更新于：2023-10-01
Sanofi
更新于：2023-10-01
概览
标签
感染
呼吸系统疾病
肿瘤
小分子化药
预防性疫苗
单克隆抗体
疾病领域得分
一眼洞穿机构专注的疾病领域
技术平台
公司药物应用最多的技术
靶点
公司最常开发的靶点
关联
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
药物最高研发状态 |
首次获批国家/地区 |
首次获批日期 |
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
药物最高研发状态 |
首次获批国家/地区 |
首次获批日期 |
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
药物最高研发状态 |
首次获批国家/地区 |
首次获批日期 |
A Phase IV, Open Label, Clinical Trial to Assess Safety and Efficacy of Fexofenadine HCL + Pseudoephedrine HCL Fixed Dose Combination in Indian Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (FAST Trial)
A Phase 2, Single Arm, Multicohort, Open Label, Multicenter Trial of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Patients With High-risk Myeloid Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Randomized Phase II Study of Belumosudil vs. Placebo for Preemptive Treatment of Chronic Graft Versus Host Disease
登录后查看更多信息
2022-03-01Clinical Pharmacology in Drug Development4区 · 医学
Absolute Bioavailability, Mass Balance, and Metabolic Profiling Assessment of [C]-Belumosudil in Healthy Men: A Phase 1, Open-Label, 2-Part Study
4区 · 医学
Article
作者: Schueller, Olivier ; Skucas, Ed ; Regev, Galit ; Shaw, Iain ; Singh, Nand ; Sanghvi, Mitesh ; Croft, Marie ; Lohmer, Lauren ; Alabanza, Anginelle ; Patel, Jeegar
Belumosudil is a selective Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitor. ROCK2 has been shown to drive proinflammatory response and fibrosis that occurs with chronic graft-versus-host disease; therefore, inhibition of ROCK2 has emerged as a therapeutic target for chronic graft-versus-host disease. In this phase 1 two-part study, the pharmacokinetics, mass balance, and metabolic profile of belumosudil were evaluated after single doses of unlabeled belumosudil oral tablets (200 mg), radiolabeled belumosudil intravenous (IV) microtracer infusions (100 μg), and radiolabeled oral capsules (200 mg). Absolute bioavailability based on area under the plasma concentration-time curve from time 0 to infinity for the oral dose/area under the plasma concentration-time curve from time 0 to infinity for the IV dose was calculated as 63.7%. Radiolabeled IV microtracer dosing demonstrated a low extraction ratio and distribution of belumosudil into tissues. The majority of total radioactivity was recovered in feces, with minimal amounts recovered in urine, suggesting minimal renal elimination of belumosudil. In addition to parent and main metabolite KD025m2, metabolites identified in plasma included the phase 2 metabolites O-dealkylated belumosudil sulfate and belumosudil glucuronide. These metabolites (with the exception of the glucuronide) in addition to monohydroxy-belumosudil, and belumosudil diol were identified in feces. No metabolites in urine accounted for >10% of the radioactive dose.
2022
Downstream processing: New modalities, next generation solutions and need for speed
作者: Ma, Junfen ; Li, Yi ; Brower, Kevin ; Capito, Florian ; Boscheinen, Oliver ; Tugcu, Nihal
The field of biotherapeutics has been developing quickly- our pipelines have been greatly diversified over the last few years to include different hosts, multi-specific antibodies and antibody-drug conjugates, nanobodies, synthorins relying on an expanded genetic code, gene and cell therapies, enzymes, vaccines and mRNA. In addition, during the COVID-19 pandemic, we have experienced the need to perform process development and to solve very challenging problems in the fast lane. Given the diversity of the pipelines and the need for speed, our collective need for next generation solutions supporting harvest through purification and final formulation has been at the forefront. New chromatog. resins and matrixes with better selectivity and impurity removal, synthetic depth filters with better controlled material attributes, along with solutions offering faster downstream operations, are just a few. Different modes of operation, such as continuous and integrated processing, have also received increased emphasis in order to address the need for speed, for functionally closed operations, using online-monitoring for process operations as well as their ability to control quality attributes and variability in supply requirements. In addition, modeling-aided development, high throughput process development and the utilization of platform knowledge have become more pronounced enablers to meet today's challenges. In this presentation, we will cover these aspects with industry-wide examples and Sanofi-specific case studies.
2022
Development of a robust control strategy for continuous diafiltration
作者: Malladi, Shashi ; Thomas, Crystal Y. ; Coolbaugh, Michael J.
Batch processing has traditionally been employed in the pharmaceutical industry for the purification of monoclonal antibodies (mAbs). However, in recent years, integrated continuous biomanufg. (ICB) technologies have been increasingly developed and adopted within these purification processes due to their advantages such as process intensification, smaller footprint, and more homogenous product quality. Nevertheless, implementation of end-to-end ICB still requires (1) addnl. development for post-chromatog. unit operations, including diafiltration and (2) a high-fidelity continuous control strategy systematically integrating all the unit operations. This presentation addresses both considerations, as described below: Most prior ICB efforts have focused primarily on the chromatog. operations in the protein purification process. Diafiltration, which occurs towards the end of the process train for buffer exchange, also has the potential for continuous operation. Operating DF in a continuous format requires precise control over the process parameters such that the exiting protein concentration remains well-controlled and the target buffer exchange is achieved, regardless of the fluctuations in the feed stream. In this work, a control framework for continuous diafiltration (cDF) was designed to address the stated requirements. Experiments were conducted to develop semi-empirical process models relating the key parameters governing the DF operation. The models were subsequently coupled with simulations to determine the optimal design and operating space, which were then adopted to develop the control. The control strategy was evaluated for its robustness in conjunction with other unit operations. Our automated cDF will not only be useful in developing an integrated workflow but will also provide guidelines for improved design of cDF filters. In summary, the development of an integrated continuous control strategy is critical for end-to-end success, but challenging, as it would have to ideally identify all real-time process disturbances and minimize their subsequent effects on the critical quality attributes of the drug substance. Our unified exptl. and modeling approach, as demonstrated for diafiltration operation, can be leveraged towards the development and implementation of a successful continuous control strategy essential for end-to-end ICB.
2023-09-29
引进/卖出并购
2023-09-29
管线布局
2023年10月04日管线快照
管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期
药物发现
13
63
临床前
临床申请批准
1
35
临床1期
临床2期
77
33
临床3期
申请上市
5
185
批准上市
其他
1062
登录后查看更多信息
当前项目
登录后查看更多信息
营收
使用 Synapse 探索超过 36 万个组织的财务状况。
登录
或
科研基金(NIH)
访问超过 200 万项资助和基金信息，以提升您的研究之旅。
登录
或
投资
深入了解从初创企业到成熟企业的最新公司投资动态。
登录
或
融资
发掘融资趋势以验证和推进您的投资机会。
登录
或
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。