AskBio的Viralgen将为帕金森病REGENERATE-PD基因治疗II期试验提供商业规模的药物产品供应-动脉网

AskBio's Viralgen to Supply Commercial-Scale Drug Product for REGENERATE-PD Investigational Gene Therapy Phase II Trial for Parkinson’s Disease

拜耳等信源发布 2026-04-20 14:08

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April

四月

2026

08:00 AM

早上8:00

Europe/Amsterdam

欧洲/阿姆斯特丹

AskBio's Viralgen to Supply Commercial-Scale Drug Product for REGENERATE-PD Investigational Gene Therapy Phase II Trial for Parkinson’s Disease

AskBio的Viralgen将为帕金森病REGENERATE-PD基因治疗II期试验提供商业规模的药物产品供应

Not intended for UK Media

不适用于英国媒体

Summary

摘要

Ametefgene parvec (AB-1005) manufactured at Viralgen commercial manufacturing facility with next-generation process to deliver high-purity product with greater efficiency

在Viralgen商业生产设施利用下一代工艺制造Ametefgene parvec（AB-1005），以更高效率提供高纯度产品。

Berlin, Germany, and Durham, N.C., USA, April 20, 2026 –

德国柏林，美国北卡罗来纳州达勒姆，2026年4月20日 –

AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that it has introduced its proprietary, commercially ready manufacturing process to supply ametefgene parvec (AB-1005), an investigational gene therapy for the treatment of Parkinson’s disease (PD) and multiple system atrophy-parkinsonian type (MSA-P), following submission of a United States Food and Drug Administration (FDA) Investigational New Drug Application (IND) amendment..

AskBio公司（AskBio），一家由拜耳公司全资拥有并独立运营的基因治疗公司，今日宣布，在提交美国食品药品监督管理局（FDA）研究性新药申请（IND）修正案后，已引入其专有的、商业化的生产流程，以供应基因治疗药物ametefgene parvec（AB-1005），该药物用于治疗帕金森病（PD）和多系统萎缩-帕金森型（MSA-P）。

This enables AskBio to now advance its REGENERATE-PD Phase II clinical trial in the United States with the material produced at the commercial manufacturing facility of AskBio’s wholly owned subsidiary, Viralgen, with other trial sites to follow, using an intensified, high-efficiency, next-generation large-scale suspension manufacturing process that provides a consistently high purity product..

这使得 AskBio 现在能够在其全资子公司 Viralgen 的商业生产设施生产的材料基础上，推进其在美国进行的 REGENERATE-PD 二期临床试验，并将使用一种强化的、高效率的下一代大规模悬浮生产工艺，提供始终如一的高纯度产品，其他试验地点也将陆续跟进。

“Today’s news marks another important advancement in our Parkinson’s program,” said Canwen Jiang, MD, PhD, Chief Development Officer and Chief Medical Officer at AskBio. “We are initiating supply with our manufacturing platform, to deliver our investigational gene therapy to participants in our ametefgene parvec trials, including our REGENERATE-PD trial, which recently saw the randomization of our first participants in Germany.

“今天的新闻标志着我们在帕金森病项目中的又一重要进展，”AskBio的首席开发官兼首席医学官姜灿文博士表示，“我们正在通过我们的制造平台启动供应，将我们的研究性基因疗法提供给参与我们ametefgene parvec试验的受试者，其中包括我们的REGENERATE-PD试验，该试验最近在德国进行了首批参与者的随机分组。”

The trial is currently enrolling participants in Poland, the United Kingdom, and the United States.”.

该试验目前正在波兰、英国和美国招募参与者。

“Manufacturing efficiency of our AAV gene therapy-based drug product is mission critical for our Phase II Parkinson’s disease trial,” said Christian Rommel, PhD, Global Head of Research and Development for Bayer’s Pharmaceuticals Division. “It underscores the innovation of our production technology and reflects our continued commitment to meet high regulatory standards.”.

“我们基于AAV基因治疗的药物产品的生产效率对于帕金森病二期试验至关重要，”拜耳制药部门全球研发主管Christian Rommel博士说道，“这体现了我们生产技术的创新性，并反映了我们持续致力于满足高标准监管要求的承诺。”

In December 2025, AskBio was granted Pioneering Regenerative Medical Product designation (SAKIGAKE) in Japan for ametefgene parvec, and in February 2025 the company was granted Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.

