The purpose of this study is to survey the safety of LUPKYNIS in patients with lupus nephritis under actual use conditions. In addition, information on efficacy will be collected.

开始日期2025-07-01

申办/合作机构

Otsuka Pharmaceutical Co., Ltd.

CTR20250444

/ CompletedN/A

伏环孢素软胶囊在空腹条件下的人体生物等效性试验

考察健康受试者在空腹条件下，单次口服1粒由杭州中美华东制药有限公司提供的伏环孢素软胶囊（受试制剂T，规格：7.9mg）与单次口服1粒由Aurinia Pharmaceuticals, Inc.持证的伏环孢素软胶囊（参比制剂R，商品名：Lupkynis®，规格：7.9mg）的药动学特征，评价两制剂的生物等效性及安全性，为该受试制剂注册申请提供依据。

开始日期2025-02-16

申办/合作机构

杭州中美华东制药有限公司

NCT05962788

/ Enrolling by invitation临床3期

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescent and pediatric subjects with lupus nephritis.

开始日期2024-03-27

申办/合作机构

Aurinia Pharmaceuticals, Inc.

100 项与伏环孢素相关的临床结果

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100 项与伏环孢素相关的转化医学

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100 项与伏环孢素相关的专利（医药）

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161

项与伏环孢素相关的文献（医药）

2025-06-20·MEDICINE

Voclosporin: A comprehensive review of its role as a novel calcineurin inhibitor in the management of systemic lupus erythematosus.

Review

作者: Edache, Akogwu Ocholi ; Eniola, Akande ; Wireko, Andrew Awuah ; Abdul-Rahman, Toufik ; Ozioma, Chukwu Bethrand ; Ashinze, Patrick ; Banerjee, Suvam ; Obafemi, Eniola ; Emmanuel, Egbunu ; Mafua, Nelson

Systemic lupus erythematosus is an autoimmune disease with diverse clinical manifestations, including lupus nephritis. Calcineurin inhibitors (CNIs) are a treatment option, but traditional CNIs have limitations. Voclosporin, a novel oral CNI, inhibits calcineurin to modulate T-cell activation and stabilize podocytes in lupus nephritis. This review assesses voclosporin's therapeutic potential in treating SLE (lupus nephritis), examining its mechanism of action, clinical efficacy, safety profile, and advantages over other CNIs. A broad search was conducted to identify studies published from 2009 to 2024 on voclosporin and other CNIs in lupus nephritis, using databases such as PUBMED, SCOPUS, Google Scholar and Cochrane Library. MeSH Keywords included "voclosporin," "lupus nephritis," "systemic lupus erythematosus," and "calcineurin inhibitors." Studies were included if they reported relevant clinical outcomes, evaluated voclosporin in lupus nephritis, or provided comparative data on voclosporin versus other CNIs, focusing on randomized controlled trials, systematic reviews, meta-analyses, retrospective studies and cohort studies. Voclosporin demonstrated higher renal response rates at 52 weeks than standard treatment alone (40.8% vs 22.5%). It has stable pharmacokinetics, reducing the need for individualized dose adjustments and frequent monitoring. Safety outcomes show a lower incidence of adverse effects like hypertension and hyperlipidemia compared to traditional CNIs. Voclosporin offers superior efficacy and safety compared to traditional CNIs for managing lupus nephritis, with predictable dosing and a favorable side effect profile. Continued research is needed to optimize voclosporin's use and support personalized medicine approaches.

2025-06-01·INFLAMMOPHARMACOLOGY

Voclosporin promotes neurological function recovery by inhibiting inflammation and maintaining blood–brain barrier integrity following rtPA reperfusion after MCAO in mice

Article

作者: Sun, Wei ; Ma, Shubei ; Luo, Yumin ; Zheng, Yangmin ; Yan, Feng

Hemorrhagic transformation (HT) is the most serious complication after rtPA thrombolytic therapy in patients with acute ischemic stroke, which greatly limits the clinical application of rtPA. rtPA disruption of the blood-brain barrier (BBB) by inducing inflammation after cerebral ischemia may be an important mechanism for the development of HT, and maintaining BBB integrity can significantly reduce the risk of HT. Our study found that a new generation of calcineurin inhibitors, voclosporin can improve neurological function, reduce neuronal damage, and reduce cerebral infarction volume in mice. By Evans blue extravasation assay and cerebral water content measurement, it was found that voclosporin could improve BBB injury and reduce brain edema caused by rt-PA. The ELISA and immunofluorescence experiments further proved that voclosporin can reduce the expression of IL-1β/TNF-α, increase the expression of IL-10/IL-4, and protect the integrity of the BBB by promoting microglia/macrophage to M2 type polarization, providing new thinking for clinical rtPA combined therapy to alleviate BBB damage.

2025-05-02·Cureus Journal of Medical Science

Combination Therapy With Voclosporin and Anifrolumab in Two Patients With Lupus Nephritis and Discoid Lupus Erythematosus

Article

作者: Dykema, Arbor G ; Karagenova, Ralina ; Krieger, Adam ; Vodusek, Ziga ; Timlin, Homa

Current therapeutic options in systemic lupus erythematosus (SLE) vary in effectiveness, and remission may not be achievable in many patients. Unfortunately, although many patients achieve an initial response with conventional immunosuppressant regimens, relapse is common, and current therapies are associated with damaging adverse effects and the risk of infection. Therefore, it is critical to identify safe targets for lupus disease activity, minimizing drug toxicity and preventing damage accrual. We present two cases with disease features of discoid lupus erythematosus (DLE) and lupus nephritis (LN), who were treated safely and successfully with Voclosporin and Anifrolumab, resulting in disease remission without the use of oral steroids.

