Cemiplimab-RWLC

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

旧引擎熄火的年份,才最考验一家药企的成色。 2026年2月4日,再生元(Regeneron,NASDAQ: REGN)向SEC递交2025财年10-K。数字乍看相当平淡:全年营收143.43亿美元,同比增长不到1%,几乎原地踏步。但往报表深处多翻两页,会看到另一个再生元:净利润45.05亿美元创历史新高,研发投入58.5亿美元同比增长14%,账上还趴着超过150亿美元净现金。 这是一次典型的空中换引擎。撑了十几年现金流的眼科药物EYLEA,正被生物类似药成群围剿;同一时间,赛诺菲负责销售的Dupixent冲上178亿美元,成为全球卖得最好的自免药物。一边坠落,一边登基,中间站着一家坚持不靠并购买产品的公司。2025年,就是它换引擎的一年。 一、营收原地踏步,利润却创了新高 把2025年的损益表拆开看,会发现"停滞"只是表象。营收143.43亿美元只比2024年多出1.41亿,但结构发生了剧烈换血:自产产品销售收入从76.29亿降到63.09亿,少了13.2亿;来自赛诺菲的合作收入从45.31亿猛增到58.84亿,多了13.53亿,几乎精准对冲。 利润端反而更漂亮。净利润45.05亿美元,稀释每股收益41.48美元;销售及管理费用不升反降,从29.54亿回落到27.00亿——主要因为减少了向患者援助组织的捐赠支出。真正花钱的地方只有一个:研发。58.5亿美元的投入占营收41%,在同等体量的美国药企里,这个比例名列前茅。 2026年的后劲验证了换引擎的成色:二季度营收42.9亿美元,同比增长17%,连续第二个季度双位数增长。停滞,只是账面上的过渡态。 二、EYLEA的黄昏:一年蒸发20亿美元美国销售额 眼科是再生元的龙兴之地,也是当下最疼的伤口。2025年,EYLEA美国销售额27.48亿美元,同比暴跌42%,一年蒸发超过20亿美元。10-K里写得直白:销量下降源于竞争加剧、患者流向低价的贝伐珠单抗调配药,以及老患者向自家8 mg新版本EYLEA HD的转移。 EYLEA HD确实在接棒——美国销售额16.37亿美元,同比增长36%,去年11月又拿下视网膜静脉阻塞(RVO)适应症和每4周给药方案。但新旧切换的过程中,缺口是真实的:EYLEA与EYLEA HD合计占公司营收的比重,从2024年的42%掉到2025年的31%。 更棘手的是生产端的一场无妄之灾。代工厂Catalent印第安纳工厂收到FDA的OAI警告,直接导致EYLEA HD预充式注射器在2025年10月被开CRL,同一张检查报告还连累了血液瘤新药Ordspono的上市申请。直到12月换了新灌装厂获批,这件事才算翻篇。进入2026年,阿柏西普2 mg生物类似药成批上市,EYLEA二季度美国销售额再跌45%至4.12亿美元。所幸EYLEA HD同比增长52%至5.96亿美元,已占美国眼科 franchise 的六成,创新品牌市场份额57%,成为唯一份额环比还在涨的品牌。 三、Dupixent登基:178亿美元背后的分成生意 真正的增量引擎是Dupixent。2025年全球净销售178.07亿美元,同比增长26%;2026年二季度单季冲上60亿美元,同比再增38%,活跃治疗患者超过150万,横跨特应性皮炎、哮喘、慢阻肺等9个适应症,是皮肤科、呼吸科医生处方量第一的生物药。 对再生元来说,这是一门分账生意:全球销售由赛诺菲记账,再生元按比例分利润,2025年分得52.42亿美元,分成比例29%,且还在逐年走高(2023年26%、2024年27%)。更关键的变化发生在2026年二季度末——再生元把欠赛诺菲的约31亿美元开发垫付款全部还清。从三季度起,Dupixent每卖一美元,落到再生元账上的比例将出现实质性跳升。 这门生意的独特点在于:药是再生元科学家在自己的VelocImmune小鼠平台上做出来的,销售体系却借用了跨国巨头的全球网络。自己造药,别人卖药,利润大头往自己口袋流——这是再生元与辉瑞、BMS们靠并购续命完全不同的生存方式。 四、不买药的巨头:实验室才是它的BD部门 看一家药企的底色,看它的钱花在哪。2025年再生元最大的一笔"并购式支出"只有8000万美元——付给豪森的一个授权首付款。对比动辄百亿美金买公司的同行,这家公司几乎把所有筹码押在了内部研发上,平均雇员15261人,一半以上在实验室和临床线上。 它的底气来自两套自研平台。一套是VelociSuite:VelocImmune小鼠把600万个碱基的抗体基因替换成人类基因,能直接产出全人源抗体——Dupixent、EYLEA、Libtayo、Praluent全部产自这里。另一套是再生元遗传学中心(RGC),累计完成超过300万例样本测序,2025年又拿下UK Biobank蛋白质组计划,并与Truveta签约测序最多1000万美国志愿者样本。别人买管线,它买的是"靶点从哪里来"的上游能力。 指标(亿美元) 2023 2024 2025 总营收 131.17 142.02 143.43 净利润 39.54 44.13 45.05 研发费用 44.39 51.32 58.50 EYLEA美国销售 57.20 47.67 27.48 Dupixent全球销售 115.88 141.48 178.07 五、五十个临床资产:下一张牌桌在哪 10-K里列出的在研管线约50项,真正值得盯的是几张新牌。血液瘤方向,BCMA×CD3双抗Lynozyfic已获FDA和欧盟批准用于复发难治多发性骨髓瘤,这是再生元少有的自己独立商业化的产品,2026年ASCO又披露了其在系统性轻链淀粉样变性的积极数据。补体赛道,cemdisiran治疗全身性重症肌无力的三期达标,FDA已受理并给优先审评,2026年11月见分晓。 更远的牌桌上坐着三个高赔率标的:治疗先天性耳聋的基因疗法Otarmeni(原DB-OTO),EMA已受理加速审评,一旦获批是全球首款"让聋儿听见"的基因治疗;治疗进行性骨化性纤维增殖不良症的garetosmab三期达到主要终点;代谢领域,抗肌生长抑制素抗体trevogrumab联用司美格鲁肽减脂不减肌,两个抗凝血Factor XI抗体也将在2026年启动三期。当然也有坏消息:IL-33抗体itepekimab在慢阻肺两项三期一中一负,与K药头对头的LAG-3抗体fianlimab在黑色素瘤三期中憾失主要终点——数值上多出约5个月无进展生存,但统计学不认。 六、风险清单:分成依赖、专利悬崖与一场豪赌 冷静看,再生元的软肋同样清晰。第一,营收结构高度依赖两家伙伴:Dupixent贡献的利润分成占2025年营收的37%,EYLEA海外又全系挂在拜耳账下,赛诺菲和拜耳任何一次策略摇摆都会直接传导到损益表。第二,Dupixent美国成分专利2031年3月到期,按照生物类似药的节奏,留给这门分成生意的高增长窗口大约只剩四五年。第三,管线虽多,但真正能接Dupixent班的三期资产尚未出现——itepekimab和fianlimab两个2025年的挫折说明,平台再强,三期临床照样不保证通关。 再生元的回应方式很有它的性格:2025年2月董事会批准30亿美元回购,2026年上半年已花掉20亿;同时继续加注自研。用CEO施莱弗的话说,公司要做的就是把科学翻译成更多新药。 一句话收尾:不买产品的公司,必须让自己的实验室永远比专利悬崖跑得快。再生元已经证明过一次,现在它需要再证明一次。