Nuvectis Secures NXP100 MAAs for PNH, Adds NXP200 Phase 1b BRAF Inhibitor
NVCT•Nuvectis Pharma licensed ex-China rights to Haisco’s NXP100, a once-daily Factor B inhibitor with two MAAs under review for PNH and Phase 3 IgAN trials. It also licensed NXP200, a paradox-breaker BRAF inhibitor showing durable responses and now entering Phase 1b for V600X and class II/III mutations.
1. Licensing Agreement Details
Nuvectis Pharma entered an exclusive ex-China licensing agreement with Haisco Pharmaceutical Group to acquire two clinical-stage assets, transforming its portfolio into late-stage development. The deal grants Nuvectis exclusive rights to develop, manufacture and commercialize NXP100 and NXP200 outside China and includes a conference call to introduce the products to investors.
2. NXP100 Clinical and Regulatory Status
NXP100 (HSK39297) is a once-daily oral Complement Factor B inhibitor with two Marketing Authorization Applications under review by Chinese regulators for treatment-naive and C5 inhibitor–refractory PNH patients. The asset has completed a Phase 2 and ongoing Phase 3 trial in IgAN and is advancing through a Phase 2 study in Lupus Nephritis.
3. NXP200 Preclinical and Trial Data
NXP200 (HSK42360) is an oral, brain-penetrant paradox-breaker BRAF inhibitor targeting V600X and class II/III non-V600 mutations. It has generated durable single-agent responses in CNS, colorectal, melanoma and NSCLC tumors and is now enrolling patients in a Phase 1b study in China.
4. Strategic Outlook
This agreement bolsters Nuvectis’ late-stage pipeline and positions the company for potential regulatory milestones in complement-mediated diseases and oncology. Exclusive ex-China rights, robust IP protection and upcoming trial readouts could materially enhance the company’s valuation.
