A Multi-center, Single-arm Phase IV Clinical Trial to Evaluate the Safety of Belumosudil in Indian Participants, 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)

This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older.
Study details include:
* The study duration will be up to 12 months per participant.
* The treatment duration will be up to 24 weeks.
* The number of visits will be 7.

开始日期2025-11-28

申办/合作机构

Sanofi

NCT07116031

/ Recruiting临床2期

An Open-label, Phase 1/2, Multicenter Study of Belumosudil in Children Aged 1 to <18 Years Requiring Systemic Treatment for Active Moderate-to-severe Chronic Graft Versus Host Disease (cGVHD)

This is an open-label, single group, Phase 1/2, 1-arm study for treatment of children aged 1 to <18 years with active moderate-to-severe cGVHD that is refractory to or recurred after at least 2 prior lines of systemic therapy for cGVHD.
The purpose of Phase 1 is to determine the PK profiles and to establish the Recommended Pediatric Equivalent Dose (RPED) of belumosudil in participants aged 1 to <12 years with active moderate to severe cGVHD. Upon completion and evaluation of Phase 1, Phase 2 will commence with the purpose of determining safety and efficacy (ORR by 24 weeks) of belumosudil in participants aged 1 to <18 years.
Study details include:
The end of study is defined as 3 years after the last participant is recruited or all participants have discontinued treatment, or have died, whichever comes first.
Minimum of 6 participants ages 1 to 6 years will be enrolled for each phase of study
Individual participant duration on study will consist of:
Up to 4 weeks for screening. Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD, experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first.
4 weeks of post treatment safety follow-up. Long-term follow-up until death or end of study, whichever occurs first.

开始日期2025-12-15

申办/合作机构

Sanofi

CTIS2024-511508-18-00

/ Not yet recruiting临床1/2期

An open-label, Phase 1/2, multicenter study of belumosudil in children aged 1 to <18 years requiring systemic treatment for active moderate-to-severe chronic graft versus host disease (cGVHD).

开始日期2025-10-30

申办/合作机构

Sanofi-Aventis Recherche & Développement SA

100 项与甲磺酸贝舒地尔相关的临床结果

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100 项与甲磺酸贝舒地尔相关的转化医学

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100 项与甲磺酸贝舒地尔相关的专利（医药）

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159

项与甲磺酸贝舒地尔相关的文献（医药）

2025-12-01·JOURNAL OF PHARMACOLOGICAL SCIENCES

Rho kinase 2 promotes epithelial-mesenchymal transition and proliferation in human prostate cancer PC-3 cells

Article

作者: Yamamura, Aya ; Hayashi, Hisaki ; Sato, Motohiko ; Nayeem, Md Junayed ; Hossain, Alamgir ; Karnan, Sivasundaram ; Takahashi, Rie

Prostate cancer is the second most common cancer in men. Although androgen deprivation therapy is initially effective, resistance inevitably develops. Most patients eventually progress to castration-resistant prostate cancer, a stage with limited treatment options and poor prognosis. Rho kinases (ROCK1 and ROCK2) have been implicated in cancer progression, but their therapeutic targeting remains limited. This study examined the pathological roles of ROCK1 and ROCK2 in epithelial-mesenchymal transition (EMT) and proliferation of prostate cancer cells. ROCK1 expression was comparable between human prostate epithelial cells (PrECs) and androgen-independent prostate cancer cells, PC-3 and DU145. In contrast, ROCK2 expression was higher in PC-3 cells than in PrECs and DU145 cells. EMT marker analysis revealed that PC-3 cells exhibited decreased E-cadherin and increased N-cadherin and Snail expression. ROCK2 knockdown reversed this EMT phenotype, reducing cell proliferation, migration, 3D tumor spheroid formation, and spheroid cell viability. Similar inhibitory effects were observed by the ROCK2-selective blocker KD025 (IC₅₀ = 422 nM). Furthermore, ROCK2 deficiency attenuated the tumor growth of PC-3 cells in a xenograft mouse model. These findings indicate that ROCK2 promotes EMT process and tumor progression in PC-3 cells. Targeting ROCK2 may represent a promising therapeutic strategy for androgen-independent prostate cancer.

