First global approval of a once-daily, orally administered, Complement Factor B inhibitor

全球首个每日一次口服补体因子B抑制剂获批

Approval based on robust efficacy and safety data from Haisco's broad completed clinical development program in PNH

基于海思科在阵发性睡眠性血红蛋白尿症（PNH）领域广泛且已完成的临床开发计划所提供的稳健疗效和安全性数据而获得的批准

Ciprocopan application for marketing approval in China for the treatment of patients with PNH previously treated with anti-C5 therapies is currently under review

西普罗考潘用于治疗既往接受过抗C5疗法的阵发性睡眠性血红蛋白尿症（PNH）患者的上市许可申请目前正处于审评阶段。

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

西普罗考潘有望成为多种补体介导疾病的有效疗法，并作为每日一次的口服治疗方案，为需要终身持续治疗的患者提供便利优势。

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)..

新泽西州李堡，2026年7月23日（环球电讯社）——临床阶段生物制药公司Nuvectis Pharma, Inc.（纳斯达克股票代码：NVCT）（“Nuvectis”或“公司”），专注于开发用于治疗补体相关疾病和肿瘤的创新疗法，今日宣布其每日一次口服补体因子B抑制剂ciprocopan（NXP100）已获得中国国家药品监督管理局（NMPA）的上市批准，用于治疗既往未接受过补体抑制剂治疗（初治）的阵发性睡眠性血红蛋白尿症（PNH）患者。

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..

作为全球首个获批的每日一次口服补体因子B抑制剂，西普罗潘为阵发性睡眠性血红蛋白尿症（PNH）患者提供了一种新型、有效、安全且便捷的治疗选择，并提供了重要的临床和监管验证，进一步支持了每日一次口服因子B抑制剂在PNH及其他补体介导疾病中的治疗潜力。

“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.

“我们很高兴西普罗科潘在中国获得首个上市批准，用于治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）患者，并祝贺我们的合作伙伴海思科取得这一重大成就。”Nuvectis公司董事长兼首席执行官罗恩·本特苏尔表示。

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.”.

本苏尔先生继续表示：“随着B因子抑制剂有望随着时间的推移成为价值数十亿美元的阵发性睡眠性血红蛋白尿症（PNH）市场中的主导药物类别，西普罗科潘作为目前唯一的每日一次口服疗法，如果在中国以外获得批准，将有望获得可观的市场份额。除PNH外，西普罗科潘还可能成为其他几种补体介导疾病的重要治疗选择，其便利性优势对于提高患者依从性和改善长期临床结局可能具有重要意义。”

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.'

海思科首席执行官庞克彦博士表示：“此次西普罗可潘的首次获批，对于中国阵发性睡眠性血红蛋白尿症（PNH）患者而言是一个重要的里程碑。我们期待与Nuvectis紧密合作，将这一重要的新治疗方案带给全球患者。”

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.

批准的关键依据是一项在既往未接受补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）患者中开展的西普罗考潘与索利里斯（依库珠单抗）头对头比较的III期研究。该研究达到了所有主要和次要终点，并证明了西普罗考潘优于依库珠单抗，包括：59.5%的西普罗考潘治疗患者达到了12 g/dL的血红蛋白目标值，而依库珠单抗治疗患者仅为8.3%；血红蛋白较基线升高约5.0 g/dL，而依库珠单抗组为2.2 g/dL；输血需求减少，研究期间94.6%的西普罗考潘治疗患者无需输血，而依库珠单抗组为69.4%。

The study also demonstrated a favorable safety profile for ciprocopan vs eculizumab with no adverse events leading to treatment discontinuation or study withdrawal..

该研究还表明，与依库珠单抗相比，西普罗考潘具有良好的安全性，未发生导致治疗中断或退出研究的不良事件。

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..

与索利瑞斯（Soliris）和乌托莫瑞斯（Ultromiris）等C5抑制剂这类末端补体抑制剂不同，B因子抑制在阻断旁路途径扩增的同时保留经典途径和凝集素途径，旨在全面控制血管内和血管外溶血，头对头临床试验表明，其疗效优于C5抑制剂。

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..

海思科独立研发西普罗潘，并负责其在中国的开发、监管审批和商业化。根据2026年6月与海思科签订的独家许可协议，Nuvectis拥有在大中华区、印度及某些东南亚国家以外地区开发和商业化西普罗潘的独家权利。

About Nuvectis Pharma, Inc.

关于 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..

Nuvectis Pharma, Inc. 是一家处于临床阶段的生物制药公司，专注于开发用于治疗免疫补体相关疾病和肿瘤的创新疗法。该公司的产品管线包括 NXP100（一种正在开发中用于治疗补体介导疾病的补体因子 B 抑制剂），以及肿瘤药物候选物 NXP900 和 NXP200（均处于开发阶段，用于治疗晚期癌症）。

Forward Looking Statements

前瞻性陈述

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.

本新闻稿包含美国联邦证券法律意义上的“前瞻性陈述”，这些陈述受到重大风险和不确定性的影响。除历史事实陈述外，本新闻稿中的所有陈述均为前瞻性陈述。本新闻稿中的前瞻性陈述可通过使用“预期”、“相信”、“考虑”、“可能”、“估计”、“期望”、“打算”、“寻求”、“可以”、“或许”、“计划”、“潜在”、“预测”、“规划”、“目标”、“旨在”、“应当”、“将”、“将会”等词语或这些词语的否定形式或其他类似表述来识别，尽管并非所有前瞻性陈述都包含这些词语。

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.

前瞻性陈述基于 Nuvectis Pharma, Inc. 对当前可用数据和信息的预期与解读，包括其管线产品 ciprocopan（NXP100）迄今产生的临床前和临床安全性、药代动力学、药效学及疗效数据，以及关于 ciprocopan 在阵发性睡眠性血红蛋白尿症（PNH）及其他补体介导疾病中商业潜力预测的陈述。

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.

这些前瞻性陈述中所述事件的结果受固有不确定性、风险、假设、市场及其他条件以及其他难以预测的因素的影响。此外，某些前瞻性陈述基于对未来事件的假设，而这些假设可能被证明是不准确的。

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 an.

这些及其他风险和不确定性也可能受到市场及其他条件的影响，并在我们2026年第一季度10-Q表格以及向美国证券交易委员会（“SEC”）提交的其他公开文件中标题为“风险因素”的部分中有更全面的描述。然而，这些风险并非详尽无遗。

Company Contact:

公司联系人：

Ron Bentsur

罗恩·本特苏尔

Chairman, Chief Executive Officer and President

董事长、首席执行官兼总裁

rbentsur@nuvectis.com

rbentsur@nuvectis.com

Media Relations Contact:

媒体联络人：

Kevin Gardner

凯文·加德纳

LifeSci Advisors

生命科学顾问

kgardner@lifesciadvisors.com

kgardner@lifesciadvisors.com