2025年12月，AskBio在日本为其药物ametefgene parvec获得了先锋再生医疗产品（SAKIGAKE）认定，并于2025年2月获得美国食品药品监督管理局（FDA）的再生医学先进疗法（RMAT）认定。

1,2

Prior to that, AskBio received FDA Fast Track designation and the Innovation Passport, the United Kingdom Medicines and Healthcare products Regulatory Agency (UK MHRA) innovative medicine designation.

在此之前，AskBio 获得了 FDA 快速通道指定和创新护照，即英国药品和健康产品管理局 (UK MHRA) 的创新药物指定。

All designations were for PD.

所有指定都是针对PD的。

AskBio is also exploring ametefgene parvec in participants in the United States with the parkinsonian subtype of MSA-P in a fully enrolled Phase I clinical trial to assess the preliminary safety, tolerability, and efficacy for this rapidly progressing neurodegenerative condition.

AskBio公司还在美国进行了一项已全部入组的I期临床试验，评估ametefgene parvec在帕金森亚型MSA-P患者中的初步安全性、耐受性和疗效，针对这种快速进展的神经退行性疾病。

Ametefgene parvec is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated.

Ametefgene parvec 是一种研究性基因疗法，尚未获得任何监管机构的批准，其有效性和安全性尚未确定或完全评估。

About Parkinson’s disease

关于帕金森病

Parkinson’s disease (PD) is a progressive neurodegenerative disease.

帕金森病 (PD) 是一种进展性神经退行性疾病。

It has a significant impact on a person’s daily life.

它对一个人的日常生活有重大影响。

In PD, the progressive death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function.

在帕金森病中，大脑中产生多巴胺的神经细胞逐渐死亡，导致运动功能的持续丧失。

Symptoms include tremors, muscle rigidity, and slowness of movement.

症状包括震颤、肌肉僵硬和运动迟缓。

Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression.

此外，帕金森病患者还会经历非运动症状，包括疲劳、缺乏精力、认知问题和抑郁。

Symptoms typically intensify over time and make everyday tasks increasingly demanding.

症状通常会随着时间的推移而加重，使日常任务变得越来越艰巨。

The prevalence of PD has doubled over the past 25 years.

过去 25 年间，PD 的患病率翻了一番。

Today, more than 10 million people worldwide are estimated to be living with PD.

今天，全世界估计有超过一千万人患有帕金森病。

This makes it the world’s second most prevalent neurodegenerative disease.

这使得它成为世界上第二常见的神经退行性疾病。

It is also the most frequent movement disorder.

它也是最常见的运动障碍。

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At present there is no cure, and current treatment options lack the holistic management of symptoms, so there is an urgent need for new therapies.

目前尚无治愈方法，且当前的治疗方案缺乏对症状的整体管理，因此迫切需要新的疗法。

About Parkinsonian subtype of multiple system atrophy

关于多系统萎缩的帕金森亚型

The parkinsonian subtype of multiple system atrophy (MSA-P) can initially be difficult to distinguish from Parkinson’s disease and is marked by slow movement, lack of coordination, imbalance, dizziness, and fainting, among other symptoms.

多系统萎缩的帕金森型（MSA-P）最初可能难以与帕金森病区分，其特征是行动迟缓、协调能力丧失、失衡、头晕和晕厥等症状。

Individuals experience increasing difficulty with movement and autonomic dysfunction as a result of progressive loss of nerve cells in the brain and spinal cord.

由于大脑和脊髓中的神经细胞逐渐丧失，个体在运动和自主神经功能方面遇到的困难不断增加。

Affecting approximately 400,000 people worldwide, MSA-P is a rare disease, and its exact cause is unknown.

影响全球约40万人的MSA-P是一种罕见疾病，其确切病因尚不清楚。

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Symptoms usually start to develop around the age of 50, followed by rapid progression within 5–10 years.

症状通常在50岁左右开始出现，并在5到10年内迅速进展。

At present there is no cure and no approved treatments for MSA-P, so there is an urgent need for new therapies.

目前，MSA-P尚无治愈方法，也无获批的治疗方案，因此迫切需要新的疗法。

About REGENERATE-PD

关于REGENERATE-PD

REGENERATE-PD is a Phase II, randomized, double-blind, surgery controlled trial of the efficacy and safety of intraputaminal ametefgene parvec (AB-1005) in the treatment of adults (45–75 years) with moderate-stage Parkinson’s disease.

