Givastomig

Mark A. Hagler先生是国际顶尖商业化专家，对重磅创新药商业化战略制定、全球商业化体系建立有着深厚积累，擅长根据商业化目标设计临床研究及获批路径，为创新药全球上市及业务拓展提供决策性依据，标志着新桥生物完成从临床研发到全球商业化战略能力的闭环 Hagler先生行业声望斐然、商业化背景出众。在逾25年的职业生涯中，他曾主导Abraxane®（白蛋白紫杉醇）和Afinitor®（依维莫司）两款重磅肿瘤药的全球上市及商业化管理，多次在肿瘤、眼科等产品线规划和全球市场策略方面取得卓越成绩 新桥生物正处于临床研发关键阶段，其中Givastomig（一线胃癌治疗潜在FIC/BIC Claudin 18.2/4-1BB双抗）获FDA认可具备加速批准上市的资格，已推进至注册性III期研究。Hagler先生的加入，将确保Givastomig 从III期临床设计到全球商业化体系落地，都具备世界级战略眼光和重磅创新药执行标准 全球性生物技术平台公司新桥生物（纳斯达克股票代码：NBP，下称“新桥生物”或“公司”）今日宣布，国际顶尖商业化专家Mark A. Hagler先生正式出任总裁兼首席商业官，负责公司商业化战略制定与体系搭建，为重磅创新药全球上市及业务拓展提供决策性依据，驱动公司全球业务快速增长。 Mark A. Hagler先生拥有逾25年全球肿瘤药物商业化领导经验，曾主导Abraxane®（白蛋白紫杉醇）和Afinitor®（依维莫司）两款重磅肿瘤药的核心适应症全球上市及商业化管理。Hagler先生在肿瘤、眼科等高价值创新药领域，全球商业化履历斐然，是全球少数同时具备“重磅药物全球上市经验”与“临床设计与商业目标结合能力”的顶尖专家之一。 傅唯  新桥生物董事会主席  执行董事长 “欢迎Mark的加入，这是新桥生物从临床研发迈向全球商业化战略的关键一步。今年以来，公司势头强劲——Givastomig与VIS-101在中期临床中均取得极具说服力的数据，展现出同类首创/同类最佳疗法的巨大潜力。Mark在肿瘤、眼科等高价值领域拥有丰富的商业化经验，以及对重磅创新药全球商业化的深刻洞察。他的加入，将有助于我们从顶层设计上优化临床研发方案、确保关键研究从启动就对标全球注册和支付标准，显著加速研发进程，让重磅创新药更快、更稳地惠及全球患者。” Mark A. Hagler 新桥生物总裁 首席商业官 “生物制药发展迅猛，而新桥生物凭借着管线优势、管理团队及康桥资本强大的后盾力量，毫无疑问已经成为全球生物技术平台的领先者之一，且具有更远大的发展前景。非常荣幸有这个机会加入新桥生物，很期待与同事们合作，将Givastomig和VIS-101推进至关键研究阶段。这些管线已取得了令人信服的临床数据，展现出了巨大的商业潜力。我将与团队紧密合作，聚焦于创新药全球商业化战略布局，将为商业化阶段提前夯实基础，确保公司资产的巨大潜力得以充分兑现。”   Mark A. Hagler个人履历 作为国际顶尖商业化专家，Mark A. Hagler拥有超过25年的行业经验，专注于制药领域商业化体系的构建、扩展与转型。他在肿瘤学、免疫学、眼科以及罕见病领域有着丰富经验。 加入新桥生物前，Hagler先生曾担任太阳药业（Sun Pharmaceuticals）首席商业官，负责管理超过10亿美元的产品组合，以及逾600人的专业团队。在他的领导下，太阳药业在美国的肿瘤业务从零起步，实现盈利。此外，他还领导了该公司眼科部门的转型，建立了稳健的运营标准，实现了正向现金流。同时，他还主导了多项战略性收购，为公司管线增值并扩大了市场覆盖。 在职业生涯早期，Hagler先生曾在益普生（Ipsen S.A.）、赛诺菲（Sanofi）、诺华（Novartis AG）和Abraxis BioScience担任高管，主导了Afinitor®（依维莫司）、 Abraxane®（白蛋白紫杉醇）等多个肿瘤疗法的全球上市和生命周期策略，显著推动了这些疗法在临床上的广泛应用，以及长期商业价值。其经验涵盖制药领域的诸多领域，包括从新药临床试验申请（IND）到商业化的药物开发全流程、管线优先级排序、业务开发、定价与市场准入策略、跨职能组织领导，以及针对高科技壁垒市场的销售模式优化。 Hagler先生是三项美国医疗技术创新设计专利的署名发明人，拥有约翰霍普金斯大学（Johns Hopkins University）企业金融MBA学位，以及美国海军学院（United States Naval Academy）工程学士学位。  >关于新桥生物 新桥生物是一家全球生物科技平台公司，致力于加速创新药物的可及性。我们将专业的业务拓展能力与敏捷的转化临床开发相结合，以发现、加速并推进突破性资产。通过衔接科学、战略和执行，新桥生物使变革性疗法能够从发现阶段快速推进至有需求的患者。公司的差异化管线主要由Givastomig和VIS-101领衔。其中，Givastomig是一款潜在全球同类首创且同类最佳的CLDN18.2靶向疗法；VIS-101是一款潜在同类最佳的双功能生物制剂，靶向VEGF-A/ANG2。Givastomig通过4-1BB信号通路，在表达Claudin 18.2的肿瘤微环境中条件性激活T细胞。Givastomig正开发用于治疗Claudin 18.2阳性的胃癌及其他胃肠道恶性肿瘤，目前已获美国食品药品监督管理局（FDA）确认，具备加速批准上市的资格，预计最早于2026年第四季度启动一项注册性III期联合试验，拟以客观缓解率（ORR）作为主要终点，申报加速批准。新桥生物还与合作伙伴ABL Bio合作开发Ragistomig，这是一款双特异性抗体，在实体瘤中将PD-L1作为肿瘤结合靶点、4-1BB作为条件性T细胞激活剂。此外，新桥生物拥有Uliledlimab在中国以外地区的全球权益。Uliledlimab是一款抗CD73抗体，靶向肿瘤中由腺苷介导的免疫抑制。VIS-101 靶向 VEGF-A /ANG-2，可为湿性年龄相关性黄斑变性(湿性AMD)和糖尿病性黄斑水肿(DME)患者提供更强有力且持久的疗效。目前，VIS-101 正在开展一项针对湿性 AMD 的大型、随机、剂量范围的 IIa 期研究，预计在2026年下半年开启IIb期剂量探索研究。新桥生物是 Visara 的控股股东，Visara 拥有 VIS-101 在大中华区及亚洲某些国家以外全球权益的独家许可。欲了解更多信息，请访问：https://www.novabridge.com  [ 往期回顾 ]  前瞻性说明 本公告包含前瞻性声明。这些声明依据1995年美国《私人证券诉讼改革法案》的“安全港”条款作出。可以通过术语例如“将”、“预计”、“相信”、“旨在”、“预期”、“未来”、“打算”、“计划”、“潜在”、“估计”、“有信心”等以及类似表述(或其反义表述)来识别这些前瞻性声明。新桥生物也可能在其提交给美国证券交易委员会(SEC)的定期报告、向股东发布的年度报告、新闻稿及其他书面材料中，以及公司高管、董事或员工向第三方所作的口头陈述中作出书面或口头的前瞻性声明。