2025-12-01·CURRENT OPINION IN IMMUNOLOGY

Approved and emerging therapies for glucocorticoid-refractory chronic graft-versus-host disease

Review

作者: Ren, Yuxin ; Huang, Ruihao ; Zhang, Xi ; Zhang, Xinwen ; Wang, Xiaoqi

Glucocorticoid-refractory chronic graft-versus-host disease (glucocorticoid-refractory cGVHD) remains a major barrier to long-term survival and quality of life following allogeneic hematopoietic stem cell transplantation (allo-HSCT), affecting 30-70% to half of patients with chronic GVHD who fail corticosteroid therapy. In recent years, the Food and Drug Administration (FDA) has approved four agents - ibrutinib, ruxolitinib, belumosudil, and axatilimab - each targeting distinct immune and fibrotic pathways. This review systematically evaluates their mechanisms of action, efficacy across organ systems, and safety profiles while highlighting persistent limitations. We further summarize emerging therapies in clinical and preclinical development, including kinase inhibitors, monoclonal antibodies, cellular approaches, and tissue-specific interventions. A dual-axis framework - distinguishing inflammatory versus fibrotic phenotypes and organ-specific manifestations - is proposed to support biomarker-guided, individualized treatment. In addition, combination regimens and AI-assisted strategies offer new opportunities to optimize outcomes and reduce treatment burden. Despite these advances, challenges remain, including irreversible fibrosis, disease heterogeneity, lack of standardized diagnostic criteria, and balanced GVHD and graft versus tumor effect. Greater incorporation of patient-reported outcomes and long-term functional assessments into clinical trials and practice is urgently needed. Collectively, this review offers a roadmap for optimizing glucocorticoid-refractory cGVHD management, and evolving strategies hold promise for transforming glucocorticoid-refractory cGVHD from a life-limiting condition into a manageable chronic disease.

2025-12-01·INTERNATIONAL JOURNAL OF HEMATOLOGY

Efficacy of ibrutinib and diagnostic liver biopsy for idiopathic refractory ascites after allogeneic stem cell transplantation

Article

作者: Nakashima, Yasuhiro ; Ido, Kentaro ; Takahata, Shota ; Nakamae, Mika ; Horiuchi, Mirei ; Nakamae, Hirohisa ; Makuuchi, Yosuke ; Nakaya, Yosuke ; Hino, Masayuki ; Sakatoku, Kazuki ; Nishimoto, Mitsutaka ; Okamura, Hiroshi ; Shiohara, Masanori ; Kuno, Masatomo

Idiopathic portal hypertension-related refractory ascites (IRA) is a rare but potentially life-threatening complication following allogeneic hematopoietic cell transplantation (allo-HCT). Its pathogenesis remains unclear, and optimal diagnostic and therapeutic strategies have yet to be established. Here, we report a case of a 58-year-old man who developed progressive ascites after allo-HCT. Although the clinical findings met diagnostic criteria for hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), liver histology revealed no hallmark features of VOD/SOS, such as sinusoidal dilatation or central venous fibrosis. Instead, portal venopathy with lymphocytic infiltration and fibrosis suggested a subclinical chronic graft-versus-host disease (GVHD)-like pathology, supporting a diagnosis of IRA by exclusion. Treatment with belumosudil, one of the available treatment options for chronic GVHD, was ineffective. Subsequent treatment with ibrutinib, a Bruton's tyrosine kinase inhibitor, led to resolution of ascites within three days. This is the second reported case of successful treatment of IRA with ibrutinib, and highlights the importance of considering ibrutinib-responsive immune-mediated mechanisms in the differential diagnosis of post-transplant ascites. Given the fundamental differences in treatment strategies between IRA and VOD/SOS, our findings underscore the need for accurate diagnosis, including histopathological evaluation, to guide effective therapy and improve patient outcomes in this challenging clinical scenario.

142

项与甲磺酸贝舒地尔相关的新闻（医药）

2025-11-14

·FiercePharma

Otsuka's HAE med Dawnzera, Lilly's oral SERD Inluriyo among drugs scoring EU endorsements