REGENERATE-PD 是一项二期、随机、双盲、手术对照试验，评估了脑内注射 ametefgene parvec（AB-1005）在治疗中度帕金森病成人（45-75 岁）中的疗效和安全性。

The trial will include an estimated number of 127 participants with trial sites located in Germany, Poland, the United Kingdom, and the United States.

试验将包括大约127名参与者，试验地点位于德国、波兰、英国和美国。

For more information about the REGENERATE-PD clinical trial, visit clinicaltrials.gov (

有关 REGENERATE-PD 临床试验的更多信息，请访问 clinicaltrials.gov (

NCT06285643

), or visit askbio.com.

），或访问 askbio.com。

About ametefgene parvec (AB-1005)

关于阿米特夫根副球菌（AB-1005）

Ametefgene parvec (AB-1005) is an investigational gene therapy intended to slow disease progression and improve motor outcomes in people with Parkinson’s disease (PD). Composed of an adeno-associated viral vector containing the human glial cell line-derived neurotrophic factor (GDNF) transgene, ametefgene parvec allows for stable and continuous expression of GDNF in localized regions of the brain after direct neurosurgical injection with convection-enhanced delivery..

Ametefgene parvec（AB-1005）是一种研究性基因疗法，旨在减缓帕金森病（PD）患者的疾病进展并改善运动功能。该疗法由含有载有人胶质细胞源性神经营养因子（GDNF）转基因的腺相关病毒载体组成，通过直接神经外科注射和对流增强递送，ametefgene parvec能够在大脑局部区域实现GDNF的稳定和持续表达。

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16，17

In nonclinical studies, GDNF has been shown to promote the survival and morphological differentiation of dopaminergic neurons, which could aid in the preservation and restoration of dopaminergic neuronal circuitries normally lost in the disease.

在非临床研究中，GDNF 已被证明能够促进多巴胺能神经元的存活和形态分化，这有助于保护和恢复通常在疾病中丧失的多巴胺能神经元回路。

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17，18

GDNF has long been evaluated as a potential disease-modifying treatment for diseases, such as PD which are marked by progressive degeneration of midbrain dopaminergic neurons.

GDNF 早已被评估为一种潜在的疾病修饰治疗方法，用于治疗如帕金森病 (PD) 等以中脑多巴胺能神经元进行性退化为特征的疾病。

Through a combination of an investigational gene therapy and innovative neurosurgical delivery approach, building on the promising outcomes of the open-label Phase 1b trial, we can now test the GDNF hypothesis by getting this neurotrophic factor to these degenerating nigrostriatal neurons in a well-controlled clinical study to understand the effects of GDNF in a moderate PD population..

通过结合一种研究中的基因疗法和创新的神经外科递送方法，并基于开放标签的1b期试验的有希望的结果，我们现在可以通过在一项严格控制的临床研究中将这种神经营养因子递送到这些正在退化的黑质纹状体神经元，来测试GDNF假说，以了解GDNF在中度帕金森病人群中的作用。

About AskBio

关于AskBio

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to steering gene therapy into a new era where it can transform the lives of a wider range of people living with rare and more common diseases. The company maintains a portfolio of clinical programs across a range of disease indications related to a single gene or multiple factors across cardiovascular, central nervous system, and neuromuscular conditions, with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease.

AskBio Inc. 是拜耳集团全资拥有并独立运营的子公司，是一家完全集成的基因治疗公司，致力于将基因治疗引入一个新时代，使其能够改变更广泛患有罕见和常见疾病的人们的生活。该公司在心血管、中枢神经系统和神经肌肉疾病领域中，针对单基因或多种因素相关的疾病适应症，拥有多项临床项目组合，其临床阶段的研发管线包括用于治疗充血性心力衰竭、肢带型肌营养不良、多系统萎缩症、帕金森病和庞贝病的在研药物。

AskBio’s end-to-end gene therapy platform includes our Pro10™ technology and Aava™ manufacturing platform, which make gene therapies more accessible by making research and commercial grade manufacturing more affordable. With global headquarters in Research Triangle Park, North Carolina, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

AskBio的端到端基因治疗平台包括我们的Pro10™技术和Aava™制造平台，这些平台通过使研究和商业级制造更加经济实惠，使得基因治疗更为普及。公司总部位于北卡罗来纳州研究三角公园，在全球范围内已经生成了数百种专有的衣壳和启动子，其中一些已进入临床前和临床测试阶段。

An early innovator in the gene therapy field with over 900 employees in five countries, the company holds more than 600 patents and patent applications in areas such as AAV production and chimeric capsids. Learn more at .