194

项与伏环孢素相关的新闻（医药）

2025-07-07

·CPHI制药在线

环肽的药理作用研究进展（二）

关注并星标CPHI制药在线在环肽中，除了上文简述的抗癌、抗细菌和抗真菌活性，环肽还具有抗炎、抗病毒以及其他药物活性。相关阅读：《环肽的药理作用研究进展（一）》04抗炎环肽研究表明，环肽因其独特的生物活性和稳定性，正成为治疗炎症性疾病的有力候选者。Flaxseed linusorbs（FLs）是从亚麻籽油中提取的环肽，已显示出抗炎作用。在脂多糖（LPS）诱导的 RAW 264.7 细胞中，FLs 可通过靶向抑制 TLR4 的激活来抑制 NF-κB/MAPK 信号通路的调节，可显著抑制炎症细胞因子（即TNF-α、 IL-1β和 IL-6）和炎症介质蛋白（即 iNOS 和Cox-2）的转录和表达。大环化合物 X15856是一种新型六环肽的类肽混合物，其在 LPS 刺激的 BV2 小胶质细胞中具有抗炎作用，在LPS 处理的 BV2 小胶质细胞中能显著抑制IL-6、TNF-α、c-c 基序趋化因子配体2（CCL2）、CCL3、C-X-C 基序趋化因子配体 2（CXCL2）和 CXCL10 的表达和释放。该化合物的抗炎作用部分可以通过调节 p38 丝裂原活化蛋白激酶（MAPK）、 p42/44 MAPK（ERK1/2）、蛋白激酶 C（PKC）和核因子（NF）-κB 的磷酸化来解释。05抗病毒环肽目前已经上市的抗病毒类环肽药物有帕利瑞韦（paritaprevir）、格拉瑞韦（grazoprevir）、伏西瑞韦（voxilaprevir）。这三种药物都主要用于治疗慢性丙型肝炎病毒（HCV）感染，特别是针对基因型 1的 HCV 感染。三者都是通过抑制 HCV 的蛋白酶（特别是 NS3/4A 蛋白酶）来发挥抗病毒作用。NS3/4A蛋白酶在 HCV 的多蛋白加工和病毒复制过程中起关键作用，因此抑制该酶可以阻断病毒的复制。环肽药物与其他抗病毒药物相比具有明显的优势，已成为目前新药研发的一种新趋势。Aspergillipeptide D是从真菌曲霉属（Aspergillus sp.）的培养液中分离出来的一种环状五肽，其对Vero 细胞系（IC50= 9.5 μmol/L）的非细胞毒性浓度下，对 1型单纯疱疹病毒（HSV-1）表现出良好的抗病毒活性。它还显示出对 HSV-1-106 和HSV-1-153（对阿昔洛韦有抗药性的临床分离株）具有近 50%的抗病毒活性。在深海衍生的真菌菌株Simplicillium中分离的环肽 Simplicilliumtides J 对Aspergillus versicolor和Curvularia australiensis表现出显著的抗真菌活性和抗 HSV-1 作用，IC50值分别为14.0、16.7 和15.6 μmol/L。Simplicilliumtides K 是从深海来源的菌株Simplicillium obclavatum EIODSF 020.87 中发现的，它对 HSV-1 表现出有效的抗病毒活性，IC50值为14.0 μmol/L。还有研究报道了流感病毒包膜蛋白血凝素相结合的一类环肽- iHA的开发。在所研究的 28 种iHA 中，iHA-24 和iHA-100 对体外多种甲型流感病毒复制具有抑制作用。特别是 iHA-100，它能通过结合血凝素的活性区域，对血凝素介导的吸附和膜融合过程展现出双重抑制作用。在小鼠和食蟹猕猴的实验模型中，iHA-100 环肽展现出了显著的抑制高致病性流感病毒增殖的能力，并能有效预防感染后期可能导致的严重肺炎。还有研究报道根据雉鸡抗菌素（pheasant cathelicidin）的结构特征，设计并合成了一系列肽类物质。研究结果表明，在这些设计的肽类物质中，Pc-4 与Pc-5 展现出了对 H1N1 病毒复制的显著抑制效果。 Pc-5 能够强力诱导 I型干扰素生成及干扰素诱导基因的表达，这一新发现凸显了 Pc-5 作为治疗 H1N1 病毒感染的新型候选药物的巨大潜力和价值。06其他生物活性环肽近年来，许多具有其他生物活性的环肽也被报道。例如，伏环孢素（voclosporin）是环孢素的一种衍生物，当前被视为一种极具潜力的钙调神经磷酸酶抑制剂。它通过抑制钙调神经磷酸酶的活性，进而阻断白细胞介素-2 的表达，抑制 T细胞介导的免疫反应，从而稳定肾脏足细胞。相较于传统的钙调神经磷酸酶抑制剂，伏环孢素展现出了更为可预测的药代动力学与药效学特性（可能无须进行治疗药物监测），具有更强的效力（相较于环孢素 A）以及更优的代谢特征。肢端肥大症是一种罕见且诊断困难的疾病，95%以上的病例是由生长激素（GH）分泌的垂体腺瘤引起。