[Translation] A multicenter, prospective, open-label study evaluating the pharmacokinetics and safety of gadoquatrane in pediatric subjects (birth to <18 years old) undergoing contrast-enhanced magnetic resonance imaging (CE-MRI)

研究人员正在寻找一种更好的方法来帮助 18 岁以下的儿童解决计划进行“对比增强”磁共振成像 (MRI) 的任何已知或疑似问题。医生使用 MRI 来创建身体内部的详细图像以识别健康问题。有时，医生需要静脉注射造影剂以完成 “对比增强”MRI (CE-MRI)。 CE-MRI 可以让医生识别某些健康问题或改进他们的评估。 MRI 中常用的造影剂是基于钆造影剂 (GBCA)。 GBCA 含有一种称为钆 (Gd) 的“稀土”元素，它是增强 MRI 信号强度和对比度所必需的。这些造影剂中的钆被包裹在一个分子中（螯合物）。基于CE-MRI 研究，研究人员正在开发含较低剂量Gd 的新型造影剂。 Gadoquatrane 是这些新型造影剂之一。之前已经在几项研究中对其进行了测试。这项研究的主要目的是了解gadoquatrane如何进入、通过和排出身体，以及它对儿童的安全性。研究人员将在单次注射后的不同时间点测量血液中的gadoquatrane含量。

[Translation]

Researchers are looking for a better way to help children under 18 with any known or suspected problems scheduled for a "contrast enhanced" magnetic resonance imaging (MRI). Doctors use MRI to create detailed images of the inside of the body to identify health problems. Sometimes, doctors need to inject contrast dye intravenously to complete a "contrast enhanced" MRI (CE-MRI). CE-MRI can allow doctors to identify certain health problems or improve their evaluation. The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd), which is necessary to enhance the strength and contrast of the MRI signal. The gadolinium in these contrast agents is enclosed in a molecule (chelate). Based on the CE-MRI studies, researchers are developing new contrast agents that contain lower doses of Gd. Gadoquatrane is one of these new contrast agents. It has been tested in several studies before. The main goal of this study is to understand how gadoquatrane enters, passes through, and exits the body, and how safe it is for children. Researchers will measure the amount of gadoquatrane in the blood at different time points after a single injection.

Start Date11 Oct 2023

Sponsor / Collaborator

Bayer Healthcare Co., Ltd.

CTR20230182

/ Active, not recruitingPhase 4

一项考察维立西呱在中国HFrEF患者中的有效性和安全性的多中心、双臂、开放性、外部对照上市后研究

[Translation] A multicenter, two-arm, open-label, externally controlled post-marketing study to investigate the efficacy and safety of Vericipirax in Chinese patients with HFrEF

这是一项观察性研究，将收集要接受维立西呱治疗的中国HFrEF患者的数据，与标准治疗（SOC）治疗的数据进行比较。维立西呱通过增加一种新型可溶性鸟苷酸环化酶（sGC）起作用。有助于调节心脏和血管功能。维立西呱目前已经在中国和其他国家可供医生开处方。本研究的主要目的是收集更多关于SOC加维立西呱与当前SOC相比，在中国HFrEF患者中的有效性的数据。有效性意味着治疗可以防止以下情况发生：因心血管死亡; 因心衰住院此外，研究团队将收集更多关于研究药物对中国HFrEF患者的安全性的信息。患者将根据批准的产品信息，在日常实践中按照医生的处方服用维立西呱。对于维立西呱组，数据将在常规访视中收集，本研究无强制要求。对照数据（SOC组）将来自中国心力衰竭中心的数据库。患者的以下数据将在每 3 个月进行的常规访视期间记录：基础疾病和伴随疾病; 既往用药; 实验室参数; 生命体征，如血压、心率; 心脏检查结果（如超声心动图）。维立西呱组患者将接受长达12个月的治疗和随访，或提前终止研究。（以先发生者为准）

[Translation]