Ten new meds are now off to the European Commission for a final review. Shortly after crossing the FDA’s finish line, Ionis Pharmaceuticals’ RNA-targeted hereditary angioedema (HAE) treatment Dawnzera is on its way to breaking ground in the European market with an endorsement from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).Dawnzera, which is under the stewardship of Ionis’ partner Ostuka Pharmaceuticals in Europe and the Asia Pacific region, won CHMP’s favor based on a phase 3 study that showed the drug was associated with an 81% reduction in HAE attacks versus placebo.The genetic condition is hallmarked by recurrent attacks of severe swelling in various parts of the body and is estimated to affect some 1 in 50,000 people worldwide, according to Ionis.The CHMP opinion is a “key milestone in advancing access to potentially life-changing treatments for the HAE community,” Otsuka's chief executive in Europe said in a statement. The drug won its first approval in the U.S. in August amid a recent upswell in new HAE treatments. Along with being the first RNA-targeted treatment for the condition, Dawnzera sets itself apart with its dosing schedule and availability in pre-filled pens for at-home injections. Now, Otsuka's EU application is off to the European Commission (EC), which will give the final call on approval for those ages 12 and older, CHMP said. Nods for Eli Lilly, Sanofi and more Eli Lilly also received good news among CHMP’s group of Nov. 13 decisions, with the Indianapolis pharma scoring an endorsement for its oral selective estrogen receptor degrader (SERD) Inluriyo. The monotherapy, for patients with locally advanced or metastatic breast cancer with an activating ESR1-mutation, is the second oral SERD to pass muster with regulators in Europe or the U.S. after Italy’s Menarini first broke into the tricky treatment space in 2023.Lilly’s offering, if approved by the EC, would hold a European label for use in patients who have experienced disease progression after treatment with an endocrine-based regimen, CHMP said.CHMP’s latest meeting cleared the way for 10 products in total, including two biosimilars and two generics. Others to earn a thumbs-up include Sanofi’s disease-modifying Type 1 diabetes infusion Teizeild, which was classified under CHMP’s priority medicine (PRIME) pathway to speed up drugs that meet an unmet need. The FDA recently took a similar approach with Tzield, giving it an expedited review under the new FDA Commissioner's National Priority Voucher program for a potential label expansion.Elsewhere, CHMP signed off on a radionuclide generator made by Curium Romania SRL, a whooping cough (pertussis) vaccine made by BioNet Europe and Fondazione Teleth’s Waskyra, the first gene therapy that can treat Wiskott-Aldrich syndrome. Fondazione Telethon is the first non-profit organization to have spearheaded a drug’s path from research all the way to regulatory approval, it said in a press release. As for biosimilars, Gan & Lee’s copy of Sanofi’s long-acting insulin Lantus and Theramex Ireland’s version of Amgen’s bone meds Prolia and Xgeva also secured CHMP endorsements, as did Accord’s generic version of Astellas and Pfizer’s prostate cancer drug Xtandi. Viatris’ generic copy of Takeda’s short bowel syndrome injection Revestive also made the grade at this week's CHMP meeting.CHMP also announced that it has begun its re-examination of Sanofi’s Rezurock in the third-line treatment of chronic graft-versus-host disease. The company received a negative CHMP opinion on the med last month and quickly pledged to seek a re-review.Avanex Life Sciences’ bid for its blarcamesine prospect in early Alzheimer’s disease, meanwhile, received a “negative trend vote” by the committee, the company said. Avanex’s shares fell 35% on the Friday news.

