Gadoquatrane

WHIPPANY, NJ, USA I January 14, 2025 I 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 regulatory filing submissions underway for key growth drivers darolutamide, finerenone, and elinzanetant. “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. “Our new operating model is visibly becoming a key enabler to drive growth and efficiency gains.” Topline improved and poised for future growth Bayer continues to strengthen its leadership position in prostate cancer with the anticipated launch of a third indication in 2025 for the oral androgen receptor inhibitor (Ari)darolutamide, marketed under the brand name NUBEQA ® ,supported by data from the ARANOTE trial. Darolutamide plus androgen deprivation therapy (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 (mHSPC). 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 U.S. and the EU earlier in 2024. NUBEQA achieved global blockbuster status in September 2024 after crossing the threshold of one billion euros in annual sales. Additionally, NUBEQA is now the fastest growing androgen receptor inhibitor in the U.S., with nearly 45,000 patients in the U.S. and 100,000 patients globally treated as of the end of 2024. For important risk and use information about NUBEQA, please see the full Prescribing Information . In Cardiovascular, Bayer submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and CDE of China’s NMPAfor finerenone, marketed as KERENDIA ® , for the treatment of patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, initiating a major step forward in expanding its reach. Further regulatory filings are planned with a potential market launch by the end of 2025. Filing submissions are based on positive results from the Phase III FINEARTS-HF trial that showed finerenone achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as either an unplanned hospitalization for HF or an urgent HF visit, by 16% in patients with HF and a LVEF of ≥40% compared to placebo in addition to a patients’ prescribed treatment regimen. The robust data from Kerendia’s clinical development program underscore its potential to become a pillar of therapy for patients with chronic kidney disease associated with Type 2 Diabetes and patients with heart failure with an LVEF of ≥40%. For important risk and use information about KERENDIA, please see the full Prescribing Information . In Women´s Healthcare, another significant clinical milestone for investigational compound elinzanetant was secured in early 2025 following three positive Phase III readouts in 2024 (OASIS 1,2,3). OASIS 4, which was conducted outside of the U.S., is a Phase III study evaluating elinzanetant as a non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in women with breast cancer or at high risk of developing breast cancer. Elinzanetant successfully met the primary endpoints of the study demonstrating statistically significant reductions in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo. The study also achieved all secondary endpoints demonstrating reductions in severity of VMS at week 4 and 12, VMS frequency reduction at week 1 as well as maintaining the effects over the study period. The detailed results from OASIS 4 are planned to be presented at an upcoming scientific congress. Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause. In Radiology, Bayer is advancing its pipeline. A significant milestone was achieved with its Phase III QUANTI clinical development program, which evaluated the investigational compound gadoquatrane. The first data from the program showed that gadoquatrane successfully achieved its primary endpoint, highlighting its potential to offer a low dose contrast agent option to patients. The QUANTI program showcases Bayer’s leadership in radiology and its commitment to advancing innovation in medical imaging. Pipeline value improved and early lead positions strengthened 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. 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. 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 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. Targeted investments in R&D and platform companies in recent years are already strengthening Bayer’s early and late pipelines. 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. It has initiated Phase I trials with oral KEAP1 activator in solid tumors and oral STAT3 inhibitor in solid and hematologic malignancies and has IND-enabling programs including a RAS-P13KCA program for RAS-driven cancers. 