Long-Term Extension Study (AtDvance) to Evaluate the Safety and Efficacy of GSK1070806 in Participants With Moderate to Severe Atopic Dermatitis. - AtDvance

开始日期2024-07-23

申办/合作机构-

NCT06447506

/ Active, not recruiting临床2期

Long-Term Extension Study (AtDvance) to Evaluate the Safety and Efficacy of GSK1070806 in Participants With Moderate to Severe Atopic Dermatitis.

The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).

开始日期2024-06-05

申办/合作机构

GSK Plc

JPRN-jRCT2071230084

/ Not yet recruiting临床2期IIT

A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Dose Finding study to evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GSK1070806 SC injection in Adult Participants with Moderate to Severe Atopic Dermatitis

开始日期2023-12-26

申办/合作机构-

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项与 Aletekitug 相关的文献（医药）

2017-09-01·Clinical science (London, England : 1979)2区 · 医学

Cytokines of the IL-1 family: recognized targets in chronic inflammation underrated in organ transplantations

2区 · 医学

Review

作者: Striz, Ilja

Interleukin 1 (IL-1) family is a group of cytokines with multiple local and systemic effects, which regulates both innate and adaptive immune responses. Generally, most IL-1 family cytokines express prevailing pro-inflammatory activities (IL-1α, IL-1β, IL-18, IL-33, IL-36 α, β, γ), whereas others are anti-inflammatory (IL-1Ra (IL-1 receptor antagonist), IL-36Ra, IL-38, IL-37). In addition to their immunomodulatory roles, some of them are also involved in the physiological modulation of homeostatic processes and directly affect mRNA transcription. IL-1 family cytokines bind to specific receptors composed of a ligand-binding chain and an accessory chain. The pro-inflammatory effects of IL-1 family cytokines are regulated on the level of transcription, enzymatic processing of precursors, release of soluble antagonists, and expression of decoy receptors. Members of the IL-1 family regulate the recruitment and activation of effector cells involved in innate and adaptive immunity, but they are also involved in the pathogenesis of chronic disorders, including inflammatory bowel disease, rheumatoid arthritis, and various autoimmune and autoinflammatory diseases. There are only limited data regarding the role of IL-1 cytokines in transplantation. In recent years, targeted therapeutics affecting IL-1 have been used in multiple clinical studies. In addition to the recombinant IL-1Ra, anakinra (highly effective in autoinflammatory diseases and tested for other chronic diseases), the monoclonal antibodies canakinumab, gevokizumab, and rilonacept (a long-acting IL-1 receptor fusion protein) provide further options to block IL-1 activity. Furthermore, new inhibitors of IL-18 (GSK 1070806, ABT-325, rIL-18BP (IL-18 binding protein)) and IL-33 (CNTO-7160) are presently under clinical studies and other molecules are being developed to target IL-1 family cytokines.

2014-10-01·International journal of clinical pharmacology and therapeutics4区 · 医学

Safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose antiinterleukin- 18 mAb GSK1070806 in healthy and obese subjects

4区 · 医学

Article

作者: Reid, Juliet ; Abberley, Lee ; Mistry, Prafull ; Taylor, Adam ; DeWal, Stephen ; Pouliquen, Isabelle ; del Cura, Marian Rocha ; McHugh, Simon ; Tong, Xin ; McKie, Elizabeth

OBJECTIVE:

To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK1070806, a novel IgG1 mAb that neutralizes human interleukin (IL)-18.

METHODS:

In this first-timein-human (FTIH) study, cohorts of healthy and obese subjects were randomly allocated to receive single doses of GSK1070806 (0.008 - 10 mg/kg) or placebo. Blood was sampled ≤ 274 days post-dosing, and safety monitored.

RESULTS:

GSK1070806 was generally well tolerated. The most common AEs were nasopharyngitis and headache, arising as frequently in the placebo as in the active drug groups; most AEs were mild to moderate and unrelated to dose level. There were no allergic, delayed-type hypersensitivity, or infusion-related reactions and the incidence of immunogenicity was low. GSK1070806 plasma pharmacokinetic profiles were comparable in healthy and obese subjects; there was no major deviation from dose proportionality for AUC(∞) and C(max) although a trend for dose-dependent increase in t(1/2) was observed. Serum drug-bound IL-18 levels increased post-dosing and were sustained for a long time-period following GSK1070806 administration. Ex-vivo whole blood assay demonstrated prolonged pharmacological activity of GSK1070806 as determined by its primary immunological mechanism of action, inhibition of IL-18-induced IFN-γ production.

