Zanidatamab

3 月 31 日，康宁杰瑞发布公告，其与石药集团子公司津曼特生物合作开发的 KN026 联合注射用多西他赛（白蛋白结合型）(HB1801）用于人表皮生长因子受体 2（HER2）阳性乳腺癌（BC）新辅助治疗的 III 期临床研究（研究代号：KN026-004），达到预先设定的总体病理完全缓解率（tpCR）的主要终点，结果具有显著的统计学和临床意义。 来源：康宁杰瑞公告 KN026-004 是一项随机、对照、开放、多中心、III 期临床试验，计划纳入约 520 例早期或局部晚期 HER2 阳性 BC 患者，按照 1:1 随机分配。该研究旨在比较 KN026 联合 HB1801±卡铂对比曲妥珠单抗联合帕妥珠单抗和多西他赛±卡铂新辅助治疗早期和局部晚期 HER2 阳性 BC 的有效性及安全性。 主要研究终点为盲法独立评估委员会（BIRC）评估的 tpCR。研究结果显示，与现有标准治疗相比，KN026 联合 HB1801 ±卡铂显著提高了患者的 tpCR。详细数据将在近期国际学术会议上公布。 KN026 是康宁杰瑞采用具有自主知识产权 Fc 异二聚体平台技术（CRIB）开发的 HER2 双特异性抗体，可同时结合 HER2 的两个非重叠表位，阻断 HER2 信号。通过抗体诱导的受体聚集，增强 ADCC 和 CDC 效应，同时下调细胞表面 HER2 受体。 KN026 已获美国 FDA 授予孤儿药资格，用于治疗 HER2 阳性或 HER2 低表达胃癌（GC）。同时 KN026 还获得了国家药监局授予的突破性疗法认定，用于二线及以上治疗 HER2 阳性 GC/胃食管结合部癌。此外，KN026 联合化疗用于此适应症的新药上市申请于 2025 年 9 月获国家药监局受理，目前处于上市申请审评中。 目前，KN026 针对一线 HER2 阳性GC/胃食管结合部癌、一线 HER2 阳性 BC、HER2 阳性 BC 新辅助及辅助治疗等等适应症的多项注册临床研究正在进行中。 2021 年 8 月，康宁杰瑞与津曼特生物达成授权合作，津曼特生物获得 KN026 在中国内地（不包括香港、澳门及台湾地区）BC 及 GC 适应症的排他性开发与独占性商业化许可权。 Insight 数据库显示，目前国内有超 40 款 HER2 双抗在研，已经获批上市的有 1 款，即百济神州从 Zymeworks 引进的泽尼达妥单抗。而 KN026 是进展最快的国产 HER2 双抗。 封面来源：站酷海洛 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。 编辑：月牙 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

VANCOUVER, British Columbia, April 01, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced the appointment of Ms. Kristin Stafford as Chief Financial Officer, effective April 1, 2026. “Kristin brings deep experience across the life sciences industry, with a strong track record in strategic planning, disciplined capital allocation, and executing complex capital markets and strategic transactions, including acquisitions, during her time at Royalty Pharma,” said Kenneth Galbraith, Chair and Chief Executive Officer. “We are excited to welcome her to the team and look forward to her contributions as we continue building a differentiated and durable business at Zymeworks.” Ms. Stafford recently served as Senior Vice President, Chief Accounting Officer for Royalty Pharma plc, since December 2018. Prior to this position, she served as Vice President, Finance of Royalty Pharma and Chief Financial Officer of BioPharma Credit plc, an affiliate of Royal Pharma, from 2016 to 2018. Previously, Ms. Stafford was a director at Ernst & Young LLP Capital Markets in London, specializing in U.S. transactions involving European life sciences companies. She also previously managed the external SEC reporting for iHeartMedia and was an auditor at Deloitte. Ms. Stafford is currently a Board Member at Novocure. She is a CPA and holds a B.Sc. degree in business administration from Sonoma State University. “I’m excited to join Zymeworks at such an important moment as the company advances its pipeline and executes on its strategic priorities,” said Ms. Stafford. “Zymeworks has built a strong foundation with a differentiated business model and high-quality assets, and I look forward to partnering with the leadership team to drive disciplined capital allocation, operational excellence, and long-term value creation.” About Zymeworks Inc. Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks’ asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates, such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the development of innovative medicines. Zymeworks engineered and developed Ziihera, a HER2-targeted bispecific antibody using the Zymeworks’ proprietary Azymetric™ technology and has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zymeworks is rapidly advancing a robust pipeline of product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Zymeworks’ complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutics. These capabilities have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities and long-term strategy to maximize value creation; the expected contributions of personnel to Zymeworks’ strategic goals and long-term shareholder value; the anticipated benefits of strategic partnerships; Zymeworks’ and its partners’ clinical development of product candidates; future regulatory filings and approvals; the commercial potential of technology platforms and product candidates; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, “preserve”, “intend”, “could”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments or royalties under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of global and regional geopolitical or public health developments on Zymeworks’ business, research and clinical development plans and timelines and results of operations; zanidatamab may not be successfully commercialized; Zymeworks’ business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ evolution of its business strategy may not deliver meaningful shareholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue-generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; data providing early validation of our antibody drug conjugate platform and next generation pipeline programs may not be replicated in future studies; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at and ). Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. Contacts: Investor Inquiries: Shrinal Inamdar Vice President, Investor Relations (604) 678-1388 ir@zymeworks.com Media Inquiries: Diana Papove Vice President, Corporate Communications (604) 678-1388 media@zymeworks.com