Nuvectis’ NXP200 Receives Breakthrough Designation for Glioma
Nuvectis Pharma has announced that China’s Center for Drug Evaluation (CDE) has granted Breakthrough Therapy Designation (BTD) to NXP200 (HSK42360) for patients with BRAF V600-mutant, recurrent or progressive high-grade glioma.
NXP200 is an oral, brain-penetrant BRAF inhibitor designed to block the BRAF signalling pathway without causing the paradoxical activation associated with some first-generation BRAF inhibitors.
The candidate has demonstrated single-agent clinical activity in heavily pre-treated patients, including those previously treated with BRAF inhibitors.
Clinical activity has been reported across primary central nervous system tumours and other cancers, including non-small cell lung, colorectal and papillary thyroid cancers.
The BTD provides a regulatory pathway intended to support the development and review of therapies for serious conditions where preliminary clinical evidence indicates potential improvement over available treatments.
Nuvectis obtained exclusive worldwide rights to NXP200 outside Greater China from Haisco Pharmaceutical Group in June 2026.
Haisco is responsible for development activities in Greater China.
The company plans to continue advancing NXP200 towards a US Investigational New Drug (IND) submission targeted for the fourth quarter of 2026.
Nuvectis’ oncology pipeline also includes NXP900, an oral small-molecule inhibitor targeting SRC family kinases.
The company is additionally developing ciprocopan (NXP100), a Factor B inhibitor for complement-mediated diseases.
