First global approval of a once-daily, orally administered, Complement Factor B inhibitorApproval based on robust efficacy and safety data from Haisco&#39;s broad completed clinical development program in PNHCiprocopan

NVCT

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

Nuvectis Gains China Approval for ciprocopan, Signaling Near-Term Upside

<section class="insight" data-version="1">
  <section data-block="information">
    <h3>Information</h3>
    <p>First global approval of a once-daily, orally administered, Complement Factor B inhibitorApproval based on robust efficacy and safety data from Haisco&amp;#39;s broad completed clinical development program in PNHCiprocopan</p>
  </section>

  <section data-block="ai-summary-paragraph">
    <h3>AI Summary</h3>
    <p>Nuvectis announced NMPA approval of ciprocopan (NXP100), a once-daily oral Factor B inhibitor, for PNH in China (treatment-naive). The head-to-head study versus Soliris met endpoints, supporting potential global commercialization under a June 2026 exclusive license with Haisco. This milestone could catalyze investor sentiment and expand NVCT&#039;s addressable market.</p>
  </section>

  <section data-block="ai-summary-bullets">
    <h3>Key Points</h3>
    <ul><li>China approves ciprocopan (NXP100) for treatment-naive PNH.</li><li>First global approval of a once-daily oral Factor B inhibitor.</li><li>Exclusive outside Greater China license to Nuvectis via Haisco.</li><li>Head-to-head vs Soliris shows superiority on Hb and transfusion need.</li><li>Potential expansion to other complement-mediated diseases; near-term upside.</li></ul>
  </section>

  <section data-block="companies-mentioned">
    <h3>Companies Mentioned</h3>
    <ul><li><strong>Nuvectis Pharma, Inc. (NVCT)</strong>: Announced NMPA approval; near-term share upside and potential international expansion.</li><li><strong>Haisco (N/A)</strong>: Exclusive rights agreement (June 2026) to develop and commercialize ciprocopan outside Greater China.</li><li><strong>Soliris (eculizumab) (AZN)</strong>: Comparator in pivotal trial; ciprocopan shown superior Hb outcomes and transfusion reduction.</li></ul>
  </section>

  <section data-block="category">
    <h3>Industry News</h3>
    <p>Category: Industry News. Regulatory approval and licensing expansion fit industry-mover dynamics for biotech upstarts; NVCT-specific upside depends on execution and later-stage approvals.</p>
  </section>

  <section data-block="market-moving">
    <h3>Market-Moving</h3>
    <ul><li>NMPA approval validates ciprocopan&#039;s market potential and Factor B class.</li><li>Exclusive license outside Greater China positions NVCT for global commercialization.</li><li>Regulatory momentum could drive near-term stock volatility; monitor Haisco progress.</li><li>Soliris benchmark creates potential for upside if ciprocopan expands.</li></ul>
  </section>

  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>Date: July 23, 2026 — Nuvectis announces NMPA approval for ciprocopan (NXP100).</li><li>Ciprocopan approved for PNH in patients previously untreated with complement inhibitors.</li><li>Head-to-head Phase 3 vs Soliris: 12 g/dL Hb target achieved in 59.5% vs 8.3%.</li><li>Hemoglobin increase from baseline: ~5.0 g/dL vs ~2.2 g/dL.</li></ul>
  </section>

  <section data-block="trading-thesis">
    <h3>Trading Thesis</h3>
    <p>Bullish over the next 3–6 months as China approval may unlock near-term upside and international licensing momentum.</p>
  </section>
</section>


