MEK acts as an upstream regulator in the extracellular signal-regulated kinase (ERK) pathway, and MEK inhibitors can suppress tumor growth by inhibiting the activity of the RAS-regulated RAF/MEK/ERK pathway. The Phase III registration clinical trial for TQ-B3234 in treating adult plexiform neurofibromas has been approved by the CDE. This study aims to confirm its efficacy and safety in a larger patient population, addressing the existing treatment gap in the country. The inclusion of TQ-B3234 in the BTD program will expedite its market approval process, potentially benefiting more patients in the near future.

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