尼莫利珠单抗(Nemolizumab) - 药物靶点：IL-31RA_在研适应症：中度特应性皮炎，重度特应性皮炎，结节性痒疹_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-IL-31-receptor-monoclonal-antibody、IL-31RA monoclonal antibody、Nemolizumab (Genetical Recombination)

+ [13]

靶点

IL-31RA

作用机制

IL-31RA抑制剂(interleukin 31 receptor A inhibitors)

治疗领域

免疫系统疾病遗传病与畸形皮肤和肌肉骨骼疾病+ [1]

在研适应症

中度特应性皮炎重度特应性皮炎结节性痒疹+ [3]

非在研适应症-

原研机构

Chugai Pharmaceutical Co., Ltd.

在研机构

Maruho Co., Ltd.

Galderma Holding SAGalderma International SAS

+ [3]

非在研机构

Galderma Research & Development SNC

最高研发阶段批准上市

首次获批日期

日本 (2022-03-28),

特应性皮炎

最高研发阶段(中国)-

特殊审评优先审评 (美国)、突破性疗法 (美国)

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结构/序列

Sequence Code 81291H

来源: *****

Sequence Code 1151753L

来源: *****

关联

40

项与尼莫利珠单抗相关的临床试验

JPRN-jRCT2021230034

/ Suspended临床2期IIT

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Nemolizumab in Patients with Acquired Reactive Perforating Collagenosis

开始日期2023-11-09

申办/合作机构-

JPRN-jRCT2031230174

/ Recruiting临床3期IIT

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Infant and Pediatric Atopic Dermatitis Patients with moderate to severe pruritus

开始日期2023-06-25

申办/合作机构-

NCT05056779

/ Withdrawn临床3期

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable

The primary objective of this study is to investigate the efficacy of nemolizumab administered in combination with topical background therapy (topical corticosteroids [TCS] with or without topical calcineurin inhibitors [TCI]) in adult participants with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with or are not advised to use oral cyclosporine A (CsA) for medical reasons. The secondary objective is to investigate the safety of nemolizumab in adult participants with moderate-to-severe AD who are not adequately controlled with or are not advised to use oral CsA for medical reasons.
The study will be carried out in up to 70 different locations across Europe.

开始日期2023-01-01

申办/合作机构

Galderma Holding SA

100 项与尼莫利珠单抗相关的临床结果

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100 项与尼莫利珠单抗相关的转化医学

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100 项与尼莫利珠单抗相关的专利（医药）

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131

项与尼莫利珠单抗相关的文献（医药）

2025-02-01·Birth Defects Research

Pre‐ and Postnatal Development Study of Nemolizumab, a Humanized Anti‐Interleukin‐31 Receptor A Monoclonal Antibody, in Cynomolgus Monkey

Article

作者: Matsuo, Saori ; Chiba, Shuichi ; Sasaki, Masanori ; Arima, Akihiro ; Kaneko, Akihisa ; Katagiri, Ryuichi ; Ikegami, Hisashi

ABSTRACT:

Background:

Nemolizumab, a humanized monoclonal antibody against interleukin‐31 receptor A (IL‐31RA), is used to treat atopic dermatitis and prurigo nodularis. These inflammatory skin diseases affect a wide range of age groups, including pregnant women and children; however, little is known about their biological effects on pre‐ and postnatal development. Therefore, we report and discuss the results of an enhanced pre‐ and postnatal development study in cynomolgus monkeys treated with nemolizumab, which also incorporates an assessment of juvenile toxicities.

Methods:

Nemolizumab was subcutaneously administered at doses of 1 or 25 mg/kg to pregnant cynomolgus monkeys once every 2 weeks (biweekly) from Gestation Day 20 until delivery, to investigate the potential toxicities on pre‐ and postnatal development. Additionally, their offspring were subcutaneously dosed biweekly with 1 or 25 mg/kg from approximately 1 to 7 months after birth to investigate the potential toxicities on juveniles, considering the age of the target patient population. The examination included tests for immune function and nervous system involvement by IL‐31, as well as the standard assessments outlined in the ICH S5 guideline to comprehensively assess the safety profile.

