Nuvectis' NXP100 Just Achieved the First Marketing Approval Ever for a Once-Daily Oral Factor B Inhibitor

WSW, NY, July 23rd, 2026, FinanceWire

Nuvectis Pharma (NASDAQ: NVCT) announced this morning that ciprocopan (NXP100) has been approved by China's National Medical Products Administration (NMPA) for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received a complement inhibitor. It is the first once-daily oral Complement Factor B inhibitor ever approved, anywhere in the world. A second Chinese application, on the same molecule, covering PNH patients who have failed prior C5 inhibitor therapy, remains under review at the same agency. If the second Chinese application is approved, ciprocopan's pivotal Phase 3 program in China will span the same two PNH populations (complement-inhibitor-naïve and C5-experienced) that Novartis's iptacopan pivotal program (APPOINT-PNH and APPLY-PNH) covered as the basis for Fabhalta's FDA approval (NYSE: NVS).

Breaking down NXP100

Ciprocopan is a once-daily oral small molecule that shuts down the alternative complement pathway at Factor B, the amplification step that drives red-blood-cell destruction in PNH. Approval rests on a randomized Phase 3 head-to-head study in Chinese treatment-naïve PNH patients, comparing ciprocopan directly against eculizumab (Soliris), the infused C5 inhibitor that has anchored PNH care for nearly two decades. In that study, 59.5% of ciprocopan patients achieved transfusion-free normal hemoglobin, versus 8.3% on eculizumab - a more than seven-to-one gap on the primary endpoint of an active-controlled trial. Hemoglobin gain from baseline was 5.0 g/dL on ciprocopan versus 2.2 g/dL on eculizumab. Nearly 95% of ciprocopan patients avoided transfusion during the study, versus 69% on eculizumab. No patient discontinued ciprocopan due to an adverse event.

Ciprocopan was discovered and developed by Haisco Pharmaceutical Group (SHE: 002653), one of China's most active drug developers, which ran the Phase 3 program to completion in-country and filed the NMPA applications. In June, Nuvectis in-licensed exclusive rights to the molecule outside Greater China, India, and certain Southeast Asian territories, for $40 million in upfront and near-term payments and up to $1.421 billion in potential development, regulatory, and commercial milestones, plus tiered royalties. What that structure means today is straightforward: the clinical work is done, the first regulatory approval is in hand, and every ex-China approval, every ex-China dollar of net sales, and every ex-China milestone that follows flows through Nuvectis's own P&L. The Haisco partnership is not incidental - it is why Nuvectis has an approved product on July 23, 2026, and why the rest of the ex-China world is theirs to build.

The massive potential of what Nuvectis now owns ex-China

The global PNH market is estimated at more than $5 billion in 2026, dominated by AstraZeneca's Soliris and Ultomiris - the infused C5 franchise that anchored AstraZeneca's $39 billion acquisition of Alexion in 2021. That franchise is now visibly losing share to oral Factor B inhibition. Novartis's Fabhalta, the twice-daily oral Factor B inhibitor currently on the market, posted $169 million in Q1 2026 sales alone, more than doubling year-over-year, while Soliris sales fell 14% over the same period. Second-quarter sales then climbed to $225 million, up 88% year-over-year, extending the ramp. Jefferies has projected Fabhalta peak sales of approximately $3.6 billion, with Novartis targeting $3 billion+ across indications.

Grand View Research projects the overall PNH treatment market roughly doubling to nearly $10 billion by 2030 as the shift to oral therapy continues. NXP100 enters that shift as the first and only once-daily oral option in the class, with head-to-head Phase 3 data superior to the infused standard. And the same molecule is separately in a Phase 3 program in IgA nephropathy and a Phase 2 program in lupus nephritis - additional complement-mediated indications with their own multi-billion-dollar addressable markets.

The deal comps framing the setup

The market has spent 2026 explicitly repricing what a simpler-dosing rare-disease asset is worth, and the price tags keep climbing. On July 6, Vertex Pharmaceuticals (NASDAQ: VRTX) agreed to acquire Crinetics Pharmaceuticals (NASDAQ: CRNX) for roughly $10 billion in cash, a 102% premium, for Palsonify, a once-daily oral in a rare endocrine disorder. Jade Biosciences (NASDAQ: JBIO) is valued above $1.3 billion on Phase 1 data alone. TG Therapeutics has climbed above $8 billion in part on a self-administered subcutaneous anti-CD20 in multiple sclerosis. In April, Servier paid $2.5 billion for Day One Biopharmaceuticals to own a first-generation BRAF asset — the same category Nuvectis's second Haisco-licensed compound, NXP200, is designed to leapfrog. Ciprocopan now fits the exact profile – approved in China and being advanced outside it by Nuvectis, first-in-class, once-daily, best-in-class Phase 3 data, ex-China rights owned outright that strategics have been paying nine and ten figures to acquire this cycle.

Recent News Developments from Nuvectis Pharma (NVCT):

Nuvectis Announces Marketing Approval of Ciprocopan (NXP100) in China for the Treatment of Patients with PNH Previously Untreated with Complement Inhibitors

Nuvectis Pharma Announces Pricing of $100 Million Public Offering of Common Stock

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

Nuvectis Pharma, Inc. To Participate in the H.C. Wainwright 4th Annual BioConnect Investor Conference at NASDAQ

Nuvectis Pharma, Inc. Reports First Quarter 2026 Financial Results and Business Highlights

Nuvectis Pharma Announces Upcoming Presentations for NXP900 at the 2026 American Association for Cancer Research Meeting

Nuvectis Pharma, Inc. Reports 2025 Financial Results and Business Highlights

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