生长抑素受体配体（SRL）是目前治疗肢端肥大症的一线用药，可以使 40%～70%患者GH和IGF -1 水平正常，并能改善肢端肥大症患者高血糖、高血压、心功能不全等并发症。第一代 SRL 包括奥曲肽（octreotide）、奥曲肽长效缓释剂和兰瑞肽（lanreotide），第二代 SRL 为帕瑞肽（pasireotide）。生长抑素（somatostatin）是一种含二硫键的 14 肽环肽，对受体活性强且亲和力高，但血浆半衰期极短（<3 min）。通过骨架环化（如二硫键、酰胺键）优化，得到的一代类似物奥曲肽和兰瑞肽（八肽），均缩小了骨架环大小并保留了关键药效团。奥曲肽于 1988 年上市，用于治疗肢端肥大症，半衰期提升至约 100 min，较生长抑素提高 33 倍。兰瑞肽于 1990 年在欧洲上市，2007 年获 FDA 批准，同样用于治疗肢端肥大症，活性更强且作用持久，给药频率低至每 2周或每月一次。二代类似物帕瑞肽进一步缩小骨架环，保留关键药效团并引入脯氨酸头尾酰胺键关环，增强分子刚性。该药物于 2012 年获 EMA 和FDA 批准用于治疗库欣病，2014 年再获 FDA 批准用于肢端肥大症治疗，帕瑞肽与靶点的结合亲和力超越一代类似物。α-促黑色素激素（afamelanotide）是一种由前黑素皮质素蛋白水解产生的线性 13 肽衍生物，对皮肤色素沉着调节具有关键作用。然而，由于其易受蛋白酶水解影响，体内半衰期较短。通过构效关系研究，确定了调节皮肤色素沉着及其他促黑色素激素功能的关键药效（His-Phe-Arg-Trp）。基于这一发现，通过赖氨酸与天门冬氨酸侧链的内酰胺桥合成了布美兰肽（bremelanotide），以及利用半胱氨酸侧链间的二硫键桥合成了司美诺肽（setmelanotide）。其中，布美兰肽作为一种非选择性黑皮质激素受体激动剂，主要作用于 GPCRs 家族的 MC3 和MC4 受体，于 2019 年获得 FDA 批准，用于治疗绝经前女性的全身性性欲减退症，其半衰期达到 2.7 h。司美诺肽于 2020 年被 FDA 批准用于治疗罕见遗传性肥胖症，可优先激动 GPCR 受体-MC4R，可有效减轻由 POMC、PCSK1 或LEPR 缺乏导致的个体肥胖，这三种蛋白的基因变异会损伤 MC4R 通路（负责调节饥饿和能量消耗）。Pentaminomycin A和B 是从链霉菌属菌种的培养物中获得了两个环状肽。Pentaminomycin A 通过减缓酪氨酸酶、酪氨酸酶相关蛋白-1（TRP-1）和酪氨酸酶相关蛋白 2（TRP-2）等黑色素生成酶的表达来抑制α-MSH 刺激的黑色素的合成。Anabaenopeptins 1是从波罗的海蓝藻提取物中提取的具有生物活性的环状六肽，该物质包含Dolichospermum spp.（10%）、Aphanizomenon flos-aquae（40%）和Nodularia spumigena（50%）。它们均对蛋白质磷酸酶 1和羧肽酶 A表现出抑制作用，但对胰蛋白酶、胰凝乳蛋白酶和凝血酶没有抑制作用。Peginesatide是FDA 近年来批准上市的第一个从头开发的药物，该药用于治疗无法使用促红细胞生成素所导致的严重贫血。另有研究中通过针对红细胞生成素的噬菌体逐级筛选而发现的受体。然后将其与聚乙二醇（PEG）发生二聚，从而增加血液中的亲和力、效力和循环时间，但是遇到临床试验中的许多问题，在批准一年后自愿退出市场。除这些化合物外，最近还报道了许多其他生物活性环肽。例如，环亚麻肽（CL）除了具有抗疟和免疫抑制作用之外，还具有破骨细胞分化抑制活性。该小组利用 TRAP 活性作为破骨细胞分化的指标，筛选了在先前的植物化学研究中分离出的化合物，结果发现，环亚麻肽所显示出的破骨细胞分化抑制活性能力明显强于阳性对照。新型环肽蛋白模拟物 c(MyD 4-4)可抑制TLR 配体的炎性反应以及对 NF-κB 进行激活。该种环肽可以特异性地阻断髓样分化因子（MyD88），防止 MyD88 二聚化，以及降低小鼠多发性硬化症。参考资料[1]陈恩奇,马惠钟,王昱壁,等.环肽在药学领域的应用进展[J].药学学报,2025,60(05):1390-1406.[2]董家潇,宋亚红,李修政,等.环肽的结构多样性及药理作用[J].河北医药,2022,44(19):3009-3013+3019. 作者简介：小泥沙，食品科技工作者，食品科学硕士，现就职于国内某大型药物研发公司，从事营养食品的开发与研究。END智药研习社近期直播预告来源：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~

