-
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
View the Zacks #1 Rank List
Nuvectis Pharma Announces First Global Approval of Once-Daily Oral Complement Factor B Inhibitor Ciprocopan in China for PNH
Ciprocopan, a once-daily oral Factor B inhibitor, received first global approval for treating PNH in China, demonstrating strong efficacy and safety.
Quiver AI Summary
Nuvectis Pharma announced that ciprocopan (NXP100), the first globally approved once-daily oral Complement Factor B inhibitor, received marketing approval from China’s National Medicinal Products Administration for treating patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received Complement inhibitors. This approval is supported by robust clinical data showing ciprocopan's effectiveness and safety compared to current treatments like eculizumab, with significant superiority in hemoglobin targets and transfusion requirements. Nuvectis highlights ciprocopan's potential for broad application in other complement-mediated diseases, emphasizing its convenience as a once-daily therapy, which could enhance patient compliance. The collaboration with Haisco, which developed ciprocopan, is aimed at making this innovative treatment available globally, with Nuvectis holding rights for commercialization outside of Greater China and certain Southeast Asian regions.
Potential Positives
Potential Negatives
FAQ
What is ciprocopan?
Ciprocopan is a once-daily oral complement Factor B inhibitor developed for treating Paroxysmal Nocturnal Hemoglobinuria (PNH).
Which regulatory body approved ciprocopan?
Ciprocopan received marketing approval from the National Medicinal Products Administration of China (NMPA).
What are the advantages of ciprocopan?
Ciprocopan offers improved efficacy, safety, and convenient once-daily dosing for patients with PNH.
How does ciprocopan compare to eculizumab?
A Phase 3 study demonstrated ciprocopan's superiority over eculizumab in achieving hemoglobin targets and reducing transfusions.
What is Nuvectis Pharma's role in ciprocopan's development?
Nuvectis holds exclusive rights to develop and commercialize ciprocopan outside Greater China, India, and certain Southeast Asian countries.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$NVCT Insider Trading Activity
$NVCT insiders have traded $NVCT stock on the open market 2 times in the past 6 months. Of those trades, 2 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $NVCT stock by insiders over the last 6 months:
To track insider transactions, check out Quiver Quantitative's insider trading dashboard. You can access data on insider stock transactions through the Quiver Quantitative API insider transaction endpoint.
$NVCT Hedge Fund Activity
We have seen 34 institutional investors add shares of $NVCT stock to their portfolio, and 9 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard. You can access data on hedge funds moves and 13F filings through the Quiver Quantitative API 13F endpoint.
$NVCT Price Targets
Multiple analysts have issued price targets for $NVCT recently. We have seen 2 analysts offer price targets for $NVCT in the last 6 months, with a median target of $36.0.
Here are some recent targets:
Full Release
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
Read full article here »