CONCLUSION:

GSK1070806 warrants clinical investigation in patients.

PloS one3区 · 综合性期刊

A Study to Investigate the Efficacy and Safety of an Anti-Interleukin-18 Monoclonal Antibody in the Treatment of Type 2 Diabetes Mellitus

3区 · 综合性期刊

ArticleOA

作者: Abberley, Lee ; Gil-Extremera, Blas ; Reid, Juliet L ; McKie, Elizabeth A ; Ambery, Philip D ; Mistry, Prafull C ; DeWall, Stephen L

OBJECTIVE:

Evidence suggests that chronic subclinical inflammation plays an important role in the pathogenesis of type 2 diabetes (T2DM). Circulating levels of interleukin (IL)-18 appear to be associated with a number of micro- and macrovascular comorbidities of obesity and T2DM. This study was designed to investigate whether inhibition of IL-18 had any therapeutic benefit in the treatment of T2DM. Preliminary efficacy, safety and tolerability, pharmacokinetics, and pharmacodynamics of the anti-IL-18 monoclonal antibody, GSK1070806, were assessed.

RESEARCH DESIGN AND METHODS:

This was a multicentre, randomized, single-blind (sponsor-unblinded), placebo-controlled, parallel-group, phase IIa trial. Obese patients of either sex, aged 18-70 years, with poorly controlled T2DM on metformin monotherapy were recruited. Patients received two doses, of placebo (n = 12), GSK1070806 0.25 mg/kg (n = 13) or GSK1070806 5 mg/kg (n = 12). The primary end-point was the change from baseline in fasting plasma glucose and weighted mean glucose area under the curve (AUC)(0-4 hours) postmixed meal test on Days 29, 57, and 85.

RESULTS:

Thirty-seven patients were randomized to one of the three treatment arms. There were no statistically significant effects of GSK1070806 doses on fasting plasma glucose levels, or weighted mean glucose AUC(0-4 hours) compared with placebo.

CONCLUSIONS:

GSK1070806 was well tolerated, and inhibition of IL-18 did not lead to any improvements in glucose control. However, because of study limitations, smaller, potentially clinically meaningful effects of IL-18 inhibition cannot be excluded.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01648153.