临床研究

2025-05-21

·同写意

5亿美元授权背后：潜龙在渊的口服多肽开发全景

同写意年度巨献！！大会特设“多肽与小分子药物开发”分会，7月25-26日，邀您相聚金鸡湖畔，与5000人一起为中国医药创新“同写意”！TONACEA01口服多肽热度持续走高，再造授权大单2025年4月15日，Cyprumed与默沙东达成了一项引人注目的合作协议。根据协议内容，默沙东将获得Cyprumed创新口服多肽递送平台的全球非独占使用权，并拥有对特定靶点技术的独占授权选择权。Cyprumed有望从此次合作中获得高达4.93亿美元的里程碑付款，并在默沙东行使独占选择权后获得额外收入。该协议由默沙东全权承担后续产品的研发、生产与商业化工作，充分反映了全球制药巨头对口服多肽递送技术商业潜力的认可。这项交易是Cyprumed继建立自主口服片剂平台之后的重要里程碑。Cyprumed专注于口服肽类药物递送，开发创新的口服多肽配方，可显著提高肽类药物的口服生物利用度。他们还将此技术平台拓展至高分子量、低水溶性的BCS IV类注射用药物的口服递送，建立了相应的递送平台，涵盖如PROTAC类药物的研发合作。BCS IV指的是生物药剂分类系统（Biopharmaceutics Classification System, BCS）中的第IV类化合物，这类药物具有两个显著特点：即水溶性差（Low Solubility）和渗透性低（Low Permeability）。由于溶解性和渗透性都差，BCS IV类药物口服吸收效率极低，往往需要依赖注射剂型进行给药。在开发口服制剂时，通常面临在胃肠道中几乎不溶解，无法有效释放活性成分的问题。即便溶解，也难以通过肠道上皮进入血液循环。传统口服剂型技术手段通常难以实现满意的生物利用度。Cyprumed的口服制剂技术平台与口服多肽药物未来的发展方向非常契合。尽管多肽药物在代谢性疾病、罕见病和肿瘤治疗等多个领域取得了重要进展，但其在剂型上长期受限于注射方式。这一方面降低了患者的用药依从性，另一方面也制约了部分潜在适应症的市场拓展。多肽类药物在胃肠道环境中易被蛋白酶降解，且分子量较大、极性较强，穿越肠上皮细胞的能力有限，因而被认为是“最难被口服化的分子类别之一”。正是在这一挑战之下，递送技术的创新，成为口服多肽药物开发能否实现突破的关键。TONACEA02开发口服多肽药物的系统性挑战尽管多肽类药物在临床上展现出高度靶向性与安全性优势，其口服递送却长期受限，核心难点并非源于药效学本身，而是多重生物药剂学屏障与递送路径的不适配性所致。口服多肽制剂的成功开发，必须在以下几个方面同时实现突破：• 胃肠道酶降解与酸性环境的不稳定性多肽分子在胃肠道中易受到胃蛋白酶、胰蛋白酶、胰凝乳蛋白酶等多种消化酶（proteolytic enzymes）的水解作用，导致其在口服途径中肽链断裂、失活。此外，胃酸环境（pH ~1.5）对多数天然多肽的稳定性构成额外威胁，形成化学降解与酶学降解的叠加效应。因此，如何实现胃肠道稳定性增强是所有口服多肽技术平台面临的首要课题。• 低膜通透性限制跨上皮转运效率多肽通常为高分子量（>1000 Da）、亲水性强、带电荷的结构，大多不符合口服制剂的利平斯基五规则（Lipinski’s Rule of Five）。这些性质导致其无法有效通过肠上皮细胞的跨细胞（transcellular）转运路径，而细胞间通道（paracellular route）又受限于tight junctions的高选择性（通常只允许高极性的极小分子通过）。整体结果是多肽药物的口服生物利用度（oral bioavailability）极低，常不足1%（表1）。很多口服多肽制剂的开发，得益于多肽超高的体内活性，这在很大程度上弥补了极低的口服生物利用度的桎梏，例如desmopressin口服制剂（口服生物利用度0.1%左右）就是依靠这个优势开发出来并成功上市的。• 转运蛋白介导的主动外排机制即便有少量多肽分子进入上皮细胞内，也可能被P-gp（P-glycoprotein）、MRP2等外排转运体（efflux transporters）主动转运回肠腔而无法进入血液循环系统，进一步削弱其系统暴露水平。这一机制在多肽类、大环肽及某些PROTAC等新型分子中尤其显著。• 口服药代动力学特性不可预测性高由于递送效率低且变异来源多（如肠道pH、胃排空时间、酶表达差异），口服多肽通常表现为吸收窗口窄、生物利用度高度个体化、Cmax波动大，这给临床剂量设计和疗效预测带来极大不确定性，甚至成为IND申请和后续监管审评的关键风险点。• 递送系统需兼顾药效增强与CMC可行性即使找到可提升透膜性或稳定性的辅助技术，如渗透促进剂（permeation enhancers）、酶抑制剂（enzyme inhibitors）、载体系统（lipid-based carriers、polymeric nanoparticles），仍需评估其毒理学安全性、肠道耐受性、递送一致性及产业化生产工艺复杂度（CMC complexity）。很多技术在实验室或动物模型中有效，但无法满足人用长期用药与商业化制剂的标准。表1. 部分上市口服多肽图1. 部分上市口服多肽化学家结构TONACEA03为什么口服多肽成为当下的热点领域？过去十年间，全球多肽药物市场持续扩容，临床需求与品类数量显著增长，但剂型受限于注射仍是限制其广泛适用与患者依从性的核心障碍。随着创新递送技术的不断成熟，将多肽药物“口服化”不仅成为技术攻坚目标，更演变为新药开发中的重要竞争高地，原因主要包括以下几点：• 临床顺应性驱动多肽类药物广泛应用于代谢性疾病（如糖尿病、肥胖）、炎症与自身免疫疾病（如类风湿性关节炎、炎症性肠病）等慢性病领域，这些适应症往往要求长期甚至终身用药。