凡不属于历史事实的陈述(包括关于公司的信念和预期的陈述)均为前瞻性声明。本新闻稿中的前瞻性声明包括但不限于以下内容：新总裁兼首席商业官任命的潜在影响；公司对策略、以及Givastomig、VIS-101和其他候选药物(包括Ragistomig)的战略、临床开发、计划、结果、安全性和有效性的预期；新桥生物候选药物(包括 Givastomig、Ragistomig和VIS-101)的战略与临床开发；预期的临床里程碑和结果及相关时间；以及新领导层任命的影响。  前瞻性声明涉及的风险和不确定性可能导致实际结果与这些前瞻性声明中包含的结果存在重大差异，包括但不限于以下因素：公司证明其候选药物安全性和有效性的能力；候选药物的临床结果(可能支持也可能不支持进一步开发或新药申请/生物制品许可申请(NDA/BLA)的批准)；相关监管机构就公司候选药物监管审批所作决定的内容和时间；公司在候选药物获批后的商业成功能力；公司获得并维护其技术和药物知识产权保护的能力；公司对第三方开展药物开发、生产制造及其他服务的依赖；公司有限的运营历史，以及公司获得额外运营资金并完成其候选药物开发和商业化的能力；以及公司已于2026年4月7日向美国SEC提交的20-F年度报告中“风险因素”部分更全面讨论的风险，以及公司随后向SEC提交的文件中讨论的潜在风险、不确定性和其他重要因素。所有前瞻性声明均基于公司当前可获得的信息。除法律要求外，公司不承担因获得新信息、未来事件或其他原因而公开更新或修订任何前瞻性声明的义务。 商标、商号与服务商标 我们拥有或有权使用我们在业务运营中使用且出现在本新闻稿中的商标或商号。本新闻稿还包含对其他实体所拥有的商标和商号的引用。本文所列的所有商标、版权及其他知识产权的权利均归其各自所有者所有，我们对其的使用或展示并不意味着与任何其他实体存在关联关系或获得其认可。

Seasoned Biopharma leader bringing deep commercial experience to shape and inform corporate strategy, clinical trial design and business development discussions Strong industry reputation and commercial track record in high-value pharmaceutical markets including oncology and ophthalmology Strengthens NovaBridge’s leadership team as the Company advances givastomig, a potential first-in-class Claudin 18.2 x 4-1BB bispecific antibody for first line (1L) gastric cancer, toward registrational pivotal studies and continues to advance VIS-101, purpose-designed, potential best-in-class, dual VEGF-A x ANG-2 inhibitor for wet AMD ROCKVILLE, Md., April 22, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (“NovaBridge” or the “Company”), a global biotechnology platform company committed to accelerating access to innovative medicines that address significant unmet needs, today announced the appointment of Mark Hagler as President and Chief Commercial Officer . Mr. Hagler brings deep commercial expertise to shape and inform corporate strategy, clinical trial design and business development discussion. He brings a strong industry reputation and track record in high-value pharmaceutical markets including oncology and ophthalmology. Mr. Hagler built the commercial strategy for Abraxane® in new indications and led the global launch of a core Afinitor® indication. “Welcoming Mark adds meaningful commercial and operational leadership experience to NovaBridge. This year, NovaBridge has demonstrated strong momentum, with compelling clinical data from our two mid-stage, potential best-in-class/first-in-class programs, givastomig and VIS-101. As we progress towards pivotal studies, Mark’s perspective will be instrumental in defining our path forward to maximize the value of our pipeline for shareholders and patients,” said Fu Wei, Executive Chairman of the Board of NovaBridge. “Joining NovaBridge at this pivotal time is incredibly exciting. I look forward to partnering with my colleagues as we advance givastomig and VIS-101 to pivotal studies. The pipeline is supported by compelling proof-of-concept data, and has the potential to deliver meaningful commercial value. My focus will be on collaboration across the