Pumitamig plus docetaxel demonstrated encouraging responses in squamous and non-squamous non-small cell lung cancer across PD-L1 expression levels with a confirmed objective response rate of 36.7% following progression on or after immunotherapy plus chemotherapy Pumitamig联合多西他赛在不同PD-L1表达水平的鳞状和非鳞状非小细胞肺癌中均显示出令人鼓舞的疗效，在免疫治疗联合化疗期间或之后出现疾病进展的患者中，经确认的客观缓解率为36.7%。An early median progression-free survival of 6.9 months was observed 观察到早期无进展生存期中位数为6.9个月Significant unmet need remains for patients who have progressed on an 对于已经进展的患者，仍存在显著的未满足需求immunotherapy-containing regimen, with 含免疫治疗的方案，与the average progression-free survival below 4 months for standard of care 标准治疗的中位无进展生存期低于4个月docetaxel 多西他赛Data represent the third global Phase 2 dataset for pumitamig in lung cancer and reinforce its potential to improve outcomes over current standards of care 数据代表了pumitamig在肺癌治疗中的第三个全球二期临床试验数据集，并进一步证实了其相较于当前标准治疗方案在改善患者预后方面的潜力。MAINZ, Germany, and PRINCETON, USA, October 25, 2026 德国美因茨和美国普林斯顿，2026年10月25日– –BioNTech SE BioNTech SE(Nasdaq: BNTX, “BioNTech”) and （纳斯达克股票代码：BNTX，“BioNTech”）和Bristol Myers Squibb Company 百时美施贵宝公司(NYSE: BMY, “BMS”) today announced first data from the global Phase 2 ROSETTA Lung-107 clinical trial ( （纽约证券交易所代码：BMY，“BMS”）今日宣布全球2期ROSETTA Lung-107临床试验的首批数据（NCT06841055 NCT06841055) evaluating pumitamig, an investigational PD-L1xVEGF-A bispecific immunomodulator (BNT327/BMS986545), in combination with docetaxel in patients with metastatic non-small cell lung cancer (“NSCLC”) whose disease progressed on or after first-line immunotherapy plus chemotherapy. ) 评估在一线免疫治疗联合化疗期间或之后疾病进展的转移性非小细胞肺癌（“NSCLC”）患者中，将研究性PD-L1xVEGF-A双特异性免疫调节剂pumitamig（BNT327/BMS986545）与多西他赛联合使用的疗效。The data showed encouraging antitumor activity, with responses observed in both squamous and non-squamous NSCLC and across PD-L1 expression levels, together with a manageable safety profile consistent with prior global datasets for pumitamig. The data were presented today in a late-breaking rapid oral presentation (. 数据显示出令人鼓舞的抗肿瘤活性，在鳞状和非鳞状非小细胞肺癌（NSCLC）患者中以及不同PD-L1表达水平人群中均观察到缓解，且安全性可控，与此前公布的普米塔利单抗（pumitamig）全球数据集一致。该数据于今日以最新快速口头报告形式发布。abstract #LBA76 摘要 #LBA76) at the European Society for Medical Oncology (“ESMO”) Congress 2026 in Madrid, Spain. ）在2026年于西班牙马德里举行的欧洲肿瘤内科学会（ESMO）大会上。“Despite meaningful advances in first-line treatment, outcomes remain poor for the many patients with non-small cell lung cancer whose disease progresses after immunotherapy plus chemotherapy, a setting where docetaxel has remained the standard of care for years,” “尽管一线治疗取得了显著进展，但对于许多在免疫治疗联合化疗后疾病进展的非小细胞肺癌患者而言，预后仍然不佳；在这一情况下，多西他赛多年来一直是标准治疗方案。”1 1said 说Byoung Chul Cho, M.D., Ph.D., Trial Investigator and Professor of Medical Oncology at Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. 赵炳哲，医学博士、哲学博士，试验研究者，韩国首尔延世大学医学院延世癌症中心肿瘤内科教授。“These first data from ROSETTA Lung-107 show encouraging response rates and progression-free survival across PD-L1 expression levels and histology, suggesting that pumitamig may help re-engage antitumor immunity in patients who have progressed on prior immunotherapy plus chemotherapy. These findings support continued investigation of pumitamig in this population with high unmet need.”