环孢素(Cyclosporine) - 药物靶点：CaN_在研适应症：变应性结膜炎，角结膜炎，春季角膜结膜炎_专利_临床

概要

基本信息

药物类型

非降解型分子胶、合成多肽

别名

(Nva2)-cyclosporine、Ciclosporin、ciclosporin

+ [83]

靶点

CaN

作用方式

抑制剂

作用机制

CaN抑制剂(钙神经素抑制剂)

治疗领域

肿瘤免疫系统疾病神经系统疾病+ [8]

在研适应症

变应性结膜炎角结膜炎春季角膜结膜炎+ [41]

非在研适应症

急性红细胞白血病急性移植物抗宿主病急性肾损伤+ [151]

原研机构

Novartis Pharma AG

在研机构

Novartis Pharmaceuticals KK

National Cancer Institute

Novartis Pharmaceuticals Corp.

+ [25]

非在研机构

Allergan UCNational Institutes of Health Clinical Center

National Eye Institute

+ [10]

最高研发阶段批准上市

首次获批日期

美国 (1983-11-14),

器官移植排斥

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、临床急需境外新药 (中国)

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结构/序列

分子式C62H111N11O12

InChIKeyPMATZTZNYRCHOR-CGLBZJNRSA-N

CAS号59865-13-3

Sequence Code 13844772

关联

887

项与环孢素相关的临床试验

NCT06658002

/ Not yet recruiting临床3期IIT

Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A

The goal of this clinical trial is to learn if adjunctive topical Cyclosporine A eye drops combined with standard of care topical Natamycin treatment improves vision outcomes in patients with fungal keratitis.

开始日期2025-06-01

申办/合作机构

The University of California, San Francisco

[+1]

NCT06752694

/ Recruiting临床2期IIT

Ruxolitinib Based GVHD Prophylaxis Regimen for Older Adults Receiving Non-ATG Containing Non-Myeloablative Hematopoietic Cell Transplantation for Acquired Aplastic Anemia

This phase II trial tests how well a ruxolitinib-based graft versus host disease (GVHD) prevention (prophylaxis) regimen works before, during, and after bone marrow/stem cell transplantation (hematopoietic cell transplantation [HCT]) in patients with acquired aplastic anemia. Acquired aplastic anemia (AA) is a condition in which the bone marrow is unable to produce blood cells. Affected patients typically present with infections due to abnormally low number of neutrophils, bleeding due to low platelet count, and/or fatigue due to a lower-than-normal number of red blood cells (anemia). Its incidence varies with age, occurring most frequently in patients aged 2-5 years, 20-25 years, and 55 years and older. Treatment of AA includes either immunosuppressive therapy (IST) or bone marrow/stem cell transplantation (HCT) with first-line therapy in younger adults often being HCT, while adults over 40 still frequently trial IST first due to the morbidity and mortality concerns with HCT. GVHD is a common complication after donor stem cell transplantation, resulting from donor immune cells recognizing recipients' cells and attacking them. Ruxolitinib, a drug in a class of oral medications called JAK inhibitors has been approved for the treatment of acute and chronic GVHD. It has also been shown to decrease GVHD when used in the prevention setting in patients with myelofibrosis. The current study aims to assess whether adding ruxolitinib to a standard GVHD prevention regimen may reduce the risk of Grade II-IV acute and chronic GVHD after bone marrow/stem cell transplantation in older patients with acquired aplastic anemia.

开始日期2025-05-16

申办/合作机构

Fred Hutchinson Cancer Research Center

[+1]

NCT06898853

/ Not yet recruitingN/AIIT

The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Ocular Surface Innate and Adaptive Immune Response in Dry Eye Disease

Dry eye disease (DED) is a common, long-lasting condition that affects the surface of the eye. It happens when there's a problem with tear production or quality, which can lead to inflammation and discomfort. The immune system plays a big role in how DED develops and continues.
Researchers have found that in people with DED, there are more immune cells and inflammatory substances in the tears and on the eye's surface. This includes various types of immune cells, like T cells and dendritic cells, which are part of the body's defense system.
The first treatment for DED is usually artificial tears, but because the condition is chronic and can flare up, clinicians often use anti-inflammatory treatments too. One such treatment is cyclosporine A (CsA), which comes as eye drops. CsA works by reducing inflammation and affects how immune cells behave.
Researchers can study the immune cells on the eye's surface using a special microscopy technique called in vivo confocal microscopy (IVCM). A newer version of this method, called functional IVCM (Fun-IVCM), allows researchers to watch how these cells move and behave over time.
In the current study, researchers want to compare 0.1% CsA with a lubricating eye drop to see how they affect the immune cells on the eye's surface. The researchers will use Fun-IVCM to look at the number, shape, and movement of immune cells of the eye. The researchers will also collect samples from the eye's surface and tears to measure various markers of inflammation.
The goal is to better understand how CsA works in treating DED by directly observing its effects on the immune response in the eye, which is unexplored. This could help improve treatments for people suffering from this condition and expand the use of CsA in DED.

