BioNTech和百时美施贵宝宣布达成全球战略合作，共同开发并商业化下一代双特异性抗体候选药物BNT327，广泛应用于多种实体瘤类型-动脉网

BioNTech and Bristol Myers Squibb Announce Global Strategic Partnership to Co-Develop and Co-Commercialize Next-generation Bispecific Antibody Candidate BNT327 Broadly for Multiple Solid Tumor Types

BioNTech 等信源发布 2025-06-02 18:50



可切换为仅中文







BNT327,

BNT327，

BioNTech’s PD-L1xVEGF-A bispecific antibody, is a clinically advanced investigational immunotherapy candidate with the potential to surpass current checkpoint inhibitor outcomes and set a new standard of care in multiple tumor types

BioNTech的PD-L1xVEGF-A双特异性抗体是一种临床进展迅速的免疫治疗候选药物，有潜力超越当前检查点抑制剂的效果，并在多种肿瘤类型中树立新的治疗标准。

The co-development and co-commercialization collaboration with a 50/50 profit/loss split will leverage both partners’ expertise, resources and global footprint to accelerate BNT327’s path towards potential regulatory approvals and market launches

与合作伙伴各占50/50的利润/损失分摊的共同开发和共同商业化合作将利用双方的专业知识、资源和全球影响力，加速BNT327迈向潜在监管批准和市场推出的进程。

BioNTech and Bristol Myers Squibb will jointly execute a broad clinical development program to evaluate and advance BNT327 across numerous solid tumor types

BioNTech和百时美施贵宝将共同开展一项广泛的临床开发计划，以评估和推进BNT327在多种实体瘤类型中的应用。

MAINZ, Germany, and PRINCETON, USA, June 2, 2025

德国美因茨和美国普林斯顿，2025年6月2日

BioNTech SE

(Nasdaq: BNTX, “BioNTech”) and

（纳斯达克：BNTX，“BioNTech”）和

Bristol Myers Squibb

百时美施贵宝

(NYSE: BMY, “BMS”) today announced that the companies have entered into an agreement for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types. Under the agreement, BioNTech and BMS will work jointly to broaden and accelerate the development of this clinical candidate.

（纽约证券交易所代码：BMY，“BMS”）今天宣布，两家公司已达成协议，将在全球范围内共同开发和商业化BioNTech的在研双特异性抗体BNT327，涵盖多种实体瘤类型。根据协议，BioNTech和BMS将共同努力，扩大并加速这一临床候选药物的开发。

。

BioNTech’s BNT327, a next-generation bispecific antibody candidate targeting PD-L1 and VEGF-A, is currently being evaluated in multiple ongoing trials with more than 1,000 patients treated to date, including global Phase 3 trials with registrational potential evaluating BNT327 as first-line treatment in extensive stage small cell lung cancer (“ES-SCLC”) and non-small cell lung cancer (“NSCLC”).

BioNTech的BNT327是一种下一代双特异性抗体候选药物，靶向PD-L1和VEGF-A，目前正在多个正在进行的试验中评估，迄今为止已有1000多名患者接受治疗，其中包括全球性的、具有注册潜力的III期试验，评估BNT327作为广泛期小细胞肺癌（“ES-SCLC”）和非小细胞肺癌（“NSCLC”）的一线治疗。

A global Phase 3 trial evaluating the candidate in triple negative breast cancer (“TNBC”) is planned to start by the end of 2025. Preliminary data from ongoing trials underscore the potential for combining anti-PD-L1 and anti-VEGF-A – two well-established therapeutic targets – into a single molecule to deliver synergistic clinical benefits for patients across multiple tumor types..

计划在2025年底前启动一项全球III期试验，评估该候选药物在三阴性乳腺癌（“TNBC”）中的疗效。正在进行的试验的初步数据强调了将抗PD-L1和抗VEGF-A（两个已确立的治疗靶点）结合到一个单一分子中的潜力，从而为多种肿瘤类型的患者带来协同的临床益处。

Under the terms of the agreement, the companies will jointly develop and commercialize BNT327, including the development of BNT327 as monotherapy and in combination with other products. Both companies have the right to independently develop BNT327 in further indications and combinations, including combinations of BNT327 with proprietary pipeline assets..

根据协议条款，两家公司将共同开发和商业化BNT327，包括将BNT327作为单一疗法和与其他产品联合使用进行开发。两家公司都有权独立开发BNT327用于更多的适应症和组合，包括将BNT327与自有管线资产进行组合。

“We believe BNT327 has the potential to become a foundational immuno-oncology backbone, moving beyond single-mechanism checkpoint inhibitors and expanding into multiple solid-tumor indications. Our collaboration with BMS, a pioneering leader in immuno-oncology, aims to accelerate and broadly expand BNT327’s development to fully realize its potential,” said .