上市批准临床结果临床3期疫苗

2025-11-12

·搜狐新闻

贝舒地尔是首个针对ROCK2靶点的创新药物

处在药物研发的严谨世界之中，杂质研究尽管好像冷门，然而却是保障药品安全必不可少的防线，其直接关联到每一位患者的用药安全。贝舒地尔，是全球首个专门针对ROCK2靶点起抑制效果的物质，其独特之处在于，能够对免疫系统产生双向调节作用，一方面，抑制具有促炎活性的Th17细胞，另一方面，增强具备调节功效的Treg细胞功能，这种双重作用机制，使其能够同时应对慢性移植物抗宿主病，也就是cGVHD里的炎症反应以及组织纤维化问题。对于那些传统激素治疗没有效果的患者而论，该药物给出了 new 的选择。特别是在难治性肺纤维化那些病例之中，它呈现出超过三分之一的有效比率，给这一部分重症患者带去了希望。它的适应症明确地用以针对 12 岁以上、经历过激素治疗失败的 cGVHD 患者。这款药物的开发进程，十足展现出政策对于创新的扶持，因它在cGVHD后线治疗范畴具备空白价值，所以先后得到了美国FDA以及中国NMPA的突破性治疗药物认定，这些认定极大地加快了审评审批程序，致使其在中国仅仅花费616天就被批准上市。在2024年的时候，该药物成功被纳入到国家医保目录之中，其价格从处于高位的水平 fellto 大约在1.38万元左右，这明显地减轻了患者所面临的经济负担哦。当前呢，研究人员正在积极地向前推进其用于一线治疗的III期临床试验工作，与此同时还在探索它在实体器官移植这个领域的应用潜力呢。尽管cGVHD是属于罕见病范围之内的，患者群体是有限的，然而贝舒地尔依靠明确的临床价值确立了市场地位。研究数据表明，使用这个药物的患者总体生存率能够达到89%，这一硬性指标支撑了它的市场定价。该药物的增长跟移植手术数量以及医保覆盖程度紧密相关。从竞争的格局方面来看，该药物的化合物专利保护期限到2026年，这给它提供了暂时的市场独占时期。企业需要在这个期间加快新适应症的拓展，与此同时通过真实世界研究积累更多临床证据，为未来的市场竞争做好准备。在药物制造进程里，杂质把控是确保药品品质的要害要点，贝舒地尔尤为留意基因毒性杂质的监测跟控制，此类杂质即便处于微量程度也兴许对人体产生损害，制造进程中运用了先进的剖析技术予以严格监管。历经持续不断的工艺优化，生产企业已然能够把杂质水平把控在百万分之一的等级，清晰知晓药物于储存进程里可能因氧化、水解进而产生的降解产物，以此为制定科学的贮藏条件供给了依据，这些举措一同构成了完备的质量控制体系。在实际开展质量控制操作期间，检测人员运用高效液相色谱 - 质谱联用技术，针对杂质实施精准的定量工作。此方法具备高灵敏度的特性，能够检测出含量极低的杂质，以此确保每一批次产品的质量保持一致性。与此同时，还建立起了完善的稳定性考察方案，。按照研究得出的结果显示，此药物应当于25℃以下、避开潮湿因素的状况里储存。医护工作人员以及患者均要留意防止与对CYP3A4酶活化影响的药物一同运用，在有必要的时候要对剂量予以调整。这些精细的要求全都是为了确保药物的有效性还有安全性。伴随着该药物长时间的应用，研究人员得进一步去探寻其代谢产物于人体内的毒理学特性。这对于那些需要长期用药的cGVHD患者而言格外重要。与此同时，随着临床使用经验的不断积累，现有的杂质控制策略有可能需要进一步加以优化。未来，制药企业要留意不同人群用药之时存在的差异，尤其是在同其他药物共同运用期间所涉及的安全性方面的问题。这些相关研究能够给该药的长期安全利用提供更多的科学性依据，而且也对拓展其临床应用的范畴有所帮助。难道不是在您留意创新药物之际，最先着重考量的究竟是其治疗效果，还是安全性能，又或者是价格方面所需考虑的因素呢？若您愿意把自身之见解分享于评论区域，而您要是觉得这文章对您有所助益，那就请点赞予以支持吧！在贝舒地尔的研发与生产过程中，可以到CATO查阅全套贝舒地尔杂质对照品的COA及相关图谱，为制药企业提供精准分析工具，从方法开发到质控验证全程护航，确保药物安全性与有效性，惠及全球患者。返回搜狐，查看更多