开始日期2025-05-01

申办/合作机构

The University of New South Wales

[+1]

100 项与环孢素相关的临床结果

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100 项与环孢素相关的转化医学

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100 项与环孢素相关的专利（医药）

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74,065

项与环孢素相关的文献（医药）

2025-12-31·Gut Microbes

Gut microbes metabolize strawberry phytochemicals and mediate their beneficial effects on vascular inflammation

Article

作者: Neilson, Andrew P. ; Della Lucia, Ceres Mattos ; Zhong, Ying ; Anandh Babu, Pon Velayutham ; Iglesias-Carres, Lisard ; Wankhade, Umesh D. ; Symons, J David ; Petersen, Chrissa ; Satheesh Babu, Adhini Kuppuswamy ; Paz, Henry A. ; Shankar, Kartik ; Jalili, Thunder

Evidence suggests that a healthy gut microbiome is essential for metabolizing dietary phytochemicals. However, the microbiome's role in metabolite production and the influence of gut dysbiosis on this process remain unclear. Further, studies on the relationship among gut microbes, metabolites, and biological activities of phytochemicals are limited. We addressed this knowledge gap using strawberry phytochemicals as a model. C57BL/6J mice were fed a standard diet [C]; strawberry-supplemented diet (~2 human servings) [CS]; strawberry-supplemented diet and treated with antibiotics (to deplete gut microbes) [CSA]; high-fat diet (HFD) [HF]; strawberry-supplemented HFD [HS]; and strawberry-supplemented HFD and treated with antibiotics [HSA] for 12 weeks. First, antibiotic treatment suppressed the production of selected metabolites (CSA vs. CS), and p-coumaric acid was identified as a strawberry-derived microbial metabolite. Second, HFD-induced dysbiosis negatively affected metabolite production (HS vs. HF), and hippuric acid was identified as a microbial metabolite in HFD conditions. Third, dietary strawberries improved HFD-induced vascular inflammation (HS vs. HF). However, antibiotic treatment reduced metabolite production and abolished the vascular effects of strawberries (HSA vs. HS), indicating the importance of gut microbes in mediating the vascular benefits of strawberries via metabolites. Fourth, strawberry supplementation decreased Coprobacillus that was positively associated with vascular inflammation, whereas it increased Lachnospiraceae that was negatively associated with vascular inflammation and positively associated with hippuric acid. Fifth, hippuric acid was negatively associated with vascular inflammation. Our study fills in some pieces of the giant puzzle regarding the influence of gut microbes on the biological activities of phytochemicals. HFD-induced gut dysbiosis negatively impacts metabolite production and a strong association exists among gut microbes, strawberry-derived microbial metabolites, and the vascular benefits of dietary strawberries. Further, our study provides significant proof of concept to warrant future research on the use of strawberries as a nutritional strategy to prevent vascular complications.

2025-12-31·RENAL FAILURE

Factors associated with chronic calcineurin inhibitor nephrotoxicity in children with minimal-change disease

Article

作者: Yang, Shicong ; Yue, Zhihui ; Jin, Bei ; Mo, Ying ; Cheng, Cheng ; Lu, Ziji ; Lin, Aihua ; Chen, Lizhi ; Pei, Yuxin ; Jiang, Xiaoyun

BACKGROUND:

Calcineurin inhibitors (CNIs), such as cyclosporine (CsA) and tacrolimus (TAC), are commonly used to treat children with complicated minimal change nephrotic syndrome. However, chronic nephrotoxicity associated with CNIs poses a significant safety concern. This study aimed to identify the risk factors that contribute to chronic nephrotoxicity in these patients.

MATERIAL AND METHODS:

Clinical and pathological data of MCD children treated with CsA or TAC in our center between 1 January 2003 and 31 December 2022, were retrospectively reviewed. Kidney biopsies were performed on 80 patients who received CNI treatment for more than 6 months.

