拜耳医药增长战略进展顺利-动脉网

Bayer’s Pharma Growth Strategy Progressing Well as Pipeline Advances

拜耳等信源发布 2025-01-14 02:35

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January

一月

2025

19:30 PM

19：下午30点

Europe/Amsterdam

欧洲/阿姆斯特丹

Bayer’s Pharma Growth Strategy Progressing Well as Pipeline Advances

拜耳制药增长战略进展顺利

Not intended for U.S. and UK Media

不适用于美国和英国媒体

Summary

摘要

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid cardiomyopathy (ATTR-CM), reinforcing Bayer’s leadership in these important therapeutic areas / Phase III OASIS 4 trial achieves all primary and key secondary endpoints for elinzanetant, an innovative, non-hormonal treatment for vasomotor symptoms associated with menopause or caused by adjuvant endocrine therapy in women with or at high risk of developing hormone receptor positive breast cancer / Phase III QUANTI program for gadoquatrane, Bayer’s investigational MRI contrast agent, successfully met primary and main secondary endpoints, underlining Bayer’s leading position in radiology / Bemdaneprocel, an investigational stem cell-based therapy for Parkinson's disease, advances directly to Phase III clinical development / First participants randomized in the Phase II REGENERATE-PD study, evaluating gene therapy AB-1005 in patients with moderate-stage Parkinson's disease / Vividion’s precision oncology platform is advancing while further expanding capabilities with the acquisition of Tavros Therapeutics.

监管文件正在进行中，以获得前列腺癌中达鲁胺的第三种适应症，常见形式的心力衰竭中的芬尼酮和甲状腺素转运蛋白淀粉样心肌病（ATTR-CM）中的阿可拉米斯的第三种适应症，加强了拜耳在这些重要治疗领域的领导地位/III期OASIS 4试验实现了Elizanetant的所有主要和关键次要终点，Elizanetant是一种创新的非激素治疗方法，用于治疗与更年期相关的血管舒缩症状，或由患有或患有激素受体阳性乳腺癌的高风险女性的辅助内分泌治疗引起的血管舒缩症状/拜耳研究性MRI造影剂gadoquatrane的III期QUANTI计划，成功达到了主要和次要终点，突显了这一点拜耳在放射学/Bemdaneprocel方面的领先地位，这是一种基于干细胞的帕金森病研究疗法，直接进入III期临床开发/II期REGENATE-PD研究中随机分组的首批参与者，评估中度帕金森病/Vividion精确肿瘤学平台患者的基因治疗AB-1005正在进步，同时随着Tavros Therapeutics的收购进一步扩大了能力。

San Francisco, CA, USA, January 14, 2025

美国加利福尼亚州旧金山，2025年1月14日

– On the occasion of the 43rd J.P. Morgan Healthcare Conference in San Francisco, Bayer AG announces further progress in its pharmaceutical growth strategy, with multiple filing submissions underway for key growth drivers darolutamide and finerenone, acoramidis and elinzanetant.

–在旧金山举行的第43届J.P.Morgan医疗保健会议上，拜耳公司宣布其制药增长战略取得进一步进展，目前正在提交多份关键增长驱动因素达罗鲁胺和芬尼酮、阿柯拉米迪斯和埃莉萨尼坦的申请。

“We are successfully delivering on our ambitious business goals despite significant headwinds. At the same time, the value of our pipeline is growing by accelerating breakthrough innovations,” said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division.

拜耳股份公司管理委员会成员、拜耳制药部总裁斯特凡·奥尔里奇（Stefan Oelrich）表示：“尽管面临重大阻力，但我们仍成功实现了雄心勃勃的业务目标。与此同时，通过加速突破性创新，我们的管道价值正在增长。”。

“Our new operating model is visibly becoming a key enabler to drive growth and efficiency gains.”.

“我们的新运营模式显然正在成为推动增长和提高效率的关键因素。”。

Topline improved and poised for future growth

Topline得到改善，为未来的增长做好了准备

Bayer continues to strengthen its leadership position in Prostate Cancer with the anticipated launch of a third indication for darolutamide (marketed under the brand name Nubeqa™) in 2025, which is supported by strong data from the ARANOTE trial. Darolutamide plus ADT now has positive data both with and without chemotherapy (docetaxel) based on two pivotal Phase III studies (ARASENS and ARANOTE) in metastatic hormone-sensitive prostate cancer.