突破性疗法临床3期

2025-10-26

·信狐药迅

1类创新药：杭州中美华东迈华替尼片获批上市| 新获批(10.20-10.26）

每周药品注册获批数据，分门别类呈现，一目了然。(10.20-10.26）新药上市申请药品名称企业注册分类受理号迈华替尼片杭州中美华东制药有限公司 1 CXHS2400041 迈华替尼片杭州中美华东制药有限公司 1 CXHS2400040 HR20031片(Ⅱ) 山东盛迪医药有限公司 2.3 CXHS2300100 HR20031片(Ⅰ) 山东盛迪医药有限公司 2.3 CXHS2300099 新药临床申请药品名称企业注册分类受理号 ARTS-023片安锐生物医药科技(广州)有限公司 1 CXHL2500835 ARTS-023片安锐生物医药科技(广州)有限公司 1 CXHL2500834 HRS-7058片山东盛迪医药有限公司 1 CXHL2500832 HRS-7058片山东盛迪医药有限公司 1 CXHL2500831 HRS-7058胶囊山东盛迪医药有限公司 1 CXHL2500830 HRS-7058胶囊山东盛迪医药有限公司 1 CXHL2500829 HRS-4642注射液上海恒瑞医药有限公司 1 CXHL2500827 HRS-4642注射液上海恒瑞医药有限公司 1 CXHL2500826 TQB3122胶囊正大天晴药业集团股份有限公司 1 CXHL2500825 TQB3122胶囊正大天晴药业集团股份有限公司 1 CXHL2500824 HRS-4642注射液上海恒瑞医药有限公司 1 CXHL2500821 HRS-4642注射液上海恒瑞医药有限公司 1 CXHL2500820 IPG7236片南京艾美斐生物医药科技有限公司 1 CXHL2500814 IPG7236片南京艾美斐生物医药科技有限公司 1 CXHL2500813 HRS-2430注射液江苏恒瑞医药股份有限公司 1 CXHL2500810 HRS-2430注射液江苏恒瑞医药股份有限公司 1 CXHL2500811 SYH2061注射液石药集团中奇制药技术(石家庄)有限公司 1 CXHL2500812 APH03621片广州一品红制药有限公司 1 CXHL2500803 APH03621片广州一品红制药有限公司 1 CXHL2500802 SA1211注射液苏州时安生物技术有限公司 1 CXHL2500790 注射用ADB116 江苏艾迪药业集团股份有限公司 2.1;2.2;2.4 CXHL2500785 BIFC胶囊装微片北京天衡药物研究院有限公司 2.2 CXHL2500788 HKGM-453 黑龙江亿达鸿药业有限公司 2.3 CXHL2500761 结合雌激素乳膏新疆新姿源生物制药有限责任公司 2.4 CXHL2500833 吡非尼酮胶囊北京康蒂尼药业股份有限公司 2.4 CXHL2500836 苹果酸法米替尼胶囊江苏恒瑞医药股份有限公司 2.4 CXHL2500828 羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司 2.4 CXHL2500823 羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司 2.4 CXHL2500822 PRT-062鼻喷雾剂四川普锐特药业有限公司 2.4;2.2 CXHL2500838 PRT-062鼻喷雾剂四川普锐特药业有限公司 2.4;2.2 CXHL2500837 呼吸道合胞病毒mRNA疫苗云南沃森生物技术股份有限公司 1.2 CXSL2500642 呼吸道合胞病毒mRNA疫苗云南沃森生物技术股份有限公司 1.2 CXSL2500641 AZD0901 阿斯利康全球研发(中国)有限公司 1 CXSL2500694 注射用SHR-1826 苏州盛迪亚生物医药有限公司 1 CXSL2500689 SHR-4610注射液上海盛迪医药有限公司 1 CXSL2500686 注射用BL-M24D1 成都百利多特生物药业有限责任公司 1 CXSL2500680 QX029N注射液江苏荃信生物医药股份有限公司 1 CXSL2500679 注射用FH-006 上海甫弘生物医药有限公司 1 CXSL2500687 注射用SHR-9839 (sc) 苏州盛迪亚生物医药有限公司 1 CXSL2500685 IBI363 信达生物制药(苏州)有限公司 1 CXSL2500672 IBI363 信达生物制药(苏州)有限公司 1 CXSL2500671 SCTC21C注射液神州细胞工程有限公司 1 CXSL2500670 JH032注射液百泰生物药业有限公司 1 CXSL2500668 