RESULTS:

Chronic CNI nephrotoxicity (striped interstitial fibrosis with tubular atrophy) was observed in 15% (12/80) of patients. Higher CNI culminating amounts were shown in patients who developed nephrotoxicity regardless of CsA or TAC treatment. Risk factors for chronic CNI nephrotoxicity included persistent nephrotic-range proteinuria for more than 30 days during CNI treatment, increased urinary NAG level, and CNI resistance. Multivariate analysis revealed that increased urinary NAG level and CNI resistance were the independent risk factors for chronic CNI nephrotoxicity in children with MCD.

CONCLUSION:

MCD children who developed CNI resistance were susceptible to chronic CNI nephrotoxicity. Urinary NAG might be a valuable biomarker for CNI nephrotoxicity prediction in MCD children.

2025-12-01·JOURNAL OF CLINICAL IMMUNOLOGY

Restitutio ad integrum: Rescuing the Alveolar Macrophage Function with HSCT in Pulmonary Alveolar Proteinosis Due to CSF2Rα Deficiency

Article

作者: Mishra-Sopori, Varsha ; Pandrowala, Ambreen ; Bodhanwala, Minnie ; Khan, Sanaa ; Hiwarkar, Prashant ; Chandane, Parmarth ; Khosla, Indu ; Kataria, Darshan ; Prabhudesai, Pralhad ; Sehgal, Kunal

Hereditary pulmonary alveolar proteinosis (hPAP) is a rare lung-related primary immunodeficiency. In hPAP, variants of genes encoding the heterodimeric GM-CSF receptor alpha or beta-chains (CSF2Rα, CSF2Rβ) lead to perturbations in GM-CSF signalling. These perturbations impair the scavenging function of pulmonary alveolar macrophages leading to accumulation of surfactant proteins and lipids within the alveoli. The replacement of defective pulmonary alveolar macrophages can be achieved with allogeneic hematopoietic stem cell transplantation. However, previous reports highlight undesirable pulmonary outcomes associated with this therapeutic approach. We report a 4-year-old developmentally normal girl born of second-degree consanguineous marriage diagnosed with severe form of CSFRα-deficient PAP. She required recurrent whole lung lavage and hence was treated with allogeneic hematopoietic stem cell transplantation. A reduced toxicity treosulfan-based myeloablative regimen with alemtuzumab serotherapy was used for conditioning. Ciclosporin, mycophenolate mofetil and FAM (fluticasone inhaler, azithromycin, montelukast) were used to prevent graft-versus-host disease and immune-related complications of lung. Her post-transplant course was uneventful with full donor chimerism and complete resolution of symptoms. We demonstrate for the first time in a case of severe CSF2Rα-deficient PAP, the successful use of hematopoietic stem cell transplantation as a primary curative treatment, restoring normal lungs both anatomically and functionally. The case report provides evidence for considering allogeneic hematopoietic stem cell transplant in severe forms of CSF2R-deficient PAP.

867

项与环孢素相关的新闻（医药）

2025-04-21

·医药地理

康方生物银屑病1类新药获批上市，4针每年

4月18日，国家药品监督管理局官网发布最新消息，康方生物研发的1类新药依若奇单抗注射液获批上市。该药物主要用于治疗对环孢素、甲氨蝶呤（MTX）等传统系统性治疗手段或PUVA疗法无效、存在使用禁忌或无法耐受的中重度斑块状银屑病成人患者。据康方生物公开资料介绍，依若奇单抗注射液是一种针对IL-12/IL-23的全人源单克隆抗体。其每年仅需给药4次（首年5次）的特点，有助于提升患者用药的依从性，改善生活质量。银屑病是一种常见的慢性、易复发的炎症性皮肤病，患者一旦患病通常需要终身接受治疗，承受着沉重的疾病负担。传统药物治疗往往难以取得稳定且良好的效果，且不良反应较多，容易使患者难以耐受。相比之下，生物制剂在中重度银屑病治疗领域发挥着越来越重要的作用。银屑病的发生与异常的免疫反应密切相关。IL-12和IL-23是炎症和免疫反应中自然产生的细胞因子，二者具有共同的p40亚基。其中，IL-12能促使辅助性T细胞1（Th1细胞）增殖，并释放干扰素与肿瘤坏死因子α（TNF-α）；IL-23则能诱导辅助性T细胞17（Th17细胞）发育，并释放白介素-17（IL-17）等细胞因子，这些细胞因子在炎性和免疫反应中起到推波助澜的作用。依若奇单抗作为一种新型全人源的IL-12/IL-23单克隆抗体，其作用机制是与p40亚基结合，同时阻断IL-12和IL-23与细胞表面受体的相互作用，进而减少T细胞释放干扰素、TNF-α、IL-17等相关细胞因子，中断由这些因子介导的细胞免疫反应，从而抑制银屑病的异常免疫反应，实现治疗银屑病的目的。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