Results:

No nemolizumab‐related toxicities were observed in both dams and offspring up to 25 mg/kg. Maternal plasma nemolizumab concentrations were well maintained during the gestation period, gradually decreasing after delivery. Plasma concentrations in the offspring, higher than in dams, was maintained until scheduled necropsy.

Conclusion:

Blocking IL‐31 signaling with repeated dosing of nemolizumab did not adversely affect pregnancy, parturition, nursing, or postnatal physical and functional development in cynomolgus monkeys.

2025-02-01·JAMA Dermatology

Efficacy and Safety of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis

Article

作者: Cohen, David ; Parish, Jennifer L. ; Korman, Neil J. ; Plotkin, Adam ; Parodi, Aurora ; Maintz, Laura ; Buhl, Timo ; Muglia, Jennie J. ; Sticherling, Michael ; Gordon, Kathleen Pieroni ; Peris, Ketty ; Wolnik-Trzeciak, Grazyna ; Skov, Lone ; Naldi, Luigi ; Groysman, Vlada ; Micali, Giuseppe ; Toth, Mariann ; Thaçi, Diamant ; Snyder, Robert A. ; Sofen, Howard ; Teller, Craig ; Elewski, Boni E. ; Beattie, Paula ; Lasagni, Claudia ; Feliciani, Claudio ; Fuxench, Zelma C. Chiesa ; Pedrozo, Alejandro ; Yosipovitch, Gil ; Helfrich, Yolanda ; Legat, Franz J. ; Goldman, Mitchel ; Stone, Melody L. ; Sivamani, Raja ; Kolodziej, Tomasz ; Goebeler, Matthias ; Yazdi, Amir ; Holzer, Gregor ; Patsinakidis, Nikolaos ; Ladoyanni, Evmorfia ; Reich, Kristian ; Ständer, Sonja ; Argenziano, Guiseppe ; Tsianakas, Athanasios ; Janowicz, Anna ; Paul, Carle ; Zakrzewski, Marcin ; Yamauchi, Paul Steven ; Sieniawska, Joanna ; Fargnoli, Maria Concetta ; Kuzmina, Natalia ; Walker, Kirsten Ann ; Wollenberg, Andreas ; Lajos, Kemeny ; Stingeni, Luca ; Anadkat, Milan J. ; Caban, Francis ; Simon, Dagmar ; Reich, Adam ; Homey, Bernhard ; Slugocki, Rafal ; Guenther, Lyn C.C. ; Almadi, Tamas ; Ruëff, Franziska ; Fage, Simon ; Holmes, Faith L. ; Ling, Mark Russell ; Zook, Matthew Brent ; Amerio, Paolo ; Pink, Andrew ; Jabbar-Lopez, Zarif K. ; Weiss, Eduardo T. ; Meggitt, Simon Jon ; Draelos, Zoe Diana ; Sepp, Norbert ; Weisshaar, Elke ; Krishna, Sheila ; Staubach-Renz, Petra ; Metz, Martin ; Volc, Sebastien ; Primka, Edward J. ; Lane, Joshua ; Woseth, Douglas M. ; Cristaudo, Antonio ; Lam, Yaohan Adrienne ; Sundaram, Hema ; Gerdes, Sascha ; Wohlrab, Johannes ; Gadzia, Joseph E. ; Metelitsa, Andrei ; Augustin, Matthias ; Podda, Maurizio ; Chen, Xiaoxiao ; Fekete, Aniko Maria Dobribanne ; Galus, Ryszard ; Kwatra, Shawn G. ; Herzog, Rebeca ; Piketty, Christophe ; Zink, Alexander ; Renczynska-Matysko, Joanna

Importance:

Prurigo nodularis (PN) is a chronic and debilitating skin condition, characterized by intense itch with multiple nodular lesions. Nemolizumab demonstrated significant improvements in itch and skin nodules in adults with moderate to severe PN in a previous 16-week phase 3 study (OLYMPIA 2).

Objective:

To assess the efficacy and occurrence of adverse events in adults with moderate to severe PN treated with nemolizumab vs those receiving placebo.

