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Presentations showcase progress in BioNTech’s late-stage lung cancer programs, reinforcing the potential of the Company’s differentiated portfolio spanning immunomodulators, antibody-drug conjugates, mRNA cancer immunotherapies, and their combinations
演示文稿展示了BioNTech在晚期肺癌项目中的进展,进一步证实了公司涵盖免疫调节剂、抗体药物偶联物、mRNA癌症免疫疗法及其组合的差异化产品组合的潜力。
Data updates for pumitamig, a PD-L1xVEGF-A bispecific immunomodulator, from three clinical trials conducted in China further strengthen the evidence supporting its previously observed efficacy and safety profile in lung cancer
来自中国开展的三项临床试验的数据更新进一步加强了对pumitamig(一种PD-L1xVEGF-A双特异性免疫调节剂)在肺癌中先前观察到的有效性和安全性特征的支持证据。
Results of stage 1 from the global Phase 3 PRESERVE-003 clinical trial of gotistobart showed clinically meaningful survival outcomes and antitumor activity compared to the current standard of care in second-line or later therapy of squamous non-small cell lung cancer
全球三期PRESERVE-003临床试验的第一阶段结果显示,与目前用于二线或后线治疗鳞状非小细胞肺癌的标准疗法相比,gotistobart显示出具有临床意义的生存结果和抗肿瘤活性。
MAINZ, Germany, March 24, 2026
德国美因茨,2026年3月24日
– BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present data from its diversified portfolio in the field of lung cancer at the European Lung Cancer Congress (“ELCC”) held in Copenhagen, Denmark, from March 25-28, 2026. The data updates covered in both oral and poster presentations highlight progress across late-stage immunomodulator candidates pumitamig and gotistobart, as well as antibody-drug conjugate (“ADC”) programs, across various lung cancer subtypes and lines of treatment.
– BioNTech SE(纳斯达克代码:BNTX,“BioNTech”或“公司”)将于2026年3月25日至28日在丹麦哥本哈根举行的欧洲肺癌大会(“ELCC”)上展示其在肺癌领域的多样化产品组合数据。通过口头报告和海报展示呈现的数据更新,突显了晚期免疫调节剂候选药物普米塔米格(pumitamig)和戈蒂索巴特(gotistobart),以及抗体药物偶联物(“ADC”)项目在各类肺癌亚型和治疗线中的进展。
BioNTech’s clinical portfolio 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 across all stages of the disease..
BioNTech的临床产品组合包括单药疗法和与标准治疗方法的联合疗法,以及旨在为各阶段肺癌患者提供差异化治疗效果的新型联合疗法。
“The data we will present at this year’s ELCC further define the potential of our late-stage portfolio in lung cancer. With updates on pumitamig and gotistobart, as well as first clinical data for our HER3-targeted ADC, we continue to advance differentiated treatment approaches across lung cancer settings while building the clinical evidence to guide their further development,” said .
“我们将在今年的ELCC上展示的数据进一步明确了我们晚期肺癌产品组合的潜力。随着对pumitamig和gotistobart的更新,以及我们HER3靶向ADC的首批临床数据,我们继续在各类肺癌治疗领域推进差异化的治疗方法,同时积累临床证据以指导它们的进一步开发,”该公司表示。
Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech
Özlem Türeci教授,医学博士,BioNTech联合创始人兼首席医疗官
. “Our aim is to offer patients with lung cancer transformative treatment options that help provide meaningful long-term benefit across all stages of the disease.”