项与 Aletekitug 相关的新闻（医药）

2025-10-01

·BioDialectics

特应性皮炎的多面驱动因子—IL-18

特应性皮炎（AD）作为一种常见的慢性炎症性皮肤病，以剧烈瘙痒、皮肤屏障功能障碍及免疫细胞浸润为核心特征，其发病机制复杂且尚未完全阐明。近期发表的文章《IL-18 in atopic dermatitis-A multifaceted driver of skin inflammation》，系统揭示白细胞介素-18（IL-18）在AD病理生理过程中的关键作用，为理解AD炎症调控机制及开发新型治疗策略提供了重要理论依据。一、IL-18的生物学特性：激活、调控与功能多样性 IL-18作为IL-1细胞因子家族成员，其生物学活性的发挥依赖精准的激活调控与信号传导，且功能具有显著的组织和语境依赖性。 1.产生与激活：多途径调控的“炎症开关” 1）细胞来源与储备：生理状态下，IL-18以无活性前体（pro-IL-18）形式组成表达于上皮细胞（尤其是皮肤基底及棘层角质形成细胞）、巨噬细胞、树突状细胞（DCs）等，皮肤是其最主要的储备组织；炎症刺激（如病原体入侵、组织损伤）可进一步诱导其表达上调。 2）pro-IL-18的激活途径需经蛋白酶切割方可激活，主要途径包括：经典焦亡途径：模式识别受体（PRR）激活后组装炎症小体（如NLRP1、NLRP3、AIM2等），激活胱天蛋白酶-1（caspase-1），切割pro-IL-18生成成熟IL-18，同时释放的N端GasderminD（N-GSDMD）形成膜孔，介导IL-18选择性释放；非经典途径：胞内脂多糖（LPS）直接激活人caspase-4/5，不依赖炎症小体即可切割pro-IL-18；其他途径：Fas诱导的caspase-8激活、细菌蛋白酶（如链球菌致热外毒素B）、NK细胞/CD8⁺T细胞衍生颗粒酶等，也可在炎症小体非依赖模式下激活pro-IL-18。 2.信号传导与调控：精准平衡的“分子网络” 1）受体与信号通路：成熟IL-18需与异二聚体受体（IL-18Rα/IL-18RAP）结合，通过招募MyD88、TRAM等适配器分子，激活IRAK1/4-TRAF6信号轴，进而调控NF-κB、AP-1等转录因子，同时激活MAPK（ERK、JNK）、PI3K/Akt及STAT3通路，参与炎症反应、细胞存活及应激应答。 2）内源性抑制机制：IL-18活性受双重调控以维持免疫稳态： IL-18结合蛋白（IL-18BP）：作为可溶性诱饵受体，与IL-18高亲和力结合使其失活，血清中IL-18BP浓度远超IL-18，约95%循环IL-18处于结合抑制状态，且IL-18诱导的IFN-γ可反向上调IL-18BP，形成负反馈； IL-37：通过竞争结合IL-18Rα并招募IL-1R8/SIGIRR，阻断IL-18信号传导，同时触发抗炎反应，其表达可由LPS、TNF-α等炎症刺激诱导。 3.功能多样性：语境依赖的“炎症调节器” IL-18的功能并非固定不变，而是受组织微环境、协同细胞因子及细胞类型影响： 1）经典功能：传统认知中，IL-18主要促进NK细胞、Th1细胞分泌IFN-γ，参与Th1型免疫应答； 2）AD中的特殊作用：在AD等过敏性疾病中，IL-18可转向促进Th2型炎症，通过激活致病性Th2（pTh2）细胞、2型固有淋巴细胞（ILC2）等，诱导IL-4、IL-5、IL-13等Th2细胞因子分泌； 3) 组织特异性：在胃肠道中，IL-18支持黏膜免疫与屏障完整性，而在皮肤中则主要加剧allergic炎症，这种差异反映了其功能的语境依赖性。二、IL-18在AD中的作用机制：从屏障破坏到炎症放大在AD病理过程中，IL-18通过多维度调控，贯穿“屏障损伤-炎症激活-炎症放大”的全链条，成为连接皮肤屏障功能障碍与免疫紊乱的关键分子。 1.破坏皮肤屏障：形成“恶性循环” 直接抑制屏障相关蛋白：体外实验证实，IL-18可下调角质形成细胞中丝聚蛋白（FLG）、兜甲蛋白（LOR）的表达，这两种蛋白是皮肤角质层的核心结构成分，其表达降低直接导致经表皮水分流失（TEWL）增加、天然保湿因子（NMF）减少，加剧屏障功能障碍；反向促进自身释放：FLG或LOR敲低的角质形成细胞会进一步增加IL-18分泌，形成“IL-18破坏屏障→屏障受损促进IL-18释放”的恶性循环。临床研究显示，AD患者（尤其是携带FLG突变者）皮肤角质层IL-18水平显著升高，且与TEWL呈正相关，印证了这一机制的临床相关性。 2.驱动微生物相关炎症：链接菌群失调与免疫激活 AD皮肤常伴随金黄色葡萄球菌（S.aureus）定植增加，而IL-18是介导微生物刺激与炎症反应的关键桥梁： S.aureus的直接诱导：S.aureus的毒力因子（如肠毒素B、蛋白A）可激活角质形成细胞NLRP1炎症小体，促进caspase-1依赖的IL-18释放；同时，S.aureus感染还可激活巨噬细胞炎症小体，进一步放大IL-18介导的炎症；共生菌的间接影响：皮肤共生菌表皮葡萄球菌分泌的酚溶性调节蛋白，也可触发角质形成细胞caspase-1激活与IL-18释放，且FLG缺陷会增强这一响应，提示IL-18可能是结构屏障缺陷与菌群紊乱交互作用的“分子枢纽”。 