Pumitamig

Pumitamig plus B7H3-targeting elfetabart drozuntecan delivers the first data in lung cancer for any PD-(L)1xVEGF bispecific immunomodulator combined with an antibody-drug conjugate, underscoring BioNTech’s leadership in novel-novel combination treatment strategies Updated overall survival data for gotistobart from the PRESERVE-003 Phase 3 clinical trial will add to the growing body of evidence for this chemotherapy-free treatment approach in the second- and later-line treatment of advanced squamous non-small cell lung cancer following prior immunotherapy BioNTech is advancing a diversified development program in lung cancer treatment spanning more than 16 ongoing clinical trials across subtypes, biomarkers and treatment settings, including five ongoing Phase 3 clinical trials and two novel-novel combination trials MAINZ, Germany, August 20, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer (“WCLC”) in Seoul, Republic of Korea, from September 12-15, 2026. The breadth of data highlights the latest progress across key strategic assets, pumitamig (BNT327/BMS986545) and gotistobart (BNT316/ONC-392), as well as BioNTech’s mRNA-based immunotherapy approaches, highlighting the strength of BioNTech’s lung cancer treatment pipeline. Additionally, a late breaking oral presentation will detail data from the novel-novel combination trial of pumitamig with the investigational B7H3-targeted antibody-drug conjugate (“ADC”) elfetabart drozuntecan (elfe-D or BNT324/DB-1311), representing the first combination data for any PD-(L)1xVEGF bispecific immunomodulator and an ADC in lung cancer. “Progress in lung cancer care means both improving treatment outcomes for patients and, importantly, finding better options for more patients who still do not sufficiently benefit from current standard therapies,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech . “The data we are presenting at this year’s WCLC provide further clinical evidence for our late-stage assets, gotistobart and pumitamig, and help to define the role of next-generation immunomodulators in addressing unmet medical needs in lung cancer. We are also presenting the first clinical evidence from a novel-novel treatment combination in lung cancer as part of our evaluation of pumitamig as a potential backbone for combination strategies of complementary mechanisms. Taken together, these data will inform the next steps in our clinical development programs and our broader efforts to expand treatment options for patients.” Highlights from BioNTech’s presentations at WCLC 2026: Novel-novel combination trial of pumitamig, developed in collaboration with Bristol Myers Squibb Company (“BMS”), and elfetabart drozuntecan, developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”): Advanced/metastatic SCLC and NSCLC : First data from the global Phase 1/2 trial ( NCT06892548 ) evaluating pumitamig in combination with the B7H3-targeting ADC elfetabart drozuntecan in patients with advanced or metastatic small cell lung cancer (“SCLC”) and NSCLC will be presented for this novel-novel treatment combination approach, underlining BioNTech’s leadership in novel-novel combination treatment strategies. Gotistobart – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. (“OncoC4”): 2L+ squamous NSCLC : Updated overall survival data from stage 1 of the PRESERVE-003 Phase 3 clinical trial ( NCT05671510 ) of gotistobart in patients with squamous non-small cell lung cancer (“NSCLC”) who progressed on prior PD-(L)1 inhibitor treatment will be presented. The results further contribute to the growing body of evidence for this chemotherapy-free treatment approach. The pivotal stage 2 part of the trial is ongoing. All abstracts are available through the WCLC website . Further information on BioNTech’s lung cancer pipeline can