拜耳继续加强其在前列腺癌领域的领导地位，预计2025年将推出第三种达罗鲁胺适应症（以品牌Nubeqa™销售），这得到了ARANOTE试验强有力数据的支持。基于转移性激素敏感性前列腺癌的两项关键III期研究（ARASENS和ARANOTE），达鲁酰胺加ADT现在在有和没有化疗（多西紫杉醇）的情况下都有阳性数据。

Bayer recently submitted an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for this third indication for darolutamide, in addition to filings in the EU and the U.S. earlier in 2024. Nubeqa achieved blockbuster status in September 2024 after crossing the threshold of one billion euros in annual sales.

拜耳公司最近向中国国家医药产品管理局（NMPA）药物评估中心（CDE）提交了达罗鲁胺第三种适应症的申请，此外还于2024年初在欧盟和美国提交了申请。在年销售额突破10亿欧元的门槛后，Nubeqa于2024年9月取得了大片地位。

Additionally, Nubeqa is now the fastest growing androgen receptor inhibitor in the U.S., with 100,000 patients treated around the world as of the end of 2024..

此外，Nubeqa现在是美国增长最快的雄激素受体抑制剂，截至2024年底，全球共有100000名患者接受治疗。。

In Cardiovascular, Bayer also recently submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and to the CDE of China’s NMPA

在心血管方面，拜耳最近还向美国食品和药物管理局（FDA）和中国国家药品管理局（NMPA）的CDE提交了补充新药申请（sNDA）

for finerenone (Kerendia™) in heart failure, initiating a major step forward in expanding its reach. Further regulatory filings are planned with a potential market launch as early as end of 2025. Filing submissions are supported by data from FINEARTS-HF Phase III trial, where finerenone demonstrated statistically significant cardiovascular benefits in patients with heart failure and a left ventricular ejection fraction of greater than or equal to 40%.

对于心力衰竭的finerenone（Kerendia™），在扩大其范围方面迈出了重要的一步。计划进一步提交监管文件，最早可能在2025年底上市。提交的文件得到了FINEARTS-HF III期试验数据的支持，Fineenone在心力衰竭和左心室射血分数大于或等于40%的患者中显示出统计学上显着的心血管益处。

The robust data from Kerendia’s clinical development program underscore its potential to become an important therapy for both patients with kidney disease and heart failure..

凯伦迪亚临床开发计划的可靠数据强调了其成为肾脏疾病和心力衰竭患者的重要治疗方法的潜力。。

Additionally, in early 2025, EU approval is anticipated for acoramidis, which demonstrated near-complete stabilization (≥90%) of transthyretin (TTR), for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). This follows positive Committee for Medicinal Products for Human Use (CHMP) opinion in December 2024..

此外，预计在2025年初，欧盟将批准acoramidis用于治疗甲状腺素转运蛋白淀粉样心肌病（ATTR-CM），该药物显示出转甲状腺素蛋白（TTR）接近完全稳定（≥90%）。这是根据2024年12月人类使用药品积极委员会（CHMP）的意见。。

In the area of Women’s Healthcare, elinzanetant marked another significant clinical milestone in early 2025 following three positive Phase III read-outs in 2024 (OASIS 1-3). OASIS 4, the first pivotal international Phase III study evaluating a treatment for vasomotor symptoms (VMS, also known as hot flashes) caused by adjuvant endocrine therapy in women being treated or at high risk for breast cancer, met all primary and key secondary endpoints with elinzanetant, demonstrating statistically significant reductions in the frequency of moderate to severe VMS compared to placebo.

在女性医疗保健领域，继2024年三次积极的III期读数（OASIS 1-3）之后，elinzanetant在2025年初标志着另一个重要的临床里程碑。OASIS 4是第一项评估辅助内分泌治疗引起的血管舒缩症状（VMS，也称为潮热）治疗的关键性国际III期研究，用于治疗正在接受治疗或患有乳腺癌高风险的女性，符合所有主要和关键次要终点。与安慰剂相比，elizanetant，显示中度至重度VMS的频率在统计学上显着降低。

Elinzanetant also reduced the severity of VMS and improved sleep disturbances and quality of life. The detailed results from OASIS 4 are planned to be presented at an upcoming scientific congress. With regulatory submissions under review around the world, Bayer anticipates a potential launch this year, aiming for fast market penetration building on Bayer's strength in women's healthcare.