相比之下，传统的注射给药频繁、对患者日常生活干扰大，成为限制疗效达成与依从性提升的关键障碍。特别是在门诊为主、基层使用频繁的治疗场景中，口服剂型可显著降低护理负担，提高患者自我管理能力与治疗坚持率。更重要的是，这类慢性疾病的患者群体与肿瘤治疗人群不同，并非处于“病急就医”状态，更关注用药便利性、剂型舒适度与生活质量。因此，与肿瘤药物相比，多肽类药物在代谢与免疫类疾病中“口服优先”导向更强烈，市场接受度也更高。口服剂型不仅有助于扩大目标人群覆盖，还可在生命周期管理中延长专利保护、优化支付路径。• 市场体量与商业回报潜力巨大据市场调研机构预测，全球多肽药物市场将在未来五年持续保持双位数增长，其中一大部分增长点将来自于口服剂型的适应症扩展与人群下沉（指从高风险、重度患者人群向早期、轻中度、基层或广谱人群扩展适应症与使用范围的过程）。诺和诺德的Rybelsus即是典型案例，其在2024年全球销售额达到34亿美元，验证了“低生物利用度也可成就大品种”的市场逻辑。更重要的是，诺和诺德正在积极准备扩展Rybelsus的标签，他们已向FDA递交申请，寻求将Rybelsus的适应症从2型糖尿病扩展至“降低重大不良心血管事件（MACE）风险”，特别是针对合并动脉粥样硬化性心血管疾病（ASCVD）或慢性肾病（CKD）的患者。这是Rybelsus自2019年获批以来的第一个潜在适应症拓展。适应症拓展将进一步增强其“高端口服降糖药+心血管保护”的战略价值。除了拓展适应症之外，诺和诺德还希望将口服semaglutide用于其主战场肥胖症，FDA已于5月2日接受了诺德诺德的申请。• 技术突破随着SNAC、TPE（Transient Permeability Enhancer，瞬时渗透性增强剂）、微针、脂质体、纳米胶束等口服递送平台的不断成熟，开发者不再仅仅依赖“高结构稳定性+被动扩散”来筛选可口服化分子，而是可以通过平台化手段系统性解决多肽的吸收屏障。这也使得Cyprumed，Enteris，Rani Therapeutics等公司转型为“递送解决方案提供者”，在与大药企合作中获得战略地位。• 监管接受度提高随着多个口服多肽制剂获得FDA批准，监管机构已建立起基于生物等效性、生物利用度优化及递送机制验证的审评框架，使“注射转口服”的路径不再是新物种开发，而是可控的二代产品策略。这使得拥有既有多肽管线的企业更有动力进行剂型创新与生命周期管理。目前已经有包括semaglutide, cyclosporine A, voclosporin, desmopressin, linaclotide和octreotide等众多多肽口服制剂获得了监管部门的批准上市（图1）。TONACEA04口服多肽制剂开发技术前沿多肽类药物因其分子量大、亲水性强、易降解等特点，导致其口服生物利用度极低。为解决这一难题，研究者从穿透增强、分子改造与载体包封三大方向构建递送策略。• 渗透增强技术（Permeation Enhancement）渗透增强剂（Permeation Enhancers,PEs）通过短暂性调控上皮屏障结构或细胞膜通透性，实现增强多肽肠道吸收的目的（表2）。表2. 口服多肽制剂开发常见渗透增强机制• 化学结构修饰（Chemical Modification）通过对多肽主链或侧链结构的化学修饰，可有效提升其酶稳定性、水溶性和体内半衰期（表3）。表3. 口服多肽制剂开发常见化学改性策略• 胶体递送系统（Colloidal Delivery Systems）将多肽包封于微纳米结构中可提供胃肠道保护、缓释释放与靶向吸收能力，是目前应用最广泛的递送平台之一（表4）。表4. 口服多肽制剂开发常见胶体递送机制TONACEA05口服多肽制剂市场展望根据市场研究数据，2025年全球口服多肽治疗药物市场规模约为87.8亿美元，预计到2032年将增至191亿美元，年均复合增长率达到13.83%。这一增长预期不仅反映了技术突破推动产品落地的潜力，也说明各大药企正加速将口服多肽递送平台纳入长期战略布局。近年来，随着多肽药物在糖尿病、肥胖、骨代谢、炎症性疾病、罕见病等多个慢性病治疗领域的持续渗透，口服制剂因其在便利性、依从性和慢病长期管理中的优势，成为产业重点攻坚方向。主要驱动因素包括技术进步（递送系统不断成熟，解决吸收、生物稳定性等核心难点、）患者需求导向（非注射剂型提高依从性，尤其适用于基层医疗、早期治疗与年轻患者群体）、监管推动和全球化推动（亚太地区，尤其是中国、印度在基础设施、医保普及和药品可及性方面的加速推进，成为重要增量市场）。重要的口服多肽制剂开发商包括：艾伯维、阿斯利康、礼来、辉凌、益普生、强生、默沙东、诺华、诺和诺德、赛诺菲、武田、梯瓦等。口服多肽制剂的主要市场将在肿瘤学、代谢疾病和中枢神经系统疾病等领域。TONACEA06口服多肽最新项目在近期的会议上，BMS首次公开了其新一代PD-L1抑制剂BMS-986238的分子结构（图2），标志着这一项目迈入新阶段。作为一种采用大环肽结构设计的创新分子，BMS-986238不仅突破了传统抗体药物的模态限制，也预示着BMS有意在免疫检查点抑制剂这一竞争激烈的赛道上，通过差异化的技术路线重新布局，重塑其在这一领域的话语权。尽管抗体类药物在PD-1/PD-L1靶点上长期占据主导地位，BMS多年来一直在探索更小、更灵活的药物模态，试图通过肽类分子实现机制相同但形式迥异的免疫阻断策略。