. “ROSETTA Lung-107研究的初步数据显示，在不同PD-L1表达水平和组织学亚型中，均观察到令人鼓舞的缓解率和无进展生存期，这表明pumitamig可能有助于在既往接受免疫治疗联合化疗后疾病进展的患者中重新激活抗肿瘤免疫反应。这些结果支持在这一存在高度未满足需求的人群中继续开展pumitamig的研究。”ROSETTA Lung-107 is evaluating pumitamig 1400 mg in combination with docetaxel every three weeks. The July 10, 2026, data cut-off included 50 patients with a median follow-up of 12.2 weeks, and 33 patients remained on treatment. Among 30 efficacy-evaluable patients, pumitamig plus docetaxel showed a confirmed objective response rate (“cORR”) of 36.7% with a disease control rate (“DCR”) of 90.0%. ROSETTA Lung-107 研究正在评估每三周一次给予 1400 mg pumitamig 联合多西他赛的疗效。截至 2026 年 7 月 10 日的数据截止时，共纳入 50 名患者，中位随访时间为 12.2 周，其中 33 名患者仍在接受治疗。在 30 名可评估疗效的患者中，pumitamig 联合多西他赛治疗的确认客观缓解率（cORR）为 36.7%，疾病控制率（DCR）为 90.0%。Responses were observed across PD-L1 expression levels (cORR: 42.9% TPS ˂ 1%; 33.3% TPS 1–49%; 40.0% TPS ≥ 50%) and histologies (cORR: 57.1% squamous; 30.4% non-squamous), with DCRs above 80% in all subgroups. Median time to response was 1.4 months. In the overall treated population (n=50), median progression-free survival (“PFS”) was 6.9 months (95% CI: 4.2 – not reached), with a six-month PFS rate of 63.3%. 在PD-L1表达水平（cORR：TPS < 1%为42.9%；TPS 1–49%为33.3%；TPS ≥ 50%为40.0%）和组织学亚型（cORR：鳞状细胞癌为57.1%；非鳞状细胞癌为30.4%）中均观察到缓解，所有亚组的疾病控制率（DCR）均高于80%。中位缓解时间为1.4个月。在整个治疗人群（n=50）中，中位无进展生存期（PFS）为6.9个月（95% CI：4.2 – 未达到），6个月PFS率为63.3%。Historically, standard-of-care docetaxel has delivered a median PFS of approximately 3.6 or 3.9 months for non-squamous and squamous metastatic NSCLC patients, respectively, following prior immunotherapy plus chemotherapy.. 从历史上看，对于既往接受过免疫治疗联合化疗的非鳞状和鳞状转移性非小细胞肺癌（NSCLC）患者，标准治疗药物多西他赛分别实现了约3.6个月和3.9个月的中位无进展生存期（PFS）。1 1“Our ambition is to improve outcomes for patients across the full spectrum of lung cancer, spanning disease subtypes, stages and lines of therapy,” “我们的雄心是改善涵盖所有亚型、分期和治疗线数的全谱系肺癌患者的治疗结局。”said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech BioNTech 联合创始人兼首席医疗官、医学博士 Özlem Türeci 教授表示. “These encouraging results for pumitamig plus docetaxel extend the clinical evidence to patients whose disease has progressed after immunotherapy plus chemotherapy, a setting in which treatment options remain limited. Together with our findings in first-line NSCLC and extensive-stage small cell lung cancer, they support our strategy to develop pumitamig across a broad range of lung cancer settings, including those with particularly high unmet medical need.”. “普米塔单抗联合多西他赛取得的这些令人鼓舞的结果，将临床证据扩展至免疫治疗联合化疗后疾病进展的患者群体，而该群体的治疗选择仍然有限。结合我们在一线非小细胞肺癌和广泛期小细胞肺癌中的研究结果，这些数据支持我们在包括医疗需求尤其未被满足的多种肺癌适应症中开发普米塔单抗的战略。”“This is the third global Phase 2 dataset to show consistent activity for pumitamig in lung cancer across PD-L1 expression levels, and it extends our evidence into a second-line setting where current options fall short,” said “这是第三个显示pumitamig在肺癌中无论PD-L1表达水平如何均具有一致活性的全球II期数据集，并将我们的证据扩展至当前治疗方案不足的二线治疗环境，”Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb Cristian Massacesi，百时美施贵宝公司执行副总裁、首席医疗官兼研发负责人. “Together with BioNTech, we are advancing one of the broadest development programs in the class as we continue to build the growing body of clinical evidence for pumitamig across multiple types and treatment lines of lung cancer, with four ongoing global Phase 3 trials, and we look forward to defining the path forward for pumitamig in second-line NSCLC.”