Design, Setting, and Participants:

OLYMPIA 1 was a multicenter, placebo-controlled, phase 3 randomized clinical trial, conducted from August 2020 to March 2023 at 77 centers across 10 countries in adults with moderate to severe PN (at least 20 nodules and an Investigator’s Global Assessment [IGA] score ≥3) and Peak Pruritus Numerical Rating Scale (PP-NRS) score of at least 7.0; consisted of screening (up to 4 weeks), 24-week treatment, and 8-week follow-up periods.

Interventions:

Patients were randomized (2:1) to nemolizumab monotherapy, 30 mg or 60 mg (depending on baseline weight of less than 90 kg vs 90 kg or greater, respectively), or matching placebo administered every 4 weeks for 24 weeks.

Main Outcomes and Measures:

The primary end points were the proportion of patients with itch response (≥4-point improvement from baseline in weekly average PP-NRS) and IGA success (score of 0/1 [clear/almost clear] and 2-grade or more improvement from baseline) at week 16.

Results:

Of 286 patients (mean [SD] age, 57.5 [13.0] years; mean [SD] body weight, 85.0 [20.7] kg; 166 [58.0%] female), 190 were randomized to receive nemolizumab, and 96 were randomized to placebo. A significantly greater proportion of patients assigned to nemolizumab vs placebo achieved itch response (111/190 [58.4%] vs 16/96 [16.7%]; Δ, 40.1% [95% CI, 29.4%-50.8%]; P &lt; .001) and IGA success (50/190 [26.3%] vs 7/96 [7.3%]; Δ, 14.6% [95% CI, 6.7%-22.6%]; P = .003) at week 16. At week 24, the proportion of patients with itch response was 58.3% vs 20.4% (Δ, 38.7% [95% CI, 27.5%-49.9%]) in the ad hoc analysis, and IGA success was 58/190 (30.5%) vs 9/96 (9.4%) (Δ, 19.2% [95% CI, 10.3%-28.1%]) in the nemolizumab-treated vs placebo group. During the treatment period, 134 patients (71.7%) receiving nemolizumab vs 62 patients (65.3%) receiving placebo had at least 1 adverse event; most events were of mild to moderate severity.

Conclusions and Relevance:

In this randomized clinical trial, nemolizumab monotherapy led to clinically meaningful and statistically significant improvements in core signs and symptoms of PN.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04501666

2025-02-01·JOURNAL OF DERMATOLOGY

English version of clinical practice guidelines for the management of atopic dermatitis 2024

Article

作者: Nakahara, Takeshi ; Narita, Masami ; Tanizaki, Hideaki ; Furuta, Junichi ; Arakawa, Hirokazu ; Katsunuma, Toshio ; Tsunemi, Yuichiro ; Matsubara, Tomoyo ; Yamamoto‐Hanada, Kiwako ; Murota, Hiroyuki ; Futamura, Masaki ; Saeki, Hidehisa ; Nagao, Mizuho ; Ohya, Yukihiro ; Katoh, Norito ; Ichiyama, Susumu ; Hide, Michihiro ; Tanaka, Akio ; Fujisawa, Takao ; Masuda, Koji

Abstract:

This is the English version of the 2024 clinical practice guidelines for the management of atopic dermatitis (AD). AD is a disease characterized by relapsing eczema with pruritus as a primary lesion. A crucial aspect of AD treatment is the prompt induction of remission via the suppression of existing skin inflammation and pruritus. To achieve this, topical anti‐inflammatory drugs, such as topical corticosteroids, tacrolimus ointment, delgocitinib ointment, and difamilast ointment, have been used. However, the following treatments should be considered in addition to topical therapy for patients with refractory moderate‐to‐severe AD: oral cyclosporine, subcutaneous injections of biologics (dupilumab, nemolizumab, tralokinumab), oral Janus kinase inhibitors (baricitinib, upadacitinib, abrocitinib), and phototherapy. In these revised guidelines, descriptions of five new drugs, namely, difamilast, nemolizumab, tralokinumab, upadacitinib, and abrocitinib, have been added. The guidelines present recommendations to review clinical research articles, evaluate the balance between the advantages and disadvantages of medical activities, and optimize medical activity‐related patient outcomes with respect to several important points requiring decision‐making in clinical practice.