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. Its potential is underscored by Breakthrough Therapy Designations from both the FDA and Chinese 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. Further, a Phase I clinical trial with BAY3498264, an investigational oral selective Son of Sevenless Homologue 1 (SOS1) inhibitor, has recently been initiated (outside of the US). 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. 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 radium Ra 223 dichloride injection therapy, marketed as XOFIGO ® , for patients with metastatic castration-resistant prostate cancer. Bayer´s evolving TRT portfolio includes novel targeting approaches which combine alpha radionuclides such as actinium-225 with different targeting moieties, including antibodies, small molecules or peptide-based molecules. 225 Ac-pelgifatamab (BAY 3546828) and 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). For important risk and use information about XOFIGO, please see the full Prescribing Information . 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. With the anti-alpha2 antiplasmin antibody program, Bayer is developing a new modality and mechanism of action-based thrombolytic agent. Based on investigational research, the antibody works by specifically blocking the endogenous plasmin inhibitor, α2AP, potentially leading to the lysis of acute embolic or thrombotic clots with a tolerable safety profile. The investigational antibody is currently being evaluated in Phase II in patients with deep vein thrombosis and could be used for indications of high medical relevance. About Bayer 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. 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. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com . © 2025 Bayer BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer. Find more information at www.pharma.bayer.com Our online press service is just a click away: www.bayer.us/en/newsroom Follow us on Facebook: http://www.facebook.com/pharma.bayer Follow us on X: https://X.com/BayerUS SOURCE: Bayer

临床研究项目QUANTI评估了在研磁共振（MRI）对比剂gadoquatrane在各种潜在适应症和所有年龄段患者中的有效性和安全性 在本研究中，Gadoquatrane达到诊断有效性终点；与剂量为0.1 mmol Gd/kg体重的大环状含钆对比剂相比，Gadoquatrane的钆剂量降低了60% 近日，放射学领域全球领导者拜耳今天公布了关键III期临床研究QUANTI积极的初步结果。该研究评估了Gadoquatrane的有效性和安全性。Gadoquatrane是一种用于MRI的在研含钆对比剂。在所有QUANTI研究中，Gadoquatrane均按0.04 mmol Gd/kg体重的钆剂量给药，与按0.1 mmol Gd/kg体重给药的现有大环状含钆对比剂相比，Gadoquatrane的钆剂量减少了 60%。与现有大环状含钆对比剂相比，Gadoquatrane以最低的钆剂量为患者评估诊断的有效性，成功达到了所有 QUANTI研究的主要和关键次要终点。 QUANTI临床研究项目包括两项跨国III期研究，即针对成人患者的QUANTI CNS（中枢神经系统）和 QUANTI OBR（其他身体部位），以及 QUANTI Pediatric（研究从新生儿到18岁以下的儿童患者全身各部位的药代动力学和安全性）。 在QUANTI CNS和QUANTI OBR中，研究人员评估了使用Gadoquatrane（0.04 mmol Gd/kg体重）在MRI扫描中显示和检测已知或疑似病变的能力，并与未注射对比剂的扫描以及使用剂量为0.1 mmol Gd/kg 体重的大环状钆对比剂的扫描进行了比较。 QUANTI Pediatric 的结果表明，Gadoquatrane在儿童中的药代动力学表现与成人相当。 QUANTI研究中观察到的成人以及从新生儿到 18 岁以下儿童患者的安全性特征与之前关于Gadoquatrane和其他大环状含钆对比剂的数据基本一致，未观察到新的安全性特征。 德国波恩大学医院首席研究员Julian A. Luetkens教授说： “ 对比增强MRI是一种重要的诊断工具，对于帮助可能患有癌症、心血管或中枢神经系统相关严重疾病的患者制定治疗路径尤其重要。QUANTI临床研究项目是探索在减少患者接受钆剂量的同时达到诊断有效性终点的关键一步。这对于需要重复进行对比增强MRI检查的患者以及儿科患者等弱势群体尤为重要。 ” 拜耳影像诊断研发负责人Konstanze Diefenbach博士表示： “ 作为放射学领域的领导者，我们致力于推动创新，建立新的医疗标准，包括减少钆剂量的潜在方案。我们对 QUANTI研究展现的积极结果感到满意，并期待与科学界分享这些数据。 ” 拜耳计划向全球多个卫生监管机构提交包括QUANTI研究结果在内的数据资料，以获得上市许可。 向上滑动阅览 关于Gadoquatrane III期临床研究项目 QUANTI临床研究项目包括两项大型多中心、随机、前瞻性双盲、交叉III期研究——QUANTI CNS和QUANTI OBR——以及QUANTI儿科研究。该计划总共涵盖15个国家的808名患者。 QUANTI CNS评估了Gadoquatrane在成人已知或高度怀疑患有中枢神经系统病变对比增强 MRI 中的有效性和安全性。对常见的中枢神经系统疾病，如脑肿瘤、脑转移瘤和多发性硬化症，MRI在诊疗决策中发挥着关键作用。 QUANTI OBR评估了Gadoquatrane在成人所有其他身体部位，如头部和颈部、胸部（包括乳腺和心脏）、腹部、骨盆、四肢和血管（结合磁共振血管成像）对比增强 MRI 中的安全性和有效性。 QUANTI Pediatric评估了Gadoquatrane在接受对比增强 MRI检查的新生儿至18岁以下儿童的药代动力学和安全性。 上述III期临床研究方案的设计和给药剂量基于II期临床研究的积极结果。II期临床研究评估了Gadoquatrane在0.04 mmol Gd/kg体重剂量下的有效性和安全性。II期研究是一项多中心、单盲、适应性剂量探索研究，对已知或高度怀疑患有中枢神经系统病变的成年患者进行单次静脉注射Gadoquatrane的对比增强MRI，并进行相应的盲态阅片。 关于Gadoquatrane Gadoquatrane是拜耳在研的细胞外大环状对比剂，目前正在临床研究中评估其在对比增强MRI中的作用。这种大环状含钆对比剂具有独特的四聚体结构，拥有高稳定性和高弛豫率。据估计，全球每年进行6500万例手术，对比增强 MRI 在其中发挥关键作用。MRI是一种非侵入性、无辐射的成像方法，可提供关于人体的详细影像，有助于识别和区分器官和组织中的潜在异常病变，支持临床医生回答与疾病检测、表征和监测相关的重要医学问题。 关于拜耳影像诊断 拜耳在放射学领域拥有约100年的悠久历史，拜耳致力于提供创新产品和高质量的服务。拜耳影像诊断的产品组合包括用于计算机断层扫描（CT）、X射线和磁共振成像（MRI）的对比剂、用于精确管理对比剂使用的设备、支持高效和最佳患者护理的信息学解决方案以及公认的医学培养教育计划。此外，拜耳还致力于研发并利用人工智能，从而进一步推动了医学成像领域的创新。所有这些产品都可以帮助放射科医生完成其任务，从诊断到治疗，提供明确的方向。 关于拜耳 拜耳作为一家跨国企业，在生命科学领域的健康与农业方面具有核心竞争力。公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2023财年，拜耳的员工人数约为100,000名，销售额为476亿欧元。不计特殊项目的研究开发投入为58亿欧元。更多信息请见www.bayer.com。 前瞻性声明 本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站http://www.bayer.com/上公开的拜耳各项报告。本公司没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。