A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin (NKTR-358) Monotherapy in the Treatment of Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis

This is an interventional, randomized, parallel group, treatment, Phase 3, double blind study to assess the effect of Rezpegaldesleukin in participants 12 years of age or older with moderate to severe atopic dermatitis, as compared to placebo.
The estimated participant overall duration is approximately 15 months.

开始日期2026-07-01

申办/合作机构

Nektar Therapeutics

NCT07142252

/ Recruiting临床2期IIT

Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus

This Phase 2 study is a 2-arm, multi-center, double-masked (masking of the participant, care provider and investigator), placebo-controlled, 2:1 randomized 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2026-05-14

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

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）

2026-03-23·Cureus Journal of Medical Science

Biologic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Bayesian Network Meta-Analysis of Established and Investigational Agents

Review

作者: Babul, Najib ; Soliman, Yssra ; Babul, Arya ; Mehta, Devina ; Hussain, Momina

Biologic therapies targeting maladaptive type 2 inflammation have transformed the management of moderate‑to‑severe atopic dermatitis (AD); however, comparative evidence integrating both approved and next‑generation investigational agents remains limited. This Bayesian network meta‑analysis (BNMA) provides the first unified evaluation of all biologic monoclonal antibodies approved as monotherapy for AD (dupilumab, lebrikizumab, tralokinumab) together with emerging immunotherapies, including amlitelimab, rademikibart, rezpegaldesleukin, rocatinlimab, telazorlimab, temtokibart, and zumilokibart, across key efficacy measures. A PRISMA‑2020-compliant systematic review and PROSPERO‑registered protocol (CRD420251162704) identified phase 2-3 randomized, double‑blind, placebo‑controlled trials reporting week‑16 outcomes (week‑24 for rocatinlimab). A Bayesian random‑effects NMA estimated relative risks (RRs) for EASI‑75, EASI‑90, IGA‑AD 0/1, and ≥4‑point improvement in itch Numeric Rating Scale (NRS). Treatment hierarchy was evaluated using both Bayesian (SUCRA) and frequentist (P‑score) approaches. Seventeen randomized controlled trials (RCTs) involving more than 6,000 patients were included in the analysis. Dupilumab demonstrated the most consistent and reliable efficacy across all evaluated endpoints, including improvements in EASI-75, EASI-90, IGA-AD 0/1, and itch NRS. Among investigational therapies, rocatinlimab showed a notable signal for deep clinical responses, although the available evidence remains limited and less precise. Other emerging agents, including rademikibart, temtokibart, and zumilokibart, demonstrated encouraging efficacy profiles, whereas telazorlimab showed comparatively modest clinical benefit. Ranking analyses consistently positioned dupilumab as the most reliable and highest-performing therapy overall, followed by rocatinlimab. Overall, biologic therapies were generally well tolerated in the short term; however, dupilumab remains the only agent supported by extensive long-term safety data extending up to a decade. This analysis relied on indirect comparisons anchored to short‑term placebo‑controlled induction periods, limiting assessment of long‑term safety and durability, particularly for mechanistically distinct agents such as rezpegaldesleukin, a regulatory T cell (Treg) pathway agonist, and rocatinlimab, an OXO pathway inhibitor. Evidence for several emerging therapies was restricted to small phase 2 trials, resulting in wide credible intervals (Crls) and lower certainty in comparative rankings. Trial heterogeneity in baseline severity, ethnic composition, and geographic setting may have introduced residual confounding despite sensitivity and meta‑regression analyses. These factors should be considered when interpreting relative efficacy estimates This NMA demonstrates that dupilumab remains the most reliable and effective biologic monotherapy for moderate‑to‑severe AD, supported by the greatest precision, reproducibility, and long‑term safety. Rocatinlimab shows promising investigational efficacy but requires efficacy and long-term safety validation. Zumilokibart, rademikibart, and temtokibart emerge as additional candidates with encouraging activity, whereas telazorlimab showed limited clinical benefit. Collectively, these findings provide a comprehensive comparative framework to inform biologic selection and therapeutic sequencing.

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.