84

项与尼莫利珠单抗相关的新闻（医药）

2025-02-18

·PMLiVE

EC approves Galderma’s Nemluvio to treat atopic dermatitis and prurigo nodularis

The European Commission (EC) has approved Galderma’s Nemluvio (nemolizumab) to treat both atopic dermatitis and prurigo nodularis. The drug has been authorised for use in atopic dermatitis patients aged 12 years and older, and adults with prurigo nodularis. Eligible patients must also have moderate-to-severe cases of the skin diseases and be candidates for systemic therapy. Atopic dermatitis, characterised by persistent itch and recurrent skin lesions, affects up to 40 million people in the EU, with up to 66% of adults experiencing moderate-to-severe forms of the condition. Meanwhile, prurigo nodularis, which causes intense itch and thick skin nodules, is estimated to affect up to 111 people per 100,000 in the EU depending on the country. Despite available treatments, Galderma said there is a need for new options to effectively relieve the signs and symptoms of both conditions. Initially developed by Chugai Pharmaceutical and administered as a subcutaneous injection every four weeks, Nemluvio is designed to inhibit signalling of the neuroimmune cytokine interleukin-31, which drives itch and is involved in inflammation and skin barrier dysfunction. The EC’s decision comes two months after the European Medicines Agency’s human medicines committee recommended Nemluvio for both indications and makes the drug the first approved monoclonal antibody that specifically targets interleukin-31 receptor alpha. The approval in atopic dermatitis was based on results from the late-stage ARCADIA 1 and 2 studies, in which Nemluvio in combination with background topical corticosteroids (TCS) was associated with statistically significant improvements in the co-primary and key secondary endpoints compared to placebo plus TCS after 16 weeks of treatment, with significant itch relief observed from as early as week one. The authorisation in prurigo nodularis was supported by data from the phase 3 OLYMPIA 1 and 2 trials, which met both primary and key secondary endpoints, demonstrating that treatment with Nemluvio resulted in significant and clinically meaningful improvements in itch and skin nodules at week 16, with reductions in itch observed from week four. Lead investigator of the ARCADIA studies in Europe, Diamant Thaçi, University of Lubeck, said: “Atopic dermatitis and prurigo nodularis can severely impact quality of life due to the associated debilitating symptoms… With this approval, patients in the EU have a new treatment option, which extensive data has shown can help to safely, quickly and effectively ease the key symptoms of these diseases and therefore the burden on patients’ lives.”

临床结果上市批准临床3期

2025-02-18

·galderma.com

Galderma’s Nemluvio® (nemolizumab) granted marketing authorization in the United Kingdom and Switzerland for moderate-to-severe atopic dermatitis and prurigo nodularis

