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Bayer Healthcare Co., Ltd.
Last update 25 Feb 2025
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CTR20244192
一项旨在携带HER2激活突变的局部晚期或转移性非小细胞肺癌（NSCLC）患者中评估BAY 2927088口服给药与标准治疗相比作为一线治疗的有效性和安全性的III期开放性、随机、阳性对照、多中心试验
[Translation] A Phase III open-label, randomized, active-controlled, multicenter trial to evaluate the efficacy and safety of oral BAY 2927088 compared with standard of care as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2-activating mutations
CTR20242979
一项开放性、I 期、首次人体的剂量递增和剂量扩展，旨在评价二酰基甘油激酶α 抑制剂（DGKai）BAY 2862789 治疗晚期实体瘤研究参与者的安全性、耐受性、最大耐受或最大给药剂量、药代动力学、药效学和肿瘤缓解特征的研究
[Translation] An open-label, Phase I, first-in-human, dose-escalation and dose-expansion study to evaluate the safety, tolerability, maximum tolerated or maximum administered dose, pharmacokinetics, pharmacodynamics, and tumor response characteristics of the diacylglycerol kinase alpha inhibitor (DGKai) BAY 2862789 in study participants with advanced solid tumors
CTR20242872
在选定晚期实体瘤参与者中评估抗CCR8抗体BAY 3375968单药治疗以及与帕博利珠单抗联合用药的安全性、耐受性和药代动力学的首次人体剂量递增和扩展研究
[Translation] A first-in-human dose-escalation and expansion study evaluating the safety, tolerability, and pharmacokinetics of the anti-CCR8 antibody BAY 3375968 as monotherapy and in combination with pembrolizumab in participants with selected advanced solid tumors
100 Clinical Results associated with Bayer Healthcare Co., Ltd.
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01 Oct 2024Quantitative Imaging in Medicine and Surgery
Monoenergetic reconstructions and iodine density maps for visualization of coronary artery stents using 8-cm dual-layer detector spectral computed tomography: an in vitro phantom study
Article
Author: Luo, Yongbai ; Pan, Ning ; Zhou, Yinan ; Guo, Jianxin ; Li, Yaofeng ; Hu, Bin ; Chen, Lihong ; Jian, Zhijie ; Dong, Shushan ; Yang, Jian
Background:
The effectiveness of coronary computed tomography (CT) angiography in assessing stent restenosis is hindered by heavy metal artifacts. This study aimed to evaluate the image quality of monoenergetic reconstructions and iodine density map for coronary stent imaging using an 8-cm dual-layer detector spectral CT.
Methods:
In this study, 8 stents with a diameter <3 mm (group A) and 10 with a diameter ≥3 mm (group B) were placed in plastic tubes filled with iodinated contrast media and scanned. The internal diameter of the prepared stents was then measured by intravascular ultrasound. The reconstructed images included iodine density maps, conventional images, and different energy levels. The visualization of the stent lumen and stent structure was subjectively assessed using a 4-point Likert scale. The objective evaluation was performed using the in-stent lumen signal-to-noise ratio (SNRis), non-stent lumen SNR (SNRns), internal diameter difference (IDD), and blooming artifact index (BAI). The Friedman test and analysis of variance were used for multiple comparisons.
Results:
For lumen visualization, the optimal monoenergetic images received the highest score for both group A (2.56±0.51) and group B (3.1±0.55). Multiple comparisons showed that there were significant differences between the optimal monoenergetic images and iodine density maps. However, for stent structure, iodine density maps received the highest score for group A (3.0±0.52) and group B (3.8±0.41). For quantitative assessment, the optimal monoenergetic images had the highest SNRis and SNRns, while the iodine density maps had the lowest SNRis and SNRns. For IDD and BAI, the iodine density maps yielded the smallest value.
Conclusions:
The monoenergetic images on the second-generation dual-layer detector CT provide better visualization of the lumen and higher SNR. However, iodine density maps are superior for evaluating stent structure and IDD and BAI compared to monoenergetic and conventional reconstructions.