be accessed here. Full presentation details: Candidate Abstract Title Abstract Number/Presentation Details Pumitamig + elfetabart drozuntecan Pumitamig (PD-L1 x VEGF-A bsAb) + Elfetabart Drozuntecan (Elfe-D, B7H3 ADC) in Patients with Advanced/Metastatic Lung Cancer (NSCLC or SCLC) Abstract # OA14.01 Oral Presentation The Breakthrough Immunotherapy for Advanced NSCLC Sep 15, 2026: 12:30 - 01:45pm KST Pumitamig First-line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Malignant Mesothelioma: Long-term PFS and OS Abstract #MO04.09 Mini Oral Novel Therapeutics and Molecular Insights in Thymic Malignancies and Pleural Mesothelioma Sep 13, 2026: 4:45 - 6:00pm KST ROSETTA Lung‑201: A Phase 3 Trial of Pumitamig Monotherapy vs Durvalumab in Unresectable Stage III NSCLC Post-Chemoradiation Abstract #P2.330 Poster Clinical Trials in Progress Sep 14, 2026: 10:30am - 12:00pm KST ROSETTA Lung-202: A Phase 3 trial of first-line pumitamig monotherapy vs pembrolizumab in locally advanced/metastatic NSCLC Abstract #P2.355 Poster Clinical Trials in Progress Sep 14, 2026: 10:30am - 12:00pm KST Gotistobart Gotistobart vs Docetaxel in Metastatic Squamous NSCLC After PD-(L)1 Progression: Updated Overall Survival of the stage 1 of PRESERVE-003 Abstract #MO07.04 Mini Oral Novel Immunotherapeutic Strategies in mNSCLC Sep 14, 2026: 5:00 - 6:15pm KST BNT116 Neoadjuvant BNT116 + Cemiplimab + Carboplatin + Paclitaxel in Resectable NSCLC: Preliminary Results From a Phase I Trial Abstract #MO06.03 Mini Oral Emerging Precision Approaches in Perioperative Therapy for Resectable NSCLC Integrating Targeted Therapy, Immunotherapy, Biomarkers, and Multimodal Strategies Sep 14, 2026: 3:30 - 4:45pm KST About BioNTech in Lung Cancer Treatment Lung cancer is one of BioNTech’s key focus areas. Through a diversified portfolio of investigational next-generation immunomodulators, ADCs and mRNA-based cancer immunotherapies, the Company is pursuing multiple approaches designed to address significant unmet needs for patients across lung cancer subtypes, histologies and treatment settings. BioNTech’s clinical pipeline encompasses both monotherapies and combinations with standard of care treatments, as well as novel-novel combination regimens aimed at delivering differentiated therapeutic profiles for the treatment of patients with lung cancer. With 16 ongoing lung cancer trials, including five pivotal Phase 3 and two novel-novel combination trials, BioNTech is advancing a comprehensive development strategy with the aim of improving outcomes for patients across the continuum of lung cancer. About BioNTech BioNTech 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. 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. For more information, please visit . BioNTech Forward-Looking Statements 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: the initiation, timing, progress and results of BioNTech’s research and development programs in oncology, including the targeted timing and number of additional potentially registrational trials; BioNTech’s and its collaborators’ current and future preclinical and clinical trials in oncology, including the investigational bispecific immunomodulator pumitamig (BNT327/BMS986545) in unresectable malignant mesothelioma, the investigational anti-CTLA-4 antibody gotistobart (BNT316/ONC-392) in metastatic squamous NSCLC, the investigational B7H3-targeted ADC elfetabart drozuntecan (BNT324/DB-1311) in combination with pumitamig in (N)SCLC, and the investigational mRNA cancer immunotherapy candidate BNT116 in resectable NSCLC; the nature and characterization of and timing for release of clinical data across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or submission for and receipt of product approvals and potential commercialization with respect to BioNTech’s product candidates; and the potential safety and efficacy of BioNTech’s product candidates. 