This Phase 2 study is a 2-arm, multi-center, double-masked, placebo-controlled, 2:1 randomized sequential trial design in new onset T1D participants (within 100 days of diagnosis). Participants will be administered rezpegaldesleukin/placebo once every 14 days over 26 weeks with an additional 6-month follow-up period.

开始日期2025-11-13

申办/合作机构

National Institute of Diabetes & Digestive & Kidney Diseases

NCT06340360

/ Active, not recruiting临床2期

A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)

This is an interventional, randomized, double blind, parallel group, placebo-controlled, Phase 2b, 3-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with severe to very severe alopecia areata.
The estimated duration includes a screening period of up to 35 days, a 36-week treatment period, an optional 16-week treatment extension period, and a 24-week follow-up period. The maximum study duration is approximately 81 weeks for all participants.

开始日期2024-04-02

申办/合作机构

Nektar Therapeutics

NCT06136741

/ Active, not recruiting临床2期

A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (REZOLVE-AD)

This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis.
The estimated duration is 15-35 days for screening, an Induction Period of 16 weeks, a Maintenance Period from Week 16-Week 52, and a Posttreatment Follow-Up Period for an additional year up to approximately Week 104 for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.

开始日期2023-11-15

申办/合作机构

Nektar Therapeutics

100 项与 Rezpegaldesleukin 相关的临床结果

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100 项与 Rezpegaldesleukin 相关的转化医学

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100 项与 Rezpegaldesleukin 相关的专利（医药）

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项与 Rezpegaldesleukin 相关的文献（医药）

2025-04-18·Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences

[Biological activity and antitumor effect of long-acting recombinant human interleukin-2 drug].

Article

作者: Zhang, Fengxia ; Zhu, Jingjing ; Jin, Ting ; Liang, Xuejun

OBJECTIVE:

To investigate the biological activity and antitumor effect of pegylated recombinant human interleukin 2 (PEG-rhIL-2) obtained by site-specific conjugation of polyethylene glycol (PEG) with non-natural amino acids, and to explore its antitumor mechanism.

METHODS:

The binding activities of PEG-rhIL-2 at three different sites (T41, Y45, and V91) to human interleukin 2 receptors α (IL-2R_α) and β (IL-2R_β) and were detected by surface plasmon resonance (SPR) technology. Western blot was used to detect the levels of the Janus kinase-signal transducer and activator of transcription 5 (JAK-STAT5) signaling pathway activated by different doses of rhIL-2 and PEG-rhIL-2 in CTTL-2 and YT cells. Blood was collected after a single administration in mice to detect the drug concentration at different time points and evaluate the pharmacokinetic parameters of Y45-PEG-rhIL-2. Mouse hepatoma cell line Hepa1-6, pancreatic cancer cell line Pan-02, and colon cancer cell line MC-38 were selected. Tumor models were constructed in C57BL/6 mice. Different doses of Y45-PEG-rhIL-2 and excipient control were administrated respectively to evaluate the tumor suppression effect of the drug. In the MC-38 colon cancer model, the tumor suppression effect of Y45-PEG-rhIL-2 combined with anti-programmed death-1 (PD-1) monoclonal antibody was evaluated. Hepa1-6 mouse tumor models were constructed and rhIL-2, Y45-rhIL-2 and Y45-PEG-rhIL-2 were administrated respectively. The proportion of tumor-infiltrating lymphocytes was analyzed by flow cytometry.

RESULTS:

The SPR detection results showed that the binding activities of PEG-rhIL-2 to IL-2R_α/IL-2R_β were both reduced. The affinity of Y45-PEG-rhIL-2 to IL-2R_α was reduced to approximately 1/250, and its affinity to IL-2R_β was reduced to 1/3. Western blot results showed that the activity of Y45-PEG-rhIL-2 in stimulating JAK-STAT5 signaling in CTLL-2 cells expressing heterotrimeric IL-2 receptor complex IL-2R_αβγwas reduced to approximately 1/300, while its activity in YT cells expressing heterodimeric IL-2 receptor complex IL-2R_βγwas reduced to approximately 1/3. The pharmacokinetic evaluation after a single dose in the mice showed that the elimination half-life of Y45-PEG-rhIL-2 was 17.7 h. Y45-PEG-rhIL-2 has pharmacokinetic characteristics superior to those of rhIL-2. Y45-PEG-rhIL-2 showed dose-dependent tumor suppression activity, and the combination of Y45-PEG-rhIL-2 and anti-PD-1 antibody had a better tumor-inhibiting effect than the single use of Y45-PEG-rhIL-2 or anti-PD-1 antibody. Flow cytometry analysis demonstrated that 72 h after the administration of Y45-PEG-rhIL-2, the proportion of tumor-infiltrating cytotoxic T lymphocytes (CD8⁺T cells) increased by 86.84%. At 120 h after administration, the ratio of CD8⁺T cells to regulatory T cells (Treg) increased by 75.10%.