01 Aug 2024ADVANCES IN THERAPY
Cost-effectiveness of Finerenone in Addition to Standard of Care for Patients with Chronic Kidney Disease and Type 2 Diabetes in China
Article
Author: Pochopień, Michał ; Ming, Jian ; Li, Hongchao ; Xu, Yingrui ; Mernagh, Paul ; Hong, Guanqi
INTRODUCTION:
Adding finerenone to current standard of care (SoC), as recommended by Chinese guidelines, has shown substantial benefit in delaying chronic kidney disease (CKD) progression and reducing cardiovascular risk in patients with CKD and type 2 diabetes (T2D) in the landmark FIDELIO-DKD trial. This study aimed to evaluate the cost-effectiveness of finerenone + SoC versus SoC alone among Chinese patients with T2D and CKD from a healthcare system perspective.
METHODS:
A cost-effectiveness model (FINE-CKD) has been developed and published, with health states defined for CKD stages (CKD 1/2, CKD 3, CKD 4, and CKD 5 without renal replacement therapy (RRT), dialysis, or transplant) and cardiovascular event history. Additionally, the model also considered adverse events. Transition probabilities and event risks were derived using patient-level data from Asian population analysis of FIDELIO-DKD. Since the price of finerenone after the national reimbursement drug list (NRDL) inclusion was confidential, the cost of finerenone in the model was assumed to be the same as that of SoC. Other health resource costs were gathered from literature and supplemented by physician interviews. Measured by the EQ-5D-5L questionnaire, quality of life was translated into utilities based on the Chinese EQ-5D-5L value set.
RESULTS:
Discounted at 5.0% annually, over a lifetime horizon, finerenone + SoC resulted in a quality-adjusted life years (QALYs) gain of 0.321 versus SoC alone (8.660 vs. 8.338 QALYs), due to a reduction in the incidence of cardiovascular events and dialysis. Total costs per patient were lower under finerenone + SoC than SoC alone (381,130 CNY vs. 392,390 CNY). As a result, finerenone + SoC was a dominant treatment strategy compared with SoC alone. Sensitivity analysis has confirmed the robustness of this study.
CONCLUSION:
Adding finerenone to SoC was likely to be either a dominant or cost-effective treatment option compared with SoC alone in Chinese patients with CKD and T2D.
01 Jun 2024F&S reports
Vilaprisan for the treatment of symptomatic endometriosis: results from a terminated phase 2b randomized controlled trial
Article
Author: Seitz, Christian ; Wenzl, Rene ; Tamussino, Karl ; Faustmann, Thomas ; Oppelt, Peter ; Taylor, Hugh S ; Groettrup-Wolfers, Esther ; Dong, Liying ; Ren, Xiaowei ; Haikonen, Johanna
Objective:
To evaluate the efficacy and safety of 2 doses of vilaprisan vs. placebo in participants with symptomatic endometriosis.
Design:
Multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2b trial (NCT03573336). The initially planned sample size was 315 patients. Recruitment was paused to assess long-term toxicity findings in rodents; although the findings were assessed as likely to be of limited clinical relevance in humans, the study was closed by the sponsor. During the pause, enrolled patients completed 3 or 6 months of treatment per their assigned regimen.
Setting:
University hospitals, a regional hospital, and a private clinic.
Patients:
Premenopausal adults with confirmed endometriosis and moderate-to-severe pelvic pain (≥4/10 on a numerical rating scale) were enrolled. Inclusion required protocol adherence, including ≥24 diary entries, and an average pain score of ≥3.5.
Intervention:
Participants were randomly assigned 1:1:1 to receive vilaprisan (2 mg), vilaprisan (4 mg), or placebo.
Main Outcome Measures:
The primary outcome was a change in the 7-day mean "worst pain" (per the endometriosis symptom diary item 1) from baseline to month 3. All analyses were descriptive only.
Results:
Eight participants were randomly assigned to treatment before the study pause: 6 received vilaprisan (4 mg, n = 4 and 2 mg, n = 2), and 2 received placebo. The 6 vilaprisan recipients experienced an improvement in endometriosis-associated pelvic pain, whereas the 2 placebo recipients experienced no change or increased pain; all 8 participants had decreased use of pain medication. Bleeding intensity decreased from baseline in the vilaprisan group.
Conclusion:
The study findings suggest that vilaprisan may improve outcomes in patients with endometriosis. Further studies in larger populations would be needed to accurately assess treatment effects.
Clinical Trial Registration Number:
NCT03573336.
100 Deals associated with Bayer Healthcare Co., Ltd.
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Pipeline Snapshot as of 04 Mar 2025
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
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