3.调控免疫细胞：放大Th2型炎症 IL-18通过靶向多种免疫细胞，精准放大AD中的Th2型炎症反应，其作用具有细胞特异性：致病性Th2（pTh2）细胞：pTh2细胞是AD中Th2炎症的核心效应细胞，与常规Th2细胞不同，其持续表达IL-18受体（IL-18R），IL-18可显著增强其IL-13、IL-22分泌；且IL-9可进一步上调pTh2细胞IL-18R表达，形成“IL-9-IL-18-pTh2”的正向放大环路； 2型固有淋巴细胞（ILC2）：皮肤ILC2高表达IL-18R，IL-18可直接激活其分泌IL-5、IL-13，且与IL-3协同作用时激活效应更强；IL-18敲除小鼠的AD模型中，ILC2浸润与细胞因子分泌显著减少，证实其对ILC2的调控作用； NK细胞：AD患者存在NK细胞数量减少、细胞毒性受损的现象，IL-18通过激活诱导细胞死亡（AICD）、NK细胞fratricide（自相残杀）及TNF-α介导的细胞死亡，导致NK细胞耗竭；同时，IL-18还可使NK细胞从分泌IFN-γ转向分泌TNF-α，削弱其抑制Th2炎症的能力，进一步加剧免疫失衡。三、IL-18与AD的临床关联：从生物标志物到治疗靶点 IL-18不仅是AD病理机制中的关键分子，还具有重要的临床转化价值，可作为AD的生物标志物及潜在治疗靶点。 1.AD生物标志物：评估病情与治疗响应诊断与严重度评估：AD患者血清及皮肤IL-18水平均显著升高，且与疾病严重度评分（EASI/SCORAD）呈中等程度正相关（r≈0.35-0.60），其相关性优于胸腺基质淋巴细胞生成素（TSLP）。预测与监测价值：非病变皮肤IL-18升高可在AD临床症状出现前预测疾病发生，提示其潜在的早期诊断价值；此外，皮肤IL-18水平可随局部治疗（如外用药物）正常化，血清IL-18则对系统性治疗（如度普利尤单抗）响应敏感，可用于监测治疗效果；亚型区分：IL-18在外源性AD（高IgE、Th2主导）中水平显著高于内源性AD（正常IgE、Th1/Th17主导），为AD亚型分型提供了分子依据。 2.治疗靶点：新型干预策略的开发基于IL-18在AD中的核心作用，多种靶向IL-18的治疗策略已进入临床开发阶段，主要包括：抗IL-18抗体：AVTX007（IIa期）、GSK1070806（IIb期）、CMK389（II期已完成）等药物均显示出良好的短期安全性，且GSK1070806在早期临床试验中呈现剂量依赖性的EASI评分改善及瘙痒缓解，提示其临床潜力。重组IL-18BP：IL-18BP作为内源性抑制剂，已在巨噬细胞活化综合征等疾病中验证疗效，其白蛋白结合修饰形式可延长半衰期，在小鼠AD模型中，该修饰形式的抗炎效果优于抗IL-18单克隆抗体。上游炎症小体/焦亡抑制剂：抑制炎症小体组装（如NLRP1抑制剂）或焦亡关键分子（如GSDMD抑制剂），可减少IL-18激活释放，小鼠模型显示此类干预可缓解AD样皮炎。四、总结思考：治疗机遇与挑战 IL-18作为AD炎症的多面驱动因子，其研究为AD病理机制解析及治疗突破提供了重要视角，但从基础研究到临床应用仍需解决多重关键问题。 1.安全性平衡：规避长期抑制的潜在风险 IL-18在正常免疫防御（如抗菌、抗肿瘤）中具有重要作用，长期抑制可能带来免疫功能受损风险：短期安全性验证：目前临床研究显示抗IL-18药物短期安全性良好，但需长期随访评估其对感染（如皮肤细菌/病毒感染）、肿瘤发生的影响；局部治疗优先：鉴于皮肤是IL-18的主要作用部位，开发局部IL-18抑制剂（如外用IL-18BP、局部炎症小体抑制剂）可能在增强疗效的同时降低全身毒性。 3.联合治疗：协同改善AD多维度病理 AD的复杂性决定了单一靶点治疗难以完全控制疾病，联合治疗具有广阔潜力：与Th2细胞因子抑制剂联用：IL-18主要作用于pTh2细胞上游激活环节，与IL-4/IL-13抑制剂（如度普利尤单抗）联用，可从“上游激活-下游效应”双重阻断Th2炎症，增强疗效；与JAK抑制剂联用：JAK抑制剂可抑制IL-18下游信号通路（如STAT3、NF-κB），与IL-18抑制剂联用可能产生协同抗炎效应，同时覆盖AD中的多种炎症通路；与屏障修复剂联用：针对IL-18介导的屏障破坏，联合使用皮肤屏障修复剂（如神经酰胺、胆固醇），可打破“屏障受损-IL-18释放”的恶性循环，提升长期治疗效果。 IL-18作为AD病理中的关键分子，IL-18靶向疗法有望成为AD治疗的重要补充，为更多难治性AD患者带来新的治疗选择。但同时也需认识到，AD的异质性及IL-18功能的复杂性仍需进一步研究，只有通过多学科协作、基础与临床转化结合，才能真正实现IL-18靶向治疗的临床价值。《IL-18 in atopic dermatitis - A multifaceted driver of skin inflammation》，The Journal of Allergy and Clinical Immunology，2025