Elinzanetant还降低了VMS的严重程度，改善了睡眠障碍和生活质量。OASIS 4的详细结果计划在即将举行的科学大会上公布。随着全球监管机构提交的报告正在审查中，拜耳预计今年将有可能推出产品，旨在借助拜耳在女性医疗保健领域的优势快速渗透市场。

Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist with potential to transform the management of menopause, broadening treatment choices, and addressing major unmet needs in women’s health..

Elinzanetant是第一种双重神经激肽-1和3（NK-1和3）受体拮抗剂，有可能改变更年期的管理，扩大治疗选择，并解决女性健康中未满足的主要需求。。

In Ophthalmology, Eylea 8mg (aflibercept 8 mg) has the potential to become the new standard of care in the treatment of certain exudative retinal diseases. In the global Phase III QUASAR study evaluating the efficacy and safety of aflibercept 8 mg in patients with macular edema following retinal vein occlusion (RVO), including central, branch, hemi-retinal vein occlusion, the primary endpoint at week 36 was met.

在眼科，Eylea 8mg（aflibercept 8 mg）有可能成为治疗某些渗出性视网膜疾病的新标准。在评估阿柏西普8 mg治疗视网膜静脉阻塞（RVO）后黄斑水肿（包括中央，分支，半视网膜静脉阻塞）患者的疗效和安全性的全球III期QUASAR研究中，达到了第36周的主要终点。

Patients receiving aflibercept 8 mg every 8 weeks (after initial monthly doses) achieved non-inferior visual acuity gains compared to those receiving the current standard therapy Eylea 2 mg (aflibercept 2 mg) every four weeks..

与每四周接受当前标准疗法Eylea 2 mg（阿柏西普2 mg）的患者相比，每8周接受阿柏西普8 mg（初始每月剂量后）的患者获得了非劣效视力提高。。

In Radiology, Bayer substantially advanced the development of innovative contrast agents for magnetic resonance imaging (MRI), achieving a significant milestone with its Phase III QUANTI clinical development program. The first data from the program show that the investigational gadolinium-based MRI contrast agent gadoquatrane successfully met the primary and main secondary diagnostic efficacy and safety endpoints in patients using a 60% lower gadolinium dose compared to trial comparators.

在放射学方面，拜耳大大推进了磁共振成像（MRI）创新造影剂的开发，其III期QUANTI临床开发计划取得了重大里程碑。该计划的第一个数据显示，与试验比较者相比，使用低60%钆剂量的患者，研究性钆基MRI造影剂钆喹烷成功地达到了主要和主要的次要诊断功效和安全性终点。

The QUANTI program showcases Bayer's commitment as a leader in radiology, bringing forward innovation in medical imaging..

QUANTI计划展示了拜耳作为放射学领导者的承诺，推动了医学成像的创新。。

Pipeline value improved and early lead positions strengthened

管道价值提高，早期领先地位加强

Bayer is making significant progress with its cell and gene therapy platform, achieving important clinical trial milestones, especially in the field of Parkinson’s disease.

拜耳在其细胞和基因治疗平台方面取得了重大进展，实现了重要的临床试验里程碑，尤其是在帕金森病领域。

Bemdaneprocel will directly advance to Phase III clinical development in Parkinson’s disease, based on positive data from the Phase I exPDite trial. Bemdaneprocel is an investigational stem cell-based therapy that surgically implants dopamine-generating nerve cell precursors into the brain. The FDA granted bemdaneprocel Regenerative Medicine Advanced Therapy (RMAT) designation for its innovative potential in treating Parkinson's disease..

根据I期exPDite试验的积极数据，Bemdaneprocel将直接进入帕金森病的III期临床开发。Bemdaneprocel是一种基于干细胞的研究性疗法，通过手术将产生多巴胺的神经细胞前体植入大脑。FDA授予bemdaneprocel再生医学高级疗法（RMAT）称号，以表彰其在治疗帕金森病方面的创新潜力。。

AB-1005 is advancing in Phase II, with the randomization of participants in the REGENERATE-PD clinical trial focusing on patients with moderate-stage Parkinson's disease. AB-1005 is an investigational AAV-based gene therapy that delivers the human glial cell line-derived neurotrophic factor (GDNF) transgene to the brain to potentially protect and restore dopamine-generating neurons.

AB-1005正在第二阶段取得进展，REGENATE-PD临床试验的参与者随机分组，重点关注中度帕金森病患者。AB-1005是一种基于AAV的研究性基因疗法，可将人神经胶质细胞系衍生的神经营养因子（GDNF）转基因传递至大脑，以潜在地保护和恢复产生多巴胺的神经元。

AB-1005 has received U.S. FDA Fast Track and UK Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport designations, highlighting its potential to address significant unmet medical needs..