organization to shape our commercial approach and strengthen pre-commercial readiness to realize the full potential of our programs,” said Mr. Hagler. About Mark Hagler Mark Hagler is a biotechnology commercial executive with more than 25 years of experience building, scaling, and transforming biopharmaceutical and specialty pharmaceutical businesses. He brings distinctive expertise in driving accelerated growth, commercial readiness, and organizational development for companies in oncology, immunology, ophthalmology, and rare disease markets. Before joining NovaBridge, Mr. Hagler served as Chief Commercial Officer for Sun Pharmaceuticals Industries Limited (Sun), where he led a $1B+ portfolio and organization of 600+ professionals, with accountability for strategy, performance and growth. Under his leadership, Sun’s U.S. Oncology business scaled from inception to profitability. In addition, Mr. Hagler led the transformation of the Ophthalmology division, establishing robust operational standards and delivering positive cash flow. He also executed strategic acquisitions that added value to the company’s pipeline and expanded its market reach. Earlier in his career, Mr. Hagler held senior leadership roles at Ipsen S.A., Sanofi, Novartis AG, and Abraxis BioScience, Inc., where he shaped the global launch and lifecycle strategies for oncology therapies including Afinitor® and Abraxane®, driving meaningful clinical adoption and long-term commercial value. Mr. Hagler’s experience spans IND-to-commercialization drug development, pipeline prioritization, business development, pricing and market access strategy, cross-functional organizational leadership, and field model optimization for high-science markets. Mr. Hagler is a named inventor on three U.S. design patents for medical technology innovations. He holds an MBA in Corporate Finance from Johns Hopkins University and is a graduate of the United States Naval Academy. About NovaBridge NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. The Company combines deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need. The Company’s differentiated pipeline is led by givastomig, a potential first-in-class and best-in-class, Claudin 18.2 X 4-1BB bispecific antibody, and VIS-101, purpose-designed, potential best-in-class, dual VEGF-A X ANG-2 inhibitor. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. The product candidate is being evaluated in a global, randomized Phase 2 study, following the recent announcement of positive topline results from a Phase 1b, multi-center, open label study in first line gastric cancer. The Company is also collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors. Additionally, NovaBridge owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody that targets adenosine-driven immunosuppression in cancer. VIS-101 targets VEGF-A and ANG-2 to provide more rapid, robust and durable treatment responses for patients with retinal vascular diseases including wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. VIS-101 has completed a randomized, dose-ranging Phase 2a study for wet AMD and expects to initiate a dose-determining Phase 2b study in H2 2026. NovaBridge is the majority shareholder of Visara, Inc., and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia. For more information, please visit and follow us on LinkedIn. Forward Looking Statements This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. NovaBridge may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the expected impact of the new President and Chief Commercial Officer appointment; the Company’s expectations regarding the strategy, clinical development, plans, results, safety and efficacy for givastomig, VIS-101 and its other drug candidates; the strategic and clinical development of NovaBridge’s drug candidates, including givastomig, VIS-101, ragistomig, and uliledlimab; anticipated clinical milestones and results, and related timing. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: the Company’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval or eligibility for or achievement of the FDA’s Accelerated Approval Pathway; the content and timing of decisions made by the relevant regulatory authorities, including the FDA, regarding regulatory approval of the Company’s drug candidates; the Company’s ability to achieve commercial success for its drug candidates, if approved; the Company’s ability to obtain and maintain protection of intellectual property for its technology and drugs; the Company’s reliance on third parties to conduct drug development, manufacturing and other services; the Company’s limited operating history and the Company’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of macroeconomic conditions, including inflation, tariffs, volatile interest rates, regulatory uncertainty, potential government shutdowns, volatility in the capital markets, and regional and other global events, including ongoing armed conflicts in different regions of the world; and those risks more fully discussed in the “Risk Factors” section in the Company’s annual report on Form 20-F filed with the SEC on April 7, 2026 as well as the discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to the Company. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. Trademarks, Trade Names And Service Marks We own or have rights to trademarks or trade names that we use in conjunction with the operation of our business and that appear in this press release. This press release also contains references to trademarks and trade names belonging to other entities. All rights to trademarks, copyrights and other intellectual property listed herein belong to their respective owners and our use or display thereof does not imply an affiliation with, or endorsement by, any other entities. NovaBridge Investor & Media Contacts PJ Kelleher LifeSci Advisors +1-617-430-7579 pkelleher@lifesciadvisors.com NovaBridge Biosciences +1-240-745-6330 IR@novabridge.com