This is an observational study that will collect data from Chinese HFrEF patients who are to be treated with Vericipigat compared to standard of care (SOC) treatment. Vericipigat works by increasing a new type of soluble guanylate cyclase (sGC). This helps regulate heart and blood vessel function. Vericipigat is currently available for prescription by doctors in China and other countries. The primary goal of this study is to collect more data on the effectiveness of SOC plus Vericipigat compared to current SOC in Chinese HFrEF patients. Effectiveness means that the treatment can prevent the following: Death from cardiovascular causes; Hospitalization for heart failure In addition, the research team will collect more information on the safety of the study drug in Chinese HFrEF patients. Patients will take Vericipigat as prescribed by their doctors in their daily practice according to the approved product information. For the Vericipigat group, data will be collected during routine visits, which are not mandatory for this study. The control data (SOC group) will come from the database of the Chinese Heart Failure Center. The following patient data will be recorded during routine visits every 3 months: Underlying diseases and concomitant diseases; Previous medications; Laboratory parameters; Vital signs, such as blood pressure, heart rate; Cardiac examination results (such as echocardiogram). Patients in the Vericipirax group will be treated and followed up for up to 12 months, or terminate the study early. (Whichever occurs first)

Start Date25 Apr 2023

Sponsor / Collaborator

Bayer AG

[+1]

CTR20230520

/ TerminatedPhase 3

一项在18岁及以上有卒中风险的男性和女性房颤受试者中比较口服FXIa抑制剂asundexian（BAY 2433334）与阿哌沙班预防卒中或体循环栓塞的有效性和安全性的国际多中心、随机、活性药物对照、双盲、双模拟、平行组、双臂III期研究

[Translation] An international, multicenter, randomized, active-controlled, double-blind, double-dummy, parallel-group, two-arm phase III study comparing the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) versus apixaban for the prevention of stroke or systemic embolism in male and female subjects with atrial fibrillation aged 18 years and older at risk of stroke

房颤表现为心跳频率快且不规则，可导致心脏血栓形成，血栓可能随血流堵塞其他血管，从而引发卒中或体循环栓塞。抗凝药物可预防血栓形成，口服使用的抗凝药物称为口服抗凝剂 (OACs)，包括阿哌沙班。OACs可降低房颤患者发生血栓相关事件的风险，而其主要副作用则是增加出血风险。研究治疗用药asundexian是目前正处于临床开发阶段的一种新型口服抗凝药，其研发旨在进一步降低需接受抗凝治疗患者的出血风险。本研究的主要目的是收集更多关于asundexian在房颤患者中预防卒中和体循环栓塞方面有效性的数据，并评估其安全性。为了解asundexian的有效性，研究人员将比较asundexian及阿哌沙班的有效时长。有效的治疗意味着可预防卒中和/或体循环栓塞的发生。为了解 asundexian的安全性，研究人员将比较使用 asundexian和阿哌沙班治疗后大出血的发生率。大出血是指对人体健康有严重影响甚至危及生命的出血。受试者将被随机分配至A或B两治疗组的其中之一，每日一次口服asundexian或每日两次口服阿哌沙班，持续治疗约9-33个月。

[Translation]

Atrial fibrillation is characterized by a rapid and irregular heartbeat, which can lead to the formation of blood clots in the heart. The clots may travel with the bloodstream and block other blood vessels, causing stroke or systemic embolism. Anticoagulants can prevent blood clots from forming. Anticoagulants taken by mouth are called oral anticoagulants (OACs), including apixaban. OACs reduce the risk of thrombotic events in patients with atrial fibrillation, but their main side effect is an increased risk of bleeding. The investigational treatment drug asundexian is a new oral anticoagulant currently in clinical development. Its development aims to further reduce the risk of bleeding in patients who need anticoagulant therapy. The main purpose of this study is to collect more data on the effectiveness of asundexian in preventing stroke and systemic embolism in patients with atrial fibrillation and to evaluate its safety. To understand the effectiveness of asundexian, researchers will compare how long asundexian and apixaban are effective. Effective treatment means that stroke and/or systemic embolism can be prevented. To understand the safety of asundexian, researchers will compare the incidence of major bleeding after treatment with asundexian and apixaban. Major bleeding refers to bleeding that has a serious impact on human health or even threatens life. Subjects will be randomly assigned to one of the two treatment groups, A or B, and take asundexian orally once a day or apixaban orally twice a day for about 9-33 months.