早期候选物BMS-986189展示出对PD-L1的极高亲和力，并在健康志愿者中实现了低浓度条件下的靶点饱和，为大环肽结构在该靶点上的药效验证提供了临床依据。然而，其极短的体内半衰期和每日给药的需求，暴露出药代属性方面的严重不足，成为其进一步开发的主要障碍。图2. PD-L1抑制剂BMS-986238分子结构为解决这一问题，BMS随后对分子设计进行了系统优化，推出新一代分子BMS-986238。该分子在保留高亲和力基础上，通过引入一系列结构修饰策略显著改善了药代动力学性能，尤其是在延长体内暴露时间方面取得了关键进展。优化措施包括提高与白蛋白的结合能力、引入脂肪酸结构延长循环时间、设计PEG间隔以减少空间位阻，以及对结合动力学参数进行精细调控以确保靶点结合特异性和功能完整性。值得注意的是，BMS-986238的化学结构涵盖了环肽、N-甲基氨基酸、非蛋白质氨基酸和脂化支链等众多符合口服多肽发展方向的属性（图2）。BMS-986238在非临床模型中已显示出优于前代分子的半衰期表现，在大鼠和猴中均超过19小时，同时具备潜在的口服剂型开发前景。值得关注的是，BMS在开发策略上更强调药效窗口与暴露特征之间的匹配，而非单纯追求生物利用度的绝对提高。在已有数据中，BMS-986189已被证实在低血药浓度下亦可实现PD-L1的有效占据，因此新一代分子若能维持类似亲和力，结合更长的体内暴露时间，即有可能通过较低Cmax实现持续疗效。这一逻辑为口服制剂的可行性提供了理论支持，也反映了BMS对于PK/PD协同机制的深度考量。BMS-986238的出现，不仅延续了大环肽作为非抗体免疫检查点抑制剂的研发思路，也标志着该公司在突破传统模态限制方面迈出了实质性一步。在抗体已高度成熟化的PD-1/PD-L1赛道中，BMS正试图通过结构和策略的双重创新，建立新的竞争优势。TONACEA07口服多肽制剂未来展望随着肽类药物在靶向性、安全性和功能可设计性方面优势的不断显现，其应用领域正从传统的注射制剂逐步延伸至口服治疗场景。长期以来，由于肽类分子易被胃肠道酶降解、渗透性差、半衰期短等限制，口服制剂的开发面临显著挑战。然而，近年来在分子修饰、递送系统、吸收促进剂以及PK/PD建模等方面的技术进展，正在逐步突破这些瓶颈。未来，口服肽类药物的发展趋势将不仅聚焦于提高生物利用度这一单一指标，更强调整体给药策略的合理性，包括药效窗口的设计、暴露曲线的优化以及与现有治疗方案的协同可能性。以BMS-986238为代表的新一代分子正在证明，通过结构合理化和动力学参数调控，即便在生物利用度有限的前提下，仍可实现有效、可控的口服治疗路径。可以预见，随着新技术的不断融合和产业化能力的提升，肽类口服制剂将成为未来药物开发中一个高度活跃的方向，尤其在慢性病、肿瘤维持治疗和免疫调节等长期用药场景中展现出更广阔的临床价值。多肽递送平台和多肽分子结构设计方面必然会迎来爆发式的进步，而资本市场也会出现越来越多以口服多肽为核心的资产交易。参考文献：（上下滑动查看更多）1.Cyprumed Enters License and Option Agreement with MSD for the Development of Oral Peptide Therapeutics. Cyprumed Press Release. 15. 04. 2025.2.Dunleavy, K. FDA reviews Novo Nordisk's bid to expand Rybelsus as oral GLP-1 cuts heart disease risks. Fierce Pharma. 31. 03. 2025.3.Global Oral Peptide Therapeutics Market. Market Research Intellect. May. 2025.4.Henderson, T. Peptide Pills: The Future of Oral Peptide Medications. Lab Manager. 17. 03. 2025.5.Wang, X. et al. Obstacles, research progress, and prospects of oral delivery of bioactive peptides: a comprehensive review. Front. Nutr. 11:1496706. doi: 10.3389/fnut.2024.14967066.Discovery of BMS-986238, a second-generation macrocyclic peptide inhibitor of programmed death-ligand 1 (PD-L1). ACS. https://acs.digitellinc.com/p/s/discovery-of-bms-986238-a-second-generation-macrocyclic-peptide-inhibitor-of-programmed-death-ligand-1-pd-l1-6201967.Halford, B. 12 drug candidates debuted in San DiegoStructures unveiled during first-time disclosures symposium. C&EN 103, 10, 17-218.US FDA accepts Novo Nordisk's application for oral Wegovy for weight loss. Reuters. 02. 05. 2025.