“我们相信，BNT327有潜力成为免疫肿瘤学领域的基础支柱，超越单一机制的检查点抑制剂，并扩展到多种实体瘤适应症。我们与免疫肿瘤学领域的先驱领导者BMS的合作，旨在加速并广泛推动BNT327的开发，以充分实现其潜力，”他表示。

Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech

乌古尔·萨欣教授，医学博士，BioNTech首席执行官兼联合创始人

. “Our focus remains on advancing high-impact, pan-tumor programs and combination strategies in oncology, with BNT327 complementing our antibody-drug conjugate programs and mRNA-based immunotherapies. We are dedicated to delivering truly transformative options for patients in need.”

“我们的重点仍然是推进高影响力的泛肿瘤项目和联合策略，BNT327将补充我们的抗体药物偶联项目和基于mRNA的免疫疗法。我们致力于为有需要的患者提供真正变革性的选择。”

“Our deep experience and expertise in advancing and delivering groundbreaking immuno-oncology medicines positions BMS well to collaboratively realize the potential of BNT327, an asset with significant potential for transforming the standard of care for patients with solid tumors,” said

“我们在推进和提供突破性免疫肿瘤药物方面的深厚经验和专业知识，使百时美施贵宝能够很好地协作实现BNT327的潜力，这一资产具有显著改变实体瘤患者治疗标准的潜力，”

Christopher Boerner, Ph.D., Board Chair and CEO of Bristol Myers Squibb

百时美施贵宝董事长兼首席执行官 Christopher Boerner 博士

. “The science behind BNT327 and its leading clinical position in multiple hard-to-treat tumor types, further bolsters our pursuit of novel mechanisms and multiple modalities in oncology, and enhances our growth trajectory. We are impressed by the innovation that BioNTech has achieved to date, and we look forward to partnering to accelerate existing clinical trials and time to market, while expanding the number of potential indications.”.

“BNT327 背后的科学及其在多种难治性肿瘤类型中的领先临床地位，进一步巩固了我们在肿瘤学领域对新机制和多模式的追求，并增强了我们的成长轨迹。BioNTech 迄今为止取得的创新成果让我们印象深刻，我们期待合作加速现有的临床试验和上市时间，同时扩大潜在适应症的数量。”

BMS will pay BioNTech $1.5 billion in an upfront payment and $2 billion total in non-contingent anniversary payments through 2028. These tax-deductible charges will be recorded as Acquired IPR&D Expense when incurred, with the $1.5 billion being incurred in Q2. In addition, BioNTech will be eligible to receive up to $7.6 billion in additional development, regulatory and commercial milestones.

百时美施贵宝将向BioNTech支付15亿美元的首付款，并在2028年前支付总计20亿美元的非或有周年付款。这些可抵税的费用将在发生时记为已收购的IPR&D（在研项目）支出，其中15亿美元将在第二季度记账。此外，BioNTech还有资格获得高达76亿美元的额外开发、监管和商业里程碑付款。

BioNTech and BMS will share joint development and manufacturing costs on a 50:50 basis, subject to certain exceptions. Global profits/losses will be equally shared between BioNTech and BMS. .

BioNTech和BMS将按照50:50的比例分担共同开发和制造成本，但某些例外情况除外。全球利润/亏损将由BioNTech和BMS平分。

About BNT327

关于BNT327

BNT327 is a novel investigational bispecific antibody combining two complementary, validated mechanisms in oncology into one single molecule. BNT327 combines PD-L1 checkpoint inhibition aimed at restoring T cells’ ability to recognize and destroy tumor cells with the neutralization of VEGF-A. The blocking of VEGF-A is aimed at reversing the tumor’s immuno-suppressive effect in its microenvironment and cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), with the intention of preventing the tumor from growing and proliferating.

BNT327 是一种新型的双特异性抗体研究药物，将肿瘤学中两种互补且经过验证的作用机制结合在一个单一分子中。BNT327 结合了旨在恢复 T 细胞识别和摧毁肿瘤细胞能力的 PD-L1 检查点抑制作用，以及对 VEGF-A 的中和作用。阻断 VEGF-A 的目的是逆转肿瘤在其微环境中的免疫抑制效应，并切断为肿瘤细胞提供养分的血液和氧气供应（抗血管生成效应），以期防止肿瘤生长和增殖。

BNT327 may be differentiated via its mechanism of action of targeting PD-L1 on tumor cells to localize anti-VEGF activity within the tumor microenvironment, aiming to enhance therapeutic precision and minimize systemic exposure. A treatment with BNT327 is intended to help normalize blood vessels at the tumor site, improving delivery and potential effectiveness of combination therapies.