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. 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. 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, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, 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 the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; the impact of tariffs and escalations in trade policy; 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 development 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 BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. 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 . 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. CONTACTS Media Relations Jasmina Alatovic Media@biontech.de Investor Relations Douglas Maffei, PhD Investors@biontech.de

PREFACE 前言 近日，随着半年报陆续披露，全球畅销药Top50榜单“新鲜出炉”。 276.93亿美元，是礼来替尔泊肽（Mounjaro/Zepbound）半年的销售额，断层第一。排在第二的，是诺和诺德司美格鲁肽，175.25亿美元。 一年前，司美还领先替尔泊肽近19亿美元；如今反被反超逾百亿美元，攻守之势彻底逆转。 而曾经的“药王”Keytruda（K药）自Q1跌落神坛，滑至第三之后，便“一蹶不振”，Q2增速几乎腰斩，由8%跌至4%。 肿瘤赛道，PD-1“英雄落幕”的故事令人唏嘘；代谢领域，GLP-1“少年得志”的传奇才刚开篇。 如此“冰火两重天”背后，是全球创新药的最强增长引擎正在换挡，时代正在加速更迭——而这一次，中国药企不再是看客。 01 一个时代的兴起，始于一个靶点代名词的反复提及。 过去十年，Keytruda卖到了世界的各个角落，PD-(L)1成为肿瘤免疫治疗的代名词。 随着Keytruda专利悬崖的逼近，默沙东也愈发焦虑，无论是收购还是BD，出手的频率都明显增多。然而，真正能替代Keytruda的又一款世界级大药，默沙东还没摸到边。 尽管如今旧王退位，GLP-1新王登基。但Keytruda已经成为传奇，而传奇之所以被歌颂，恰恰是因为稀有。 回看Keytruda的来时路，默沙东为其定制的超级生命周期版图不仅给肿瘤患者带来新希望，更为药企管线布局提供范本。 2014-2016年，从黑色素瘤到NSCLC，从后线到一线；2017-2018年，从泛实体瘤适应症，到联合化疗方案，默沙东以“一年一突破”的节奏“踩烂”FDA门槛。 截至目前，Keytruda已获批用于40多项肿瘤适应症，覆盖19个瘤种与2个泛瘤种，遍布全球超95个国家。 2026年，Keytruda痛失“药王”宝座，但并不意味着归于平庸。2025年超300亿美元的销售额，依然是全球最成功的创新药之一。 但不可否认的是，其增速已从高位明显放缓，褪下“药王”光环后的疲态，反映出Keytruda正在接近PD-(L)1赛道的商业天花板。 进入后Keytruda时代，PD-1单药作为“广谱免疫基石”的第一阶段使命已经完成。但PD-1并未退场，而是以“通路内核”的形式进入第二阶段。而这第二阶段，恰恰是中国创新药十年崛起之路的缩影。 ① PD-(L)1/VEGF双抗由中国企业定义——康方AK112头对头击败K药，三生/辉瑞12.5亿首付、荣昌/艾伯维6.5亿首付、普米斯系BNT327被BMS 15亿首付接盘，5款国产出海总包超200亿美元； ② PD-1系 + ADC成为MNC打包采购范式，百利天恒/BMS、信达/武田、信达/辉瑞把“IO底座+ADC杀伤”一起授权； ③ PD-1/IL-2（信达IBI363）、PD-1×VEGF×CTLA-4（基石CS2009）、TCE等延伸形态填补PD-L1低表达与原发耐药空白。 国家药监局披露口径下，2026上半年中国创新药共披露81笔对外授权，总包约1100亿美元，规模已达2025全年的80%。其中，全球Top10 BD榜单中国占据8席，而肿瘤IO类高价交易全都锚定“PD-1的下一个接棒者”。 就在全球医药行业在期待肿瘤赛道“下一个Keytruda”诞生之际，一个早于PD-(L)1近10年上市的老靶点——GLP-1，开始被反复提及。 02 旧壶装新酒，GLP-1重新出发，接棒代谢的下一个十年。 如果说PD-1代表着临床终点的胜利，那么GLP-1便是医药工业对慢病风险的一次系统接管。 从2005年全球首款GLP-1激动剂Byetta获批用于2型糖尿病，到2021年司美格鲁肽口服片切入减重适应症，诺和诺德称霸GLP-1赛道十几年。 2022年，礼来以GIP/GLP-1双靶点激动剂替尔泊肽加入牌桌，开启"双雄对决"。 仅仅四年，礼来就把“老师傅”诺和诺德掀翻在地——替尔泊肽在近280亿美元基数上仍保持88%增速，半年277亿登顶全球药王。 而这得益于GLP-1的减重适应症拓展与口服剂型的上市。据2024年《柳叶刀》发表的最新数据，全球肥胖人口已超10亿。有机构预测，到2030年，全球肥胖药市场份额或达千亿美元。 目前礼来与诺和诺德在减重适应症上拿出的数据，已足以震撼整个行业。然而，GLP-1还在不断捅破预期天花板。 2024年3月，基于此前直降20%的数据，司美格鲁肽口服片被FDA批准用于降低不良心血管事件风险。 这意味着，GLP-1正式从“治疗药物”变成“风险管理药物”——服药周期从“治病期间”延长到“终身管理”，人群从“患者”扩大到“风险人群”。这一变化带来的市场扩容，才是令行业和资本真正兴奋的点。 于是，便出现了默沙东陷入Keytruda专利悬崖焦虑，而礼来与诺和诺德却“风生水起”的局面。 但这一次，中国药企不再是跟在MNC身后“捡漏”的角色，而开始引领新时代的GLP-1浪潮。 信达便是第一个吃螃蟹的人。2025年，其自礼来买下的玛仕度肽在中国获批，成为全球首个获批用于体重管理的GCG/GLP-1双受体激动剂。 上市后其迅速放量。据机构测算，仅2026年第一季度，线上终端销售额便超过2.6亿元，交银国际预计其2026年销售额或将达到18亿元。 不过，信达的独占期也不会太久。根据上半年的管线进展与BD授权情况，2026年必然会成为中国GLP-1创新药爆发元年： 国内药企GLP-1管线布局与近期临床和BD进展，根据公开资料整理。 大批管线进入密集商业化兑现：博瑞BGM0504、翰森奥莱泊肽已受理NDA，恒瑞HRS9531、HRS-7535计划年内报产； BD出海呈现新高度：联邦制药凭UBT251顺利完成临床Ⅱ期拿到诺和诺德1350万美元里程碑款；甘李以7.26亿欧元将博凡格鲁肽推入欧洲39国； 差异化方向代表全球前沿：双周制剂（甘李、众生）、口服小分子（恒瑞HRS-7535）、三靶点（联邦UBT251）。 其中，部分国产下一代管线已交出具有国际竞争力的数据——BGM0504的15mg组52周减重达19.3%，玛仕度肽9mg剂量48周减重达20.1%，已接近甚至媲美替尔泊肽的疗效。 可以说，上一个十年，GLP-1是礼来与诺和诺德两大巨头的双人游戏；这一个十年，巨头开始抄中国GLP-1作业。 |结语 PD-1的退潮不是终点，GLP-1的接棒也不是终点。 每一次“药王”换人，背后都是一场技术范式的迁徙：从“杀死肿瘤细胞”到“管理代谢风险”，从“治已病”到“治未病”。 而真正值得记录的，是中国创新药在这两次换挡中都不再是旁观者——PD-1/VEGF双抗中国定义，GLP-1下一代中国引领。这一次，牌桌上的筹码，有一半是中国人下的。 注：资料转载自各大公司官网、公开信息源。版权归原作者所有，仅供读者学习、研究或者欣赏，不得用于商业用途，如涉及作品内容、版权和其他问题，请在30日内联系删除；本公众号对转载、分享的内容、陈述、观点判断保持中立，不对所包含内容的真实可靠性或完善性提供任何明示或暗示的保证，仅供读者学习、参考。本文仅为行业分析，不构成投资建议。股市有风险，投资需谨慎。