218

项与 Rezpegaldesleukin 相关的新闻（医药）

2026-07-14

·E药经理人

一夜暴涨90%！“头顶”生意杀疯了，能否再现GLP-1神话？

全民颜值焦虑之下，这桩人人刚需的 “头” 等大事，究竟能否孕育出下一个GLP-1级别的超级重磅赛道？撰文｜Erin 最近，一家沉寂已久的行业小透明，近日上演股价“旱地拔葱”式暴涨，瞬间搅动整个脱发医药赛道。过去几年，医保控费的风从中国一路吹往全球，英国NHS收紧预算，美国“特朗普医改”不断施压，德国GKV-BStabG法案持续压缩药价空间……支付端层层加码之下，创新药无论走到哪个市场，日子似乎都不太好过。但替尔泊肽年赚365亿美元，迅速超越司美格鲁肽成新“药王”，又让行业看见了另一种可能：当一款药从严肃医疗切入，又同时击中外貌焦虑、消费需求和自费市场，天花板可能难以估量。 “头”顶上的生意就是其中之一。 7月13日，海外Biotech Q32 Bio公布斑秃药物bempikibart的Ⅱ期临床数据。市场迅速捕捉到一个新故事：这款靶向IL-7Rα的药物，或许有机会绕开JAK抑制剂的安全性包袱，成为斑秃治疗的下一代选择。一夜之间，这家行业“小透明”被推到聚光灯下，股价收盘暴涨90.72%，K线几乎拔地而起。无独有偶。另一家美股Biotech Veradermics，手握一款用于雄激素性脱发的缓释口服米诺地尔制剂。尽管核心成分仍是老药，公司却凭借凝胶基质缓释技术讲出了一个“更安全、更便捷”的新故事。自年初上市以来，其股价一路水涨船高，从30多美元飙升至约110美元。有意思的是，大洋彼岸的中国市场，却是另一番景象：一边是押注雄脱创新药的开拓药业，始终难以挽回股价颓势；另一边是靠一款米诺地尔产品三年狂赚44亿元的三生蔓迪，港股上市进程依旧悬而未决。同样是做“头”顶生意，有人一夜暴涨，有人深陷估值困局；有人靠创新靶点点燃市场，有人凭一款老药赚得盆满钵满。在全员“服美役”的时代，这场“头”等大事，是否真能诞生下一个GLP-1？又一个GLP-1潜力股不能否认，司美格鲁肽、替尔泊肽等GLP-1产品之所以能够不断刷新全球畅销药的天花板，关键不只在于疗效有多强，更在于它们将糖尿病这一严肃医疗场景，带入了减肥这个兼具疾病治疗、外貌管理和消费属性的超级市场。抗肿瘤药、自免药再重磅，患者终究有限；减肥药的市场，谁也不知道天花板在哪。与减肥同属“服美役”刚需的防脱生发，也因此被市场反复追问：下一个GLP-1，会不会长在头上？在7月13日，Q32 Bio公布bempikibart之前，JAK抑制剂治疗斑秃一直承载这样的潜力。公开数据显示，全球脱发市场规模在2025年约为105亿美元，预计2033年达到268亿美元，其中包含雄激素性脱发、斑秃等多种疾病。其中，作为自身免疫病的斑秃，已经被JAK抑制剂率先打开了处方药市场。随着巴瑞替尼、利特昔替尼、deuruxolitinib等产品相继获批，美国斑秃JAK药物销售额在短短几年内从5400万美元增至约5亿美元，接近十倍扩容。不过，JAK抑制剂始终未能摆脱严重感染、恶性肿瘤、心血管事件和血栓等安全性问题黑框警告的影响，为其接下来的市场规模增长蒙上阴影。也正是在这个时候，Q32 Bio带着抗IL-7Rα单抗bempikibart冲到了聚光灯下。它与JAK抑制剂的最终目标相同，都是压住攻击毛囊的异常T细胞，但下手的位置并不一样。