。。

As part of its transformation, Bayer has sharpened its focus in R&D to build a highly differentiated pipeline for long-term growth in oncology, cardiology and renal diseases, neurology and rare diseases, and immunology. Through rigorous assessment and prioritization, Bayer Pharmaceuticals is now fully focused on the areas of greatest unmet need and highest value potential..

作为转型的一部分，拜耳加强了研发重点，为肿瘤学、心脏病学和肾脏疾病、神经病学和罕见病以及免疫学的长期发展建立了高度分化的渠道。通过严格的评估和优先排序，拜耳制药现在完全专注于最大未满足需求和最高价值潜力的领域。。

Targeted investments in R&D and platform companies in recent years are already strengthening Bayer’s early and late pipeline. With Vividion’s acquisition of the precision oncology platform company Tavros Therapeutics, Bayer continues to leverage its chemoproteomics platform technology to unlock traditionally undruggable targets with precision small-molecule therapeutics.

近年来，对研发和平台公司的定向投资已经加强了拜耳的前期和后期计划。随着Vividion收购精准肿瘤平台公司Tavros Therapeutics，拜耳继续利用其化学蛋白质组学平台技术，用精准小分子疗法解锁传统上无法治疗的靶标。

It has initiated Phase I trials with oral KEAP1 activator in solid tumors and oral STAT3 inhibitor in solid and hematologic malignancies, and also has IND-enabling programs including a RAS-PIK3CA program for RAS-driven cancers..

它已经启动了在实体瘤中使用口服KEAP1激活剂和在实体瘤和血液系统恶性肿瘤中使用口服STAT3抑制剂的I期临床试验，并且还启动了IND启用程序，包括针对RAS驱动的癌症的RAS-PIK3CA程序。。

Additionally in the field of precision oncology, investigational BAY 2927088, an oral, small molecule, tyrosine kinase inhibitor as a potential new targeted therapy for patients with non-small cell lung cancer (NSCLC) harboring HER2 activating mutations, showed promising results as a second line therapy in the ongoing Phase I/II SOHO-01 study evaluating safety and efficacy.

此外，在精准肿瘤学领域，研究BAY 2927088是一种口服小分子酪氨酸激酶抑制剂，可作为携带HER2激活突变的非小细胞肺癌（NSCLC）患者的潜在新靶向治疗方法，在正在进行的I/II期SOHO-01研究评估安全性和有效性的二线治疗中显示出有希望的结果。

Its potential is underscored by Breakthrough Therapy Designations from both the FDA and Chinese Centre for Drug Evaluation (CDE). Beyond the SOHO-01 trial, BAY 2927088 is also being assessed for its potential as a first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations in the SOHO-02 trial.

FDA和中国药物评估中心（CDE）的突破性治疗指定突显了其潜力。除了SOHO-01试验之外，BAY 2927088还被评估为晚期非小细胞肺癌（NSCLC）患者的一线治疗潜力，其肿瘤在SOHO-02试验中具有激活HER2突变。

Further, a Phase I clinical trial with BAY3498264, an investigational oral selective Son of Sevenless Homologue 1 (SOS1) inhibitor, has recently been initiated. The open-label, first-in-human, dose escalation study will evaluate patients with KRAS G12C-mutated metastatic cancer. This innovative approach has the potential to enhance the treatment options available for patients, offering the possibility to reduce or stop tumor progression..

此外，最近开始了使用BAY3498264（一种研究性口服选择性无七同系物1（SOS1）抑制剂的儿子）进行的I期临床试验。这项开放标签的首次人体剂量递增研究将评估KRAS G12C突变转移性癌症患者。这种创新方法有可能增强患者可用的治疗选择，提供减少或阻止肿瘤进展的可能性。。

Targeted Radionuclide Therapy (TRT) is a strategic area of focus in Oncology precision drug development at Bayer, building on more than 10 years of real-world experience with Xofigo

靶向放射性核素治疗（TRT）是拜耳肿瘤学精准药物开发的战略重点领域，建立在Xofigo 10多年的实际经验基础上

TM公司

as the first and only targeted alpha therapy for patients with metastatic castration-resistant prostate cancer. Bayer´s evolving TRT portfolio includes new targeting approaches which combine alpha radionuclides such as actinium-225 with different targeting moieties, including antibodies, small molecules or peptide-based molecules.

