REDMOND, Wash. & PRINCETON, N.J.--(BUSINESS WIRE)-- 网页链接{SystImmune, Inc}. (SystImmune), a clinical-stage biotechnology company, and 网页链接{Bristol Myers Squibb} (NYSE: BMY) today announced that SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), reported positive topline results from a pre-specified interim analysis of a Phase III study (BL-B01D1-307) evaluating izalontamab brengitecan (iza-bren), an EGFR×HER3 bispecific antibody-drug conjugate (ADC), in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose disease progressed following prior taxane therapy.
美国华盛顿州雷德蒙德和新泽西州普林斯顿——（商业资讯）临床阶段生物技术公司网页链接{再鼎医药（SystImmune, Inc.）}与网页链接{百时美施贵宝（Bristol Myers Squibb）}（纽约证券交易所代码：BMY）今日宣布，再鼎医药的母公司四川百利药业有限责任公司（Biokin）公布了一项III期研究（BL-B01D1-307）的预设中期分析阳性顶线结果。该研究评估了EGFR×HER3双特异性抗体药物偶联物（ADC）izalontamab brengitecan（iza-bren）用于既往接受紫杉烷治疗后疾病进展的不可切除局部晚期或转移性三阴性乳腺癌（TNBC）患者的疗效。
In the pre-specified interim analysis, topline results showed that iza-bren demonstrated statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy of physician’s choice, meeting both dual primary endpoints.
在预先指定的中期分析中，初步结果显示，与医生选择的化疗相比，iza-bren在无进展生存期（PFS）和总生存期（OS）方面均表现出具有统计学意义和临床意义的改善，达到了两个主要终点。
This Phase III study represents the third Phase III trial in which iza-bren has achieved its primary endpoint(s). It is the first bispecific ADC in a Phase III study to report dual positive PFS/OS results in the treatment of triple-negative breast cancer.
这项III期研究是伊扎布仑（iza-bren）达成其主要终点的第三项III期试验。它是首个在III期研究中报告在三阴性乳腺癌治疗中取得无进展生存期（PFS）和总生存期（OS）双重阳性结果的双特异性抗体偶联药物（ADC）。
“Patients with advanced triple-negative breast cancer who progress after standard therapies face an urgent need for more effective options,” said Dr. Yi Zhu, Chief Executive Officer of Biokin “These topline results further strengthen our confidence in iza-bren’s potential to deliver meaningful clinical benefit across multiple cancers.”“
接受标准治疗后病情进展的晚期三阴性乳腺癌患者迫切需要更有效的治疗方案，”Biokin首席执行官朱毅博士表示，“这些初步结果进一步增强了我们对iza-bren在多种癌症中提供显著临床获益潜力的信心。”
“These results underscore the potential of bispecific ADC technology targeting both EGFR and HER3 to meaningfully change outcomes in difficult‑to‑treat cancers,” said 网页链接{Cristian Massacesi}, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb. “We look forward to advancing the science and development of ADCs, with the hope of uncovering new options for people living with cancer.”
“这些结果凸显了靶向EGFR和HER3的双特异性ADC技术在显著改变难治性癌症治疗结果方面的潜力，”百时美施贵宝公司执行副总裁、首席医疗官兼研发负责人克里斯蒂安·马萨切西表示。“我们期待推进ADC的科学研究和开发，希望能为癌症患者带来新的治疗选择。”
These data will be presented at an upcoming medical meeting.这些数据将在即将举行的医学会议上公布。
The BL-B01D1-307 study is sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), in Mainland China. Outside of China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb (BMS) under a collaboration and exclusive license agreement.
BL-B01D1-307研究由SystImmune的母公司四川百利药业有限责任公司（Biokin）在中国大陆发起。在中国境外，依扎布伦由SystImmune与百时美施贵宝（BMS）根据一项合作及独家许可协议联合开发。
The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation (BTD) to iza-bren for the treatment of seven indications, and the U.S. FDA has granted BTD to iza-bren for previously treated NSCLC patients with an EGFR mutation. The New Drug Applications (NDAs) for two indications of iza-bren, for the treatment of locally advanced or metastatic nasopharyngeal carcinoma and for the treatment of recurrent or metastatic esophageal squamous cell carcinoma, have been accepted by the CDE and included in the priority review process.
中国国家药品监督管理局（NMPA）下属的药品审评中心（CDE）授予iza-bren用于七种适应症治疗的突破性疗法认定（BTD），美国食品药品监督管理局（FDA）则授予iza-bren用于治疗既往接受过治疗的携带EGFR突变的非小细胞肺癌患者的突破性疗法认定（BTD）。CDE已受理iza-bren的两项适应症新药申请（NDA），即用于治疗局部晚期或转移性鼻咽癌以及用于治疗复发或转移性食管鳞状细胞癌，并将其纳入优先审评程序。
About BL-B01D1-307 关于BL-B01D1-307
BL-B01D1-307 is a Phase III, randomized, open-label, multi-center clinical study in China, evaluating iza-bren in patients with unresectable locally advanced or metastatic triple-negative breast cancer whose disease progressed following prior taxane therapy. The study includes dual primary endpoints of progression-free survival (PFS) and overall survival (OS). For more detailed information, please visit clinical.trials.gov (NCT06382142).