. “我们与BioNTech携手，正在推进该类药物中范围最广的开发计划之一。我们持续积累pumitamig在多种类型及多线治疗肺癌中的临床证据，目前有四项全球III期临床试验正在进行中。我们期待明确pumitamig在二线非小细胞肺癌（NSCLC）治疗中的未来发展方向。”Across 50 patients in the safety evaluation, pumitamig plus chemotherapy showed a manageable safety profile, with no new safety signals. Pumitamig treatment-related adverse events (“TRAEs”) of any grade were reported in 52.0% of patients and grade ≥ 3 TRAEs in 18.0%, leading to treatment discontinuation in four (8.0%) patients. 在50例接受安全性评估的患者中，普米塔单抗联合化疗显示出可控的安全性特征，未发现新的安全信号。任何等级的普米塔单抗治疗相关不良事件（TRAEs） reported in 52.0%的患者中，≥3级TRAEs发生在18.0%的患者中，导致4例（8.0%）患者终止治疗。Immune- related AEs occurred in 11 (22.0%) patients and grade ≥ 3 immune- related AEs in five (10.0%) patients. VEGF-related events were reported in 13 (26.0%) patients; grade 3 events were rare (two patients, 4.0%), with no grade 4 or 5 events. Bleeding events occurred in eight (16.0%) patients and were limited to grade 1 or 2 severity. 11例（22.0%）患者发生免疫相关不良事件，其中5例（10.0%）患者发生3级及以上免疫相关不良事件。13例（26.0%）患者报告VEGF相关事件；3级事件罕见（2例，4.0%），无4级或5级事件。8例（16.0%）患者发生出血事件，严重程度仅限于1级或2级。There were no pumitamig-related deaths or dose-limiting toxicities (“DLTs”).. 未发生与pumitamig相关的死亡或剂量限制性毒性（“DLT”）。BioNTech and BMS are advancing a broad development plan for pumitamig in multiple cancer types, including lung cancer across disease stages, subgroups and lines of therapy. ROSETTA Lung-107 extends the program into the second-line NSCLC setting, and these data will inform the further development of pumitamig in this underserved patient population. BioNTech 与百时美施贵宝（BMS）正在推进 pumitamig 在多种癌症类型中的广泛开发计划，涵盖不同疾病阶段、亚组和治疗线数的肺癌患者。ROSETTA Lung-107 研究将该计划拓展至二线非小细胞肺癌（NSCLC）治疗领域，相关数据将为 pumitamig 在这一未满足医疗需求显著的患者人群中的进一步开发提供依据。. 。About ROSETTA Lung-107 关于 ROSETTA Lung-107The global, open-label, single-arm Phase 2 ROSETTA Lung-107 trial ( 全球性、开放标签、单臂的2期ROSETTA Lung-107试验（NCT06841055 NCT06841055) is evaluating pumitamig (BNT327/BMS986545) in combination with docetaxel in patients with stage IV squamous or non-squamous NSCLC whose disease progressed following first-line immunotherapy plus chemotherapy, with any level of PD-L1 expression. Patients with prior exposure to anti-VEGF monoclonal antibodies or PD-(L)1xVEGF bispecific antibodies were excluded. ）正在评估 pumitamig（BNT327/BMS986545）联合多西他赛在一线免疫治疗联合化疗后疾病进展、PD-L1 表达水平不限的 IV 期鳞状或非鳞状非小细胞肺癌（NSCLC）患者中的疗效。既往接受过抗 VEGF 单克隆抗体或 PD-(L)1/VEGF 双特异性抗体治疗的患者被排除在外。In Part 1 (safety run-in), patients received pumitamig 1400 mg or 2000 mg plus docetaxel 75 mg/m² every three weeks (Q3W). In Part 2 (dose expansion), patients received pumitamig 1400 mg plus docetaxel 75 mg/m² Q3W, the dose recommended by the internal review committee based on the totality of evidence from Part 1 and the broader pumitamig lung cancer program. 在第1部分（安全性导入期）中，患者每三周（Q3W）接受1400 mg或2000 mg的pumitamig联合75 mg/m²的多西他赛治疗。