“我们的目标是为肺癌患者提供变革性的治疗选择,帮助他们在疾病的所有阶段获得有意义的长期益处。”
Highlights of BioNTech’s lung cancer programs to be presented at ELCC 2026:
将在ELCC 2026上展示的BioNTech肺癌项目亮点:
Pumitamig (BNT327/BMS986545) – a bispecific immunomodulator candidate combining PD-L1 checkpoint inhibition and VEGF-A neutralization, developed in collaboration with Bristol Myers Squibb Company (“BMS”):
Pumitamig(BNT327/BMS986545)—— 一种双特异性免疫调节候选药物,结合PD-L1检查点抑制和VEGF-A中和作用,由百时美施贵宝公司(“BMS”)合作开发:
1L ES-SCLC:
1L ES-SCLC:
Updated follow-up data from a single-arm Phase 2 clinical trial (
更新了来自单臂二期临床试验的随访数据 (
NCT05844150
NCT05844150
) conducted in China continued to show encouraging preliminary antitumor activity and survival outcomes, together with a manageable tolerability profile for pumitamig plus chemotherapy as first-line therapy in patients with extensive-stage small cell lung cancer (“ES-SCLC”), an aggressive subtype of lung cancer.
)在中国开展的试验继续显示出令人鼓舞的初步抗肿瘤活性和生存结果,同时对于广泛期小细胞肺癌(“ES-SCLC”)患者,pumitamig联合化疗作为一线治疗方案的耐受性表现可控。
The data support the ongoing pivotal global Phase 3 ROSETTA Lung-01 clinical trial (.
数据支持正在进行的关键性全球三期ROSETTA Lung-01临床试验。
NCT06712355
NCT06712355
) in first-line ES-SCLC.
)在一线ES-SCLC中。
1L NSCLC:
1L NSCLC:
New findings from a Phase 1b/2a clinical trial (
1b/2a期临床试验的新发现 (
NCT05918445
NCT05918445
) conducted in China showed preliminary antitumor activity irrespective of PD-L1 expression levels and a manageable safety profile for pumitamig as first-line monotherapy in both squamous and non-squamous advanced non-small cell lung cancer (“NSCLC”). The results complement the ongoing global Phase 2/3 ROSETTA Lung-02 clinical trial (.
)在中国开展的试验显示,无论 PD-L1 表达水平如何,pumitamig 作为一线单药治疗在鳞状和非鳞状晚期非小细胞肺癌(“NSCLC”)中均显示出初步的抗肿瘤活性,并且安全性可控。这些结果补充了正在进行的全球 2/3 期 ROSETTA Lung-02 临床试验(。
NCT06712316
NCT06712316
) evaluating the combination of pumitamig with chemotherapy in first-line NSCLC.
)评估pumitamig与化疗联合用于一线NSCLC。
EGFR-mutant NSCLC:
EGFR突变的非小细胞肺癌 (NSCLC):
Data from a Phase 2 clinical trial (
二期临床试验的数据 (
NCT05756972
NCT05756972
) conducted in China showed clinically meaningful survival outcomes and a manageable safety and tolerability profile for pumitamig combined with chemotherapy in patients with EGFR-mutant advanced or metastatic NSCLC, regardless of PD-L1 expression level. These data highlight its potential in patients progressing on EGFR tyrosine kinase inhibitors..
)在中国开展的试验显示,对于EGFR突变的晚期或转移性非小细胞肺癌患者,无论PD-L1表达水平如何,pumitamig联合化疗均显示出具有临床意义的生存结果,并且安全性和耐受性可控。这些数据突显了其在EGFR酪氨酸激酶抑制剂治疗进展的患者中的潜力。
Gotistobart (BNT316/ONC-392) – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4 and developed in collaboration with OncoC4, Inc. (“OncoC4”):
Gotistobart(BNT316/ONC-392)——一种针对CTLA-4并与OncoC4, Inc.(“OncoC4”)合作开发的肿瘤微环境选择性调节性T细胞耗竭候选药物:
2L+ squamous NSCLC:
2L+ 鳞状非小细胞肺癌:
Data from the non-pivotal, dose-confirmation stage 1 portion of the global Phase 3 PRESERVE-003 clinical trial (
全球三期PRESERVE-003临床试验中非关键的、剂量确认的第一阶段数据 (
NCT05671510
NCT05671510
) showed clinically meaningful antitumor activity, an overall survival benefit with a 54% reduction in the risk of death compared with standard of care chemotherapy, and a manageable safety profile for gotistobart in patients with squamous NSCLC who have progressed on prior immunotherapy plus chemotherapy.