BL-B01D1-307是一项在中国开展的III期、随机、开放标签、多中心临床研究，旨在评估伊扎布伦在既往紫杉烷治疗后疾病进展的不可切除局部晚期或转移性三阴性乳腺癌患者中的疗效。该研究包含无进展生存期（PFS）和总生存期（OS）这两个主要终点。欲了解更多详细信息，请访问clinical.trials.gov（NCT06382142）。
About iza-bren 关于iza-bren
SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren's therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death.
SystImmune公司与百时美施贵宝（BMS）在中国境外合作开发伊扎布仑（BL-B01D1），这是一种双特异性抗体药物偶联物（ADC），靶向EGFR和HER3。这两种蛋白在多种上皮癌中高表达，且已知与癌细胞的增殖和存活相关。伊扎布仑的双重作用机制可阻断EGFR和HER3向癌细胞传递的信号，减少增殖和存活信号。此外，在抗体介导的内化作用下，伊扎布仑具有治疗作用的新型Topo1i载荷会被释放，产生细胞毒性应激，导致癌细胞死亡。
About SystImmune 关于SystImmune公司
SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
SystImmune是一家处于临床阶段的生物制药公司，位于华盛顿州雷德蒙德。该公司专注于利用其成熟的药物开发平台研发创新癌症疗法，重点研究双特异性、多特异性抗体以及抗体药物偶联物（ADCs）。SystImmune拥有多项资产，正处于针对实体瘤和血液疾病适应症的不同阶段临床试验中。除了正在进行的临床试验外，SystImmune还有丰富的临床前候选癌症治疗药物管线，这些药物处于发现阶段或新药临床试验申请（IND）支持阶段，代表着前沿的生物制剂研发水平。
About Bristol Myers Squibb 关于百时美施贵宝
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
百时美施贵宝是一家全球性生物制药公司，其使命是发现、研发并提供创新药物，帮助患者战胜严重疾病。如需了解更多关于百时美施贵宝的信息，请访问我们的网站BMS.com，或在领英、X、YouTube、脸书和Instagram上关注我们。
SystImmune Forward-Looking Statements SystImmune 前瞻性陈述
This press release contains forward-looking statements, including statements regarding the potential clinical benefits of iza-bren, the timing and outcomes of regulatory interactions, and the future development and commercialization of iza-bren. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. SystImmune undertakes no obligation to update any forward-looking statements contained herein, except as required by law.
本新闻稿包含前瞻性陈述，包括有关iza-bren的潜在临床益处、监管互动的时间和结果，以及iza-bren的未来开发和商业化的陈述。前瞻性陈述受风险和不确定性影响，可能导致实际结果与预期存在重大差异。除法律要求外，SystImmune没有义务更新本新闻稿中包含的任何前瞻性陈述。
Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements百时美施贵宝关于前瞻性陈述的警示声明
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about Bristol Myers Squibb’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to, the collaboration with SystImmune may not be realized by Bristol Myers Squibb or may take longer to realize than anticipated, that iza-bren (BL-B01D1) may not receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use and, if approved, whether such product candidates will be commercially successful.
本新闻稿包含1995年《私人证券诉讼改革法案》所指的“前瞻性陈述”，内容涉及药品的研究、开发和商业化等方面。所有非历史事实的陈述均为或可被视为前瞻性陈述。此类前瞻性陈述基于对百时美施贵宝未来财务业绩、目标、计划和宗旨的当前预期和预测，涉及固有的风险、假设和不确定性，包括未来几年可能延迟、转移或改变其中任何一项的内部或外部因素，这些因素难以预测，可能超出我们的控制范围，并可能导致我们未来的财务业绩、目标、计划和宗旨与陈述中所表达或暗示的内容存在重大差异。这些风险、假设、不确定性和其他因素包括但不限于：百时美施贵宝可能无法实现与SystImmune合作的预期收益及相关机遇，或实现时间可能长于预期；iza-bren（BL-B01D1）可能无法在当前预期的时间内获得本新闻稿所述适应症的监管批准，甚至可能根本无法获得批准；即使获得营销批准，其使用也可能存在重大限制；以及如果获得批准，这些候选产品是否会取得商业成功。
No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
任何前瞻性陈述都无法得到保证。本新闻稿中的前瞻性陈述应结合影响百时美施贵宝业务和市场的诸多风险与不确定性进行评估，尤其是百时美施贵宝截至2025年12月31日的10-K表年度报告中“警示性声明”和“风险因素”部分所指出的内容，以及后续10-Q表季度报告、8-K表当前报告和向美国证券交易委员会提交的其他文件中更新的相关信息。本文件中包含的前瞻性陈述仅在本文件发布之日作出，除非适用法律另有要求，否则百时美施贵宝没有义务因新信息、未来事件、环境变化或其他原因而公开更新或修订任何前瞻性陈述。
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Source: Bristol Myers Squibb 来源：百时美施贵宝
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