临床结果

2025-04-30

·EndPoints

GSK's supply chain 'reset' after Haleon spinoff to ease tariff impact, CEO says

GSK said its decoupling with Haleon is a key reason why it views itself as “well-positioned” in the face of potential pharma-specific tariffs. When the drugmaker went through its “ demerger ” with the consumer health business in 2022, there were “very intentional, deliberate choices to reset” its supply chain for “regional resilience” as well as “double sourcing” to allow for flexibility, CEO Emma Walmsley said. It has “mitigation options” that it could execute across its manufacturing networks once pharma levies are in place, the UK company said in a statement. “We’re watching it very carefully … we are well-prepared,” Walmsley said during GSK’s first-quarter earnings call with the media. Some drug developers and CDMOs have similarly expressed how their earlier moves — which were made even before the talk of tariffs emerged — would help them navigate sector-specific levies regardless of what these might look like. President Donald Trump’s tariffs have been a central theme during this earnings season as drugmakers disclose their exposures and strategies to varying degrees. Last week, Roche CEO Thomas Schinecker said the pharma tariffs could have a negative impact on dealmaking. But Walmsley somewhat disagreed, saying “there are some opportunities” for deals and that half of GSK’s pipeline comes from this business development approach. “We’re constantly looking at things … and we also continue to look at the opportunities out of China on BD. We’ve done several good deals ,” she said. GSK’s disappointing vaccine sales stood out in Q1. Sales for this franchise dropped 6% in the quarter due to “known headwinds,” GSK said. Shingrix struggled in the US due to “harder-to-reach unvaccinated customers” and increased channel inventory consumption. As for Arexvy, sales disappointed because of the FDA’s Advisory Committee on Immunization Practices’ constricted recommendation only for people aged 60 to 74. But Jefferies analysts said GSK’s vaccine sales of £2.1 billion were actually better than consensus expectations of £2.05 billion. Shingrix beat forecasts with £867 million in worldwide sales, although Arexvy sales are still notably low at £78 million. Walmsley added that both vaccines still have room for growth internationally. Despite these market challenges, Walmsley told the media GSK does not intend to change its R&D plans for vaccines. Overall, GSK had a positive total sales profile, pulling in £7.5 billion in Q1, up 4% at constant exchange rates. Its shares were up by as much as 4% on the London Stock Exchange on Wednesday morning. The company’s specialty medicines portfolio had a particularly solid performance at £2.9 billion — a 17% jump — beating Jefferies’ consensus estimates of £2.84 billion. “We’ve been able to strengthen the portfolio with a shift to more specialty medicines, and that creates oxygen through the gross margin,” Walmsley said. Notably, Jemperli pulled in £174 million in Q1 compared with a lower benchmark of £145 million. GSK said Jemperli’s US sales momentum is supported by the drug’s approval in all patients with primary advanced or recurrent endometrial cancer. GSK also touted its market progress with Ojjaara at £112 million, as the myelofibrosis therapy makes headway in the US and other territories. But analysts noted the drug’s sales just missed forecasts at £117 million. Nonetheless, GSK’s overall showing on Wednesday follows the optimistic tune played in February, when it set a higher bar for its 2031 sales outlook to at least $40 billion. This is a £2 billion jump from a prior target. Looking at its clinical pipeline, GSK discontinued a Phase 2 trial of an anti-IL18 antibody, codenamed GSK1070806, for atopic dermatitis due to pipeline prioritization. Endpoints News previously reported that GSK’s ViiV Healthcare stopped work on its HIV antiviral named VH3739937.