These are the first approvals of nemolizumab from countries within the Access Consortium framework, with regulatory review processes ongoing in the remaining countries – Australia and Singapore Nemolizumab, which is also approved in the EU and U.S., is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31 – a neuroimmune cytokine that drives itch and other symptoms in both moderate-to-severe atopic dermatitis and prurigo nodularis1-6 Zug, Switzerland – February 18, 2025 – Galderma today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency and Swissmedic have granted the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the UK and Switzerland, respectively. Specifically, the approvals are for nemolizumab’s subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years of age and older with a body weight of at least 30kg, who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.7,8 These are the first approvals from countries within the Access Consortium framework, an international collaborative initiative comprised of regulatory authorities which work together to address shared challenges. Decisions in the remaining countries within the Access Consortium, Australia and Singapore, are expected later this year. Nemolizumab is also approved in the European Union and United States for both moderate-to-severe atopic dermatitis and prurigo nodularis.5,6 Galderma’s leadership in Therapeutic Dermatology is evidenced by the recent regulatory approvals of nemolizumab, and its ongoing commitment to bringing this novel treatment to millions of patients around the world. Atopic dermatitis and prurigo nodularis are debilitating skin conditions that affect up to 1.6 million and 18,000 people in the UK, respectively, and 450,000 people altogether in Switzerland.9-14 There is a need for new treatment options for these diseases to effectively relieve the signs and symptoms such as persistent itch, skin lesions and poor sleep quality.1,2,15-17 Itch is one of the most burdensome symptoms of both conditions, with 87% of patients with atopic dermatitis saying that they are seeking freedom from itch, and 88% of patients with prurigo nodularis rating itch as their worst symptom.18,19 “These approvals offer patients with moderate-to-severe atopic dermatitis and prurigo nodularis a much-needed novel treatment option, given the potential burden and negative impact on quality of life associated with these conditions. I am looking forward to offering my patients this new treatment option which has the potential to address their most troublesome symptoms.” DR. CURDIN CONRAD PROFESSOR OF DERMATOLOGY LAUSANNE UNIVERSITY HOSPITAL, SWITZERLAND Nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.3 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis, and in fibrosis in prurigo nodularis.1-4 This approval is based on robust results from the phase III ARCADIA and OLYMPIA clinical trial programs, which demonstrated that nemolizumab clinically improved skin lesions, itch, and sleep disturbance in atopic dermatitis and prurigo nodularis, respectively.20-22 Nemolizumab was well tolerated in both clinical trial programs, and its safety profile was generally consistent with earlier data, and between trials.3,20-22 “Nemolizumab’s continued regulatory success underscores Galderma’s strong leadership in Therapeutic Dermatology, and our commitment to bringing innovative treatments to the patients. Its approval in the UK and Switzerland was driven yet again by robust data from the ARCADIA and OLYMPIA clinical trial programs, which show that nemolizumab has the potential to improve some of the most debilitating symptoms of both moderate-to-severe atopic dermatitis and prurigo nodularis.” BALDO SCASSELLATI SFORZOLINI, M.D., PH.D. GLOBAL HEAD OF R&D GALDERMA Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com. For further information: Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12 Sébastien Cros Corporate Communications Director sebastien.cros@galderma.com +41 79 529 59 85 Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43