CONCLUSION:

Y45-PEG-rhIL-2 obtained by site-specific conjugation via non-natural amino acids changed its receptor binding activity and inhibited tumor growth in dose-dependent manner in multiple tumor models by regulating CD8⁺T cells.

2022-01-01·Journal of translational autoimmunity

Selective expansion of regulatory T cells by NKTR-358 in healthy volunteers and patients with systemic lupus erythematosus

Article

作者: Furie, Richard ; Levin, Robert ; Diab, Isam ; Fanton, Christie ; Hanan, Nathan ; Chindalore, Vishala ; Zalevsky, Jonathan ; Dixit, Neha ; Dickerson, Daniel ; Haglund, Cat ; Kotzin, Brian L ; Gibbons, Jacqueline

Objective:

To evaluate NKTR-358, a polyethylene glycol-interleukin-2 conjugate composition designed to selectively induce regulatory T cells (Tregs), in first-in-human studies.

Methods:

Healthy volunteers and patients with systemic lupus erythematosus (SLE) received single- or multiple-dose (biweekly) NKTR-358 or placebo in two sequential, randomized, phase 1 studies (single ascending dose [SAD; NCT04133116] and multiple ascending dose [MAD; NCT03556007]). Primary objectives were safety and tolerability; secondary objectives included pharmacokinetics (PK) and immune effects of NKTR-358; exploratory objectives included effects on SLE disease activity.

Results:

There were eight ascending dose cohorts in the SAD study (0.3-28.0 μg/kg: n = 76; placebo: n = 24) and four in the MAD study (3-24.0 μg/kg: n = 36; placebo: n = 12). Most adverse events (AEs) were grade 1-2 injection-site reactions, with no treatment-related serious or severe AEs, or deaths. PK data showed dose proportionality and prolonged exposure (mean half-life: 7.4-12.9 days). Dose-dependent, selective, and sustained increases in percentages and absolute numbers of total CD4⁺ Tregs and CD25^bright Tregs were observed, with no significant changes in conventional CD4⁺ and CD8⁺ T cells, and low-level increases in natural killer cells. At the highest doses tested, administration of NKTR-358 resulted in a 12-17-fold increase in CD25^bright Tregs over baseline that was sustained for 20-30 days.

Conclusion:

NKTR-358 was well tolerated, had a suitable PK profile for biweekly dosing, and led to marked and selective dose-dependent increases in CD25^bright Tregs, with no significant changes in conventional T cells. These results provide strong support for further testing in SLE and other inflammatory diseases.

2021-01-01·Journal of translational autoimmunity

NKTR-358: A novel regulatory T-cell stimulator that selectively stimulates expansion and suppressive function of regulatory T cells for the treatment of autoimmune and inflammatory diseases

Article

作者: Zhang, Ping ; Kuo, Peiwen ; Dixit, Neha ; Lee, Myong ; Fanton, Christie ; Doberstein, Stephen K ; Cetz, Janet ; Sweeney, Theresa D ; VanderVeen, Laurie A ; Kamihara, Yusuke ; Chang, Thomas ; Dixit, Vidula ; Rubas, Werner ; Langowski, John L ; Kirksey, Yolanda ; Ritz, Jerome ; Tang, Yinyan ; Zalevsky, Jonathan ; Maiti, Mekhala ; Ji, Chunmei ; Kim, Grace ; Kirk, Peter

Impaired interleukin-2 (IL-2) production and regulatory T-cell dysfunction have been implicated as immunological mechanisms central to the pathogenesis of multiple autoimmune and inflammatory diseases. NKTR-358, a novel regulatory T-cell stimulator, is an investigational therapeutic that selectively restores regulatory T-cell homeostasis in these diseases. We investigated NKTR-358's selectivity for regulatory T-cells, receptor-binding properties, ex vivo and in vivo pharmacodynamics, ability to suppress conventional T-cell proliferation in mice and non-human primates, and functional activity in a murine model of systemic lupus erythematosus. In vitro, NKTR-358 demonstrated decreased affinity for IL-2Rα, IL-2Rβ, and IL-2Rαβ compared with recombinant human IL-2 (rhIL-2). A single dose of NKTR-358 in cynomolgus monkeys produced a greater than 15-fold increase in regulatory T-cells, and the increase lasted until day 14, while daily rhIL-2 administration for 5 days only elicited a 3-fold increase, which lasted until day 7. Repeated dosing of NKTR-358 over 6 months in cynomolgus monkeys elicited cyclical, robust increases in regulatory T-cells with no loss in drug activity over the course of treatment. Regulatory T-cells isolated from NKTR-358-treated mice displayed a sustained, higher suppression of conventional T-cell proliferation than regulatory T-cells isolated from vehicle-treated mice. NKTR-358 treatment in a mouse model (MRL/MpJ-Fas^lpr) of systemic lupus erythematosus for 12 weeks maintained elevated regulatory T-cells for the treatment duration and ameliorated disease progression. Together, these results suggest that NKTR-358 has the ability to elicit sustained and preferential proliferation and activation of regulatory T-cells without corresponding effects on conventional T-cells, with improved pharmacokinetics compared with rhIL-2.