在第2部分（剂量扩展期）中，患者每三周（Q3W）接受1400 mg的pumitamig联合75 mg/m²的多西他赛治疗，该剂量是内部审查委员会基于第1部分的全部证据以及更广泛的pumitamig肺癌项目数据所推荐的剂量。The primary endpoints are dose-limiting toxicities (Part 1 only), safety, and objective response rate (“ORR”) per investigator’s assessment (RECIST 1.1). Secondary endpoints include disease control rate (“DCR”), duration of response (“DOR”), depth of response, time to response, progression-free survival (“PFS”), overall survival (“OS”), pharmacokinetics, and antidrug antibody prevalence. 主要终点为剂量限制性毒性（仅限第1部分）、安全性以及研究者评估的客观缓解率（“ORR”，依据RECIST 1.1标准）。次要终点包括疾病控制率（“DCR”）、缓解持续时间（“DOR”）、缓解深度、起效时间、无进展生存期（“PFS”）、总生存期（“OS”）、药代动力学以及抗药物抗体发生率。The trial enrolled 59 patients at sites in Australia, the Republic of Korea, Spain, Türkiye, the United Kingdom, and the United States.. 该试验在澳大利亚、大韩民国、西班牙、土耳其、英国和美国的多个中心共入组了59名患者。About Pumitamig 关于普米塔米格Pumitamig is an investigational bispecific immunomodulator, jointly developed by BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is aimed at restoring the immune system’s ability to recognize and destroy tumor cells while simultaneously cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), preventing them from growing and proliferating. Pumitamig 是一款由 BioNTech 与 BMS 联合开发的在研双特异性免疫调节剂，旨在协同结合 PD-L1 和 VEGF-A。其目标是恢复免疫系统识别和摧毁肿瘤细胞的能力，同时切断为肿瘤细胞提供营养的血液和氧气供应（抗血管生成作用），从而抑制肿瘤的生长和增殖。By anchoring to PD-L1 receptors on tumor cells, we believe pumitamig localizes VEGF-A blockade within the tumor microenvironment, potentially enhancing antitumor activity while minimizing systemic exposure.. 通过与肿瘤细胞上的PD-L1受体结合，我们认为pumitamig能够将VEGF-A的阻断作用局限在肿瘤微环境中，从而在最小化全身暴露的同时， potentially 增强抗肿瘤活性。More than 4,000 patients have been treated with pumitamig in clinical trials to date. Seven global Phase 3 trials with registrational potential are currently ongoing, evaluating pumitamig plus chemotherapy compared to standard of care treatments, in first-line small cell lung cancer (ROSETTA Lung-01, . 迄今为止，已有超过4,000名患者在临床试验中接受了pumitamig治疗。目前正在进行七项具有注册潜力的全球III期临床试验，评估pumitamig联合化疗与标准治疗方案在一线小细胞肺癌中的疗效（ROSETTA Lung-01，NCT06712355 NCT06712355); first-line non-small cell lung cancer (ROSETTA Lung-02, ）；一线非小细胞肺癌（ROSETTA Lung-02，NCT06712316 NCT06712316); unresectable stage III non-small cell lung cancer (ROSETTA Lung-201, ); 不可切除的III期非小细胞肺癌（ROSETTA Lung-201，NCT07361497 NCT07361497); first-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA Lung-202, ）；一线治疗、PD-L1表达≥50%的非小细胞肺癌（ROSETTA Lung-202，NCT07361510 NCT07361510); first-line triple-negative breast cancer (ROSETTA Breast-01, ）；一线三阴性乳腺癌（ROSETTA Breast-01，NCT07173751 NCT07173751); first-line microsatellite stable colorectal cancer (ROSETTA CRC-203, ）；一线微卫星稳定型结直肠癌（ROSETTA CRC-203，NCT07221357 NCT07221357); and first-line gastric cancer (ROSETTA Gastric-204, ）；以及一线胃癌（ROSETTA Gastric-204，NCT07221149 NCT07221149). Pumitamig is also being explored in 10+ novel-novel combination trials with ADCs and other novel modalities, with the aim of expanding its role across tumor types and identifying additional pivotal opportunities. ）。Pumitamig 还在十余项与抗体偶联药物（ADC）及其他新型疗法的创新联合试验中接受探索，旨在扩大其在不同肿瘤类型中的应用范围，并识别更多关键机遇。