上市批准疫苗临床2期临床结果

2023-11-25

·医药观澜

GSK、安进、信达生物、靖因药业等公司1类新药获批临床

▎药明康德内容团队编辑中国国家药监局药品审评中心（CDE）官网公示，近两周，有超20款1类新药首次在中国获得临床试验默示许可。通过梳理发现，这些新药包括了单抗、siRNA药物、放射性治疗药物、活菌药物、TCR-T细胞疗法、重组溶瘤腺病毒产品等等新药类型。本文将挑选其中部分新药作介绍，仅供读者参阅（排名不分先后）。截图来源：CDE官网葛兰素史克（GSK）：GSK1070806注射液作用机制：抗IL-18单抗适应症：特应性皮炎公开资料显示，GSK1070806是一种抗白细胞介素18（IL-18）单克隆抗体，其可中和炎性小体活化后受损细胞释放的活化/成熟IL-18。IL-18归属于IL-1家族，其受体在自然杀伤细胞（NK）上高表达。抗IL-18单抗能够刺激NK细胞分泌产生IFN-γ，并具有广阔的免疫调节功能。根据ClinicalTrials官网，GSK1070806注射液正在开展针对特应性皮炎、克罗恩病等的1/2期临床研究。该药本次在中国获批临床，拟开发治疗特应性皮炎。靖因药业：SRSD101注射液作用机制：靶向PCSK9的siRNA药物适应症：原发性高胆固醇血症根据靖因药业新闻稿，SRSD101注射液是该公司研发的一款双链小干扰核酸（siRNA）药物，也是该公司第二款开发的小核酸药物。SRSD101能特异性肝靶向前蛋白转化酶枯草溶菌素9（PCSK9）的mRNA，阻断PCSK9的蛋白合成, 从而增强肝细胞摄取低密度脂蛋白胆固醇（LDL-C）能力来实现降血脂的作用。临床前研究数据显示，SRSD101兼具强效持久降脂疗效和良好的安全性，有望成为新一代的降血脂产品。该药本次在中国获批临床，拟开发治疗原发性高胆固醇血症。上海医药：SPH7854颗粒作用机制：免疫调节剂适应症：溃疡性结肠炎根据上海医药公告，SPH7854颗粒是一款免疫调节剂，能抑制肠道的炎症反应和增强肠道的免疫调节。临床前研究显示，该产品能改善肠炎动物模型的症状和肠道炎症反应。该药本次获批临床的适应症为溃疡性结肠炎（UC）。溃疡性结肠炎是一项造成肠胃道慢性发炎的疾病，患者可能会有的症状包含腹泻、腹痛、血便、直肠出血、体重下降与疲劳。此病严重影响患者的生活品质，他们也亟需更安全有效的口服疗法。东诚药业：177Lu-LNC1003注射液作用机制：靶向PSMA的放射性治疗药物适应症：PSMA阳性的前列腺癌公开资料显示，177Lu-LNC1003注射液是东诚药业核药创新研发平台蓝纳成生物开发的一种可靶向结合前列腺特异性膜抗原（PSMA）的放射性治疗药物，适用于PSMA阳性的前列腺癌患者的治疗。在前期研究中，177Lu-LNC1003展现出较高的结合亲和力和PSMA靶向特异性，使放射性核素能够浓聚于肿瘤病灶，实现肿瘤的精准治疗。该产品前体化学结构中含有伊文思蓝，能够增加肿瘤对药物的有效摄取，延长治疗时间窗，并可以在同等或更优的治疗效果下降低放射性核素的用量，进而降低患者的治疗成本。和正医药、中国科学院上海药物研究所：HZ-Q1070胶囊作用机制：新型BTK降解剂适应症：复发或难治性B细胞淋巴瘤根据和正医药公开资料，HZ-Q1070胶囊和正医药研发团队与上海药物所李佳团队共同开发的一个结构新颖、降解强效、选择性优异、成药性良好的BTK降解剂。