Start Date13 Apr 2023

Sponsor / Collaborator

Bayer Healthcare Co., Ltd.

100 Clinical Results associated with Bayer Healthcare Co., Ltd.

0 Patents (Medical) associated with Bayer Healthcare Co., Ltd.

Literatures (Medical) associated with Bayer Healthcare Co., Ltd.

01 Jan 2026·OPHTHALMOLOGY

Intravitreal Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration

Article

Author: Schulze, Andrea ; Hasanbasic, Zoran ; Zhang, Xin ; Zhao, Min ; Vitti, Robert ; Holz, Frank G ; Clark, W Lloyd ; Hirshberg, Boaz ; Yancopoulos, George D ; Reed, Kimberly ; Schmelter, Thomas ; Cheng, Yenchieh ; Bhore, Rafia ; Wong, Tien Y ; Lanzetta, Paolo ; Schmidt-Ott, Ursula ; Bai, Zhanying ; Sun, Xiaodong ; Chu, Karen W ; Morgan-Warren, Peter ; Korobelnik, Jean-François ; Leal, Sergio ; Berliner, Alyson J ; Eichenbaum, David ; Iida, Tomohiro

PURPOSE:

To report the efficacy, durability, and safety of intravitreal aflibercept 8 mg versus intravitreal aflibercept 2 mg every 8 weeks (2q8) in patients with neovascular age-related macular degeneration (nAMD) through 96 weeks, PULSAR (ClinicalTrials.gov identifier, NCT04423718).

DESIGN:

Phase 3, randomized, noninferiority, 96-week trial.

PARTICIPANTS:

Treatment-naive adults ≥ 50 years with nAMD.

METHODS:

Patients were randomized 1:1:1 to intravitreal aflibercept 8 mg every 12 or 16 weeks (8q12 or 8q16), or 2q8, after 3 initial monthly doses; dosing intervals in 8-mg groups were modified based on prespecified criteria.

MAIN OUTCOME MEASURES:

Change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), proportion of patients maintaining or extending the randomized dosing intervals, and safety outcomes.

RESULTS:

Of 1009 patients treated, 869 patients (8q12, n = 291; 8q16, n = 292; 2q8, n = 286) completed treatment through week 96. Least squares (LS) mean change from baseline in BCVA at week 96 was +5.6 (95% confidence interval [Cl], 4.1-7.1), +5.5 (95% Cl, 4.0-7.0), and +6.6 (95% Cl, 5.2-8.0) letters in the 8q12, 8q16, and 2q8 groups, respectively; 8q12 and 8q16 differences versus 2q8 in LS mean BCVA changes at week 96 met the noninferiority criteria specified for the primary end point at week 48. Mean (standard deviation) change in CRT from baseline was -143.9 (123.6) μm, -153.4 (140.8) μm, and -135.8 (133.1) μm in the 8q12, 8q16, and 2q8 groups, respectively. Patients completing 96 weeks of treatment in the 8q12, 8q16, and 2q8 groups received a mean of 9.7, 8.2, and 12.8 active injections, respectively. Of these, 87% of patients in the 8q12 group had last assigned dosing intervals of 12 weeks or more, whereas 78%, 53%, and 31% of patients in the 8q16 group qualified for last assigned dosing intervals of ≥ 16 weeks, ≥ 20 weeks, and 24 weeks, respectively. Incidence of ocular treatment-emergent adverse events was similar across groups.

CONCLUSIONS:

Aflibercept 8 mg delivered sustained disease control in patients with nAMD, maintaining improvements in visual and anatomic outcomes through week 96 with extended dosing intervals and similar safety profile to aflibercept 2 mg.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

01 Dec 2025·NUTRITION REVIEWS

Clinical Benefits and Safety of Multiple Micronutrient Supplementation During Preconception, Pregnancy, and Lactation: A Review

Article

Author: Kaufmann, Ligaya ; Liu, Jue ; Qi, Hongbo ; Campos Goenaga, Zigor ; Kuroda, Keiji ; Gromova, Olga ; Tetruashvili, Nana ; Di Renzo, Gian Carlo ; Mantantzis, Konstantinos

Abstract:

Objective:

In this review we sought to determine the clinical benefits and safety of a multiple micronutrient supplement/supplementation (MMS) throughout preconception, pregnancy, and lactation in the mother and their child.