一家基因治疗领域的早期创新者，在五个国家拥有900多名员工，该公司在AAV生产和嵌合衣壳等领域拥有600多项专利和专利申请。欲了解更多信息，请访问。

http://www.askbio.com

or follow us on

或关注我们

领英

。

About Viralgen

关于Viralgen

Viralgen is a leading contract development and manufacturing organization (CDMO) specializing exclusively in adeno-associated virus (AAV)–based gene therapies. Founded in 2017 as a subsidiary of AskBio Inc. within the Bayer AG group, Viralgen provides end-to-end support from early development through large-scale commercial production.

Viralgen 是一家领先的合同开发和制造组织 (CDMO)，专注于基于腺相关病毒 (AAV) 的基因疗法。该公司成立于 2017 年，是拜耳集团旗下的 AskBio Inc. 的子公司，Viralgen 提供从早期开发到大规模商业生产的端到端支持。

Leveraging its proprietary Pro10™ suspension cell line and Aava™ manufacturing platform, Viralgen achieves industry-leading, high-yield, scalable manufacturing across all AAV serotypes. Located in San Sebastián, Spain, its state-of-the-art facility includes three cGMP suites with 2,000-liter capacity each, certified by the AEMPS/EMA, and integrates services such as plasmid production, process optimization, fill-finish, and in-house QC testing.

利用其专有的Pro10™悬浮细胞系和Aava™生产平台，Viralgen实现了在所有AAV血清型中行业领先的高产量、可扩展的生产。公司位于西班牙圣塞巴斯蒂安，其最先进的设施包括三个经过AEMPS/EMA认证的cGMP套间，每个套间的容量为2,000升，并整合了质粒生产、工艺优化、灌装完成以及内部QC检测等服务。

With more than 1,200 AAV batches produced, Viralgen delivers reliable, efficient solutions that help bring life-changing gene therapies to patients with greater speed and consistency. For more information, visit .

凭借生产的 1200 多批次 AAV，Viralgen 提供可靠、高效的解决方案，有助于更快、更一致地将改变生命的基因疗法带给患者。欲了解更多信息，请访问。

https://viralgen.com/

。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无人饥饿”的使命，该公司通过支持应对不断增长和老龄化的全球人口所带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros.

拜耳致力于通过其业务推动可持续发展并产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。在2025财年，该集团拥有约88,000名员工，销售额达456亿欧元。

R&D expenses amounted to 5.8 billion euros. For more information, go to .

研发费用达58亿欧元。欲了解更多信息，请访问。

www.bayer.com

。

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12. NIH – 多系统萎缩。可访问：https://www.ninds.nih.gov/health-information/disorders/multiple-system-atrophy#toc-how-is-multiple-system-atrophy-diagnosed-and-treated。访问时间：2026年4月。

13. Vanacore N, Bonifati V, Fabbrini G, et al. Epidemiology of multiple system atrophy. ESGAP Consortium. European Study Group on Atypical Parkinsonisms. Neurol Sci. 2001;22(1):97-99.

13. Vanacore N, Bonifati V, Fabbrini G, 等。多系统萎缩的流行病学。ESGAP联盟。欧洲非典型帕金森综合征研究组。《神经科学》2001;22(1):97-99。

14. Bower JH, Maraganore DM, McDonnell SK, Rocca WA. Incidence of progressive supranuclear palsy and multiple system atrophy in Olmsted County, Minnesota, 1976 to 1990. Neurology. 1997;49(5):1284-1288.

14. Bower JH, Maraganore DM, McDonnell SK, Rocca WA。1976年至1990年期间明尼苏达州奥姆斯特德县进行性核上性麻痹和多系统萎缩的发病率。《神经病学》。1997;49(5):1284-1288。

15. ClinicalTrials.gov. A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD). Available at:

15. ClinicalTrials.gov. 一项关于AAV2-GDNF在中度帕金森病成人中的研究（REGENERATE-PD）。可在：

https://clinicaltrials.gov/study/NCT06285643

. Accessed: April 2026

访问日期：2026年4月

16. Heiss J, et al. Trial of magnetic resonance-guided putaminal gene therapy for advanced Parkinson’s disease. Mov Disord. 2019 Jul;34(7):1073-1078.

16. Heiss J, 等。磁共振引导下丘脑基因治疗晚期帕金森病的试验。《运动障碍》2019年7月；34(7):1073-1078。

17. Kells A, et al. Regeneration of the MPTP-lesioned dopaminergic system after convection-enhanced delivery of AAV2-GDNF. J Neurosci. 2010 Jul 14;30(28):9567-77.