SHR-1701注射液苏州盛迪亚生物医药有限公司 1 CXSL2500677 SHR-7367注射液上海恒瑞医药有限公司 1 CXSL2500675 注射用GenSci139 长春金赛药业有限责任公司 1 CXSL2500673 注射用HS-20093 上海翰森生物医药科技有限公司 1 CXSL2500666 IBI3026 信达生物科技有限公司 1 CXSL2500660 人源多巴胺能前体细胞注射液睿健毅联医药科技(成都)有限公司 1 CXSL2500637 人脐带间充质干细胞注射液北京第一生物科技开发有限公司 1 CXSL2500627 WSK-IM02 北京威斯克生物医药有限公司 1 CXSL2500615 阿得贝利单抗注射液上海盛迪医药有限公司 2.2 CXSL2500681 注射用瑞康曲妥珠单抗苏州盛迪亚生物医药有限公司 2.2 CXSL2500684 SHR-8068注射液苏州盛迪亚生物医药有限公司 2.2 CXSL2500678 贝伐珠单抗注射液苏州盛迪亚生物医药有限公司 2.2 CXSL2500676 阿得贝利单抗注射液上海盛迪医药有限公司 2.2 CXSL2500674 仿制药申请药品名称企业注册分类受理号盐酸曲唑酮片重庆圣华曦药业股份有限公司 3 CYHS2402015 依帕司他片石家庄康力药业有限公司 3 CYHS2402001 草酸艾司西酞普兰口服溶液江苏长泰药业股份有限公司 3 CYHS2401733 异烟肼注射液漯河市汇创医药有限公司 3 CYHS2401633 利伐沙班颗粒南京海纳制药有限公司 3 CYHS2401606 帕拉米韦注射液浙江康吉尔药业有限公司 3 CYHS2401473 多索茶碱片杭州沐源生物医药科技有限公司 3 CYHS2401241 多索茶碱片杭州沐源生物医药科技有限公司 3 CYHS2401240 氟哌啶醇注射液上海理想制药有限公司 3 CYHS2401083 氯化钾颗粒成都通德药业有限公司 3 CYHS2401070 地拉罗司颗粒上海复星医药产业发展有限公司 3 CYHS2400968 复方电解质醋酸钠注射液南京恩泰医药科技有限公司 3 CYHS2400960 溴吡斯的明缓释片上海上药中西制药有限公司 3 CYHS2400832 双嘧达莫片本溪匠成医药科技有限公司 3 CYHS2400718 聚乙二醇3350散福州基石医药科技有限公司 3 CYHS2400651 盐酸普萘洛尔注射液金诺康药业科技(石家庄)有限公司 3 CYHS2400525 盐酸奈福泮注射液安徽恒星制药有限公司 3 CYHS2303608 氯化钾颗粒苏州朗科生物技术股份有限公司 3 CYHS2303479 复方聚乙二醇电解质散(儿童型) 河北三禾实创生物科技有限公司 3 CYHS2303146 复方聚乙二醇电解质散(儿童型) 东阳祥昇医药科技有限公司 3 CYHS2302389 氧延安同辉实业有限公司 4 CYHS2500028 富马酸伏诺拉生片天津武田药品有限公司 4 CYHS2404094 格列齐特缓释片江苏德源药业股份有限公司 4 CYHS2402937 盐酸替罗非班注射用浓溶液辰欣药业股份有限公司 4 CYHS2402834 达格列净片重庆康刻尔制药股份有限公司 4 CYHS2402743 达格列净片重庆康刻尔制药股份有限公司 4 CYHS2402742 普拉洛芬滴眼液河北合渡药业有限公司 4 CYHS2402630 麦考酚钠肠溶片成都倍特药业股份有限公司 4 CYHS2402497 麦考酚钠肠溶片成都倍特药业股份有限公司 4 CYHS2402496 美阿沙坦钾片江苏永安制药有限公司 4 CYHS2402484 美阿沙坦钾片江苏永安制药有限公司 4 CYHS2402483 阿昔莫司胶囊南京海辰药业股份有限公司 4 CYHS2402482 盐酸尼卡地平注射液成都瑞尔医药科技有限公司 4 CYHS2402283 熊去氧胆酸胶囊山西同达药业有限公司 4 CYHS2402274 乙酰半胱氨酸泡腾片浙江领创优品药业有限公司 4 CYHS2402169 盐酸奥布卡因滴眼液浙江莎普爱思药业股份有限公司 4 CYHS2402105 乙酰半胱氨酸颗粒郑州韩都药业集团有限公司 4 CYHS2402056 乙酰半胱氨酸颗粒郑州韩都药业集团有限公司 4 CYHS2402055 聚多卡醇注射液成都市海通药业有限公司 4 CYHS2401861 聚多卡醇注射液成都市海通药业有限公司 4 CYHS2401860 聚多卡醇注射液成都市海通药业有限公司 4 CYHS2401859 硫酸氨基葡萄糖胶囊合肥康惠医药技术有限公司 4 CYHS2401844 二甲双胍恩格列净片(I) 河南诺美药业有限公司 4 CYHS2401765 