作为转移性去势抵抗性前列腺癌患者的第一个也是唯一的靶向α疗法。拜耳不断发展的TRT组合包括新的靶向方法，该方法将α放射性核素（如锕-225）与不同的靶向部分（包括抗体，小分子或基于肽的分子）相结合。

225

Ac-pelgifatamab (BAY 3546828) and

Ac-pelgifatamab（BAY 3546828）和

225

Ac-PSMA-Trillium (BAY 3563254), two candidates targeting PSMA (prostate specific membrane antigen), are currently in Phase I clinical trials in patients with advanced metastatic castration resistant prostate cancer (mCRPC).

Ac-PSMA延龄草（BAY 3563254）是两种靶向PSMA（前列腺特异性膜抗原）的候选药物，目前正在晚期转移性去势抵抗性前列腺癌（mCRPC）患者的I期临床试验中。

In the field of cardiovascular diseases, Bayer is making progress with its Phase II assets. With BAY3283142, an investigational soluble guanylate cyclase (sGC) activator in patients with chronic kidney disease (CKD), Bayer has entered into a Phase II clinical study. By modulating sGC via a heme-independent pathway, the investigational sGC activator now represents a new class of potential future drugs that could offer an advantage in conditions of high oxidative stress such as in diabetic nephropathy..

在心血管疾病领域，拜耳的二期资产正在取得进展。BAY3283142是一种用于慢性肾病（CKD）患者的研究性可溶性鸟苷酸环化酶（sGC）激活剂，拜耳公司已进入II期临床研究。通过不依赖血红素的途径调节sGC，研究性sGC激活剂现在代表了一类新的潜在未来药物，可以在高氧化应激条件下（如糖尿病肾病）提供优势。。

With the anti-alpha2 antiplasmin antibody program, Bayer is developing a new modality and mechanism of action-based thrombolytic agent. This antibody specifically blocks the endogenous plasmin inhibitor α2AP leading to the lysis of acute embolic or thrombotic clots without an increase in bleeding. The investigational antibody is currently being evaluated in Phase II in patients with deep vein thrombosis and will potentially be suitable for treatment in indications of high medical relevance..

通过抗α2抗血浆蛋白抗体计划，拜耳正在开发一种新的基于作用机制的溶栓剂。。目前正在对深静脉血栓形成患者的II期研究抗体进行评估，可能适用于具有高度医学相关性的适应症的治疗。。

About Bayer

拜耳简介

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.

拜耳是一家全球性企业，在医疗保健和营养等生命科学领域拥有核心竞争力。根据其“人人健康，无人饥饿”的使命，该公司的产品和服务旨在通过支持应对全球人口不断增长和老龄化带来的重大挑战，帮助人们和地球繁荣发展。

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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros.

拜耳致力于推动可持续发展，并对其业务产生积极影响。。拜耳品牌代表着全世界的信任、可靠性和质量。2023财年，该集团雇佣了约10万人，销售额476亿欧元。

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

不含特殊项目的研发费用为58亿欧元。有关更多信息，请转至。

www.bayer.com

Link to live webcast presentation of Bayer AG at J.P. Morgan’s 43rd Annual Healthcare Conference:

链接至拜耳公司在摩根大通第43届年度医疗保健大会上的在线直播演示：

Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division will present updates on the company’s pharmaceutical growth strategy and pipeline advancements on Tuesday, January 14, 2025, from 10:30 – 11:10am PST.

拜耳公司管理委员会成员、拜耳制药部总裁斯特凡·奥尔里奇（Stefan Oelrich）将于2025年1月14日（星期二）上午10:30–11:10（太平洋标准时间）介绍公司制药增长战略和管道进展的最新情况。

Investors, analysts, media professionals and members of the life sciences industry are invited to join the live webcast of the presentation via this link:

邀请投资者、分析师、媒体专业人士和生命科学行业的成员通过以下链接加入演示文稿的在线直播：

https://jpmorgan.metameetings.net/events/healthcare25/sessions/58226-bayer/webcast?gpu_only=true&kiosk=true

Find more information at

有关更多信息，请访问

https://pharma.bayer.com

在Facebook上关注我们：

http://www.facebook.com/bayer

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.

本版本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的实际未来业绩、财务状况、发展或业绩与此处给出的估计之间存在重大差异。

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

。

www.bayer.com

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

。公司不承担任何责任更新这些前瞻性声明或遵守

them to future events or developments.

他们对未来的事件或发展。

Contacts

联系人

Malena Johannes

马莱娜·约翰内斯