BNT327 可能通过其作用机制进行区分，该机制针对肿瘤细胞上的 PD-L1，将抗 VEGF 活性定位于肿瘤微环境中，旨在提高治疗的精准性并减少系统暴露。使用 BNT327 进行治疗的目的在于帮助肿瘤部位的血管正常化，改善联合疗法的递送和潜在效果。

This targeted vascular remodeling positions BNT327 as a potential backbone therapy across a wide range of solid tumors..

这种针对性的血管重塑使BNT327成为跨多种实体瘤的潜在基础治疗方案。

，2

More than 1,000 patients have been treated with BNT327 in clinical trials to date. More than 20 clinical trials are currently ongoing or planned to evaluate BNT327 either as a monotherapy or in combination with other treatment modalities targeting different oncogenic pathways in more than 10 solid tumor indications.

迄今为止，已有1000多名患者在临床试验中接受了BNT327的治疗。目前有20多项临床试验正在进行或计划中，以评估BNT327作为单一疗法或与其他针对不同致癌途径的治疗方式联合使用，在超过10种实体瘤适应症中的效果。

Multiple global trials are ongoing or planned to start in 2025, including three global clinical trials with registrational potential in first-line small cell lung cancer (“SCLC”), first-line non-small cell lung cancer (“NSCLC”) and first-line triple-negative breast cancer (“TNBC”). Additional trials will explore combining BNT327 and BioNTech’s proprietary antibody-drug conjugate candidates (“ADCs”).

多个全球性试验正在进行或计划于2025年开始，其中包括三项具有注册潜力的全球临床试验，适应症分别为一线小细胞肺癌（“SCLC”）、一线非小细胞肺癌（“NSCLC”）和一线三阴性乳腺癌（“TNBC”）。其他试验将探索BNT327与BioNTech专有的抗体药物偶联候选物（“ADC”）的联合应用。

If successfully developed and approved, BioNTech aims to use this bispecific antibody candidate as a next-generation immuno-oncology (“IO”) backbone in combination with other treatment modalities targeting a broad range of cancer indications..

如果成功开发并获得批准，BioNTech计划将此双特异性抗体候选药物用作下一代免疫肿瘤学（“IO”）支柱，与针对多种癌症适应症的其他治疗方式联合使用。

About BioNTech

关于BioNTech

Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals.

生物制药新技术公司（BioNTech）是一家全球下一代免疫疗法公司，率先开发用于癌症和其他严重疾病的新研究性疗法。BioNTech利用广泛的计算发现和治疗模式，旨在快速开发新型生物制药。

Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies.

其多样化的肿瘤学候选产品组合旨在应对癌症的整个连续过程，包括mRNA癌症免疫疗法、下一代免疫调节剂和靶向疗法，如抗体药物偶联物（ADC）和创新的嵌合抗原受体（CAR）T细胞疗法。

Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron..

基于其在mRNA开发方面的深厚专业知识和内部生产能力，BioNTech及其合作伙伴正在研究和开发多种针对不同传染病的mRNA疫苗候选药物，同时推进其多样化的肿瘤学管线。BioNTech与多家全球性和专业性制药合作伙伴建立了广泛的合作关系，其中包括百时美施贵宝、Duality Biologics、复星医药、罗氏集团成员基因泰克、Genevant、Genmab、MediLink、OncoC4、辉瑞和再生元。

For more information, please visit

欲了解更多信息，请访问

www.BioNTech.com

。

BioNTech Forward-Looking Statements

BioNTech前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: expectations regarding the impact of the collaboration with Bristol Myers Squibb (BMS) on BioNTech’s business; the creation of long-term value for BioNTech; the ability of BioNTech and BMS to successfully co-develop and co-commercialize BNT327, if approved; BioNTech’s eligibility to receive development, regulatory, and commercial milestone payments; the rate and degree of market acceptance of BioNTech’s investigational medicines, if approved; the initiation, timing, progress, results, and cost of BioNTech’s research and development programs, including BioNTech’s current and future preclinical studies and clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of studies or trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; BioNTech’s expectations regarding potential future commercialization in oncology, including goals regarding timing and indications; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; discussions with regulatory agencies; BioNTech’s expectations with respect to intellectual property; the impact of BioNTech’s collaboration and licensing agreements; the development, nature and feasibility of sustainable drug production and supply solutions; and BioNTech’s estimates of revenues, research and development expenses, selling, general and administrative expenses, and capital expenditures for operating ac.