JAK抑制剂是在细胞内部切断多种炎症因子共用的信号线路，相当于直接掐断“围攻毛囊”的通信网络；bempikibart则从上游封住IL-7Rα，同时减少IL-7和TSLP对T细胞的“续命”和“助攻”，让致病T细胞逐渐失去生存、扩增和持续作战的补给。一个强力断网，一个精准断粮。根据Q32此次公布的Ⅱ期研究数据，共纳入33例重度或极重度斑秃患者，治疗36周后，10例患者达到SALT≤20，即头皮毛发覆盖率恢复至80%以上，对应ITT人群应答率为30.3%；在预设的25例mITT人群中，这一比例达到40%。与此同时，11例患者的SALT评分较基线改善至少50%，占全部入组患者的33.3%。更让市场兴奋的是，bempikibart不仅显露出毛发再生信号，也初步呈现出相对更优的安全性，以及停药后疗效仍可能维持甚至继续加深的迹象。这恰好击中了JAK最难解决的两块短板：能不能更安全，以及能不能不靠长期持续服药维持疗效。于是，bempikibart迅速被贴上了“更安全、更持久的JAK替代方案”标签，Q32 Bio的股价也随之走出一轮旱地拔葱式暴涨。当然，现在就宣布接棒成功还远远太早。这项研究仅纳入33例患者，数据也仍是早期，且尚无头对头研究证明bempikibart在疗效、安全性或维持时间上真正优于现有JAK抑制剂。更何况，盯上JAK的，并不只有IL-7Rα。在斑秃治疗赛道，还有另外一类玩家虎视眈眈——Treg激动剂。与前两者的机制都不同，Treg，即调节性T细胞，Treg激动剂通过选择性激活IL-2通路，扩增并强化调节性T细胞，恢复免疫耐受，从而压制攻击毛囊的异常免疫反应。相当于，JAK负责强力灭火，IL-7Rα负责切断致病T细胞补给，Treg疗法则试图重建防火墙。目前，Treg激动剂治疗斑秃进展最快的公司Nektar，其产品Rezpegaldesleukin已经完成全球随机、安慰剂对照的Ⅱb期研究，并拿到52周延长治疗数据；Nektar也已确定拟用于Ⅲ期的剂量和52周注册终点。推荐阅读 *千亿市场、百余玩家，生发赛道进入洗牌倒计时 *辉瑞、礼来带不动，艾伯维狂赚500亿，下一个JAK“药王”看中国？脱发江湖，谁能把“头”顶生意做大做强？放进整个全球脱发江湖，斑秃仍然只是其中一隅。除此之外，还有雄激素性脱发、休止期脱发、瘢痕性脱发、化疗性脱发等不同类型。后三个尚未形成边界清晰、竞争激烈的创新药赛道。全球脱发药物研发版图的玩家们，主要还是围绕斑秃和雄脱。前者患者规模不算最大，却身处自身免疫疾病的“交通要道”：许多作用于特应性皮炎、白癜风等疾病的免疫机制，都可以顺势向斑秃拓展，因此吸引了JAK、IL-7Rα、Treg、IL-15、OX40、CD94等不同靶点陆续入局。后者则恰恰相反。雄脱拥有最庞大的患者池，但全球核心获批药物仍主要是外用米诺地尔和口服非那雄胺。先看斑秃。表面上，斑秃已经挤满了不同机制，实际上大致可以分为两大门派：“温和调停派”和“激进清场派”。简单来说，前者劝攻击者放下武器，让攻击型T细胞失去继续围剿毛囊的能力；后者则是直接把攻击者请出战场。其中上述JAK、IL-7Rα、Treg三大靶点，还有IL-15、OX40等，IL-15药物与IL-7Rα类似，试图断掉致病T细胞维持生存、扩增和持续攻击所需的“补给”； OX40阻断剂的思路也相近，通过压制活化T细胞的共刺激信号，降低其生存和持续作战能力。在这一门派中，中国药企与全球进度相近，已经把JAK抑制剂进行到了商业化阶段。