Background:

No guidelines for pregnancy specifically recommend supplementation with micronutrients other than folic acid and iron or continuing the use of MMS beyond the first trimester. Yet micronutrients are essential during all stages of pregnancy for healthy fetal growth and development and maternal health, with an increased intake of many micronutrients recommended during pregnancy and lactation. The MMS reviewed (Elevit, Bayer) is the most studied prenatal form of MMS, supported by 30 publications reporting studies conducted worldwide over 30 years and used by millions of women over a period of 40 years. Until now, the data have not yet been consolidated.

Methods:

We performed a literature search to identify published studies for trials that used MMS at any stage of the pregnancy journey.

Results:

Outcomes reported in 30 trials suggested that MMS improves micronutrient status, leads to a healthier reproductive environment during preconception, and can significantly reduce neural tube defects and congenital abnormalities in early pregnancy above and beyond supplementation with folic acid alone. We also found that MMS can reduce adverse pregnancy outcomes during the second and third trimesters, including miscarriage, pre-eclampsia, anemia, preterm birth, and placental insufficiency, and improve docosahexaenoic acid status. In addition, MMS improves the quality of breastmilk and reduces postpartum depression. Using MMS containing 800 μg folic acid is more effective than supplementing with 400 μg folic acid alone. Very few adverse events were reported in infants, almost all of which were considered unrelated to MMS intake. In one cohort, periconceptual MMS in children was linked to higher rates of otitis media and atopic dermatitis than placebo, but these results may be partly attributed to multiple hypothesis testing and differences in family history, respectively.

Conclusion:

Improving micronutrient status with MMS in women who are trying to conceive, pregnant, or breastfeeding may have beneficial effects on fertility, the integrity of the embryonic environment, development of the embryonic brain and nervous system, and the growth, development, and long-term health of the child.

01 Oct 2025·ADVANCES IN THERAPY

Multi-specialty Physician Preferences and Perceptions in Treatment and Management of Polycystic Ovary Syndrome in China: Survey and Discrete Choice Experiment

Article

Author: Chen, Yingyao ; Chen, Wei ; Xu, Zhe ; Gu, Zhuowei ; Ming, Jian ; Li, Yijing ; Sun, Hui ; Liu, Haijiao ; Tian, Qinjie

INTRODUCTION:

Polycystic ovary syndrome (PCOS) is one of the most common gynecological endocrine diseases in reproductive-aged women. Given the multifaceted nature of PCOS and the involvement of multiple disciplines, the diagnosis and treatment of PCOS vary among different specialties. Our study aimed to elicit preferences of physicians from multidisciplinary specialties for PCOS treatment and their perceptions of PCOS management to enhance the understanding of clinical practice in China.

METHODS:

A discrete choice experiment (DCE) was conducted to elicit the physicians' preferences of PCOS treatment, and a cross-sectional survey was performed to understand the perceptions in management of PCOS. Physicians from three hospital specialties (general gynecology, gynecological endocrinology, and reproductive endocrinology) in China were included.

RESULTS:

Responses from a total of 123 physicians were eligible for the final analysis, with 41 from each specialty. In DCE, the physicians mainly preferred the anti-androgen effect, lower probability of irregular bleeding, and additional benefits when selecting treatment for PCOS, and the decision making was found to be highly dependent on the presence of clinical hyperandrogenism. Regarding diagnostic criteria, polycystic ovary morphology (PCOM) was the most frequently used (39.84%), followed by menstrual dysfunction (37.40%) and clinical hyperandrogenism (30.08%). Fertility and menstruation regulation were selected as the most important treatment goals for PCOS by physicians. Similar preferences across the three specialties were observed.

CONCLUSION:

The decision making by physicians on PCOS treatment largely relies on the presence of clinical hyperandrogenism across all three specialties, indicating the significance of hyperandrogenism assessment in clinical practice, and the role of biochemical hyperandrogenism in PCOS treatment may require further elucidation in future clinical guidelines. Furthermore, the results emphasize the urgent need to bridge the gap between the clinical practice and guidance recommendations for the diagnosis and treatment of PCOS in China.