本新闻稿包含1995年《私人证券诉讼改革法案》（经修订）所指的前瞻性声明，包括但不限于以下方面的声明：与百时美施贵宝（BMS）合作对BioNTech业务影响的预期；为BioNTech创造长期价值；BioNTech和BMS成功共同开发和共同商业化BNT327的能力（如果获批）；BioNTech有资格获得开发、监管和商业里程碑付款；BioNTech在研药物的市场接受率和程度（如果获批）；BioNTech研发项目的启动、时间、进展、结果和成本，包括BioNTech当前和未来的临床前研究和临床试验，包括关于预计启动、入组和完成研究或试验及其相关准备工作的声明，以及结果的可用性，还有监管审批和上市授权申请的时间和结果；BioNTech对未来肿瘤学领域潜在商业化的预期，包括关于时间和适应症的目标；额外潜在注册试验的目标时间和数量，以及BioNTech可能启动的任何试验的注册潜力；与监管机构的讨论；BioNTech对知识产权的预期；BioNTech合作和许可协议的影响；可持续药物生产和供应解决方案的开发、性质和可行性；以及BioNTech对收入、研发费用、销售、一般和管理费用及资本支出的估算。

The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements.

本新闻稿中的前瞻性陈述基于BioNTech当前对未来事件的预期和信念，这些陈述既不是承诺也不是保证。您不应过度依赖这些前瞻性陈述，因为它们涉及已知和未知的风险、不确定性及其他因素，其中许多因素超出BioNTech的控制范围，并可能导致实际结果与这些前瞻性陈述中明示或暗示的结果存在重大且不利的差异。

These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulat.

这些风险和不确定性包括但不限于：研发过程中固有的不确定性，包括能否达到预期的临床终点、临床试验的启动和/或完成日期、监管提交日期、监管批准日期和/或上市日期，以及与临床前和临床数据相关的风险，包括可能出现不利的新的临床前、临床或安全性数据，以及对现有的临床前、临床或安全性数据进行进一步分析；临床数据的性质，需接受持续的同行评审、监管审查和市场解读；与政府机构、私人健康保险公司及其他第三方支付方的价格和覆盖范围谈判；关税及贸易政策升级的影响；与BioNTech产品候选相关的竞争，包括基于不同作用机制以及不同的制造和分销限制的竞争，涉及疗效、成本、存储和分发便利性、获批用途的广泛性、副作用特征和免疫反应持久性等方面；BioNTech获得并维持其产品候选监管批准的时间和能力；与监管机构的讨论。

You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended March 31, 2025 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at

您应当审阅BioNTech截至2025年3月31日的6-K表格报告中标题为“风险因素”下描述的风险和不确定性，以及BioNTech随后向SEC提交的文件，这些文件可在SEC的网站上查阅。

www.sec.gov

. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise..

这些前瞻性声明仅截至本日期有效。除非法律要求，否则BioNTech不承担更新或修改本新闻稿中包含的任何前瞻性声明的责任，不论是因为出现新信息、未来发展或其他原因。

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

百时美施贵宝是一家全球生物制药公司，其使命是发现、开发和提供创新药物，帮助患者战胜严重疾病。欲了解更多信息，请访问我们的网站。

BMS.com

or follow us on

或关注我们

领英

，

YouTube

，

Facebook

and

和

Instagram

图享

。

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 and the collaboration with BioNTech. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的关于制药产品研发、商业化以及与BioNTech合作等事项的“前瞻性陈述”。所有非历史事实的陈述均可能被视为前瞻性陈述。

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 Bristol Myers Squibb’s control and could cause its future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements.

此类前瞻性陈述基于百时美施贵宝当前对其未来财务业绩、目标、计划和目的的预期和预测，并涉及固有的风险、假设和不确定性，包括内部或外部因素，这些因素可能会在未来的几年内延迟、转移或改变其中的任何一项，且难以预测，可能超出百时美施贵宝的控制范围，并可能导致其未来的财务业绩、目标、计划和目的与这些陈述中表达或暗示的内容存在重大差异。

These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to the collaboration with BioNTech may not be consistent with the realized by Bristol Myers Squibb or may take longer to realize than anticipated, that the therapeutic potential of BNT327 may change, that Bristol Myers Squibb may fail to discover and develop any commercially successful product candidates through the collaboration with BioNTech, that such product candidates may not receive regulatory approval for the indications described in this release and, if approved, whether such product candidates will be commercially successful.

这些风险、假设、不确定性和其他因素包括但不限于：与BioNTech合作相关的预期利益和机会可能与百时美施贵宝实现的结果不一致，或其实现时间可能比预期更长；BNT327的治疗潜力可能发生改变；百时美施贵宝可能无法通过与BioNTech的合作发现并开发任何商业上成功的产品候选者；此类产品候选者可能无法获得本公告所述适应症的监管批准，且即使获批，此类产品候选者是否能在商业上取得成功尚不确定。

No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties th.

任何前瞻性声明都无法得到保证。本新闻稿中的前瞻性声明应结合诸多风险和不确定性一起评估。

CONTACTS

联系人

BioNTech

生物新科技公司

Media Relations

媒体关系

Jasmina Alatovic

贾斯米娜·阿拉托维奇

Media@biontech.de

媒体@biontech.de

Investor Relations