About NSCLC 关于非小细胞肺癌Non-small cell lung cancer (NSCLC) covers all epithelial lung cancers other than small cell lung cancer and includes squamous cell carcinoma, large cell carcinoma, and adenocarcinoma of the lung. It is the most common type of lung cancer, accounting for approximately 85% of cases, and is the leading cause of cancer-related deaths worldwide.. 非小细胞肺癌（NSCLC）涵盖除小细胞肺癌以外的所有上皮性肺癌，包括鳞状细胞癌、大细胞癌和肺腺癌。它是最常见的肺癌类型，约占病例的85%，是全球癌症相关死亡的主要原因。2 2Scientific advances have transformed the treatment of NSCLC, improving outcomes for many patients. However, NSCLC remains an aggressive disease with a poor prognosis and a 5-year survival rate of 18 to 22% in advanced stages. 科学进步已经改变了非小细胞肺癌（NSCLC）的治疗方式，改善了许多患者的预后。然而，非小细胞肺癌仍然是一种侵袭性疾病，晚期阶段的5年生存率仅为18%至22%，预后较差。3 3Patients with low levels of PD-L1 expression typically do not respond well to checkpoint inhibitor-based regimens creating a significant unmet need for new treatment options that provide durable responses to a broad range of patients. PD-L1表达水平低的患者通常对基于检查点抑制剂的方案反应不佳，因此迫切需要提供持久疗效且适用于广泛患者的新治疗选择。About BioNTech 关于 BioNTechBioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. BioNTech 是一家全球性的新一代生物制药公司，致力于开创针对癌症及其他严重疾病的新型研究性疗法。在肿瘤学领域，BioNTech 致力于变革癌症的治疗方式。其雄心在于开发具有泛肿瘤或协同潜力的创新药物，从多角度应对癌症，并覆盖从早期到晚期的疾病全程。Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.. 其日益壮大的后期肿瘤产品管线涵盖免疫调节剂、抗体偶联药物和mRNA癌症免疫疗法等互补的治疗方法。BioNTech已与多家全球及专业制药合作伙伴建立合作关系，借助互补的专业知识和资源加速创新并推动进展，合作伙伴包括百时美施贵宝、Duality Biologics、罗氏集团成员基因泰克、Genmab、MediLink、OncoC4以及辉瑞。For more information, please visit 欲了解更多信息，请访问www.BioNTech.com 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: BioNTech’s collaboration with Bristol Myers Squibb (BMS); BioNTech and BMS’s ability to successfully co-develop and co-commercialize pumitamig (also known as BNT327 or BMS986545), if approved; the rate and degree of market acceptance of pumitamig, if approved; the initiation, timing, progress, and results of BioNTech’s research and development programs, including BioNTech’s current and future clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations, including expectations regarding the potential indications in which pumitamig may be approved, if at all; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; and discussions with regulatory agencies. 本新闻稿包含经修订的《1995年私人证券诉讼改革法案》所定义的“前瞻性陈述”，包括但不限于以下方面的陈述：BioNTech与百时美施贵宝（BMS）的合作；BioNTech和BMS在获得批准的情况下成功共同开发并共同商业化pumitamig（也称为BNT327或BMS986545）的能力；在获得批准的情况下，pumitamig的市场接受速度和程度；BioNTech研发项目的启动、时间安排、进展和结果，包括BioNTech当前及未来的临床试验，其中涉及关于试验启动、入组和完成的预期时间以及相关准备工作和结果可得性的陈述，以及监管审批和上市许可申请的时间和结果，包括对pumitamig可能获批的适应症（如果有的话）的预期；额外潜在注册性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；以及与监管机构的讨论。In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.. 在某些情况下，前瞻性陈述可以通过“将”、“可能”、“应该”、“预期”、“打算”、“计划”、“旨在”、“预计”、“相信”、“估计”、“预测”、“潜在”、“继续”等术语，或这些术语的否定形式或其他类似术语来识别，尽管并非所有前瞻性陈述都包含这些词语。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对当前未来事件的预期和信念，既非承诺也非保证。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、不确定性和其他因素，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所表达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 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; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s product candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by. 