上市批准临床结果

2025-04-21

·摩熵医药

破局银屑病，康方生物1类新药获批上市！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。4月18日，中国药监局（NMPA）最新公示，康方生物1类新药依若奇单抗注射液（商品名：爱达罗）上市申请已获得批准，适用于对环孢素、甲氨蝶呤（MTX）等其他系统性治疗或PUVA（补骨脂素和紫外线A）不应答、有禁忌或无法耐受的中度至重度斑块状银屑病的成年患者的治疗。该药物为靶向IL-12/IL-23的全人源单克隆抗体，每年仅4次（首年5次）的给药频次有助于提高患者用药依从性。截图来源：NMPA官网银屑病是一种慢性、复发性的自身免疫性疾病，患者一旦发病，往往需要终身治疗，疾病负担沉重。传统药物治疗效果欠佳，且可能伴随较多不良反应，患者耐受性差。中国银屑病患病人数超过670万，并呈逐年增加趋势，需要长期用药治疗，整体疾病负担重。银屑病的发病机制与异常的免疫反应密切相关。IL-12和IL-23是两种在炎症和免疫反应中自然产生的细胞因子，它们共享一个p40亚基。IL-12能够诱导辅助性T细胞1（Th1细胞）的增殖，并促使其释放干扰素和肿瘤坏死因子α（TNF-α）；而IL-23则诱导辅助性T细胞17（Th17细胞）的发育，并促使其释放白介素-17（IL-17）。这些细胞因子在炎症和免疫反应中起着关键的促进作用。2024 年 EADV 年会上，康方生物公布了依若奇单抗的一项注册性 III 期临床研究的 52 周长期疗效和安全性数据（AK101-303）。AK101-303 研究共入组 950 例中重度银屑病患者，包含了完成 AK101-302 研究且符合条件继续参加依若奇单抗长期治疗研究的患者（第1组和第2组）。截图来源：康方生物演示材料据摩熵医药-全球药物研发数据显示，全球仅2款IL-12/IL-23 单抗获批上市，分别为乌司奴单抗（强生原研、静脉注射剂和皮下注射剂）和康方生物刚刚获批的依若奇单抗。2024年乌司奴单抗全球销售额突破103.61亿美元，依若奇单抗未来可期。END本文为原创文章，转载请留言获取授权近期热门资源获取数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025042023H2-2024H1中国药品分析报告-2025042024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-2025012024年NMPA批准上市的新药分析报告-2025012024年医保谈判及市场分析报告-2025.012024年中国医疗健康投融资全景洞察报告-202501小分子化药白皮书（上）-2025012024医美注射材料市场发展分析报告-202412中国放射性药物产业白皮书-202410近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准临床3期