175

项与 Rezpegaldesleukin 相关的新闻（医药）

2026-03-05

·医药速览

再谈Nektar旗下α偏向性IL2：一个残破的biotech的努力

▎追溯 Nektar旗下α偏向性IL2在AD（特应性皮炎）上有了初步疗效，同时的信达的IBI363同样作为α偏向性PD1/IL2在临床上肿瘤适应症也有不错的疗效，很多人就觉得是一种冲突，这两者并不冲突，同时这两者的活性完全不在一个等级上。信达IBI363中的IL2对β/γ受体的结合是经过极度的活性削弱，在未达到极致的高剂量下，在外周未激活（不表达PD1）的PBMC上其实并不能很有效增殖的，同时PD1/IL2本身也带有了PD1靶向，使得外周跟肿瘤也有了一定的差异。同时，根据rezpegaldesleukin以往的数据来看，整体低剂量的IL2确实激活treg，能够治疗自免，但是随着剂量的升高其炎性作用，或者毒性作用就开始显现。从目前的来看，高剂量的IL2，无论是否偏向一定是具有抗肿瘤作用的，rezpegaldesleukin高剂量下也一定具有抗肿瘤活性。本身IL2就是多重的性质的存在。 CD8+PD1+CD25+T细胞，根据我的经验，只要激活的CD8+T细胞其实，都会有表达PD1，CD25，而CD25诱导表达的倍数甚至高于PD1，众所周知在激活的T细胞上，PD1上调，其实CD25也是上调的。两者具有同步性。也就是为什么信达同时做了non-α偏向性IL2的2214没有推，而是推了α偏向性2149，本质上两者的抗肿瘤活性2149优于2214，综合窗口2149也更优。 2026年2月10日，Nektar公布了新的rezpegaldesleukin在特应性皮炎中的最新维持期数据。展现出来的数据不错，但是另一方面也看出一个无牌可出的biotech穷尽各种方法来做这个项目。 Nektar的方法很独特，在优效的人群中继续用药，最后来算的数据。这样的数据显然会更好些，我们来看看设计的细节：REZOLVE-AD IIb期研究设计全球 REZOLVE-AD IIb期研究共纳入 393例中重度特应性皮炎患者。患者按 3:3:3:2比例随机分组，在 16周诱导期接受三种不同剂量的 rezpegaldesleukin 或安慰剂皮下注射治疗。在完成16周诱导治疗后：达到EASI评分下降≥50%（EASI-50）的患者被再次随机分配（1:1）进入维持治疗阶段：维持治疗持续至第52周（双盲36周维持期）。每月给药（Q4W）每季度给药（Q12W）未达到EASI-50的患者则进入逃逸治疗（escape arm），治疗最长 36周。所以，可以看出rezpegaldesleukin是富集人群的维持疗法效应，而不是全人群。数据方面确实不错，但这种数据失真性很强。这种数据几乎不具有可比性，因为dupilumab是全人群。同时，来看一篇来自韩国真实世界的文章数据：在第16周、第32周和第52周，分别有 56.10%、86.59% 和 90.24% 的患者达到 EASI-75 应答；而 EASI-90 应答率在相同时间点分别为 9.76%、35.37% 和 53.66%。（PMID: 34876623）相比于rezpegaldesleukin，这个数据在EASI-75并不差，EASI-90稍逊但这是真实世界全人群数据。当然文章这次统计人数层面只有99人。不过rezpegaldesleukin每组人数也不多，甚至还要少。这篇文章在后续也讲述了其它地区的真实世界长期研究。感兴趣的可以看看，不同管理水平和方式都会对结果有一定影响。维持疗法研究，rezpegaldesleukin采用了更长周期用药，每月给药（Q4W）和每季度给药（Q12W）。所以安全性也有所提高，维持治疗期间，rezpegaldesleukin 的安全性与研究诱导阶段的观察结果一致。在为期 36 周的维持治疗和退出治疗期间，rezpegaldesleukin 耐受性良好，未发现新的安全性问题。所有患者因不良事件导致的停药率为 3.5%。重新随机分组后接受 rezpegaldesleukin 治疗的患者中，治疗期间出现的不良事件 (TEAE) 发生率为 72%；维持治疗期间接受安慰剂治疗的患者中，TEAE 发生率为 65%；所有退出治疗的患者中，TEAE 发生率为 83%。最常见的 TEAE 是注射部位反应，几乎所有注射部位反应均为轻度 (77%)，且其发生率和频率均低于研究初始诱导阶段的观察结果（因注射部位反应导致的停药率为 0.7%）。我们回溯2025年9月份的数据，16周诱导治疗用药周期更频繁Q2W和Q4W。从安全性上来看，rezpegaldesleukin具有更高的停药率。而且有意思的是，在高剂量组，关节痛高达9.6%。同时疗效数据也不及Dupi。这个时期的疗效反而被忽略了在这次的新闻发布中。 Alpha偏向性能够激活Treg，对于AD有效，是毫无疑问的。但鉴于目前的数据和临床的开发是十分针对性的，还是需要长期来观看。而且诱导治疗期的副作用，不容忽视。同时，它的理论跟信达的理论并不相悖，本身白介素往往就有多重作用，只要把rezpegaldesleukin剂量再往上一调，炎症性副作用也都会起来，IL2治疗自免的窗口并不太大，很难成为一款优异的自免药物。推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。 ©2021 医药速览保留所有权利往期链接 “小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记 PROTAC技术| 抗体药物| 抗体药物偶联-ADC 核酸疫苗 | CAR技术| 化学生物学温馨提示医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群请扫描上方二维码，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。简单操作即可星标⭐️医药速览，第一时间收到我们的推送 ①点击标题下方“医药速览” ②至右上角“...” ③点击“设为星标

