Nuvectis In-Licenses Two Clinical-Stage Assets from Haisco, Transforming into Late-Stage Biopharma with Oral Factor B and Paradox-Breaker BRAF Inhibitors
核心洞察
Nuvectis Pharma secured exclusive ex-China rights from Haisco Pharmaceutical Group (搜索) for NXP100 (搜索), a once-daily oral Complement Factor B (搜索) inhibitor, and NXP200 (搜索), a paradox-breaker BRAF (搜索) inhibitor.
Two Marketing Authorization Applications for NXP100 (搜索) in paroxysmal nocturnal hemoglobinuria (搜索) are under NMPA review, with Phase 3 data showing superiority over eculizumab (59.5% vs 8.3% response rate, p<0.001).
NXP200 (搜索) demonstrated single-agent durable responses across multiple BRAF (搜索)-mutated solid tumors including a >40% response rate in glioma, positioning it as a potential best-in-class next-generation BRAF inhibitor.
Nuvectis Pharma, Inc. (NASDAQ: NVCT) announced on June 22, 2026 a strategic portfolio expansion through an exclusive ex-China license agreement with Haisco Pharmaceutical Group (搜索) for two potentially best-in-class clinical-stage compounds. The transaction transforms Nuvectis into a late-stage clinical development company by adding NXP100 (搜索), a once-daily oral Complement Factor B (搜索) inhibitor (CFBi), and NXP200 (搜索), a brain-penetrant paradox-breaker BRAF (搜索) inhibitor, to its pipeline.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, stated, "The in-licensing of the two clinical stage drug candidates with best-in-class potential represents an expansion of Nuvectis' pipeline and strategy." Bentsur emphasized that NXP100 (搜索) "has the potential to become an effective therapy in multiple complement-mediated diseases and provide a convenience advantage as a once-daily oral treatment option for these diseases requiring life-long treatment."
Dr. Pangke Yan, Chief Executive Officer of Haisco, added, "This licensing deal, in addition to our recently completed deals, further strengthens Haisco's global research and development presence and we are excited to collaborate with Nuvectis on these two projects."
NXP100 (搜索): Late-Stage Complement Factor B (搜索) Inhibitor
NXP100 (搜索) (HSK39297) is under regulatory review in China for paroxysmal nocturnal hemoglobinuria (搜索) (PNH), with two Marketing Authorization Applications (MAAs) submitted to the Chinese National Medical Products Administration (NMPA).
The first MAA is supported by a randomized, open-label, active comparator-controlled Phase 3 study (NCT06799546) in 73 treatment-naïve PNH patients. Participants were randomized 1:1 to receive either NXP100 (搜索) or Soliris (eculizumab), a Complement C5 (搜索) inhibitor, over 24 weeks. The primary endpoint—proportion of patients achieving hemoglobin levels ≥12 g/dL without red blood cell transfusions—was met with a response rate of 59.5% (95% CI: 43.2–75.7) for NXP100 versus 8.3% (95% CI: 2.8–19.4) for eculizumab (p<0.001).
The second MAA draws on a single-arm Phase 3 study (NCT07052838) in 36 adult PNH patients with persistent anemia who had failed prior C5 inhibitor therapy. NXP100 (搜索) achieved a 52.8% response rate (95% CI: 35.5–69.6) on the same primary endpoint, with the lower bound of the 95% CI exceeding the prospectively defined 20% threshold.
Beyond PNH, NXP100 (搜索) has completed a Phase 2 trial and is currently in a Phase 3 study (NCT07390123) for immunoglobulin A nephropathy (搜索) (IgAN). In the Phase 2 study (NCT06670352), NXP100 demonstrated a 45.3% reduction in 24-hour urine protein-to-creatinine ratio (24h-UPCR) relative to placebo at the 12-week primary endpoint, with the treatment effect increasing to 57.7% at Week 24. The compound also showed excellent estimated glomerular filtration rate (eGFR) control versus placebo. A Phase 2 trial in lupus nephritis (搜索) (LN) is also ongoing.
The PNH market is projected to exceed $5 billion in 2026, with injectable C5 inhibitors Soliris and Ultomiris (Alexion/AstraZeneca) accounting for approximately $4.5 billion. The market is expected to more than double to over $10 billion within eight years. Fabhalta (iptacopan), marketed by Novartis and launched in 2024, is the only FDA-approved CFBi, administered twice daily compared with NXP100 (搜索)'s once-daily dosing. Analysts project Fabhalta peak annual revenues of $5–10 billion, with the combined PNH and IgAN markets estimated to surpass $20 billion within the next decade.
NXP200 (搜索): Next-Generation Paradox-Breaker BRAF (搜索) Inhibitor
NXP200 (搜索) (HSK42360) is an oral, brain-penetrant paradox-breaker BRAF (搜索) inhibitor targeting both BRAF V600X-mutated and Class II/III non-V600-mutated malignancies. Unlike first-generation BRAF inhibitors such as Tafinlar (dabrafenib) and Braftovi (encorafenib), which cause paradoxical MAPK pathway activation leading to treatment resistance and secondary skin malignancies, paradox-breaker BRAF inhibitors are designed to overcome this limitation.
In a completed dose-escalation study, NXP200 (搜索) monotherapy demonstrated an acceptable safety profile and single-agent durable clinical activity in heavily pre-treated patients with BRAF (搜索) V600-mutated solid tumors, including those previously treated with BRAF/MEK inhibitors. Notably, NXP200 achieved a greater than 40% response rate in low- and high-grade adult glioma, including one complete response, with durable responses also observed in non-small cell lung cancer, colorectal, and papillary thyroid cancers.
A second-generation salt form of NXP200 (搜索) was recently developed to enhance pharmacokinetics, with early data demonstrating markedly improved PK and greater single-agent clinical activity. NXP200 is currently in a Phase 1b study in China. The combined annual revenue for first-generation BRAF (搜索) inhibitors is estimated at approximately $4 billion.
Transaction Terms and Intellectual Property
Under the agreement, Haisco will receive upfront and near-term payments totaling up to $40 million and is eligible for up to $1.421 billion in additional development, regulatory, and commercial milestone payments, plus tiered royalties on future net sales. Haisco retains rights for NXP100 (搜索) in India and certain Southeast Asian territories. Both compounds benefit from strong intellectual property protection, with composition of matter patents expiring in 2043 for NXP100 and 2042 for NXP200 (搜索).
Haisco, a fully-integrated pharmaceutical company with approximately 50 marketed products and 70 research programs, recently completed licensing deals with Eli Lilly and AbbVie in the second quarter of 2026, and achieved Phase 3 success with envudeucitinib in plaque psoriasis earlier that year.