吗啉硝唑氯化钠注射液辽宁民康制药有限公司 4 CYHS2401574 帕拉米韦氯化钠注射液仁合益康集团有限公司 4 CYHS2401516 帕拉米韦氯化钠注射液仁合益康集团有限公司 4 CYHS2401515 盐酸美金刚片四川尚锐生物医药有限公司 4 CYHS2401453 沙格列汀二甲双胍缓释片山西同达药业有限公司 4 CYHS2401161 克立硼罗软膏杭州朱养心药业有限公司 4 CYHS2401154 盐酸尼卡地平注射液山东如至生物医药科技有限公司 4 CYHS2401120 依托咪酯中/长链脂肪乳注射液云南龙海天然植物药业有限公司 4 CYHS2401005 盐酸安妥沙星片仁合益康集团有限公司 4 CYHS2400920 富马酸伏诺拉生片上海延安药业有限公司 4 CYHS2400740 富马酸伏诺拉生片上海延安药业有限公司 4 CYHS2400739 玻璃酸钠滴眼液扬州中宝药业股份有限公司 4 CYHS2400713 利培酮口服溶液乐信乐美(海南)生物科技有限公司 4 CYHS2400701 丁二磺酸腺苷蛋氨酸肠溶片北京金城泰尔制药有限公司 4 CYHS2400167 胞磷胆碱注射液森淼(山东)药业有限公司 4 CYHS2400030 胞磷胆碱注射液森淼(山东)药业有限公司 4 CYHS2400031 胞磷胆碱注射液森淼(山东)药业有限公司 4 CYHS2400032 卡格列净片浙江华海药业股份有限公司 4 CYHS2303290 异硫蓝注射液康哲(湖南)制药有限公司 3 CYHL2500146 呫诺美林曲司氯铵胶囊江苏恩华药业股份有限公司 3 CYHL2500142 呫诺美林曲司氯铵胶囊江苏恩华药业股份有限公司 3 CYHL2500141 呫诺美林曲司氯铵胶囊江苏恩华药业股份有限公司 3 CYHL2500140 冻干b型流感嗜血杆菌结合疫苗北京百晖生物科技有限公司 3.3 CXSL2500616 进口申请药品名称企业注册分类受理号那米司特片 Boehringer Ingelheim International GmbH 1 JXHS2500030 那米司特片 Boehringer Ingelheim International GmbH 1 JXHS2500029 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500216 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500215 乙磺酸LY4066434片 Eli Lilly and Company 1 JXHL2500214 Icotrokinra片 Janssen Research & Development, LLC 1 JXHL2500207 Icotrokinra片 Janssen Research & Development, LLC 1 JXHL2500208 甲磺酸贝舒地尔口服混悬剂 Sanofi-Aventis Recherche & Developpement 2.2 JXHL2500201 AZD0486 AstraZeneca AB 1 JXSL2500154 AZD0486 AstraZeneca AB 1 JXSL2500153 AZD0486 AstraZeneca AB 1 JXSL2500152 AZD0486 AstraZeneca AB 1 JXSL2500151 AZD0486 AstraZeneca AB 1 JXSL2500150 MEDI5752 AstraZeneca AB 1 JXSL2500148 Lunsekimig注射液 Sanofi-Aventis Recherche & Developpement 1 JXSL2500146 Lunsekimig注射液 Sanofi-Aventis Recherche & Developpement 1 JXSL2500145 注射用SAR446523 Sanofi-Aventis Recherche & Developpement 1 JXSL2500144 MK-4280A注射液 Merck Sharp & Dohme LLC 1 JXSL2500143 ALXN1920注射液 Alexion Pharmaceuticals, Inc. 1 JXSL2500142 BAY 3401016 注射液 Bayer AG 1 JXSL2500141 中药相关申请药品名称企业注册分类受理号芍药甘草颗粒湖北济安堂药业股份有限公司 3.1 CXZS2500006 升陷颗粒神威药业集团有限公司 3.1 CXZS2400027 注：橙色字体部分结论为不批准或收到通知件；