)在先前接受过免疫治疗加化疗的鳞状非小细胞肺癌患者中,gotistobart显示出具有临床意义的抗肿瘤活性,与标准护理化疗相比,死亡风险降低了54%,并且整体生存获益和可控的安全性特征。
The pivotal stage of the Phase 3 clinical trial is ongoing..
第三阶段临床试验的关键阶段正在进行中。
BNT326/YL202 – a HER3-targeted ADC candidate developed in collaboration with MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink”):
BNT326/YL202——与迈迪克(苏州)有限公司(“迈迪克”)合作开发的一种靶向HER3的ADC候选药物:
NSCLC:
非小细胞肺癌:
First clinical data from the NSCLC cohort of a Phase 2 clinical trial with BNT326/YL202 (
BNT326/YL202二期临床试验的非小细胞肺癌队列的首批临床数据
NCT06107686
NCT06107686
) conducted in China showed antitumor activity and a favorable safety profile in patients with advanced or metastatic NSCLC who progressed after standard of care therapy. The findings support the ongoing Phase 1b/2 clinical trial (
`)在中国进行的试验显示,在接受标准治疗后病情进展的晚期或转移性非小细胞肺癌患者中,该疗法具有抗肿瘤活性和良好的安全性。这些发现支持了正在进行的1b/2期临床试验 (`
NCT07070232
NCT07070232
) evaluating the novel combination of pumitamig and BNT326/YL202.
)评估普米他单抗和BNT326/YL202的新组合。
Lung cancer is among
肺癌是其中一种
BioNTech’s tumor focus areas,
BioNTech的肿瘤重点研究领域,
as the Company aims to address the significant unmet medical needs in the treatment of patients with lung cancer. BioNTech is advancing a diversified and robust clinical development approach in lung cancer spanning investigational next-generation immunomodulators, antibody-drug conjugates, mRNA cancer immunotherapies, and their combinations.
随着公司旨在满足在肺癌患者治疗中显著未满足的医疗需求,BioNTech正在推进一个多样化且强大的肺癌临床开发策略,涵盖下一代免疫调节剂、抗体药物偶联物、mRNA癌症免疫疗法及其组合的研究。
With 16 ongoing clinical trials across various lung cancer subtypes and lines of treatment, including four ongoing pivotal Phase 3 clinical trials and five ongoing novel-novel combination trials, BioNTech is focused on developing innovative approaches to address the challenges of lung cancer treatment from early to late-stage conditions..
通过在各类肺癌亚型和治疗线路中开展的16项持续临床试验,包括四项正在进行的关键性III期临床试验和五项新型联合疗法试验,BioNTech专注于开发创新方法,以应对从早期到晚期肺癌治疗的挑战。
The abstracts are available on the
摘要可在
ELCC Congress website
ELCC大会网站
. Click
. 点击
here
这里
for further information on BioNTech’s lung cancer portfolio.
