Fort Lee, NJ — Nuvectis Pharma, Inc. (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, announced today that NXP200 (HSK42360), an oral, brain-penetrant, paradox-breaker BRAF inhibitor, has been granted Breakthrough Therapy Designation (BTD) for the treatment of patients with BRAF V600-mutant, recurrent or progressive high-grade glioma by China’s Center for Drug Evaluation (CDE).
NXP200 is a paradox-breaking BRAF inhibitor designed to block the BRAF pathway without triggering paradoxical activation that is seen with first-generation BRAF inhibitors. To date, NXP200 has demonstrated single-agent clinical activity, including in heavily pre-treated patients as well as in patients previously treated with BRAF inhibitors, against primary central nervous system (CNS) tumors and other tumor 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, commented, “We congratulate our partner Haisco for achieving this significant regulatory milestone, which is further testament to its tremendous strategic and operational capabilities. 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. In parallel, we continue to advance NXP200 toward a U.S. IND submission in the fourth quarter of 2026.”
About Nuvectis Pharma, Inc.
Nuvectis Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology. The Company’s pipeline includes ciprocopan (NXP100), a complement Factor B inhibitor in development for the treatment of complement-mediated diseases, and the oncology drug candidates NXP200 and NXP900, in development for the treatment of advanced cancers.
The company’s lead drug candidate is ciprocopan, a once-a-day Factor B inhibitor, with best-in-class potential, recently approved in China for the treatment of PNH patients previously untreated with complement inhibitors.
NXP200 is an oral, brain-penetrant, paradox-breaker BRAF inhibitor for the treatment of BRAF V600X-mutated and Class II/III non-V600-mutated solid tumor malignancies, with best-in-class potential.
NXP900 is an oral small molecule inhibitor of the SRC family kinases, including SRC and YES1.
For more infomation, please visit https://nuvectis.com/.
Company Contact
Ron Bentsur
Chairman, Chief Executive Officer and President
[email protected]
Media Relations Contact
Kevin Gardner
LifeSci Advisors
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