2026-03-01

·空之客

【药海听涛】特应性皮炎药物临床数据大全（下篇：维持期）

之前【药海听涛】特应性皮炎药物临床数据大全（上篇：诱导期）之后，懒了好久都没动手更新下篇维持期的数据，哪怕Nektar掀起了那么大的动静。在玩物丧志了好久之后（参见【智园清芬】再见，空之客；你好，空之客.ai和【智园清芬】人皇的安督利尔圣剑：从医药分析师到分析工具产品经理的起步），我的agent总算迈过了测试阶段，到了能发挥一定真实有意义的生产力的关头，那么就把由空之客.ai为主力来生成的第一篇内容用来填这个挖了很久的坑吧。注1：整个PPT内容完全由AI生成（除几处红色高亮外），虽然人工进行了校对，仍不免会有错漏，请不吝指出；注2：格式等已经要求skills遵循模板来模仿过往习惯，但还是有很多看着碍眼之处，我还在尽量调整，看官们先捏着鼻子看一阵子；注3：以下正文仍然还是碳基生物空之客手敲的，会刻意埋一些彩蛋以备核验，日后都会这样）。 1 试验设计客观上来说，目前虽然AD药物看上去卷的飞起，但真正能在维持期有画面的还并不多，基本都是Th2通路那几个熟面孔，这就使得NKTR-358这个IL2“新机制”显得尤为抢眼。除了试验周期太长以外，更直接的问题是连导入期的需求都还没怎么搞定，抢占那个阵地都还有得打。毋庸置疑，NKTR-358独一份的优势就是给药间隔，在维持期的需求中长效的价值已经深入人心（PFE点赞），每月一次和每季一次相比原来Dupi最长也就每两月一次，往上迈了一大步。 2 基线考虑都是从导入期响应受试者中重新入组的维持期试验，基线事实上应该都是EASI-75或IGA0/1（除了Dupi以外，基本都没有专门披露维持期的基线）。稍值得关注的是基础治疗和挽救治疗的情况，Abrocitinib和Tralokinumab专门强调了它们在试验中受试者基线及接受了较重的激素等治疗、挽救治疗的使用率也偏低。 3 有效性在维持期的EASI-75响应率上，Dupilumab作为门槛把每月一次的标准定在60%左右，目前看来Lebrikizumab和Upadacitinib能比较可靠地超过Dupi，而NKTR-358同样处于第一梯队，而且每季一次的药效也完全不输。在EASI-90响应率上，NKTR-358更是鹤立鸡群，说明IL-2机制在响应深度方面的巨大优势；而Dupi、Lebri、Upa基本上平分秋色。在IGA0/1响应率上，NKTR-358同样优势巨大，只有Lebrikizumab能望其项背，Dupi和Upa则略逊一筹。在瘙痒NRS-4响应率上，NKTR-358依然处于领先位置，而Lebrikizumab更胜一筹，Upa基本相当，Dupi则明显不太擅长 4 安全性严重不良反应SAE的发生率上，NKTR-358和Upa都相对偏高（且NKTR的Q3M组反而最高），不过与Dupi也并不算拉开太显著差距。因AE而停药的比率上，也只有Upa居高不下、黑框不是白给的。结膜炎这个IL4/13老生常谈的毛病，在NKTR-358身上意料之中的没有提及。 5 小结 Nektar作为IL-2领域的二十年苦主，在RESOLVE-AD维持期临床数据出炉后，瞬间市值翻倍到达$2b左右，这份答卷应该说确实是很够分量：不仅药效在多个终点都冠绝全场，而且还叠加了超长效和新机制两项重要buff，在如今尚在缠斗之中的AD市场打出了自己的一片天地。

