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

Rhea-AI Summary

Nuvectis Pharma (NASDAQ: NVCT)/b) reported that ciprocopan (NXP100), a once-daily oral Complement Factor B inhibitor, received marketing approval from China’s NMPA for treating Paroxysmal Nocturnal Hemoglobinuria (PNH) patients previously untreated with complement inhibitors.This is the first global approval of a once-daily oral Factor B inhibitor and is based on a head-to-head Phase 3 trial versus Soliris in treatment‑naive PNH patients, where ciprocopan met all primary and secondary endpoints, showed superior hemoglobin responses and transfusion avoidance, and had no discontinuations due to adverse events. Haisco developed and controls ciprocopan in China, while Nuvectis holds exclusive rights outside Greater China, India and parts of Southeast Asia.

Positive

• First global approval of once-daily oral Factor B inhibitor ciprocopan for treatment-naive PNH in China
• Phase 3 showed 59.5% vs 8.3% achieving hemoglobin ≥12 g/dL vs eculizumab
• Phase 3 showed hemoglobin increase of ~5.0 g/dL vs 2.2 g/dL with eculizumab
• 94.6% vs 69.4% of patients avoided transfusions on ciprocopan vs eculizumab
• No ciprocopan-related adverse events led to treatment discontinuation or study withdrawal
• Nuvectis has exclusive rights to develop and commercialize ciprocopan in territories outside Greater China, India and parts of Southeast Asia

Negative

• None.

Market reaction after China marketing approval: NVCT +4.46% in the Jul 23 session

+4.46%

5 alerts

+4.46% Session close to close

-5.3% Trough in 30 hr

$608.13M Market Cap

0.5x Rel. Volume

In the Jul 23 session, NVCT gained 4.46%, reflecting a moderate positive market reaction. Argus tracked a trough of -5.3% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

Recent platform history showed a 16.57% reaction to the NXP100 license agreement and a -35.54% react...

Analysis

Recent platform history showed a 16.57% reaction to the NXP100 license agreement and a -35.54% reaction to offerings. This approval can be viewed alongside the effective S-3 shelf and recent insider net buying; execution remains a consideration.

Key Figures

Trial Phase: Phase 3 Hemoglobin Target: 12 g/dL Patients Reaching Hemoglobin Target: 59.5% vs 8.3% +2 more

5 metrics

Trial Phase Phase 3 Head-to-head study versus eculizumab

Hemoglobin Target 12 g/dL Ciprocopan versus eculizumab

Patients Reaching Hemoglobin Target 59.5% vs 8.3% Ciprocopan versus eculizumab

Hemoglobin Increase 5.0 g/dL vs 2.2 g/dL Increase from baseline; ciprocopan versus eculizumab

Patients Without Transfusions 94.6% vs 69.4% Ciprocopan versus eculizumab during the study

Historical Context

5 past events · Latest: Jun 29 (Negative)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 29	Public offering	Negative	-35.5%	Common-stock offering priced at $20.00 per share for $100 million gross proceeds.
Jun 29	Public offering	Negative	-35.5%	Company announced an underwritten common-stock offering with an additional-share option.
Jun 22	License agreement	Positive	+16.6%	Haisco granted Nuvectis exclusive ex-China rights to NXP100 and NXP200.
May 14	Investor conference	Neutral	+3.4%	Management participation was scheduled for the H.C. Wainwright BioConnect conference.
May 05	Earnings report	Neutral	+9.2%	Q1 results included cash, net loss, and an NXP900 Phase 1b update.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent platform history showed negative reactions to common-stock offerings and positive reactions to the Haisco license agreement and Q1 results.

Key Terms

complement factor b inhibitor, head-to-head phase 3 study, intravascular hemolysis, extravascular hemolysis, +1 more

5 terms

complement factor b inhibitor medical

"ciprocopan (NXP100), a once-daily oral complement Factor B inhibitor"

A complement factor B inhibitor is a drug designed to block a specific protein (factor B) in the body’s immune “alarm” system, preventing that system from overreacting and damaging healthy tissue. For investors it signals a targeted therapy approach with potentially clear clinical trial milestones, market opportunity in certain immune-driven diseases, and regulatory and reimbursement risks tied to safety, efficacy and competition—much like backing a precision tool that could replace a blunt instrument in treatment.

