Regulatory2026-09-24

NXP200

Nuvectis Pharma Inc.NVCT
Indication
Solid Tumors
Stage
phase1
Event
Submission
Details

Sept. 24, 2026: Nuvectis Pharma, Inc. (NASDAQ: NVCT) said NXP200 (HSK42360), an oral brain-penetrant paradox-breaker BRAF inhibitor, received Breakthrough Therapy Designation from China’s Center for Drug Evaluation for patients with BRAF V600-mutant recurrent or progressive high-grade glioma.

The company said NXP200 is designed to inhibit the BRAF pathway without the paradoxical activation seen with first-generation BRAF inhibitors. It reported single-agent clinical activity to date, including in heavily pretreated patients and in patients previously treated with BRAF inhibitors, in primary CNS tumors and other tumor types such as non-small cell lung, colorectal, and papillary thyroid cancers.

Nuvectis also noted it in-licensed exclusive worldwide rights outside Greater China to NXP200 from Haisco Pharmaceutical Group in June 2026. An upcoming catalyst mentioned is a planned U.S. IND submission for NXP200 in 4Q 2026.

The press release also lists other pipeline programs: ciprocopan (NXP100), a Factor B inhibitor, which it says was recently approved in China for PNH patients previously untreated with complement inhibitors, and NXP900, an oral SRC/YES1 inhibitor in development for advanced cancers.