临床结果

2026-02-27

·ACROBiosystems官方

药创新章｜多款重磅疗法突围，医药行业热点速递

全球医药领域创新步伐持续加快，自身免疫性疾病、代谢性疾病等核心治疗赛道成果频出，多款创新药获批上市、临床研究斩获积极数据，药企间合作授权也愈发活跃。ACROBiosystems百普赛斯提供高活性重组蛋白、功能细胞株及抑制剂筛选试剂盒等产品矩阵，打造从靶点发现与验证、候选药物筛选与开发到CMC-生产与质量控制的全流程解决方案，助力创新疗法实现从基础研究到临床转化的高效跨越。 1 自身免疫性疾病领域：多款创新药获批，临床研究成果显著奥妥珠单抗β注射液：NMOSD治疗添本土创新力量 2月14日，北京天广实生物宣布，其自主研发的创新型第三代CD20抗体药物MIL62奥妥珠单抗β注射液（商品名：倍捷欣®）获批上市，用于治疗视神经脊髓炎谱系疾病（NMOSD）。MIL62采用独特的岩藻糖全敲除技术增强抗体ADCC功能，可选择性清除异常B细胞，对正常B细胞影响较小，II/III期临床试验中72%的蛋白尿缓解率远超传统药物。临床研究数据显示，该药物可显著降低患者复发风险，或为患者带来更具可及性的治疗选择，有望重塑该疾病领域治疗格局。达尔扑拜单抗注射液：新一代CD20抗体冲刺NMOSD市场 2月24日，百奥泰生物制药宣布，其用于治疗抗水通道蛋白4（AQP4）抗体阳性NMOSD的产品达尔扑拜单抗注射液（BAT4406F）上市许可申请获国家药监局受理。BAT4406F是新一代糖基优化的全人源抗CD20抗体，具有ADCC增强功能，其关键注册II/III期临床研究于此前获独立数据监查委员会“提前结束试验”建议，并于近期完成生物制品许可申请（BLA）。奥妥珠单抗：PMN全球III 期临床取得突破性成果 2月16日，罗氏宣布，其CD20单抗奥妥珠单抗（Gazyva/Gazyvaro）在原发性膜性肾病（PMN）全球首个III期临床研究MAJESTY中取得积极结果，达到主要终点。研究显示，与活性对照相比，奥妥珠单抗治疗组患者两年时完全缓解人数显著更多，总缓解率等次要终点也表现优异，安全性与既往一致。这一突破意味着PMN患者有望迎来首个获批的特异性治疗方案，打破长期治疗选择有限的困境。 https://doi.org/10.1007/s12325-016-0451-1 奥妥珠单抗的结构与结合特性米吉珠单抗：中国炎症性肠病治疗迎来IL-23p19抑制剂 2月11日，礼来的米吉珠单抗获国家药品监督管理局批准，用于治疗成人中重度活动性克罗恩病（CD）及溃疡性结肠炎（UC）。米吉珠单抗是靶向于IL-23p19亚基的IgG4型单克隆抗体，可选择性抑制IL-23通路，2023年成为全球首个获批用于中重度UC的IL-23p19抑制剂，目前已在美、欧、日等多地获批。此次中国获批是礼来在消化免疫领域的重要突破，将惠及更多中国炎症性肠病患者。 https://doi.org/10.3390/jcm14031001 米吉珠单抗是一种人源化IgG单克隆抗体，特异性靶向IL-23的p19亚基 Rezpegaldesleukin：特应性皮炎治疗展现优越维持疗效 2月10日，Nektar Therapeutics公布了其Rezpegaldesleukin（REZPEG）全球2b期研究REZOLVE-AD的临床数据。REZPEG是选择性激活Treg型IL-2，通过直接靶向Treg表面的IL-2受体，可促进Treg增殖并增强其功能，在中重度特应性皮炎（AD）患者中，36周盲法维持期治疗取得积极结果。24μg/kg剂量下，每月与每季度给药方案分别有71%和83%的患者维持EASI-75应答。受此影响，Nektar公司股价当日暴涨51.07%，市值达11.39亿美元。 Rezpegaldesleukin及其作用机制（图源：Nektar官网） Molbreevi：自身免疫性肺泡蛋白沉积症疗法冲刺FDA 获批 2月20日，Savara Inc.宣布，美国食品药品监督管理局（FDA）已正式受理其研发的Molbreevi的BLA申报，适应症为自身免疫性肺泡蛋白沉积症（autoimmune PAP，aPAP）。FDA同步授予该申请优先审评资格，并明确处方药用户付费法案（PDUFA）目标审评日期为2026年8月22日。据悉，该药物若顺利获批，将成为美国及欧洲首款且唯一针对aPAP的疗法。Molbreevi为重组人GM-CSF，通过Savara专有大分子吸入给药在研eFlow雾化系统递送，可有效恢复肺泡巨噬细胞功能，从疾病机制层面改善患者病情，此前已获得FDA快速通道资格、突破性疗法认定与孤儿药资格。正常肺泡与 PAP 肺泡关键差异对比（图源：Savara官网） 2 代谢性疾病领域：减重新药临床数据亮眼，推进三期研究 2月24日，诺和诺德与联邦制药共同宣布，UBT251的中国减重II期研究取得积极结果，基于此，联邦制药计划启动中国超重或肥胖患者III期临床试验。UBT251是联邦生物开发的长效GLP-1R/GIPR/GCGR三重激动剂，2025年3月诺和诺德获得其海外独家权益。该II期研究纳入205例中国受试者，基线平均体重为92.2kg、BMI 33.1kg/m²，治疗24周后，UBT251组平均体重最大降幅达19.7%（-17.5kg），显著优于安慰剂组的2.0%（-1.6kg），展现出优异的减重疗效。 