临床结果上市批准临床3期

2025-02-17

·氨基观察

信达生物IBI363再获FDA快速通道资格认定；金斯瑞2024年净利润同比重大增长

氨基观察-创新药组原创出品作者 | 黄凯信达生物出海又有收获。 2月17日，信达生物宣布，PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363获得FDA授予快速通道资格，拟定适应症为抗PD-(L)1免疫检查点抑制剂及含铂化疗治疗后进展的局部晚期或转移性鳞状非小细胞肺癌。金斯瑞生物2024年业绩似乎不错。 2月16日，金斯瑞生物科技公告称，集团预期2024年的净利润较2023年有重大增长。不过，在公告中，公司并未公布具体增幅数字。那么，究竟表现如何呢？让我们拭目以待。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）启明创投宣布主管合伙人梁颕宇离职 2月17日，启明创投宣布，长期担任主管合伙人的梁颕宇已正式离职。 / 02 / 资本信息 1）金斯瑞2024年净利润同比重大增长 2月16日，金斯瑞生物科技公告称，集团预期2024年的净利润较2023年有重大增长。 / 03 / 医药动态 1）安进罗莫索珠单抗注射液获临床许可 2月17日，据CDE官网，安进罗莫索珠单抗注射液获临床许可，开展治疗5至18岁以下儿童成骨不全症的研究。 2）百利药业注射用BL-B01D1获临床许可 2月17日，据CDE官网，百利药业注射用BL-B01D1获临床许可，拟与帕博利珠单抗双药不联合或联合化疗治疗局部晚期或转移性非小细胞肺癌患者。 3）百利药业注射用BL-M07D1获临床许可 2月17日，据CDE官网，百利药业注射用BL-M07D1获临床许可，拟用于HER2阳性乳腺癌新辅助治疗。 4）翰森生物注射用HS-20093拟获突破性疗法认定 2月17日，据CDE官网，翰森生物注射用HS-20093拟获突破性疗法认定，适应症为：用于治疗经至少二线治疗后进展的骨肉瘤患者。 5）信达生物IBI363再获FDA快速通道资格认定 2月17日，信达生物宣布，PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363获得FDA授予快速通道资格，拟定适应症为抗PD-(L)1免疫检查点抑制剂及含铂化疗治疗后进展的局部晚期或转移性鳞状非小细胞肺癌。 6）华东医药公布GLP-1R/GIPR激动剂I期研究数据 2月17日，华东医药公布GLP-1R/GIPR激动剂HDM1005注射液，在中国Ia及Ib期临床试验结果。在Ia期中，体重下降呈剂量依赖性，在第8天时5mg组体重最大平均下降为3.92kg。在Ib期中，经过4周治疗，0.5-4.0mg组在第29天时的体重平均下降4.79-7.76kg，并且在停止治疗后4周体重下降仍可维持。 7）恒瑞医药阿托品申请上市 2月17日，恒瑞医药宣布，阿托品滴眼液药品上市许可申请获国家药监局受理，申请上市的适应症为：用于延缓等效球镜度数为-0.50D至-4.00D（散光≤1.50D、屈光参差≤1.50D）的6至12岁儿童近视进展。 8）双鹭药业伊布替尼胶囊仿制药未获批准 2月17日，据NMPA官网，伊布替尼胶囊仿制药未获批准收到通知件，意味着未获批准。 / 04 / 器械跟踪 1）科曼医疗呼吸机获注册批件 2月17日，据NMPA官网，科曼医疗呼吸机获注册批件。 2）先健科技主动脉覆膜支架系统获注册批件 2月17日，据NMPA官网，先健科技主动脉覆膜支架系统获注册批件。 3）博迈医疗颈动脉球囊扩张导管获注册批件 2月17日，据NMPA官网，博迈医疗颈动脉球囊扩张导管获注册批件。 4）微创神通可解脱栓塞弹簧圈获注册批件 2月17日，据NMPA官网，微创神通可解脱栓塞弹簧圈获注册批件。 / 05 / 数字医疗日报 1）安必平：并未参与瑞金病理大模型的研究与开发 2月17日，安必平公告，公司并未参与瑞金病理大模型的研究与开发。 / 06 / 海外药闻 1）首款IL-31单抗获批日前，Galderm宣布，欧盟批准其白介素-31（IL-31）受体靶向单抗Nemluvio，用于治疗中度至重度特应性皮炎和结节性瘙痒患者。Nemluvio是首款获得批准用以抑制IL-31信号的单克隆抗体。 2）GSK组合脑膜炎球菌疫苗苗Penmenvy获批日前，GSK宣布，美国FDA已批准其疫苗Penmenvy上市，在10~25岁人群中使用。这款疫苗针对脑膜炎球菌中最常见的5大血清群，它们通常是导致侵袭性脑膜炎球菌病的原因。 3）Deciphera公司CSF1R抑制剂Romvimza获批日前，美国FDA宣布，已批准集落刺激因子1受体（CSF1R）抑制剂Romvimza上市，用于治疗腱鞘巨细胞瘤（TGCT）患者，这些患者若接受手术切除，可能会导致功能受限进一步恶化或引起严重的不良后果。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

快速通道突破性疗法临床1期ASH会议

100 项与尼莫利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11080	尼莫利珠单抗	-	DB15252

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
中度特应性皮炎	美国	Galderma Laboratories LP	2024-12-13
重度特应性皮炎	美国	Galderma Laboratories LP	2024-12-13
结节性痒疹	日本	Maruho Co., Ltd.	2024-03-26
特应性皮炎	日本	Maruho Co., Ltd.	2022-03-28

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
瘙痒	临床3期	美国	Galderma Holding SA	2021-12-29
瘙痒	临床3期	匈牙利	Galderma Holding SA	2021-12-29
瘙痒	临床3期	波兰	Galderma Holding SA	2021-12-29
瘙痒	临床3期	西班牙	Galderma Holding SA	2021-12-29
系统性硬皮病	临床2期	日本	Maruho Co., Ltd.	2022-04-20

