Nuvectis Adds Late-Stage NXP100 and NXP200 in Haisco Licensing Deal

NXP100 has two regulatory applications under review in China for PNH, while NXP200 has shown durable responses across multiple BRAF-mutated tumors, including glioma, colorectal cancer, and NSCLC.

Nuvectis Pharma has expanded its clinical pipeline through an exclusive ex-China licensing agreement with Haisco Pharmaceutical Group, gaining rights to two clinical-stage drug candidates: NXP100, an oral Complement Factor B inhibitor (CFBi), and NXP200, a brain-penetrant paradox-breaker BRAF inhibitor.

The deal transforms Nuvectis into a broader late-stage clinical development company, adding a near-commercial complement therapy with ongoing regulatory review and a next-generation oncology asset targeting BRAF-driven cancers.

NXP100 Advances Toward Regulatory Approval in PNH

NXP100 (HSK39297) is a once-daily oral Complement Factor B inhibitor under development for paroxysmal nocturnal hemoglobinuria (PNH), Immunoglobulin A nephropathy (IgAN), and lupus nephritis. Two Marketing Authorization Applications are currently under review by China’s National Medical Products Administration (NMPA) for PNH.

• Treatment-naïve patients (NCT06799546): In a 24-week Phase 3 trial, NXP100 significantly outperformed eculizumab, with 59.5% of patients achieving hemoglobin ≥12 g/dL without transfusion compared with 8.3% in the eculizumab arm (95% CI: 43.2%-75.7% vs 2.8%-19.4%; p<0.001).
• C5 inhibitor-experienced patients (NCT07052838): In a separate Phase 3 study, 52.8% of patients with persistent anemia achieved hemoglobin ≥12 g/dL without transfusion after 24 weeks (95% CI: 35.5%-69.6%).

Positive Renal Data Support Expansion into IgAN and Lupus Nephritis

A Phase 3 trial (NCT07390123) is ongoing in IgAN following positive Phase 2 results (NCT06670352). NXP100 reduced proteinuria by 45.3% at the primary endpoint assessment at Week 12, with reductions reaching 57.7% at Week 24 while maintaining favorable eGFR control. A Phase 2 study in lupus nephritis is also underway in China.

NXP200 Targets the Next Generation of BRAF Inhibition

NXP200 (HSK42360) is an oral, brain-penetrant paradox-breaker BRAF inhibitor that may overcome resistance and safety limitations associated with first-generation therapies. Unlike conventional BRAF inhibitors, which can trigger paradoxical MAPK pathway activation, NXP200 suppresses this effect and extends activity across multiple BRAF mutation classes.

Early clinical data show durable responses across glioma, NSCLC, colorectal cancer, melanoma, and papillary thyroid cancer. In adult gliomas, response rates exceeded 40%, including a complete response. A Phase 1b study of an optimized formulation is ongoing in China.

Pipeline Expansion Strategy

Nuvectis Chairman and Chief Executive Officer Ron Bentsur said the agreement broadens the company’s development strategy by adding a late-stage oral therapy for complement-mediated diseases and a differentiated targeted oncology program.

Under the agreement, Haisco will receive up to $40 million in upfront and near-term payments and may earn as much as $1.421 billion in development, regulatory, and commercial milestone payments, along with tiered royalties on future sales. Both compounds carry composition-of-matter patent protection into the 2040s, supporting long-term development opportunities in rare diseases and oncology.

Reference

Nuvectis Announces Strategic Portfolio Expansion via License Agreement for Ex-China Rights with Haisco Pharmaceutical Group for Two Potentially Best-In Class Clinical-Stage Compounds