恒瑞医药的高选择性JAK1抑制剂艾玛昔替尼于2025年获批成人重度斑秃，泽璟制药的泛JAK抑制剂吉卡昔替尼也在2026年6月获批同一适应证。石药集团的SYHX1901则是一款JAK/SYK双靶点口服药，重度斑秃Ⅱ期研究仍在推进。此外，信达生物的IBI3013是一款主打长效的抗IL-15单抗，已获批开展白癜风和斑秃临床研究，成为国内少数明确押注非JAK斑秃机制的产品。而“激进清场派”，目前主要为海外Biotech Dren Bio的DR-01一位选手。其不再满足于给异常T细胞断网、断粮或者踩刹车，而是直接识别表达CD94的细胞毒性T细胞及NK细胞，再借助抗体依赖的细胞毒作用将其清除。不过，进度仍在斑秃和白癜风患者中开展Ib期研究。当然，斑秃江湖里还有一位尚未肯摘下面具的“神秘高手”。礼来也在偷偷押注一款斑秃药物。clinicaltrials.gov官网显示，目前礼来正在招募代号为NCT07533006临床试验的患者，主要为其LY4005130产品研发斑秃适应证，不过并未披露具体靶点和机制。整体来看，中国斑秃赛道呈现出非常清晰的断层：JAK即将挤入红海，IL-15和OX40刚刚冒头，IL-7Rα、Treg和CD94仍主要由海外Biotech掌握。而到了雄脱赛道，江湖又是另一种画风。这一赛道的玩家只需要回答一个关键问题：如何比米诺地尔和非那雄胺更有效、更安全、更方便、更便宜？所以围绕这个问题，雄脱研发大致形成了三大门派：老药翻新派、雄激素围剿派和毛囊重启派。老药翻新派当然并不陌生，国内市场双寡头——三生蔓迪和振东已经带领这一赛道卷生卷死。最初的搽剂价格卷至地板价，泡沫剂型三生蔓迪率先突围，尚未受到价格战席卷；此外，还有一家来自江苏的药企则在探索将米诺地尔装进缓控释微针贴片。而虽然在国内，米诺地尔在资本市场的“挤泡沫”已经接近尾声，但在美股却仍然高潮，Veradermics公司于2026年2月以每股17美元登陆纽交所，目前股价约为110美元，已经达到发行价的约6.5倍。背后就在于其核心产品VDPHL01是专门为雄脱开发的口服缓释米诺地尔，通过凝胶基质实现更平稳、持续的药物释放，试图在保留口服米诺地尔疗效的同时，降低血药浓度骤升带来的心血管风险，其男性雄脱Ⅱ/Ⅲ期研究已经达到主要终点。雄激素围剿派其实是继承了传统产品非那雄胺的思路，在雄激素上下手。本土药企开拓药业的KX-826就属于局部雄激素受体拮抗剂，其在国内的Ⅲ期临床已达主要终点。值得一提的是，本土药企还通过核酸药物加入这一门派。凌泰氪生物的LT-010则依托小核酸透皮递送平台，以涂抹方式治疗雄脱，并于2026年6月获得美国FDA的IND许可。毛囊重启派则不再纠结于如何围堵雄激素，而是希望直接把休眠毛囊重新唤醒。在这一赛道虽然全球新药的进展都仍在早期临床，但中国药企其实也走在了第一梯队。来自和其瑞的HMI-115除了用于治疗子宫内膜异位症，其也在研发雄脱适应证。由此来看，斑秃和雄脱虽然都叫“脱发”，却正在走向两套截然不同的产业逻辑：斑秃争夺的是谁能接替JAK，既压住自身免疫，又摆脱黑框警告和长期服药的束缚，但受限于患者规模，仍然是严肃医疗的逻辑。真正可能复制“下一个GLP-1”神话的，或许还得看雄脱。毕竟要能改写米诺地尔、非那雄胺“金标准”格局，在疗效、安全性、便捷性和价格之间找到最优解，在如今全民“服美役”的时代，减肥是身材焦虑，“秃头”是门面危机，这桩“头”等大事，消费潜力未必会输给GLP-1。一审| 石宛佳二审| 李芳晨三审| 李静芝