head-to-head phase 3 study medical

"The key basis for approval was a head-to-head Phase 3 study"

A head-to-head phase 3 study is a late-stage clinical trial that directly compares a new drug or treatment against an approved or standard therapy to measure which works better and which is safer. Think of it like a final match where two established players are measured on performance and side effects under controlled conditions. Results matter to investors because they influence regulatory approval, market share, pricing, and commercial prospects.

intravascular hemolysis medical

"comprehensive control of both intravascular and extravascular hemolysis"

Destruction of red blood cells that happens inside the blood vessels, releasing hemoglobin and cell fragments directly into the bloodstream. Like a pipe bursting and spilling its contents into a hallway, this can change blood tests, cause anemia, dark urine, and strain organs such as the kidneys, so it matters to investors because it can affect safety signals, clinical trial outcomes, regulatory decisions, product labeling, and potential liability for companies in healthcare and biotech.

extravascular hemolysis medical

"comprehensive control of both intravascular and extravascular hemolysis"

Destruction of red blood cells that takes place outside the blood vessels, usually in the spleen or liver, where immune cells break the cells down and release their contents. It matters to investors because this process can cause anemia, jaundice and other clinical consequences that influence drug safety profiles, clinical trial outcomes, medical costs and regulatory decisions, which in turn affect the valuation and commercial prospects of healthcare and biotech companies.

alternative pathway medical

"blocks the amplification of the alternative pathway"

An alternative pathway is a non-standard regulatory or development route used to bring a medical product, diagnostic, or technology to market that differs from the usual approval process. Think of it like taking a side road instead of the highway: it can shorten or change the route to approval, alter required studies and costs, and affect how quickly a product can start generating revenue—factors investors watch closely.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• First global approval of a once-daily, orally administered, Complement Factor B inhibitor
  
  
• Approval based on robust efficacy and safety data from Haisco's broad completed clinical development program in PNH
  
  
• Ciprocopan application for marketing approval in China for the treatment of patients with PNH previously treated with anti-C5 therapies is currently under review
  
  
• Ciprocopan 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 patients requiring continuous life-long treatment

Fort Lee, NJ, July 23, 2026 (GLOBE NEWSWIRE) -- 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, today announced that ciprocopan (NXP100), a once-daily oral complement Factor B inhibitor, received marketing approval from the National Medicinal Products Administration of China (NMPA) for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) previously untreated with Complement inhibitors (treatment naive).

As the world's first approved once-daily oral Complement Factor B inhibitor, ciprocopan offers patients living with PNH a new, effective, safe and convenient treatment option and provides important clinical and regulatory validation and further supports the therapeutic potential of once-daily oral Factor B inhibition in PNH and other complement mediated diseases.

“We are delighted that ciprocopan received its first marketing approval in China for the treatment of patients with PNH previously untreated with Complement inhibitors, and congratulate our partner Haisco on this tremendous achievement,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur continued, “With Factor B inhibitors expected to become the leading class in the multi-billion-dollar PNH market over time, ciprocopan, as the currently only once a day oral therapy, is well positioned to obtain meaningful market share, if approved outside of China. Beyond PNH, ciprocopan could become an important treatment option across several other complement-mediated diseases, where the convenience advantage could be important for patient compliance and long-term clinical outcomes.”

Dr. Pangke Yan, Chief Executive Officer of Haisco, commented, "This first ciprocopan approval is an important milestone for Chinese patients living with PNH and we are excited to work closely with Nuvectis in order to bring this important new treatment option to patients worldwide."

The key basis for approval was a head-to-head Phase 3 study of ciprocopan versus Soliris (eculizumab) in patients with PNH patients previously untreated with Complement inhibitors. The study met all primary and secondary endpoints and demonstrated ciprocopan’s superiority over eculizumab, including reaching a hemoglobin target of 12 g/dL in 59.5% vs 8.3% in patients treated with eculizumab, a hemoglobin increase from baseline of approximately 5.0 g/dL vs 2.2 g/dL, and reduced transfusion requirements with 94.6% of patients vs 69.4% not requiring transfusions during the study. The study also demonstrated a favorable safety profile for ciprocopan vs eculizumab with no adverse events leading to treatment discontinuation or study withdrawal.