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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


NCT04562116 (CTgov)	临床2期	中度特应性皮炎 \| 重度特应性皮炎	17	CYP 450 Substrates+Nemolizumab	壓網製積蓋鑰觸鹹窪憲(鹽繭齋艱觸夢繭鏇襯糧) = 選餘鹽選膚鏇襯廠衊壓夢構艱顧顧顧蓋膚艱衊 (窪淵製鏇鏇鬱窪膚選夢, 醖憲醖構憲壓積網簾顧 ~ 築壓鏇築襯築簾遞襯觸) 更多	-	2024-12-05
NCT04501666 (OLYMPIA 1, Pubmed \| JAMA Dermatol)	临床3期	结节性痒疹	286	Nemolizumab 30 mg	鏇壓膚夢願繭憲鏇遞積(廠鑰餘齋憲衊窪築遞觸) = 廠壓餘夢膚範餘構積艱繭顧膚蓋憲窪顧繭齋壓 (膚觸獵糧艱夢繭襯鑰餘, 6.7% ~ 22.6%) 更多	积极	2024-11-27
				Placebo	鏇壓膚夢願繭憲鏇遞積(廠鑰餘齋憲衊窪築遞觸) = 構鑰繭鏇範襯製憲網觸繭顧膚蓋憲窪顧繭齋壓 (膚觸獵糧艱夢繭襯鑰餘 ) 更多
NCT05052983 (CTgov)	临床3期	结节性痒疹	34	Nemolizumab (Nemolizumab)	網鑰觸醖廠壓顧築壓壓(顧範襯壓願築網窪築網) = 衊簾願糧餘網醖餘鹽淵願顧鏇蓋壓憲顧選範淵 (簾醖築壓遞鹹繭蓋齋願, 鹹獵壓淵襯鑰艱壓鹽鏇 ~ 遞顧醖積憲廠繭構選鏇) 更多	-	2024-10-08
				Placebo (Placebo)	網鑰觸醖廠壓顧築壓壓(顧範襯壓願築網窪築網) = 蓋選齋構糧膚憲簾蓋遞願顧鏇蓋壓憲顧選範淵 (簾醖築壓遞鹹繭蓋齋願, 夢窪餘選網鑰齋艱鹽窪 ~ 積鏇衊鹹糧蓋淵鏇憲獵) 更多
NCT03989349 (ARCADIA 2, CTgov)	临床3期	中度特应性皮炎 \| 重度特应性皮炎	787	Nemolizumab (Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg)	遞製壓築顧簾積膚願觸(襯顧積廠構餘鑰鹽繭顧) = 艱壓鬱範蓋製網願齋夢膚膚範願醖餘衊鑰糧鏇 (壓積願範壓齋憲鏇簾鏇, 鑰觸窪蓋願獵網網鏇餘 ~ 蓋淵選餘範範鑰顧衊繭) 更多	-	2024-08-14
				Placebo (Initial Treatment Period (Baseline - Week 16 Predose): Placebo)	遞製壓築顧簾積膚願觸(襯顧積廠構餘鑰鹽繭顧) = 廠襯醖鑰遞築觸窪選齋膚膚範願醖餘衊鑰糧鏇 (壓積願範壓齋憲鏇簾鏇, 廠範夢製鹹選齋繭鏇願 ~ 壓鹽觸糧鏇築蓋鬱蓋觸) 更多
NCT03985943 (ARCADIA 1, CTgov)	临床3期	中度特应性皮炎 \| 重度特应性皮炎	941	Placebo (Initial Treatment Period (Baseline - Week 16 Predose): Placebo)	憲製構顧鹹網鬱範淵壓(醖憲窪鹹鹹顧壓繭鑰願) = 窪鹽襯衊壓齋壓網鬱糧淵蓋糧壓襯夢壓醖鏇鬱 (齋鹹齋蓋選膚遞積鏇齋, 築構糧淵製選網鏇壓選 ~ 餘積網鬱醖艱淵鏇醖鹽) 更多	-	2024-08-14