2026-07-13

·氨基观察

上半年全国医保系统共追回医保基金163.5亿元；默沙东口服PCSK9在国内申报上市

氨基观察-创新药组原创出品作者 | 黄凯违规使用医保，严惩不贷。 7月9日，国家医保局召开例行新闻发布会，介绍2026年上半年全国医疗保障工作情况。国家医保局相关负责人介绍，1—6月，全国医保系统累计现场检查定点医药机构33万家、处理违法违规机构28万家、追回医保基金163.5亿元，处理违法违规人员13万人，曝光典型案例1.6万件。默沙东口服PCSK9抑制剂在国内申报上市。 7月9日，据CDE官网，默沙东的口服PCSK9抑制剂恩利西肽申报上市，用于治疗原发性高胆固醇血症或混合型血脂异常。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 市场速递 1）上半年全国医保系统共追回医保基金163.5亿元 7月9日，国家医保局召开例行新闻发布会，介绍2026年上半年全国医疗保障工作情况。国家医保局相关负责人介绍，1—6月，全国医保系统累计现场检查定点医药机构33万家、处理违法违规机构28万家、追回医保基金163.5亿元，处理违法违规人员13万人，曝光典型案例1.6万件。 / 02 / 资本信息 1）英矽智能扭亏为盈 7月9日，英矽智能公告表示，2026年上半年经调整非国际财务报告准则净利润介于约4550万美元至5150万美元区间，而2025年6月30日止六个月经调整非国际财务报告准则净亏损为1540万美元。 / 03 / 医药动态 1）默沙东口服PCSK9申报上市 7月9日，据CDE官网，默沙东的口服PCSK9抑制剂恩利西肽申报上市，用于治疗原发性高胆固醇血症或混合型血脂异常。 2）甘李药业甘精胰岛素注射液获洪都拉斯药品注册批件 7月9日，甘李药业公告称，公司收到洪都拉斯国家药品监督管理局核准签发的甘精胰岛素注射液(预填充笔)注册批件，该药品适应症为糖尿病。截至2026年3月31日，公司在该项目累计投入研发费用9.44亿元。 3）晓维生物RZ-520雾化吸入溶液获临床许可 7月9日，据CDE官网，晓维生物RZ-520雾化吸入溶液获临床许可，拟开展治疗间质性肺疾病的研究。 / 04 / 海外药闻 1）全球首个自免IL-2疗法启动III期临床 7月8日，据美国临床试验收录网站显示，Nektar Therapeutics启动了Rezpegaldesleukin的首个III期临床试验（ZENITH AD-1）。该药物是全球首个进入III期阶段的IL-2受体激动剂，也是自免疾病领域首个进入III期阶段的IL-2疗法。

财报临床3期

2026-07-12

·药创新

中国生物制药一天内官宣两笔重磅交易；IgA肾病新药获FDA批准上市

“药创新”综合整理过去一周，创新药行业发生了哪些事儿？中国生物制药一天之内官宣和阿斯利康、GSK的两笔重磅交易；英矽智能首款由自有生成式AI平台研发的Rentosertib正式启动特发性肺纤维化III期临床；IgA肾病新药阿塞西普获FDA批准上市；全球首个自免IL-2疗法启动III期临床；Vertex近百亿美元收购Crinetics……详情如下：中国生物制药一天之内官宣和阿斯利康、GSK的两笔重磅交易 7月8日，中国生物制药在一天之内连续官宣两笔重磅交易，一边是将自主研发的慢性阻塞性肺疾病（COPD）创新药TQC3721（PDE3/4抑制剂）海外权益以最高19亿美元授权给全球呼吸龙头阿斯利康；另一边是进一步深化与GSK的战略合作，获得全再乐（氟替美维吸入粉雾剂）和欧乐欣（乌美溴铵维兰特罗吸入粉雾剂）两款全球重磅呼吸药物在中国内地的独家商业化权益。