3 企业合作与授权：聚焦创新药研发，推动成果转化医药企业间的合作与授权成为创新研发的重要推动力，2月以来多款潜力药物达成合作。2月2日，济川药业与普祺医药签署协议，以最高1亿元对价获得普美昔替尼鼻喷雾剂在中国大陆及港澳台地区10年独家商业化权益，该药为全球首款JAK抑制剂鼻喷雾剂，针对季节性过敏性鼻炎处于III期临床，计划2026年申报上市。2月3日，药明生物与Vertex Pharmaceuticals 就一款临床前创新三特异性T细胞衔接子（TCE）达成授权协议，Vertex 获全球独家开发商业化权益，该药拟用于B细胞介导的自身免疫性疾病，药明生物将获首付款、里程碑付款及销售分成，并提供一体化研发服务。2月23日，安斯泰来与Vir Biotechnology宣布达成全球战略合作，共同开发商业化PRO-XTEN®双掩蔽PSMA/CD3 TCE VIR-5500，用于前列腺癌治疗，Vir将获得3.35亿美元的首付款及近期付款，并有资格获得高达13.7亿美元的里程碑付款，双方将分担开发成本并分享美国市场利润。 ACROBiosystems百普赛斯提供高活性重组蛋白、功能细胞株及试剂盒等产品矩阵，覆盖靶点发现验证、药物筛选开发及CMC生产质控全流程，助力创新疗法从基础研究高效迈向临床转化。验证数据全长CD20蛋白：高生物活性经Anti-CD20 CAR结合验证 2e5 of Anti-CD20 CAR-293 cells were stained with 100 μL of 3 μg/mL Biotinylated Human CD20 Full Length Protein, Flag Tag & His, Avi tag (Cat. No. CD0-H82D3) and negative control protein respectively, washed and then followed by PE-SA and analyzed with FACS (QC tested). IL-23A蛋白：高生物活性经ELISA验证 Immobilized Human IL-23A Protein, Fc Tag (Cat. No. ILA-H525h) at 1 μg/mL (100 μL/well) can bind Mirikizumab with a linear range of 0.002-0.25 μg/mL (QC tested). CD3E & CD3D蛋白：高生物活性经ELISA验证 Immobilized Human CD20 Full Length Protein, His Tag (Cat. No. CD0-H52H3) at 2 μg/mL, add increasing concentrations of Glofitamab and then add HRP-Human CD3E & CD3D Heterodimer Protein, His Tag&Tag Free (Cat. No. CDD-HR2W3) at 1 μg/mL, with sensitivity of 40.30 ng/mL (Routinely tested). IL-2RB & IL-2RA & IL-2RG蛋白：亲和力经SPR验证 Human IL-2RB&IL-2RA&IL-2RG, Fc Tag & Fc Tag (Cat. No. ILG-H5257) captured on CM5 chip via Anti-human IgG Fc antibodies surface can bind Human IL-2, Tag Free with an affinity constant of 40.6 pM as determined in a SPR assay (Biacore 8K) (Routinely tested). 相关产品推荐点击查看详情点击查看详情 >>点击图片了解ComboX，您身边的通用型研发工具参考资料 1. Colwill M, Baillie S, Clough J, et al. Role of Mirikizumab in the Treatment of Inflammatory Bowel Disease—From Bench to Bedside[J]. Journal of Clinical Medicine, 2025, 14(3): 1001. https://doi.org/10.3390/jcm14031001 2. Tobinai K, Klein C, Oya N, et al. A review of obinutuzumab (GA101), a novel type II anti-CD20 monoclonal antibody, for the treatment of patients with B-cell malignancies[J]. Advances in therapy, 2017, 34(2): 324-356. https://doi.org/10.1007/s12325-016-0451-1 3. 智慧芽研发资讯公众号 4. 药研网公众号 5. 新药说公众号 ACROBiosystems inquiry@acrobiosystems.com 15117918562 （备注：姓名+公司）