Unlike terminal complement inhibitors such as the C5 inhibitors Soliris and Ultromiris, Factor B inhibition blocks the amplification of the alternative pathway while preserving the classical and lectin pathways, designed to provide comprehensive control of both intravascular and extravascular hemolysis, leading to better efficacy compared to the C5 inhibitors’, as demonstrated in head to head clinical trials.

Haisco independently developed ciprocopan and is responsible for its development, regulatory approvals, and commercialization in China. Under the June 2026 exclusive license agreement with Haisco, Nuvectis holds exclusive rights to develop and commercialize ciprocopan outside Greater China, India and certain Southeast Asia countries.

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 NXP100, a complement Factor B inhibitor in development for the treatment of complement-mediated diseases, and the oncology drug candidates NXP900 and NXP200, in development for the treatment of advanced cancers.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws, which are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate”, “believe”, “contemplate”, “could”, “estimate”, “expect”, “intend”, “seek”, “may”, “might”, “plan”, “potential”, “predict”, “project”, “target”, “aim”, “should”, “will”, “would”, or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward looking statements are based on Nuvectis Pharma, Inc.’s current expectations and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for its pipeline products ciprocopan (NXP100), and statements regarding the projections of the commercial potential of ciprocopan in PNH and other complement mediated diseases. The outcomes of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties may also be subject to market and other conditions and described more fully in the section titled “Risk Factors” in our first quarter 2026 Form 10-Q and our other public filings with the U.S. Securities and Exchange Commission (“SEC”). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Other than statements of historical fact, all statements are considered forward-looking statements and are based on our interpretations of past events as well as current expectations, estimates, and projections.

Company Contact:

Ron Bentsur
Chairman, Chief Executive Officer and President
rbentsur@nuvectis.com

Media Relations Contact:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

FAQ

What did Nuvectis Pharma (NVCT) announce about ciprocopan approval in China on July 23, 2026?

Nuvectis announced that ciprocopan received marketing approval in China for treating PNH patients previously untreated with complement inhibitors. According to Nuvectis, this is the first global approval of a once-daily, orally administered Complement Factor B inhibitor for treatment-naive PNH patients.

For which PNH patients is ciprocopan approved in China according to Nuvectis Pharma (NVCT)?

Ciprocopan is approved in China for patients with Paroxysmal Nocturnal Hemoglobinuria previously untreated with complement inhibitors. According to Nuvectis, this treatment-naive population gains a new oral, once-daily Factor B inhibitor option offering efficacy, safety, and convenience for long-term management.

How did ciprocopan perform versus Soliris in the Phase 3 PNH trial cited by Nuvectis Pharma (NVCT)?

Ciprocopan demonstrated superiority to Soliris in treatment-naive PNH patients in a head-to-head Phase 3 study. According to Nuvectis, more patients reached hemoglobin ≥12 g/dL, hemoglobin increases were larger, transfusion needs were lower, and no ciprocopan-treated patients discontinued due to adverse events.

What were the key hemoglobin results for ciprocopan versus eculizumab reported by Nuvectis (NVCT)?

Ciprocopan achieved a hemoglobin level ≥12 g/dL in 59.5% of patients versus 8.3% with eculizumab. According to Nuvectis, mean hemoglobin increased about 5.0 g/dL with ciprocopan compared with 2.2 g/dL for patients receiving eculizumab in the Phase 3 trial.

How did ciprocopan affect transfusion requirements compared with eculizumab in PNH patients?

Ciprocopan substantially reduced transfusion requirements compared with eculizumab in treatment-naive PNH patients. According to Nuvectis, 94.6% of ciprocopan-treated patients versus 69.4% on eculizumab did not require transfusions during the Phase 3 clinical study period.

Who holds commercialization rights for ciprocopan outside China, and what regions are included?

Nuvectis holds exclusive rights to develop and commercialize ciprocopan outside Greater China, India and certain Southeast Asia countries. According to Nuvectis, Haisco independently developed ciprocopan and retains responsibility for development, approvals and commercialization within China.

What differentiates ciprocopan’s Factor B inhibition from C5 inhibitors like Soliris and Ultromiris?

Ciprocopan inhibits Complement Factor B, blocking amplification of the alternative pathway while preserving classical and lectin pathways. According to Nuvectis, this design aims to control intra- and extravascular hemolysis and delivered better efficacy than C5 inhibitors in head-to-head clinical trials.