有关BioNTech肺癌产品组合的更多信息。
Full presentation details:
完整演示详情:
Medicine
医学
Abstract Title
摘要标题
Abstract Number/Presentation Details
摘要编号/演示详情
Pumitamig
普米塔米格
First-Line Pumitamig (PD-L1 × VEGF-A bsAb) Monotherapy in PD-L1+ Non-Squamous and Squamous Non-Small Cell Lung Cancer: Data from a Phase 1b/2a Trial in China
一线Pumitamig(PD-L1 × VEGF-A bsAb)单药治疗PD-L1阳性非鳞状和鳞状非小细胞肺癌:来自中国1b/2a期试验的数据
Abstract #69P
摘要 #69P
Poster
海报
March 27, 2026; 1:00 – 2:00pm CET
2026年3月27日;欧洲中部时间下午1:00 – 2:00
Progression-Free Survival and Overall Survival with Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer Following Progression with EGFR TKI in China: Phase 2 Study Results
Pumitamig(PD-L1 × VEGF-A bsAb)联合化疗在中国EGFR突变晚期非小细胞肺癌患者中,在EGFR TKI治疗进展后的无进展生存期和总生存期:2期研究结果
Abstract #21P
摘要 #21P
Poster
海报
March 27, 2026; 1:00 – 2:00pm CET
2026年3月27日;欧洲中部时间下午1:00 – 2:00
Phase 2 Study of First-Line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy for Extensive-Stage Small-Cell Lung Cancer (ES-SCLC): Updated Efficacy and Safety Results
一线Pumitamig(PD-L1 × VEGF-A bsAb)联合化疗治疗广泛期小细胞肺癌(ES-SCLC)的二期研究:更新的有效性和安全性结果
Abstract #426P
摘要 #426P
Poster
海报
March 26, 2026; 1:00 – 2:00pm CET
2026年3月26日;欧洲中部时间13:00 – 14:00
ROSETTA Lung-01: A Phase 3, Two-Stage Trial of Pumitamig, a PD-L1 × VEGF-A Bispecific Antibody, Plus Chemotherapy Versus Atezolizumab + Chemotherapy as First-Line Treatment in Patients with Extensive-Stage Small Cell Lung Cancer
ROSETTA Lung-01:一项关于Pumitamig(一种PD-L1 × VEGF-A双特异性抗体)联合化疗对比Atezolizumab + 化疗作为广泛期小细胞肺癌患者一线治疗的III期两阶段试验
Abstract #439TiP
摘要 #439TiP
Poster
海报
March 26, 2026; 1:00 – 2:00pm CET
2026年3月26日;欧洲中部时间下午1:00 – 2:00
ROSETTA Lung-02: A Global Phase 2/3, Randomized, Open-Label Trial of Pumitamig, a PD-L1 × VEGF-A Bispecific Antibody, in Combination with Chemotherapy in Patients (pts) With First-Line Non-Small Cell Lung Cancer
ROSETTA Lung-02:一项全球性二期/三期、随机、开放标签试验,评估Pumitamig(一种PD-L1 × VEGF-A双特异性抗体)联合化疗在一线非小细胞肺癌患者中的疗效
Abstract #149TiP
摘要 #149TiP
Poster
海报
March 27, 2026; 1:00 – 2:00pm CET
2026年3月27日;欧洲中部时间下午1:00 – 2:00
Gotistobart
Gotistobart
Anti-Tumor Activity of Gotistobart Compared to Docetaxel in Patients with Metastatic Squamous Non-Small Cell Lung Cancer (sqNSCLC) Progressing on PD-(L)1 Inhibitors: Stage 1 PRESERVE-003 Phase 3 Trial
戈蒂斯托巴特与多西他赛在进展于PD-(L)1抑制剂的转移性鳞状非小细胞肺癌(sqNSCLC)患者中的抗肿瘤活性比较:第三阶段PRESERVE-003试验的第一阶段
Abstract #3O
摘要 #3O
Proffered paper session
提供的论文会议
March 27, 2026; 3:35 – 3:45pm CET
2026年3月27日;欧洲中部时间下午3点35分至3点45分
BNT326/YL202
BNT326/YL202
First Disclosure of Efficacy and Safety Data for YL202/BNT326 (HER3 ADC) From a Phase 2 Trial in Patients (pts) with Non-Small Cell Lung Cancer (NSCLC)
YL202/BNT326(HER3 ADC)在非小细胞肺癌(NSCLC)患者中的二期试验首次披露疗效与安全性数据
Abstract #11MO
摘要 #11MO
Mini oral session
小型口头报告环节
March 27, 2026; 09:15 – 09:20am CET
2026年3月27日;欧洲中部时间上午09:15 – 09:20
BNT326-02: A Phase 1b/2 Trial of BNT326/YL202 (HER3 ADC) with Pumitamig (PD-L1 × VEGF-A bsAb) in Non-Small Cell Lung Cancer (NSCLC)
BNT326-02:BNT326/YL202(HER3 ADC)联合Pumitamig(PD-L1 × VEGF-A bsAb)在非小细胞肺癌(NSCLC)中的1b/2期试验
Abstract #6147TiP
摘要 #6147TiP
Poster
海报
March 27, 2026; 1:00 – 2:00pm CET
2026年3月27日;欧洲中部时间下午1:00 – 2:00
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治疗公司,率先开发用于癌症和其他严重疾病的新研究疗法。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.