2025-04-21

·CPHI制药在线

1年4针！国内首款IL-12/IL-23抗体新药获批，治疗中重度斑块状银屑病

关注并星标CPHI制药在线2025年4月18日，康方生物1类新药依若奇单抗正式获批上市，为国内中重度银屑病患者带来革命性选择。作为首个靶向IL-12/IL-23的全人源单抗，其"每年4针"的给药方案大幅提升用药便捷性，破解传统疗法依从性低、副作用多的痛点。临床数据显示，患者皮损改善率超79%，且疗效可稳定维持52周以上。在银屑病生物制剂竞争白热化的当下，依若奇单抗能否凭借差异化优势抢占市场？银屑病治疗困境银屑病，作为一种常见的慢性复发性炎症性皮肤病，严重影响着患者的生活质量。其特征性表现为皮肤出现鳞屑性红斑或斑块，不仅影响外观，还常伴有瘙痒、疼痛等不适症状，给患者带来身心双重折磨。据统计，中国银屑病患病人数超过670万，且呈逐年增加趋势，患者往往需要终身治疗，整体疾病负担沉重。在传统治疗手段中，常用药物如环孢素、甲氨蝶呤等免疫抑制剂，虽有一定疗效，但需长期服用，且不良反应多，包括肝肾功能损害、骨髓抑制、胃肠道不适等，许多患者难以耐受。而PUVA（补骨脂素和紫外线A）光疗，不仅治疗过程繁琐，需要频繁前往医院，而且长期使用还存在增加皮肤癌风险等隐患。这些传统治疗方法，难以满足患者对高效、安全治疗的迫切需求，银屑病治疗领域急需新的突破。依若奇单抗的出现，为广大银屑病患者带来了新的希望，有望改写银屑病的治疗格局。依若奇单抗依若奇单抗作为一款新型全人源的IL-12/IL-23单克隆抗体，其作用机制极具创新性。IL-12及IL-23是炎症反应及免疫反应中自然产生的细胞因子，二者拥有共同的p40亚基。其中，IL-12能够诱导辅助性T细胞1（Th1细胞）增殖，并促使其释放干扰素与肿瘤坏死因子α（TNF-α）；IL-23则诱导辅助性T细胞17（Th17细胞）发育，使其释放白介素-17（IL-17）等。这些细胞因子在炎性及免疫反应中起到关键的促进作用，而银屑病的发病正是与这些异常免疫反应密切相关。依若奇单抗通过精准靶向p40亚基并与之紧密结合，同时抑制IL-12和IL-23与细胞表面受体的相互作用。这一巧妙的设计，犹如在异常免疫反应的信号传导通路上设置了双重关卡，进而有效减少T细胞对干扰素、TNF-α、IL-17等相关细胞因子的释放，从根源上阻断Th1和Th17细胞介导的异常免疫反应，从而达到抑制银屑病发病进程的治疗目的。这种双靶点抑制的独特作用机制，相较于传统单靶点药物，能够更全面、更深入地干预银屑病的发病机制，为患者带来更显著的治疗效果。在给药方案上，依若奇单抗同样展现出了极大的优势，采用首年5次、后续每年仅4次的超低给药频次。这一方案的推出，堪称银屑病治疗领域的一大福音。传统药物治疗银屑病时，往往需要频繁注射，例如一些药物可能需要每周甚至更短时间注射一次。频繁的注射不仅给患者带来身体上的痛苦，还容易导致局部皮肤损伤、组织硬化等问题，同时增加了感染的风险。而依若奇单抗的低频次给药，极大地降低了患者的治疗负担。患者无需频繁奔波于医院进行注射，大大提高了治疗的便利性。同时，较低的注射次数也减少了因注射操作可能引发的各种不良反应，有助于提高患者的用药依从性。良好的用药依从性对于银屑病这种需要长期治疗的疾病至关重要，能够确保患者持续接受有效的治疗，从而更好地控制病情，提高生活质量。临床数据说话依若奇单抗的获批，并非偶然，而是基于其在临床试验中展现出的卓越疗效与安全性。康方生物针对依若奇单抗开展了大规模、多中心的临床试验，覆盖了1500例患者，为其疗效和安全性提供了坚实的数据支撑。在关键III期试验中，依若奇单抗展现出了令人瞩目的短期疗效。第16周时，接受依若奇单抗治疗的患者，PASI75应答率高达79.4%，而安慰剂组仅为16.5%。PASI（银屑病面积和严重程度指数）是评估银屑病病情的重要指标，PASI75应答率意味着患者的皮损面积和严重程度改善达到75%以上。这一数据直观地表明，依若奇单抗能够在短时间内迅速减轻患者的症状，显著改善皮损状况。同时，依若奇单抗组sPGA0/1达成率为64%，远高于安慰剂组的11.7%。