<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link><ul><li>First global approval of a once-daily, orally administered, Complement Factor B inhibitor<br></br><br></br></li><li>Approval based on robust efficacy and safety data from Haisco&#39;s broad completed clinical development program in PNH<br></br><br></br></li><li>Ciprocopan application for marketing approval in China for the treatment of patients with PNH previously treated with anti-C5 therapies is currently under review<br></br><br></br></li><li>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</li></ul>  <p>Fort Lee, NJ, July  23, 2026  (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/NVCT">NVCT</a>) ("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).</p>  <p>As the world&#39;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.</p>  <p>"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."</p>  <p>Dr. Pangke Yan, Chief Executive Officer of Haisco, commented, &#34;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.&#34;</p>  <p>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.</p>  <p>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.</p>  <p>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.</p>  <p><b>About Nuvectis Pharma, Inc.</b></p>  <p>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.</p>  <p><b>Forward Looking Statements</b></p>  <p>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.</p>  <p><b>Company Contact:</b></p>  <p>Ron Bentsur<br></br>Chairman, Chief Executive Officer and President<br></br><a href="https://www.globenewswire.com/Tracker?data=r5llE5u-Gy28fH6ld14LOTYC3ZdkIIgoohnqaE2qxgGJZqhT-kkAXxhUn-BPzYpNxuAGCUedfMmo40Pi4zxobfMJeIO5PVBRIJT__sof_RtC5kCVGK6ER9Gt3OYVuh1iJ3Ax_bIe8mpCszINzzQAR5H5dpaNCmo0M6dDlKPJAmEExirMND9UxYUkBNn0MI_bGwFK8ZolNxdsFMQAWjFiP-CjSlQFBBhXHJPNPvYGxkt02VEiLa8no7ZjQoudn-MG575rI-WglAcPW1r6c36M7w==" rel="nofollow" target="_blank">rbentsur@nuvectis.com</a><br></br></p>  <p><b>Media Relations Contact:</b></p>  <p>Kevin Gardner<br></br>LifeSci Advisors<br></br><a href="https://www.globenewswire.com/Tracker?data=ANKWA6-qGl6HdG-qDIYry-oSw3gQaaIgpZ2hbpXzFeUPmBBi25BvR2flxijr4c2h1bqkxcVoMvUnPn_TDe20nyXz-EnB51Sb1xY0QApgOEVV9o8Hfefl4xrRnK8r9QDQ2UgV1qlJWroGBuI2AIruC8VlHRkp97g5JLBlnIsBaq6UyAGPLqzQjcQrWatZgsO6vMfhWZ85mMqcO-sQnl3CNBmkCj73GqaXqplv-QAqfC6oyf74_AgO3NpviYa87GYOvX3xmQmu0uJecoRo7wkl2pjYxvKA8qOTnTn_OIm_dejFp0-wzQpaSRdsmmXqUDhK" rel="nofollow" target="_blank">kgardner@lifesciadvisors.com</a><br></br></p> <img alt="" class="__GNW8366DE3E__IMG" src="https://www.globenewswire.com/newsroom/ti?nf=OTc2NzAxOCM3NzIwMDY0IzUwMDA4MjgxNw=="></img> <br></br><img alt="" src="https://ml.globenewswire.com/media/ZDU1MjAyMmMtZWY1Zi00Mzc2LWJmMjItZmQ2ZTVkNDk3YmNhLTUwMDA4MjgxNy0yMDI2LTA3LTIzLWVu/tiny/Nuvectis-Pharma-Inc-.png" referrerpolicy="no-referrer-when-downgrade"></img><p><a href="https://www.globenewswire.com/NewsRoom/AttachmentNg/aceda01c-bc94-4579-88fa-c0294406b49f"><img src="https://ml.globenewswire.com/media/aceda01c-bc94-4579-88fa-c0294406b49f/small/nuvectispharma-logos-final-full-color-png.png" border="0" width="150" height="76" alt="Primary Logo"></img></a></p>

Nuvectis announced NMPA approval of ciprocopan (NXP100), a once-daily oral Factor B inhibitor, for PNH in China (treatment-naive). The head-to-head study versus Soliris met endpoints, supporting potential global commercialization under a June 2026 exclusive license with Haisco. This milestone could catalyze investor sentiment and expand NVCT's addressable market.

News insight

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

AI summary

Sentiment rationale

Key facts

Industry News