蛋白降解靶向嵌合体引进/卖出

2025-05-08

·PRNewswire

LUPKYNIS Strengthens Market Position as Demand for Lupus Nephritis Treatment Grows | DelveInsight

As a novel calcineurin inhibitor with proven efficacy in improving renal outcomes, LUPKYNIS addresses a high unmet medical need. With increasing awareness, supportive guidelines, and potential global expansion, it is well-positioned for steady market growth. LAS VEGAS, May 8, 2025 /PRNewswire/ -- DelveInsight's " LUPKYNIS Market Size, Forecast, and Market Insight Report" highlights the details around LUPKYNIS, the first oral lupus nephritis-specific treatment, which has expanded the therapeutic arsenal. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LUPKYNIS. The report also highlights the historical and forecasted sales from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Aurinia Pharmaceuticals/Otsuka Pharmaceutical's LUPKYNIS (voclosporin) Overview LUPKYNIS (voclosporin) is an oral immunosuppressant classified as a calcineurin inhibitor (CNI), shown to improve both short- and long-term outcomes in adult patients with active lupus nephritis when used alongside standard immunosuppressive therapies. By targeting calcineurin, LUPKYNIS helps suppress cytokine activity, inhibits interleukin-2 (IL-2) production, and reduces T-cell driven immune responses. Although the exact mechanism by which voclosporin inhibits calcineurin is not fully understood, it is known that lymphocyte activation increases intracellular calcium, which binds to calcineurin's regulatory site. This activates the calmodulin-binding catalytic subunit, leading to dephosphorylation and activation of the transcription factor NFATc (nuclear factor of activated T-cells, cytoplasmic). The drug's immunosuppressive effect results in decreased lymphocyte proliferation, reduced cytokine production, and lower expression of T-cell activation markers. The recommended initial dose of LUPKYNIS is 23.7 mg twice daily. It should be used in conjunction with mycophenolate mofetil (MMF) and corticosteroids. Learn more about LUPKYNIS projected market size for lupus nephritis @ LUPKYNIS Market Potential Lupus nephritis is a serious and potentially life-threatening complication of systemic lupus erythematosus (SLE), affecting 40–60% of those diagnosed with the disease. It is typically characterized by symptoms such as hematuria (blood in the urine) and proteinuria (protein in the urine). This condition is more prevalent in women, particularly between the ages of 20 and 40. In 2023, the United States recorded the highest number of lupus nephritis cases among the 7MM, with approximately 211K cases, a figure projected to grow by 2034. Treatment strategies for lupus nephritis depend on the kidney biopsy classification of the disease. Standard therapy often includes corticosteroids in combination with immunosuppressive drugs like cyclophosphamide, mycophenolate mofetil, azathioprine, and calcineurin inhibitors. Rituximab, a monoclonal antibody, is widely used, especially for patients with relapsing or treatment-resistant LN, due to its ability to reduce reliance on steroids. Currently, there are only two FDA-approved medications for lupus nephritis: BENLYSTA (belimumab), available as an intravenous or subcutaneous formulation, and LUPKYNIS (voclosporin), a novel oral calcineurin inhibitor. Leading pharmaceutical companies such as Novartis, AstraZeneca, Roche, and Kezar Life Sciences, among others, are actively developing innovative therapies that could redefine the treatment paradigm for lupus nephritis. The treatment landscape is rapidly evolving, shifting away from broad immunosuppression toward more precise, targeted approaches. Recent drug approvals and a strong pipeline of candidates highlight both advancements and the ongoing challenges in creating treatments that are effective, safe, and long-lasting. Emerging therapies ranging from anti-CD20 antibodies and complement inhibitors to interferon-blocking agents and CAR-T cell therapies hold promise but must address key issues such as safety, sustained efficacy, and accessibility. As our understanding of the disease's underlying mechanisms continues to grow, the future of lupus nephritis treatment is expected to become increasingly personalized, offering renewed hope to patients battling this complex disorder. Discover more about the lupus nephritis market in detail @ Lupus Nephritis Market Report Emerging Competitors of LUPKYNIS The developing pipeline for lupus nephritis treatments shows a growing variety of approaches. Multiple candidates, both in early and late stages of development, are underway, including ianalumab (VAY736) (Novartis), GAZYVA (obinutuzumab) (Roche), SAPHNELO (anifrolumab) (AstraZeneca), FABHALTA (iptacopan) (Novartis), ULTOMIRIS (ravulizumab) (AstraZeneca), as well as advanced cellular therapies like CABA-201 (Cabaletta Bio) and YTB323 (Novartis). In March 2025, the FDA accepted a supplemental Biologics License Application based on data from the Phase III REGENCY trial, where obinutuzumab demonstrated a 46.4% Complete Renal Response (CRR), compared to 33.1% for placebo. Unlike previous anti-CD20 therapies such as rituximab, it provides enhanced B-cell depletion and is the first in its class to show efficacy in a randomized Phase III lupus nephritis trial. If approved, it will become the first CD20-targeted treatment specifically indicated for lupus nephritis, with anticipated sales of USD 400 million by 2034. To know more about the number of competing drugs in development, visit @ LUPKYNIS Market Positioning Compared to Other Drugs Key Milestones of LUPKYNIS In September 2024, Japan's Ministry of Health approved it for Lupus Nephritis treatment alongside mycophenolate mofetil. In September 2022, the European Commission approved LUPKYNIS for active Class III, IV, or V Lupus Nephritis. In January 2021, Aurinia Pharmaceuticals received US FDA approval for LUPKYNIS to treat adult lupus nephritis patients in combination with immunosuppressive therapy. Discover how LUPKYNIS is shaping the lupus nephritis treatment landscape @ LUPKYNIS Lupus LUPKYNIS Market Dynamics LUPKYNIS, developed by Aurinia Pharmaceuticals, is the first FDA-approved oral therapy specifically indicated for active lupus nephritis, a serious manifestation of systemic lupus erythematosus. Approved in January 2021 in the US, LUPKYNIS entered a previously underserved market where treatment was largely dependent on off-label use of immunosuppressants like mycophenolate mofetil and corticosteroids. The drug represents a significant advancement in lupus nephritis care, offering both improved efficacy and a better safety profile compared to existing options, especially in reducing proteinuria and preserving kidney function. The market dynamics for LUPKYNIS are shaped by several key factors. On the positive side, there is a strong unmet medical need, a growing prevalence of lupus nephritis, and increasing physician awareness about early diagnosis and intervention. Moreover, LUPKYNIS benefits from a relatively high pricing strategy, supported by its novel mechanism and disease-modifying potential. Aurinia has also built a dedicated commercial infrastructure and patient support programs to drive uptake and adherence. However, LUPKYNIS faces competitive and reimbursement challenges. One of the main competitors is BENLYSTA (belimumab) from GSK, which gained FDA approval for lupus nephritis in December 2020, just a month before LUPKYNIS. Benlysta has the advantage of brand recognition and a longer track record in treating systemic lupus. Additionally, payers have shown some hesitancy in approving LUPKYNIS due to its cost, requiring extensive prior authorizations and documentation of clinical need. Patient compliance also remains an issue, given the need for frequent monitoring of kidney function and drug levels. Looking ahead, the market potential for LUPKYNIS will depend on its ability to expand its label, demonstrate long-term real-world effectiveness, and potentially enter international markets. Aurinia is also exploring lifecycle management strategies, including combination therapies and expanded indications. Partnerships or acquisitions could further boost market access and penetration. Overall, while LUPKYNIS is a pioneering therapy with strong clinical value, its commercial success will be defined by navigating payer landscapes, physician adoption, and sustained differentiation from competing therapies. Dive deeper to get more insight into LUPKYNIS's strengths & weaknesses relative to competitors @ LUPKYNIS Market Drug Report Table of Contents Related Reports Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including Hoffmann-La Roche, Chugai Pharmaceutical, Novartis Pharmaceuticals, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Hoffmann-La Roche, Qilu Pharmaceutical, Vera Therapeutics, Kyverna Therapeutics, Cabaletta Bio, Takeda, Nkarta Therapeutics, Annexon, Century Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, Inflection Biosciences, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床3期临床结果免疫疗法

100 项与伏环孢素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09033	伏环孢素	L04AD03	DB11693

研发状态

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适应症	国家/地区	公司	日期
狼疮性肾炎	美国	Aurinia Pharmaceuticals, Inc.	2021-01-22

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适应症	最高研发状态	国家/地区	公司	日期
干眼综合征	临床3期	美国	Aurinia Pharmaceuticals, Inc.	2019-10-14
干燥综合征性角膜结膜炎	临床3期	美国	Aurinia Pharmaceuticals, Inc.	2019-10-14
肾移植急性排斥反应	临床3期	-	Aurinia Pharmaceuticals, Inc.	2013-03-01
葡萄膜炎	临床3期	美国	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	奥地利	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	巴西	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	加拿大	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	捷克	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	法国	Lux Biosciences, Inc.	2011-02-01
葡萄膜炎	临床3期	德国	Lux Biosciences, Inc.	2011-02-01