17. Kells A, 等。对流增强递送AAV2-GDNF后MPTP损伤的多巴胺能系统的再生。《神经科学杂志》。2010年7月14日；30(28):9567-77。

18. Lin L, et al. GDNF: a glial cell line-derived neurotrophic factor for midbrain dopaminergic neurons. Science. 1993;260(5111):1130-1132.

18. 林琳等。GDNF：一种对中脑多巴胺能神经元起作用的胶质细胞系源性神经营养因子。《科学》。1993；260（5111）：1130-1132。

19. Barker RA, et al. GDNF and Parkinson’s Disease: Where Next? A Summary from a Recent Workshop. J Parkinsons Dis. 2020;10(3):875-891.

19. 巴克RA，等。GDNF与帕金森病：接下来的方向？最近研讨会的总结。《帕金森病杂志》。2020；10（3）：875-891。

Forward-Looking Statements

前瞻性声明

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本发布可能包含基于拜耳管理层当前假设和预测的前瞻性声明。各种已知和未知的风险、不确定性和其他因素可能导致公司实际的未来结果、财务状况、发展或业绩与这里给出的估计存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at .

这些因素包括拜耳公开报告中讨论的因素，该报告可在拜耳网站上查阅。

www.bayer.com

. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

公司不承担任何更新这些前瞻性声明或使其符合未来事件或发展的责任。

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

拜耳集团是一家在全球范围内拥有运营子公司的控股公司。文中提到的“拜耳”或“该公司”可能根据上下文需要指代一个或多个子公司。

Forward-Looking Statements AskBio

前瞻性声明 AskBio

This press release contains “forward-looking statements.” Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible,” and similar expressions are intended to identify forward-looking statements.

本新闻稿包含“前瞻性陈述”。本新闻稿中包含的任何非历史事实的陈述可能被视为前瞻性陈述。诸如“相信”、“预期”、“计划”、“预计”、“将”、“意图”、“潜力”、“可能”等词语及类似表达旨在识别前瞻性陈述。

These forward-looking statements include, without limitation, statements regarding AskBio’s clinical trials. These forward-looking statements involve risks and uncertainties, many of which are beyond AskBio’s control. Known risks include, among others: AskBio may not be able to execute on its business plans and goals, including meeting its expected or planned clinical and regulatory milestones and timelines, its reliance on third-parties, clinical development plans, manufacturing processes and plans, and bringing its product candidates to market, due to a variety of reasons, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved in a timely manner, potential disagreements or other issues with our third-party collaborators and partners, and regulatory, court or agency feedback or decisions, such as feedback and decisions from the United States Food and Drug Administration or the United States Patent and Trademark Office.

这些前瞻性声明包括但不限于关于AskBio临床试验的声明。这些前瞻性声明涉及许多风险和不确定性，其中许多是AskBio无法控制的。已知的风险包括但不限于：由于各种原因，AskBio可能无法执行其商业计划和目标，包括无法达到其预期或计划的临床和监管里程碑及时间表，依赖第三方、临床开发计划、制造流程与计划，以及将其产品候选者推向市场的能力。这些原因可能包括公司财务及其他资源的潜在限制、可能未能及时预见或解决的制造限制、与第三方合作者和合作伙伴之间可能出现的分歧或其他问题，以及来自监管机构、法院或相关单位的反馈或决定，例如来自美国食品药品监督管理局或美国专利商标局的反馈和决定。

Any of the foregoing risks could materially and adversely affect AskBio’s business and results of operations. You should not place undue reliance on the forward-looking statements contained in this press release. AskBio does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof..

上述任何风险都可能对AskBio的业务和经营结果产生重大不利影响。您不应过度依赖本新闻稿中包含的前瞻性陈述。AskBio不承担基于此后发生的事件或情况公开更新其前瞻性陈述的义务。

Contact for media inquiries Bayer:

媒体咨询请联系拜耳：

Dr. Imke Meyer, phone +49 (214) 600 012 75

Dr. Imke Meyer，电话 +49 (214) 600 012 75

Email:

电子邮件：

imke.meyer@bayer.com

Contact for media inquiries AskBio:

媒体咨询请联系AskBio：

Phil McNamara, phone +1 (984) 5207211

菲尔·麦克纳马拉，电话 +1 (984) 5207211