英矽智能首个AI分子启动III期临床 7月8日，英矽智能宣布，其首款由自有生成式AI平台Pharma.AI全程驱动研发的候选药物Rentosertib（ISM001-055）正式启动特发性肺纤维化（IPF）适应症的III期临床试验。即将开展的这项前瞻性、随机、双盲、安慰剂对照、平行组、III期研究由中国医学科学院北京协和医院徐作军教授担任牵头研究者（Leading PI），中国工程院院士、著名呼吸病学领域专家钟南山院士，和上海市肺科医院陈昶院长担任联合牵头研究者（Co-Leading PI），计划评估Rentosertib每日一次用药持续52周的有效性和安全性，预计在全国47个研究中心招募共320名受试者。 IgA肾病新药阿塞西普获FDA批准上市 7月7日，Vera Therapeutics宣布FDA加速批准其生物制剂Trutakna（Atacicept，阿塞西普）上市，用于降低存在进展风险的成人原发性IgA肾病（IgAN）患者蛋白尿。 Atacicept是全人源TACI-Fc融合蛋白，为IgA肾病上游源头靶向疗法。国内荣昌生物的泰它西普已在中国获批IgAN，本次Atacicept在美国落地，证明双靶点TACI-Fc融合蛋白是IgAN源头治疗路径之一。全球首个自免IL-2疗法启动III期临床 7月8日，Nektar Therapeutics启动核心管线Rezpegaldesleukin的第一项注册III期临床试验ZENITH AD-1，适应症为12岁及以上中重度特应性皮炎（AD）。该药物是全球首个推进至III期的选择性IL-2受体激动剂；自身免疫炎症领域第一款进入III期临床的IL-2类疗法。当前全球特应性皮炎市场被IL-4R单抗（度普利尤单抗）、口服JAK抑制剂等占据，均属于炎症阻断类对症药物；Rezpegaldesleukin是免疫稳态修复类疗法，代表自免治疗从“抑制炎症”迈向“重建免疫耐受”全新范式。 Vertex近百亿美元收购 7月6日，Vertex宣布，以每股85美元现金、总股权价值约100亿美元收购Crinetics Pharmaceuticals，扣除拟承接现金后净交易对价约88亿美元。此次收购主要看重两个核心药物。一个是PALSONIFY（paltusotine），一款用于治疗肢端肥大症的每日一次口服小分子药物，已于2025年10月在美国上市。这款药是一款每日一次的口服肢端肥大症治疗药物。其关键的III期临床试验（PATHFNDR-1和PATHFNDR-2）数据极其亮眼，在从注射SRLs转换的患者中，83%达到了主要终点（IGF-1水平≤1倍正常上限），而安慰剂组仅为4%；在初治患者中，这一比例也高达56%（对比安慰剂组的5%）。另一个核心药物是Atumelnant，是一种每日一次的口服小分子ACTH受体拮抗剂，在肾上腺皮质层面直接阻断ACTH的作用，从而在不依赖高剂量GCs的情况下，从根源上控制雄激素水平。公布的II期CAH试验Cohort 4完整数据显示，在第12周，80mg晨起给药队列中，Atumelnant使晨间血清雄烯二酮（A4）水平较基线平均降低67%；8名完成12周治疗的患者中有7名（88%）达成了生理性日剂量糖皮质激素。 END