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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


EULAR2024	N/A	狼疮性肾炎	179	Voclosporin-based, triple immunosuppressive regimen	壓獵艱簾襯餘壓夢膚鑰(鬱獵齋憲簾醖顧膚壓蓋) = The overall incidence of adverse events (AEs) was higher in IVC- and MMF-treated participants in ALMS over the 6-month period. More participants in AURA-LV and AURORA 1 reported hypertension and anemia. Due to the known hemodynamic effects of calcineurin inhibition, there was a small decrease in mean eGFR in the AURA-LV/AURORA 1 participants in the first few weeks of treatment after which mean eGFR remained stable; a greater number of events of GFR decreased were reported by AURA-LV/AURORA 1 participants. The incidence of serious AEs was similar across groups. 選顧築鬱觸膚選襯夢蓋 (餘鏇齋願餘衊製簾衊顧 ) 更多	积极	2024-06-05
				High-dose glucocorticoid and mycophenolate mofetil-based therapy
NCT03021499 (AURORA, Biospace) 人工标引	N/A	狼疮性肾炎	-	LUPKYNIS	鏇糧鏇鹹淵鬱艱觸顧製(夢淵鹹選鏇鬱餘衊願鑰) = 齋獵廠壓製艱餘積鬱網廠範鏇簾網衊觸遞製艱 (襯獵蓋鑰鑰艱遞遞積齋 )	积极	2024-05-09
NCT03021499 (AURORA, Biospace) 人工标引	N/A	狼疮性肾炎	25	LUPKYNIS, MMF, and steroids	鑰製廠遞膚餘範糧鹽選(淵網鑰壓鹽獵壓獵繭糧) = 壓網艱鬱鏇憲簾艱鹹鑰憲夢選衊範壓鹹願蓋廠 (鑰夢選簾鬱淵鑰鬱膚襯 )	积极	2024-05-09
				MMF and glucocorticoids	鑰製廠遞膚餘範糧鹽選(淵網鑰壓鹽獵壓獵繭糧) = 艱鹹窪襯鏇憲鹹壓鹽構憲夢選衊範壓鹹願蓋廠 (鑰夢選簾鬱淵鑰鬱膚襯 )
NCT03021499 (phase 3 study, Pubmed)	临床3期	狼疮性肾炎	148	Voclosporin	夢積糧製醖選壓壓願夢(蓋蓋憲夢願鹹顧構觸餘) = The incidence of adverse events was similar between the arms; mean eGFR values remained stable and within normal range in both arms 積餘餘蓋糧蓋積構範窪 (簾鏇壓願網構憲觸襯鹽 ) 更多	积极	2023-12-18
				Placebo
ACR2023	N/A	蛋白尿	-	Voclosporin	夢餘顧鏇範醖廠繭餘網(簾鑰遞夢膚積鑰積衊製) = 獵簾獵夢艱餘繭積襯鑰廠積糧鑰夢獵憲製襯糧 (壓壓糧艱壓衊簾遞淵遞 ) 更多	-	2023-11-14
				Placebo	夢餘顧鏇範醖廠繭餘網(簾鑰遞夢膚積鑰積衊製) = 鏇齋淵齋鑰鑰網鹹築淵廠積糧鑰夢獵憲製襯糧 (壓壓糧艱壓衊簾遞淵遞 ) 更多
NCT03597464 (AURORA 2, Biospace) 人工标引	临床3期	狼疮性肾炎	26	LUPKYNIS® in combination + MMF + glucocorticoids	壓廠鏇鏇鏇簾衊觸壓顧(窪衊積範餘積製衊廠鹹) = experienced numerically greater mean reductions 蓋醖鑰製願鏇製襯範糧 (鹽鑰築蓋獵範積衊壓壓 ) 更多	积极	2023-11-07
				MMF + glucocorticoids
NCT03021499 (AURORA, Biospace) 人工标引	N/A	狼疮性肾炎	-	LUPKYNIS + MMF + glucocorticoids (Black patients)	選網膚鏇淵鹹範糧遞觸(鏇選積構糧網範獵繭願) = 遞觸衊選簾夢膚鑰鹽醖膚選積顧齋憲範製憲製 (鬱餘網衊積醖遞獵窪觸 )	积极	2023-11-07
				MMF + glucocorticoids (Black patients)	選網膚鏇淵鹹範糧遞觸(鏇選積構糧網範獵繭願) = 鑰糧廠糧壓製繭鬱網鬱膚選積顧齋憲範製憲製 (鬱餘網衊積醖遞獵窪觸 )
NCT03021499 \| NCT02141672 (AURORA 1, Biospace) 人工标引	临床2/3期	狼疮性肾炎	-	LUPKYNIS® + MMF+ glucocorticoids (proteinuria >=2 g/day)	壓鬱遞餘簾鏇築選鬱鑰(願選壓選範餘積選夢蓋) = greater numeric achievement of complete renal response across biopsy classes, races, and ethnicities in LN patients with proteinuria >=2 g/day 蓋衊鏇齋膚鏇夢襯艱選 (構衊壓選糧鹽憲製醖廠 ) 更多	积极	2023-11-07
				LUPKYNIS® + MMF+ glucocorticoids (UPCR ≥2 g/g at baseline)
AURA-LV and AURORA 1 (EULAR2023)	临床2/3期	蛋白尿	-	Voclosporin	範鬱願齋網齋膚構構構(齋願膚鹽鬱艱衊餘築遞) = 鏇襯廠鏇製範選範鹹網願鏇製簾顧築繭範齋範 (鹹餘範餘構廠範構蓋餘 ) 更多	积极	2023-05-31
				Placebo	範鬱願齋網齋膚構構構(齋願膚鹽鬱艱衊餘築遞) = 鹽構窪鏇構鬱繭憲簾構願鏇製簾顧築繭範齋範 (鹹餘範餘構廠範構蓋餘 ) 更多