News (Medical) associated with Bayer Healthcare Co., Ltd.

04 May 2022

·www.biospace.com

FDA Accepts Bayer's Application to Expand Nubeqa into New Prostate Cancer Indication

Bayer announced Tuesday that The U.S. Food and Drug Administration accepted its supplemental New Drug Application (sNDA) for Nubeqa as a potential treatment for metastatic hormone-sensitive prostate cancer. The sNDA allows Bayer to make changes to its product, Nubeqa (darolutamide), which was approved in 2019 to treat non-metastatic castration-resistant prostate cancer. Nubeqa inhibits androgen binding, specifically OATP1B1 and OATP1B3 transporters, AR nuclear translocation and AR-mediated transcription. Bayer is jointly developing the drug with Finnish pharmaceutical firm Orion Corporation. The FDA approved Nubeqa in July 2019 based on positive results from its Phase III ARAMIS study involving 1,509 patients diagnosed with non-metastatic castration-resistant prostate cancer who also had a bilateral orchiectomy or were receiving a concomitant gonadotropin-releasing hormone analog. The primary endpoint to assess efficacy was metastasis-free survival. Prostate cancer is the second most commonly diagnosed cancer in men worldwide, with 1.4 million diagnosed in 2020 and around 375,000 die from the disease. Most patients already have localized prostate cancer at the time of diagnosis, which means it may be curable with radiotherapy or surgery. Upon relapse, the disease becomes hormone-sensitive, thus requiring ADT as the primary mode of treatment. For the sNDA to be accepted, the FDA looked at the results from the investigational Phase III ARASENS trial, which is published in The New England Journal of Medicine. Scientists evaluated Nubeqa plus androgen deprivation therapy and chemotherapy docetaxel in 1,306 male patients living with mHSPC and compared results with those who received just ADT plus docetaxel. The participants were given 600 mg of Nubeqa two times a day. "Today’s sNDA acceptance, confirmation of Priority Review and participation in Project Orbis, bring us closer to adding a new indication for NUBEQA in combination with docetaxel to benefit men with mHSPC," commented Christine Roth, head of the oncology SBU at Bayer and a member of the executive committee of the firm's pharmaceutical arm. The sNDA is being conducted under Project Orbis, the FDA Oncology Center of Excellence's initiative, which sets the guidelines for the review and concurrent submission of potential cancer therapies among global health authorities. Bayer also filed applications with the Ministry of Health, Labor and Welfare in Japan, the European Medicines Agency and the Center of Drug Evaluation in China. More submissions for Nubeqa's mHSPC indication will be rolled out in other countries over the next months. Aside from the mentioned indications, Bayer is exploring Nubeqa's efficacy and safety in different stages of prostate cancer. These include the ARANOTE Phase III study on Nubeqa plus ADT versus monotherapy ADT for mHSPC and the Phase III co-operative group DASL-HiCaP trial evaluating the drug as adjuvant treatment for localized prostate cancer with high recurrence risk. The latter study is being performed alongside the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Bayer is flexing its muscles in the oncology space and recently revamped its leadership roster, appointing experts from other major pharmas to join the firm. The company currently has six marketed products in its oncology arm and several other products in clinical development.

DarolutamideProstatic CancerBayer AGPriority Review

100 Deals associated with Bayer Healthcare Co., Ltd.

100 Translational Medicine associated with Bayer Healthcare Co., Ltd.

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Pipeline

Pipeline Snapshot as of 02 Feb 2026

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

IND Application

Phase 1

Phase 2

Phase 3

NDA/BLA

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Darolutamide ( AR )	Metastatic castration-resistant prostate cancer More	Approved
Ethinylestradiol/Levonorgestrel ( ER x PR )	Contraception More	Approved
Aspirin ( COX-1 x COX-2 )	Peripheral Arterial Disease More	Approved
Gadoquatrane	Central Nervous System Infections More	Phase 3
Radium Ra-223 Dichloride ( DNA )	Breast Cancer More	Phase 2

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