上市批准申请上市临床3期抗体药物偶联物

100 项与 Rezpegaldesleukin 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
斑秃	临床2期	美国	Nektar Therapeutics	2024-04-02
斑秃	临床2期	加拿大	Nektar Therapeutics	2024-04-02
斑秃	临床2期	波兰	Nektar Therapeutics	2024-04-02
中度特应性皮炎	临床2期	美国	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	澳大利亚	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	保加利亚	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	加拿大	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	克罗地亚	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	捷克	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	德国	Nektar Therapeutics	2023-11-15

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临床结果

适应症

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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


NCT06340360 (REZOLVE-AA, NEWS) 人工标引	临床2期	斑秃	92	rezpegaldesleukin low dose	積顧顧餘淵願鑰顧顧簾(願餘糧簾鑰鏇憲遞築鏇) = Both treatment arms “more than doubled the SALT score reduction than that observed with placebo, with the majority of patients experiencing hair growth at Week 16 or later.” Participants in the higher-dose group had an average 28% improvement in hair coverage, compared with about 11% in the placebo group. When researchers removed data from four patients who did not meet key eligibility requirements, both drug doses showed statistically significant improvements, with hair regrowth of roughly 30%, compared with just under 6% for placebo. 壓廠糧構壓遞製夢網艱 (艱遞獵選鹹窪觸壓積願 ) 更多	积极	2025-12-17
				rezpegaldesleukin high dose
NCT06136741 (REZOLVE-AD, PRNewswire \| ACAAI2025) 人工标引	临床2期	哮喘 \| 特应性皮炎	393	Rezpegaldesleukin (24 μg/kg q2w)	鹹襯廠築顧範願蓋窪糧(製獵衊鏇憲繭壓糧壓襯) = At least half of the patients (N=53) experienced clinically significant improvement (≥0.5 point reduction) in ACQ-5 at Week 16 across all treatment arms as compared to 13% in the placebo arm. 壓艱範獵簾鬱範糧壓願 (繭鹽鹽鹹壓鹽觸憲齋廠 ) 更多	积极	2025-11-08
				Rezpegaldesleukin (24 μg/kg q4w)
NCT06136741 (REZOLVE-AD, PRNewswire) 人工标引	临床2期	中度特应性皮炎 \| 重度特应性皮炎	393	Rezpegaldesleukin 24 µg/kg q2w	獵鏇膚鹹衊蓋醖網鹹觸(觸夢淵膚顧簾遞願選艱) = 鹽壓築築壓構蓋衊壓築顧鏇憲範夢鑰獵壓製製 (獵鏇膚簾襯獵獵網糧糧 ) 达到更多	积极	2025-06-24