其多样化的肿瘤学产品候选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, Genentech, a member of the Roche Group, 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一系列传染病的mRNA疫苗候选产品,同时还有其多样化的肿瘤学管线。BioNTech已经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,包括百时美施贵宝、Duality Biologics、罗氏集团旗下的基因泰克、Genmab、MediLink、OncoC4、辉瑞和再生元。
For more information, please visit
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: 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 bispecific immunomodulator candidate pumitamig (BNT327/BMS986545) in multiple indications, the investigational anti-CTLA-4 antibody gotistobart (BNT316/ONC-392) in multiple indications, and the HER3-targeted ADC candidate BNT326/YL202 as monotherapy and in combination with pumitamig in 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; the ability of BioNTech’s mRNA technology to demonstrate clinical efficacy outside of BioNTech’s infectious disease platform; and the potential safety and efficacy of BioNTech’s product candidates.
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:BioNTech在肿瘤学领域的研发计划的启动、时间安排、进展和结果,包括额外潜在注册试验的目标时间和数量;BioNTech及其合作伙伴当前和未来的临床前和临床试验,包括多种适应症中的双特异性免疫调节候选药物pumitamig(BNT327/BMS986545)、多种适应症中的研究性抗CTLA-4抗体gotistobart(BNT316/ONC-392),以及HER3靶向ADC候选药物BNT326/YL202作为单一疗法及与pumitamig联合用于非小细胞肺癌(NSCLC);BioNTech各平台临床数据的性质、特征及发布时间,这些数据需接受同行评审、监管审查和市场解读;BioNTech管线项目计划的下一步行动,包括但不限于关于临床试验启动或招募的时间安排或计划,或产品批准的提交与接收及针对BioNTech候选产品的潜在商业化计划;BioNTech mRNA技术在BioNTech传染病平台之外展示临床疗效的能力;以及BioNTech候选产品的潜在安全性和有效性。
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-looki.
在某些情况下,前瞻性陈述可以通过术语来识别,例如“将”、“可能”、“应该”、“预期”、“打算”、“计划”、“目标”、“预计”、“相信”、“估计”、“预测”、“潜在”、“继续”,或这些术语的否定形式或其他类似术语,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、不确定性以及其他因素,其中许多因素是BioNTech无法控制的,并且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, 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; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; 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 w.
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,包括达到预期临床终点的能力、临床试验的启动和/或完成日期、预计数据发布时间表、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,包括本公告中讨论的数据,并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,这些数据需接受持续的同行评审、监管审查和市场解读;在未来临床试验中产生可比临床结果的能力;BioNTech获得并维持对其候选产品监管批准的能力及时间安排;与监管机构就额外临床试验的时间和要求进行的讨论;BioNTech及其合作方管理并获取必要能源资源的能力;关税和贸易政策升级的影响;BioNTech识别研究机会以及发现和开发研究性药物的能力;能力及意愿等。
You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Annual Report on Form 20-F for the period ended December 31, 2025 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at
您应当查阅 BioNTech 在截至 2025 年 12 月 31 日的年度报告 Form 20-F 中标题为“风险因素”下描述的风险和不确定性,以及 BioNTech 随后向美国证券交易委员会提交的文件,这些文件可在 SEC 的网站上查阅。
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..
这些前瞻性声明仅截至本日期有效。除非法律要求,否则BioNTech不承担因新信息、未来发展或其他情况而更新或修改本新闻稿中包含的任何前瞻性声明的意图或责任。
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