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、临床试验的开始和/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，以及对现有临床前、临床或安全性数据的进一步分析；临床数据的性质，其需接受持续的同行评审、监管审查和市场解读；关税及贸易政策升级的影响；与BioNTech候选产品相关的竞争；BioNTech获得并维持其候选产品监管批准的时间安排及其能力；BioNTech识别研究机会以及发现和发展研究用药物的能力；BioNTech的第三方合作伙伴继续开展与BioNTech候选产品及研究药物相关的研发活动的能力和意愿；不可预见的安全问题，以及据称因使用由BioNTech开发或生产的产品及候选产品而引发的潜在索赔。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 June 30, 2026 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at 您应审阅BioNTech截至2026年6月30日期间提交的6-K表格报告中“风险因素”标题下所述的风险和不确定性，以及BioNTech随后向美国证券交易委员会（SEC）提交的文件，这些文件可在SEC网站获取，网址为www.sec.gov 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.. 这些前瞻性陈述仅反映截至本新闻稿发布之日的情况。除法律另有要求外，BioNTech 不承担因新信息、未来事态发展或其他原因而更新或修订本新闻稿中任何前瞻性陈述的任何意图或责任。About Bristol Myers Squibb 关于百时美施贵宝At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at 在百时美施贵宝，我们的使命是发现、开发和提供创新药物，帮助患者战胜严重疾病。我们致力于推进大胆的科学探索，以定义医药未来及我们所服务患者的无限可能。欲了解更多信息，请访问BMS.com BMS.comand follow us on 并在以下平台关注我们LinkedIn 领英, ，X X, ，YouTube YouTube, ，Facebook 脸书and 和Instagram Instagram. 。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. 本新闻稿包含1995年《私人证券诉讼改革法案》所定义的“前瞻性陈述”，内容涉及（但不限于）药品的研发及商业化。所有非历史事实的陈述均属于或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 our control and could cause 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，并涉及固有的风险、假设和不确定性，包括可能在未来几年内延迟、偏离或改变上述任何事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，并可能导致未来的财务业绩、目标、计划和宗旨与陈述中明示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 realized by Bristol Myers Squibb or may take longer to realize than anticipated, that future study results may not be consistent with the results to date, that pumitamig (also known as BNT327 or BMS986545) alone or in combination with chemotherapy (such as docetaxel) may not achieve its primary study endpoint or 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 pumitamig alone or in combination with chemotherapy 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：百时美施贵宝可能无法实现与BioNTech合作的预期收益和相关机会，或者实现时间可能长于预期；未来研究结果可能与迄今的结果不一致；pumitamig（也称为BNT327或BMS986545）单药或与化疗药物（如多西他赛）联合使用可能无法达到主要研究终点，也可能无法在当前预期的时间框架内或根本无法获得本新闻稿所述适应症的监管批准；任何获批的上市许可在使用上可能存在重大限制；以及若获批准，pumitamig单药或与化疗药物联合使用是否具有商业成功性。No forward-looking statement can be guaranteed. Forward-looking statements in this press. 任何前瞻性陈述均无法得到保证。本新闻稿中的前瞻性陈述。CONTACTS 联系人BioNTech 百欧恩泰Media Relations 媒体关系Jasmina Alatovic 亚斯米娜·阿拉托维奇Media@biontech.de Media@biontech.deInvestor Relations 投资者关系Douglas Maffei, PhD 道格拉斯·马费伊，博士Investors@biontech.de Investors@biontech.deBristol Myers Squibb 百时美施贵宝Media Relations 媒体关系media@bms.com media@bms.comInvestor Relations 投资者关系Investor.relations@bms.com investor.relations@bms.com1. Ahn MJ et al. J Clin Oncol. 2025;43(3):260–272. 1. Ahn MJ 等. 《临床肿瘤学杂志》. 2025;43(3):260–272.2. Lin Z et al. Medicine (Baltimore). 2025 Jul 25;104(30):e43300. 2. Lin Z 等. 《医学》（巴尔的摩）. 2025年7月25日;104(30):e43300.3. Liu SV et al. Immunotherapy. 2025 Oct;17(14):1005-1013. 3. 刘SV等。《免疫治疗》。2025年10月；17(14):1005-1013。