				Nemolizumab (Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg)	憲製構顧鹹網鬱範淵壓(醖憲窪鹹鹹顧壓繭鑰願) = 窪糧築範淵鹽積膚遞願淵蓋糧壓襯夢壓醖鏇鬱 (齋鹹齋蓋選膚遞積鏇齋, 憲鏇遞製鹽夢衊蓋夢窪 ~ 壓窪壓齋選鹹憲齋鹹選) 更多
NCT04501679 \| NCT04501666 (OLYMPIA 2, FDA_CDER) 人工标引	临床3期	结节性痒疹	560	NEMLUVIO (OLYMPIA 1)	遞製網顧醖鹽鏇醖範醖(齋淵艱獵觸餘淵積鏇鑰) = 網構築繭醖觸網膚選憲鹹願築蓋鹽淵鬱願壓襯 (艱獵壓積獵顧鬱顧壓憲 ) 更多	积极	2024-08-12
				Placebo (OLYMPIA 1)	遞製網顧醖鹽鏇醖範醖(齋淵艱獵觸餘淵積鏇鑰) = 觸壓顧願糧夢艱襯積繭鹹願築蓋鹽淵鬱願壓襯 (艱獵壓積獵顧鬱顧壓憲 ) 更多
NCT03985943 \| NCT03989349 (ARCADIA 2, Lancet 1 \| Lancet 2 \| Pubmed) 人工标引	临床3期	特应性皮炎	1,728	Nemolizumab 30 mg	憲衊廠齋襯網艱遞願衊(廠糧製廠夢鏇艱鬱憲憲) = 構鏇鏇夢築鏇鏇膚選鹽膚觸顧顧憲積遞窪蓋遞 (鏇艱顧衊膚願蓋鹹齋鏇 ) 更多	积极	2024-07-24
				Placebo	憲衊廠齋襯網艱遞願衊(廠糧製廠夢鏇艱鬱憲憲) = 膚衊積淵構鬱糧製觸選膚觸顧顧憲積遞窪蓋遞 (鏇艱顧衊膚願蓋鹹齋鏇 ) 更多
NCT04501666 (OLYMPIA 1, CTgov)	临床3期	结节性痒疹	286	Nemolizumab 30 mg (Nemolizumab)	鬱積窪鹽夢範願鏇獵蓋(獵餘鹹憲蓋蓋鹽鑰顧憲) = 積淵簾遞膚鹹鏇願窪顧簾淵構醖憲蓋餘鬱積壓 (製蓋築鏇簾遞膚膚淵醖, 艱膚蓋鑰鑰廠齋構餘鏇 ~ 壓齋窪鹽襯積顧壓廠夢) 更多	-	2024-07-10
				Placebo (Placebo)	鬱積窪鹽夢範願鏇獵蓋(獵餘鹹憲蓋蓋鹽鑰顧憲) = 鏇廠餘襯範製艱鑰壓窪簾淵構醖憲蓋餘鬱積壓 (製蓋築鏇簾遞膚膚淵醖, 願齋襯糧鑰鬱觸遞窪獵 ~ 遞鹽憲積築醖網衊鹽廠) 更多
NCT04501679 (OLYMPIA 2 \| Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis, CTgov)	临床3期	结节性痒疹	274	Nemolizumab (Nemolizumab)	顧積艱製鬱願顧築願憲(願廠醖蓋範醖築積膚鑰) = 鑰衊鏇淵鏇糧醖範構鏇壓窪廠淵窪齋築糧衊鬱 (觸餘艱積餘製艱鹽齋餘, 憲鹽顧遞夢鹹構簾繭網 ~ 夢夢鹹築鏇醖獵窪鏇鹽) 更多	-	2024-07-10
				Placebo (Placebo)	顧積艱製鬱願顧築願憲(願廠醖蓋範醖築積膚鑰) = 糧蓋壓繭遞範網構鏇艱壓窪廠淵窪齋築糧衊鬱 (觸餘艱積餘製艱鹽齋餘, 夢齋鬱範糧簾製遞廠醖 ~ 積鹹齋衊膚醖壓範壓醖) 更多