TQ-B3234 / Sino Biopharm - LARVOL DELTA

Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas (clinicaltrials.gov) - P3 | N=177 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P3 trial • Genetic Disorders • Neurofibromatosis • Solid Tumor • NF1

An open-label phase I trial to evaluate the safety, tolerability, and efficacy of TQ-B3234 in adults with neurofibromatosis type 1 (NF1) (ESMO 2025) - P1 | "No death occurred during the study. Conclusions TQ-B3234 exhibited a tolerable safety profile and achieved a clinically meaningful ORR in adults with NF1-PN pts, which highlight its therapeutic potential as a novel targeted therapy for this patient population."

Clinical • P1 data • Brain Cancer • Neurofibrosarcoma • Oncology • Sarcoma • Solid Tumor • NF1

Sino Biopharmaceutical Limited announced that its new drug, TQ-B3234, a selective MEK1/2 inhibitor, has been included in the Breakthrough Therapy Designation process by the Center for Drug Evaluation of China’s National Medical Products Administration. (TipRanks) - "This inclusion is for the treatment of adult plexiform neurofibromas associated with neurofibromatosis type I, a condition with significant unmet medical needs in China."

Breakthrough therapy • Neurofibromatosis

An open-label phase 1 dose-escalation and dose-expansion trial to evaluate the safety, tolerability, and efficacy of TQ-B3234 in adults with neurofibromatosis type 1 (NF1). (ASCO 2025) - P1 | "TQ-B3234 demonstrated manageable safety and a significant ORR in adult NF1- PN pts. These results support the potential of TQ-B3234 to become a new treatment option for NF1- PN pts. Additionally, TQ-B3234 showed deep and durable volume reduction in adult cNF pts, as assessed by paper frames."

Clinical • P1 data • Brain Cancer • Genetic Disorders • Neurofibromatosis • Neurofibrosarcoma • Pain • Sarcoma • Solid Tumor • NF1