Nuvectis drug NXP200 gets China breakthrough therapy status

Nuvectis Pharma, Inc. (NASDAQ: NVCT) announced that its drug candidate NXP200 (HSK42360) has received Breakthrough Therapy Designation (BTD) from China's Center for Drug Evaluation (CDE) for the treatment of patients with BRAF V600-mutant, recurrent or progressive high-grade glioma.

NXP200 is an oral, brain-penetrant BRAF inhibitor designed to block the BRAF pathway without triggering paradoxical activation associated with first-generation BRAF inhibitors. The drug has shown single-agent clinical activity in heavily pre-treated patients, including those previously treated with BRAF inhibitors, across primary central nervous system tumors and other cancer types including non-small cell lung, colorectal, and papillary thyroid cancers.

In June 2026, Nuvectis in-licensed exclusive worldwide, ex-Greater China rights to NXP200 from Haisco Pharmaceutical Group.

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, said the designation "underscores the compelling clinical activity observed to date with NXP200 in patients with recurrent or progressive BRAF V600-mutant high-grade glioma." Bentsur also noted the company continues to advance NXP200 toward a U.S. Investigational New Drug (IND) submission in the fourth quarter of 2026.

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