				Rezpegaldesleukin 18 µg/kg q2w	獵鏇膚鹹衊蓋醖網鹹觸(觸夢淵膚顧簾遞願選艱) = 衊積夢襯艱網淵鏇壓夢顧鏇憲範夢鑰獵壓製製 (獵鏇膚簾襯獵獵網糧糧 ) 达到更多
NCT04380324 (AAD2025)	临床1/2期	银屑病 \| 系统性红斑狼疮 \| 溃疡性结肠炎 ... 更多	746	Rezpegaldesleukin	範鹽顧觸積願鏇衊鹽廠(壓襯簾顧鏇網艱鹽窪構) = 襯鹽鹽選憲鹽積壓鹽蓋齋繭製選鑰憲憲齋網鑰 (積廠遞範艱簾獵願遞膚 ) 更多	积极	2025-03-07
				Placebo	範鹽顧觸積願鏇衊鹽廠(壓襯簾顧鏇網艱鹽窪構) = 繭繭繭鹽壓齋鏇獵鹽餘齋繭製選鑰憲憲齋網鑰 (積廠遞範艱簾獵願遞膚 ) 更多
NCT04119557 \| NCT04081350 (Pubmed \| Nat Commun)	临床1期	炎症性皮肤病 Eczema Area and Severity Index (EASI) \| Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) \| Psoriasis Area and Severity Index (PASI) ... 更多	-	Rezpegaldesleukin 10-12 µg/kg	繭醖鏇齋淵糧鏇築構築(網築淵淵齋淵膚膚衊願) = EASI-75 responses are maintained for 36 weeks after treatment discontinuation in 71% of week 12 responders 窪膚鹽憲憲鹹襯壓窪遞 (膚壓衊選醖艱蓋簾蓋網 ) 更多	积极	2024-10-25
NCT04433585 (ISLAND-SLE, CTgov)	临床2期	系统性红斑狼疮	291	LY3471851 (LY3471851 High Dose)	積壓鹹願鑰蓋窪構觸憲 = 鹹製網繭衊簾願壓鹹淵鹹糧獵網蓋淵壓觸選構 (鹹積憲鑰製網膚獵獵衊, 廠範顧製選夢鑰鬱窪積 ~ 繭襯製鑰遞膚餘積鏇鹽) 更多	-	2024-04-23
				LY3471851 (LY3471851 Mid Dose)	積壓鹹願鑰蓋窪構觸憲 = 鹹膚鏇製範蓋醖獵鑰選鹹糧獵網蓋淵壓觸選構 (鹹積憲鑰製網膚獵獵衊, 艱鏇廠簾構醖廠鑰顧餘 ~ 壓簾廠廠構獵夢繭齋衊) 更多
NCT04081350 (Phase 1b study, EADV2023)	临床1期	特应性皮炎 Treg	-	Rezpegaldesleukin 12 µg/kg	壓夢鹽鏇範鑰淵膚壓選(製鏇遞網齋築鹽鑰鬱齋) = 築鹹鹹鏇襯淵窪願糧糧鑰夢獵築鏇遞膚襯淵衊 (膚餘夢繭憲壓鬱膚積遞 ) 更多	积极	2023-10-11
				Rezpegaldesleukin 24 µg/kg	壓夢鹽鏇範鑰淵膚壓選(製鏇遞網齋築鹽鑰鬱齋) = 淵選願範獵獵窪膚遞艱鑰夢獵築鏇遞膚襯淵衊 (膚餘夢繭憲壓鬱膚積遞 ) 更多
NCT04677179 (INSTRUCT-UC, CTgov)	临床2期	溃疡性结肠炎	81	Placebo (Placebo (Induction Treatment Period))	積醖憲鏇鑰糧窪獵廠製 = 鏇夢選糧獵顧觸鬱願壓憲糧積網膚膚鑰範顧憲 (繭鬱構鹹襯鹽襯製簾獵, 遞選膚廠壓醖顧廠憲廠 ~ 網遞鬱鹹簾糧簾構觸廠) 更多	-	2023-09-05
				LY3471851 (Low Dose LY3471851 (Induction Treatment Period))	積醖憲鏇鑰糧窪獵廠製 = 鏇製窪襯製鑰獵遞衊願憲糧積網膚膚鑰範顧憲 (繭鬱構鹹襯鹽襯製簾獵, 鑰膚製願製網糧襯繭淵 ~ 餘淵製襯鏇觸鑰選構淵) 更多
NCT04433585 (ISLAND-SLE, Corporate Publications) 人工标引	临床2期	系统性红斑狼疮	291	rezpegaldesleukin 300mcg Q2W	構鏇憲憲構艱襯鹹夢齋(醖膚選繭夢齋範憲選範) = 鏇窪膚糧願憲網構糧艱鹹鏇願築獵憲選鏇廠蓋 (積製窪構鏇壓鑰鬱鹽鬱 ) 更多	不佳	2023-02-23
				rezpegaldesleukin 900mcg Q2W	構鏇憲憲構艱襯鹹夢齋(醖膚選繭夢齋範憲選範) = 壓鹽壓鹽蓋製淵遞餘繭鹹鏇願築獵憲選鏇廠蓋 (積製窪構鏇壓鑰鬱鹽鬱 ) 更多
NCT04081350 (Corporate Publications) 人工标引	临床1期	特应性皮炎	43	LY3471851 12 µg/kg	鑰顧鹽窪窪鬱齋餘繭壓(網範網簾構鬱築鹹淵範) = 網鑰窪夢餘衊簾網醖壓廠築觸網鬱糧淵醖衊構 (夢繭網簾觸顧選艱醖窪 ) 更多	积极	2022-09-07
				LY3471851 24 µg/kg	鑰顧鹽窪窪鬱齋餘繭壓(網範網簾構鬱築鹹淵範) = 壓淵簾願齋鬱衊憲憲獵廠築觸網鬱糧淵醖衊構 (夢繭網簾觸顧選艱醖窪 ) 更多