sPGA（静态医生总体评估）是医生对患者皮肤状况的综合评估，sPGA0/1表示皮肤几乎清除或仅有轻度疾病，这进一步证实了依若奇单抗在改善患者皮肤症状方面的显著效果。对于银屑病这种需要长期治疗的疾病，长期疗效的稳定性至关重要。依若奇单抗在这方面同样表现出色。在52周长期随访中，患者的PASI75应答率稳定维持在80%以上。这意味着依若奇单抗不仅能够在短期内快速改善患者症状，还能在长期治疗过程中持续发挥作用，维持良好的治疗效果。同时，依若奇单抗的抗药抗体发生率极低，这有效避免了因产生抗药抗体而导致的疗效下降问题，确保了患者能够长期稳定地从治疗中获益。在安全性方面，依若奇单抗也交出了一份令人满意的答卷。临床试验数据显示，依若奇单抗的不良事件发生率低，且多为轻中度不良反应，患者耐受性良好。其安全性与同类进口药相当，在感染、过敏等常见不良反应的发生率上，均处于可接受范围内。这使得依若奇单抗在长期使用过程中，能够为患者提供可靠的安全保障，让患者无需过度担忧药物的不良反应，更安心地接受治疗。市场竞争在全球IL-12/IL-23靶点市场中，强生的乌司奴单抗（Stelara）无疑占据着主导地位。自2008年首次获批以来，乌司奴单抗凭借其良好的疗效和广泛的适应症，迅速在市场中崭露头角，年销售额超百亿美元，成为自免领域的重磅药物之一。其在银屑病、银屑病关节炎、克罗恩病等多种炎症性疾病的治疗中都展现出了显著的效果，拥有庞大的患者群体和较高的市场认可度。依若奇单抗作为国产首款靶向IL-12/IL-23的药物，虽然面临着乌司奴单抗这一强劲对手，但也具备自身独特的优势。在便捷性方面，依若奇单抗"1年4针"（首年5次）的给药方案，相较于乌司奴单抗每12周注射一次，大大降低了患者的注射频率，为患者提供了更加便捷的治疗体验。对于长期受疾病困扰的患者来说，更低的注射频率意味着更少的就医次数，能有效节省时间和精力，提高生活质量。在价格方面，作为国产药物，依若奇单抗在成本控制上具有一定优势，有望通过更亲民的定价，提高患者的可及性。尤其是在国内市场，医保政策的支持和国产药物的价格优势相结合，能够让更多患者受益。然而，依若奇单抗也面临着品牌壁垒的挑战。乌司奴单抗作为市场先行者，经过多年的市场推广和临床应用，已经在医生和患者心中树立了较高的品牌形象和信任度。依若奇单抗需要在后续的市场推广中，通过优质的产品和服务，逐步打破这一壁垒，提升自身品牌影响力。除了康方生物的依若奇单抗，国内其他药企如信达生物、君实生物等也在积极布局IL-12/IL-23靶点相关管线。信达生物的匹康奇拜单抗（IBI112），特异性结合IL-23p19亚基，通过阻止IL-23与细胞表面受体结合，阻断IL-23受体介导信号通路发挥抗炎作用，目前已申报上市，用于治疗中重度斑块状银屑病。君实生物也在该领域持续投入研发，致力于推出具有竞争力的产品。未来，随着更多同类产品的上市，市场竞争将愈发激烈。竞争的焦点将主要集中在疗效持久性、适应症拓展与患者可及性等方面。在疗效持久性上，能够在更长时间内维持稳定疗效、减少复发的产品，将更受医生和患者青睐。适应症拓展也是关键，除了银屑病，若能在其他自身免疫性疾病，如克罗恩病、溃疡性结肠炎等领域取得突破，将大大拓宽产品的市场空间。提高患者可及性，包括优化给药方式、降低药物价格、提高医保报销比例等，也是企业在竞争中脱颖而出的重要因素。在这场激烈的市场竞争中，谁能更好地满足患者需求，谁就能在市场中占据一席之地，为广大患者带来更多优质的治疗选择。展望依若奇单抗的上市，不仅是国产创新药在自免领域的重大突破，更标志着银屑病治疗从"控症"迈向"长效便捷"的新阶段。面对国际巨头的围堵，康方生物以差异化临床价值撕开市场缺口，而未来国产药企的集体发力或将重塑行业格局。对患者而言，更多优质选择意味着更少治疗痛苦与更高生活质量；对行业而言，这场创新竞赛将推动中国生物药从"跟跑"转向"并跑"。期待依若奇单抗点亮更多患者的希望之光，也为国产创新药树立全新标杆。参考来源： 1、 NMPA官网 2、康方生物官网END【企业推荐】领取CPHI & PMEC China 2025展会门票来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