临床3期加速审批上市批准并购高管变更

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
中度特应性皮炎	临床3期	美国	Nektar Therapeutics	2026-07-01
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
重度特应性皮炎	临床2期	美国	Nektar Therapeutics	2023-11-15
重度特应性皮炎	临床2期	澳大利亚	Nektar Therapeutics	2023-11-15
重度特应性皮炎	临床2期	保加利亚	Nektar Therapeutics	2023-11-15
重度特应性皮炎	临床2期	加拿大	Nektar Therapeutics	2023-11-15
重度特应性皮炎	临床2期	克罗地亚	Nektar Therapeutics	2023-11-15
重度特应性皮炎	临床2期	捷克	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


NCT06136741 (REZOLVE AD, AAD2026)	临床2期	特应性皮炎诱导	393	Rezpegaldesleukin 24 g/kg q2w	觸窪顧鏇衊淵廠憲壓夢(構顧積糧衊鏇繭壓築餘) = 憲製繭網醖衊製醖夢淵繭簾鏇醖構製築壓鏇膚 (窪淵夢製構鏇築鹽夢積 ) 更多	积极	2026-03-27
				Placebo	觸窪顧鏇衊淵廠憲壓夢(構顧積糧衊鏇繭壓築餘) = 選簾網糧窪簾艱遞繭願繭簾鏇醖構製築壓鏇膚 (窪淵夢製構鏇築鹽夢積 ) 更多
NCT06136741 (REZOLVE-AD, Company_Website) 人工标引	临床2期	特应性皮炎	393	Rezpegaldesleukin 24 μg/kg Q4W	顧廠蓋襯觸選憲積繭衊(廠積壓簾願壓夢廠壓鹽) = 淵築襯艱齋鬱遞襯醖範觸遞鹹構艱憲繭淵憲襯 (簾繭網淵窪鹽繭選願淵 ) 更多	积极	2026-02-10
				Rezpegaldesleukin 24 μg/kg Q12W	顧廠蓋襯觸選憲積繭衊(廠積壓簾願壓夢廠壓鹽) = 鏇願鑰獵築憲鬱願膚醖觸遞鹹構艱憲繭淵憲襯 (簾繭網淵窪鹽繭選願淵 ) 更多
NCT06340360 (REZOLVE-AA, NEWS) 人工标引	临床2期	斑秃	92	rezpegaldesleukin low dose	鑰顧餘夢窪鏇憲淵壓願(廠選襯鏇選齋壓蓋艱鏇) = 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. 淵鬱鏇蓋選糧築簾顧繭 (艱願製網願夢鑰獵齋遞 ) 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)	選鹹網觸製遞積醖製製(鬱醖憲觸築憲艱觸鑰齋) = 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. 簾膚餘選襯鹽網衊艱糧 (糧艱廠廠衊觸構遞憲鑰 ) 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	糧醖範鬱選鹹觸窪築範(窪鏇憲膚廠壓餘鹹壓鏇) = 鏇鹹願糧遞網範憲鏇獵簾艱鬱餘簾觸淵餘鹽獵 (壓積鬱齋積廠鹹鏇製壓 ) 达到更多	积极	2025-06-24
				Rezpegaldesleukin 18 µg/kg q2w	糧醖範鬱選鹹觸窪築範(窪鏇憲膚廠壓餘鹹壓鏇) = 衊醖膚蓋餘蓋鏇製艱構簾艱鬱餘簾觸淵餘鹽獵 (壓積鬱齋積廠鹹鏇製壓 ) 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	齋選窪壓餘簾衊夢鬱積(窪製窪鬱夢網觸鹹選餘) = 憲廠遞憲窪顧顧選選網獵製鏇廠願獵鑰網簾膚 (襯憲願積顧齋觸夢範築 ) 更多	积极	2025-03-07
				Placebo	齋選窪壓餘簾衊夢鬱積(窪製窪鬱夢網觸鹹選餘) = 艱壓膚廠鏇糧淵遞網餘獵製鏇廠願獵鑰網簾膚 (襯憲願積顧齋觸夢範築 ) 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	選築鏇襯鹽糧餘蓋繭蓋(憲膚範顧鹽糧艱鏇糧蓋) = EASI-75 responses are maintained for 36 weeks after treatment discontinuation in 71% of week 12 responders 繭範醖鹹夢糧選膚鏇網 (遞觸醖願願醖鏇鬱夢憲 ) 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)	淵壓襯壓範遞顧積衊繭 = 廠膚淵蓋鏇鬱構顧鏇襯構壓蓋遞鑰憲鹽鑰鹹艱 (鹽夢鹽鹽齋顧鑰獵蓋鏇, 製繭齋網製願廠選繭構 ~ 鹹遞鏇憲淵壓構糧製製) 更多	-	2024-04-23
				LY3471851 (LY3471851 Mid Dose)	淵壓襯壓範遞顧積衊繭 = 鑰鏇窪糧壓襯蓋範廠窪構壓蓋遞鑰憲鹽鑰鹹艱 (鹽夢鹽鹽齋顧鑰獵蓋鏇, 餘淵鬱鏇醖範衊鑰築憲 ~ 築鹽壓淵願窪廠廠獵選) 更多
NCT04081350 (Phase 1b study, EADV2023)	临床1期	特应性皮炎 Treg	-	Rezpegaldesleukin 12 µg/kg	淵範淵襯鑰遞蓋齋製繭(構構憲範壓膚廠顧構衊) = 膚鏇遞遞憲窪餘膚膚願製製簾醖糧廠願顧範餘 (膚壓鏇襯積蓋願繭餘鏇 ) 更多	积极	2023-10-11
				Rezpegaldesleukin 24 µg/kg	淵範淵襯鑰遞蓋齋製繭(構構憲範壓膚廠顧構衊) = 築襯淵顧餘窪蓋艱顧醖製製簾醖糧廠願顧範餘 (膚壓鏇襯積蓋願繭餘鏇 ) 更多
NCT04677179 (INSTRUCT-UC, CTgov)	临床2期	溃疡性结肠炎	81	Placebo (Placebo (Induction Treatment Period))	積築艱鹹範壓鹹淵簾憲 = 夢顧獵膚艱獵繭繭鏇齋構衊餘憲餘餘鏇醖膚範 (夢糧蓋鹹襯網窪簾餘築, 構選願襯觸繭窪築鹹積 ~ 鑰鑰鏇網獵廠鬱鏇獵窪) 更多	-	2023-09-05
				LY3471851 (Low Dose LY3471851 (Induction Treatment Period))	積築艱鹹範壓鹹淵簾憲 = 繭糧糧淵糧積艱網獵範構衊餘憲餘餘鏇醖膚範 (夢糧蓋鹹襯網窪簾餘築, 願壓廠餘夢餘觸築襯齋 ~ 願鏇鬱蓋願製窪簾顧餘) 更多