Nuvectis Pharma (NVCT) said Thursday that China's Center for Drug Evaluation granted Breakthrough Therapy Designation to NXP200 for patients with BRAF V600-mutant, recurrent or progressive high-grade glioma, an aggressive type of brain tumor.

The biopharmaceutical company said NXP200 has demonstrated single-agent clinical activity, including in heavily pre-treated patients and patients previously treated with BRAF inhibitors, against primary central nervous system tumors and other tumor types.

These include non-small cell lung, colorectal, and papillary thyroid cancers.

In June, Nuvectis in-licensed exclusive worldwide rights, excluding Greater China, to NXP200 from Haisco Pharmaceutical Group, the company said.

"The CDE's granting of Breakthrough Therapy Designation underscores the compelling clinical activity observed to date with NXP200 in patients with recurrent or progressive BRAF V600-mutant high-grade glioma," Chairman and Chief Executive Ron Bentsur said in a statement.

"In parallel, we continue to advance NXP200 toward a US IND submission in the fourth quarter of 2026."