上市批准临床结果

100 项与环孢素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00184	环孢素	L04AD01 S01XA18	DB00091

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
变应性结膜炎	中国	Santen Oy	2022-04-29
变应性结膜炎	中国	参天制药（中国）有限公司	2022-04-29
角结膜炎	加拿大	Santen, Inc.	2018-12-24
春季角膜结膜炎	欧盟	Santen Oy	2018-07-06
春季角膜结膜炎	冰岛	Santen Oy	2018-07-06
春季角膜结膜炎	列支敦士登	Santen Oy	2018-07-06
春季角膜结膜炎	挪威	Santen Oy	2018-07-06
干眼综合征	欧盟	Santen Oy	2015-03-19
干眼综合征	冰岛	Santen Oy	2015-03-19
干眼综合征	列支敦士登	Santen Oy	2015-03-19
干眼综合征	挪威	Santen Oy	2015-03-19
角膜炎	欧盟	Santen Oy	2015-03-19
角膜炎	冰岛	Santen Oy	2015-03-19
角膜炎	列支敦士登	Santen Oy	2015-03-19
角膜炎	挪威	Santen Oy	2015-03-19
干眼症	日本	Santen Pharmaceutical Co., Ltd.	2005-10-11
干燥综合征性角膜结膜炎	美国	AbbVie, Inc.	2002-12-23
眼部炎症	美国	AbbVie, Inc.	2002-12-23
特应性皮炎	日本	Novartis Pharmaceuticals KK	2000-03-14
免疫抑制	日本	Novartis Pharmaceuticals KK	2000-03-14