申请上市临床申请

100 项与甲磺酸贝舒地尔相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11815 D11816	-	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性移植物抗宿主病	美国	Kadmon Pharmaceuticals LLC	2021-07-16

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
同种异体移植排斥反应	临床3期	美国	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	中国	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	澳大利亚	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	奥地利	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	比利时	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	加拿大	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	捷克	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	丹麦	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	芬兰	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	法国	Sanofi	2023-10-10

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ROCKREAL (EHA2025)	临床2期	慢性移植物抗宿主病	196	Belumosudil	簾網範簾範簾糧鹽鹽壓(夢鏇襯壓選範鬱鹽鏇餘) = 衊糧積齋蓋獵窪鬱鹹製鹹積醖餘鏇壓鬱憲築觸 (選襯齋夢鹹衊積築蓋鏇, 167 ~ 667)	积极	2025-05-14
				Best Available Therapy (BAT)	簾網範簾範簾糧鹽鹽壓(夢鏇襯壓選範鬱鹽鏇餘) = 網獵衊願繭遞築壓簾鑰鹹積醖餘鏇壓鬱憲築觸 (選襯齋夢鹹衊積築蓋鏇, 130 ~ 685)
NCT05305989 (CTgov)	临床2期	慢性移植物抗宿主病	23	Belumosudil (Belumosudil 200 mg QD)	觸網構構膚範鑰艱艱膚(醖衊鬱鹹壓簾積蓋顧範) = 壓廠鬱製製範鹽築膚壓廠壓鹽糧鬱積艱膚簾衊 (鹽獵鬱餘醖醖鏇製齋鬱, 範繭鏇襯鬱遞糧積憲網 ~ 觸鬱淵鏇艱構製糧壓鹽) 更多	-	2025-05-02
				Belumosudil (Belumosudil 200 mg BID)	觸網構構膚範鑰艱艱膚(醖衊鬱鹹壓簾積蓋顧範) = 鏇醖繭範鬱糧遞築顧鏇廠壓鹽糧鬱積艱膚簾衊 (鹽獵鬱餘醖醖鏇製齋鬱, 顧壓壓構網艱範窪衊餘 ~ 願夢廠夢範鑰獵鏇壓製) 更多
NCT03919799 (Pubmed \| Rheumatology (Oxford))	临床2期	弥漫性硬皮病 FOXP3 \| STAT3 \| IL23A ... 更多	-	Belumosudil 200 mg QD	繭簾鏇獵艱繭鹹齋廠鏇(製構網衊壓糧襯壓構膚) = trends of decreased fibrosis biomarker levels were seen in belumosudil-treated group vs placebo 窪淵蓋廠衊鬱膚鬱範遞 (鹹鬱鑰範鏇繭鑰鏇鏇鹹 )	不佳	2025-03-14
				Belumosudil 200 mg BID
NCT03640481 (KD025-213 \| ROCKstar Study \| ROCKstar, CTgov)	临床2期	慢性移植物抗宿主病	159	Belumosudil (KD025) (Adolescent Arm A: Belumosudil 200 mg QD)	鹹範觸選艱憲築淵衊淵 = 壓顧鬱膚範膚鑰憲艱糧構壓鏇簾鬱鹽選顧壓壓 (憲齋衊顧廠夢齋觸簾鏇, 壓艱獵觸糧製糧餘簾糧 ~ 繭選願鹹窪願憲顧壓淵) 更多	-	2024-12-12
				Belumosudil (KD025) (Adolescent Arm B: Belumosudil 200 mg BID)	鹹範觸選艱憲築淵衊淵 = 顧糧簾製積糧壓製構選構壓鏇簾鬱鹽選顧壓壓 (憲齋衊顧廠夢齋觸簾鏇, 醖窪鏇艱廠顧壓鏇夢壓 ~ 鏇選鬱願繭鏇遞築醖積) 更多
ASH2024	N/A	慢性移植物抗宿主病	-	Belumosudil	構鏇夢網醖顧製構襯衊(獵糧衊蓋鏇糧築簾網築) = 簾鏇艱繭衊艱壓廠構襯鏇鏇壓觸餘窪築築鏇選 (餘觸願齋窪襯範鹹襯鹽 ) 更多	-	2024-12-08
KD-025-2134 (EHA2024) 人工标引	N/A	类固醇难治性移植物抗宿主病	45	Belumosudil	簾鑰襯衊蓋鏇製築積築(鑰衊窪襯繭襯壓構糧鑰) = 簾製夢襯製顧壓襯壓壓繭獵鹽襯齋窪廠淵憲築 (餘艱艱憲淵網製壓鏇衊 ) 更多	积极	2024-05-14
JPRN-jRCT2011210041 (EHA 12024 \| EHA 22024) 人工标引	临床3期	慢性移植物抗宿主病	21	BelumosudilBelumosudil 200 mg	鬱鬱餘壓繭鹹鏇糧餘築(鹹鹹繭簾膚餘糧願鹹廠) = 醖膚製夢積鹽顧鏇鬱糧憲廠獵簾淵壓鑰窪遞夢 (鬱範選膚範製餘範蓋遞, 63.66 ~ 96.95) 更多	积极	2024-05-14
EHA2024	N/A	慢性移植物抗宿主病	35	Belumosudil	繭網齋淵鬱鹽觸齋衊網(糧膚願鹹襯醖遞廠淵鏇) = 2 patients where additional treatment for cGvHD had to be initiated 選鏇遞餘簾範網壓膚蓋 (憲選淵鹹醖齋築膚餘鏇 ) 更多	积极	2024-05-14
NCT04930562 (Pubmed) 人工标引	临床2期	慢性移植物抗宿主病二线	30	Belumosudil 200 mg	廠憲觸顧鹽獵鹹糧簾憲(網淵鹹構膚襯願醖鬱膚) = 願鹽艱膚網衊積窪襯齋蓋壓糧窪餘鑰觸範顧醖 (願構艱襯窪窪願鏇艱襯, 54.1 ~ 87.7) 更多	积极	2024-03-26
NCT03640481 (ROCKstar, Tandem Meetings ASTCT and CIBMTR2024) 人工标引	临床2期	移植物抗宿主病末线 \| 三线	152	Belumosudil 200 mg QD	顧顧淵艱顧網顧艱夢獵(鏇醖艱觸範蓋鹹願觸蓋) = 選淵鹹夢構鹹壓遞壓鬱淵選構繭醖醖憲膚鬱鬱 (艱壓膚鹽壓淵選鏇網醖 ) 更多	积极	2024-02-01
				Belumosudil 200 mg BID	顧顧淵艱顧網顧艱夢獵(鏇醖艱觸範蓋鹹願觸蓋) = 餘選選餘獵襯餘顧構鏇淵選構繭醖醖憲膚鬱鬱 (艱壓膚鹽壓淵選鏇網醖 ) 更多