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
眼部疾病	申请上市	加拿大	Apotex, Inc.	2025-01-01
肝移植排斥反应	临床3期	美国	Novartis Pharmaceuticals Corp.	2012-10-01
肝移植排斥反应	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2012-10-01
肝移植排斥反应	临床3期	比利时	Novartis Pharmaceuticals Corp.	2012-10-01
肝移植排斥反应	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2012-10-01
肝移植排斥反应	临床3期	丹麦	Novartis Pharmaceuticals Corp.	2012-10-01
肝移植排斥反应	临床3期	法国	Novartis Pharmaceuticals Corp.	2012-10-01
肝移植排斥反应	临床3期	德国	Novartis Pharmaceuticals Corp.	2012-10-01
肝移植排斥反应	临床3期	匈牙利	Novartis Pharmaceuticals Corp.	2012-10-01
肝移植排斥反应	临床3期	意大利	Novartis Pharmaceuticals Corp.	2012-10-01

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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


NCT00719888 (CTgov)	临床2期	急性髓性白血病 \| 淋巴浆细胞性淋巴瘤 \| 慢性期慢性髓性白血病 ... 更多	135	TBI+Fludarabine+Cyclophosphamide (Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant)	願網鹹膚鏇鏇鏇壓遞構 = 衊壓鹽選選廠壓廠衊築製遞遞夢願廠簾網鏇觸 (積顧構選齋鬱窪構鬱顧, 遞廠襯齋獵糧蓋糧壓鬱 ~ 鹽製網製鹹蓋廠繭夢獵) 更多	-	2025-03-07
				TBI+Fludarabine+Cyclophosphamide+Thiotepa (Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant)	願網鹹膚鏇鏇鏇壓遞構 = 築鹽製鏇顧鬱廠鏇襯獵製遞遞夢願廠簾網鏇觸 (積顧構選齋鬱窪構鬱顧, 繭鹹襯艱鏇願獵積範鏇 ~ 簾齋鬱夢餘鬱選築餘鏇) 更多
NCT04575779 (Pubmed \| Eur J Drug Metab Pharmacokinet)	N/A	造血干细胞移植	31	Cyclosporin A 2-h, twice-daily intravenous infusion	夢齋壓壓壓壓壓廠鹽艱(選觸網顧餘衊網齋襯築) = 鬱壓蓋醖製醖鑰艱構淵網構鏇遞顧餘觸齋衊鏇 (鏇網遞觸艱積醖窪網艱 )	积极	2024-11-27
				Cyclosporin A 22-h continuous infusion every 24 h	夢齋壓壓壓壓壓廠鹽艱(選觸網顧餘衊網齋襯築) = 鬱製醖網願鹹繭鹹製廠網構鏇遞顧餘觸齋衊鏇 (鏇網遞觸艱積醖窪網艱 )
UEGW2024	N/A	溃疡性结肠炎	-	Cyclosporine IV	餘構顧積簾製憲夢願網(窪鏇廠獵範積鹹齋膚獵) = AEs occurred in 53.3% of patients, 57.2% of them required a dose reduction or treatment discontinuation. AEs were mainly reversible, but 1 patient died of opportunistic infections (acute tuberculous pneumonia). The occurrence of AEs was not associated with the use of concomitant immunomodulators (p=0.92). Malignancy was observed in 5 patients during follow-up, mainly melanoma and non-melanoma skin cancer. 鏇顧醖遞遞膚鹽構糧觸 (製衊積繭網蓋鬱簾鹽艱 ) 更多	-	2024-10-13
				Oral Cyclosporine
NCT05745701 (CTgov)	临床1期	肥胖	16	Lotiglipron (Active Comparator: Period 1: Lotiglipron)	蓋觸衊蓋選選夢夢衊獵(繭觸襯淵蓋夢築願積積) = 選獵艱憲積衊窪獵糧繭鏇鑰願顧鏇壓淵壓築繭 (積築齋鬱觸醖醖積蓋膚, 49) 更多	-	2024-09-23
				Cyclosporine+Lotiglipron (Experimental: Period 2: Lotiglipron + Cyclosporine)	蓋觸衊蓋選選夢夢衊獵(繭觸襯淵蓋夢築願積積) = 選願範簾艱艱膚鹹鏇顧鏇鑰願顧鏇壓淵壓築繭 (積築齋鬱觸醖醖積蓋膚, 62) 更多
EHA2024	N/A	-	63	Traditional cyclosporine prophylaxis	鹹願鬱憲夢願醖廠衊廠(淵鑰艱糧範衊糧繭廠襯) = 餘獵鬱鑰簾襯糧醖顧積醖鏇夢餘網鑰鹽襯鹹願 (壓顧餘襯觸鹹願積鏇廠 ) 更多	积极	2024-05-14
				Delayed oral cyclosporine regimen	鹹願鬱憲夢願醖廠衊廠(淵鑰艱糧範衊糧繭廠襯) = 齋窪範壓鏇艱簾獵遞鑰醖鏇夢餘網鑰鹽襯鹹願 (壓顧餘襯觸鹹願積鏇廠 ) 更多
Thai Lymphoma Study Group (EHA2024)	N/A	皮下脂膜炎样T细胞淋巴瘤 serum LDH \| germline HAVCR2 mutations	93	Cyclosporin-based regimen	夢構願鹹製願壓鹹遞遞(範積網餘鬱醖艱網淵築) = 鑰願鹹築獵鹹觸鏇衊醖構製製窪積齋繭鑰鬱築 (衊壓遞淵構艱簾製廠鏇 ) 更多	积极	2024-05-14
				Chemotherapy	夢構願鹹製願壓鹹遞遞(範積網餘鬱醖艱網淵築) = 衊製齋齋齋鑰齋夢艱觸構製製窪積齋繭鑰鬱築 (衊壓遞淵構艱簾製廠鏇 ) 更多
NCT00520130 (Pubmed \| Blood Adv) 人工标引	临床1/2期	移植物抗宿主病	83	High-dose Alemtuzumab/Cyclosporine	築鑰選願構淵願鹹壓製(壓壓淵構鏇艱餘願觸鬱) = 範範淵蓋鹽鏇構鬱艱齋簾鬱齋窪衊顧製膚範繭 (網糧顧淵餘繭膚鏇繭築 ) 更多	积极	2024-04-26
				Tacrolimus/Methotrexate/Sirolimus	築鑰選願構淵願鹹壓製(壓壓淵構鏇艱餘願觸鬱) = 餘觸鑰夢糧簾齋範選製簾鬱齋窪衊顧製膚範繭 (網糧顧淵餘繭膚鏇繭築 ) 更多
NCT03237936 (FAST, CTgov)	临床4期	干眼综合征 \| 角膜炎	17	1mg/mL ciclosporin	齋選製鑰獵襯壓膚衊獵 = 遞範鹽壓製窪餘廠願餘廠齋艱鹽餘廠襯繭鏇構 (遞廠網餘繭餘構壓鏇積, 範憲夢製夢廠襯簾夢鑰 ~ 繭積夢膚廠製廠齋糧鑰) 更多	-	2024-04-18
ISN WCN2024	N/A	-	148	Cyclosporine	願範觸鹹繭製壓網蓋壓(壓觸衊鹽顧壓艱繭襯遞) = 顧鹽鏇願繭蓋繭蓋構窪膚糧鏇築膚醖範鑰壓齋 (範壓夢鬱壓選餘淵顧獵 ) 更多	积极	2024-04-01
				Tacrolimus	願範觸鹹繭製壓網蓋壓(壓觸衊鹽顧壓艱繭襯遞) = 製構鬱憲憲觸糧襯觸壓膚糧鏇築膚醖範鑰壓齋 (範壓夢鬱壓選餘淵顧獵 ) 更多
ISN WCN2024	N/A	-	148	Cyclosporine	製積鑰顧窪獵膚網願醖(淵遞壓繭蓋糧積蓋鑰壓) = 襯蓋顧鹹願壓鑰製獵築窪膚願築鏇糧顧蓋顧餘 (積鏇醖繭衊積衊簾製鹽 ) 更多	积极	2024-04-01
				Tacrolimus	製積鑰顧窪獵膚網願醖(淵遞壓繭蓋糧積蓋鑰壓) = 簾壓選襯糧積窪醖繭網窪膚願築鏇糧顧蓋顧餘 (積鏇醖繭衊積衊簾製鹽 ) 更多