据悉，和正医药采用降维设计的理念，搭建了针对“类药五原则”范畴之外（bRo5）的蛋白降解靶向嵌合体成药性技术平台DaTProD，并应用于BTK、STAT3、HPK1等靶点药物研发中。今年4月，HZ-Q1070的临床前数据在2023年美国癌症研究协会（AACR）上以口头报告形式公布。该药本次获批临床，拟开发治疗复发或难治性B细胞淋巴瘤。知微生物：TM471-1胶囊作用机制：BTK抑制剂适应症：B细胞非霍奇金淋巴瘤（NHL）根据知微生物新闻稿，TM471-1胶囊是一款BTK抑制剂。临床前研究结果显示，该产品在安全性和药效上，有多项指标（如激酶选择性、心脏安全性、能够穿透血脑屏障等）优于同类产品，具有很好的成药性。该产品获批临床的适应症为B细胞非霍奇金淋巴瘤（NHL）。南芯医疗：LF01胶囊作用机制：活菌药物适应症：拟用于治疗晚期实体瘤根据南芯医疗新闻稿，LF01胶囊是该公司自主研发的活菌制剂。研究表明，LF01菌株具有吸附于细胞表面的能力，可大幅度激活巨噬细胞向M1促炎型的巨噬细胞分化，还能分泌大量促炎因子、抗肿瘤的细胞因子或趋化因子，进一步激活或募集其他免疫细胞，使机体免疫系统发挥抗肿瘤免疫作用。该产品本次获批临床，拟用于治疗晚期实体瘤。图片来源：123RF安进：AMG 133作用机制：双特异性GIPR拮抗剂和GLP-1R激动剂适应症：体重控制安进（Amgen）申报的1类新药AMG 133在中国获批临床，拟开发用于体重控制。公开资料显示，AMG 133是一款在研的潜在“first-in-class”抗体多肽偶联药物，每个月用药一次，它能够激活胰高血糖素样肽-1受体（GLP-1R）并抑制胃抑制肽受体（GIPR）从而发挥作用。在安进早先公布的1期临床研究中，受试者经最高剂量AMG 133治疗3个月（12周）后体重减少了14.5%。辉瑞：PF-06940434注射液作用机制：整合素αvβ8拮抗剂适应症：晚期实体瘤辉瑞（Pfizer）申报的1类新药PF-06940434注射液在中国获批临床，拟开发治疗晚期或转移性实体瘤患者。公开资料显示，这是辉瑞公司在研的整合素αvβ8拮抗剂，正在海外开展1期临床研究。整合素αvβ8是一种细胞表面蛋白质，近年来的研究发现在其肿瘤的发生发展过程中起着重要的推动作用。信达生物：IBI356作用机制：靶向OX40L的免疫分子适应症：特应性皮炎信达生物1类新药IBI356在中国获批临床，拟开发治疗特应性皮炎。根据信达生物公开资料，这是该公司自身免疫性疾病领域的一款在研产品，为靶向OX40L的特色创新型免疫分子。OX40是一种主要存在于活化T细胞上的共刺激受体，它与OX40L的相互作用在T细胞活化、增殖和存活提供重要信号，因此在一系列炎症和免疫疾病的发病机制中具有重要作用。可瑞生物：CRTE7A2-01 TCR-T细胞注射液作用机制：靶向HPV16 E7的TCR-T细胞注射液适应症：HPV16阳性实体瘤可瑞生物首个免疫细胞治疗产品CRTE7A2-01 TCR-T细胞注射液获批临床，拟开发治疗HPV16阳性HLA-A*02:01阳性晚期实体肿瘤（宫颈癌、头颈部肿瘤、肛门癌和其他肿瘤类型）。据悉，可瑞生物利用自建的研发平台获得了对E7抗原活性较优，且脱靶风险低的TCR序列，然后利用该TCR开发出了TCR-T细胞注射液，用于清除HPV16阳性的肿瘤细胞。在临床前的研究中，CRTE7A2-01 TCR-T细胞注射液表现出了良好的活性和安全性。万邦医药：VT-101作用机制：新一代重组溶瘤腺病毒产品适应症：实体瘤根据复星医药公告，其控股子公司万邦医药及其控股子公司万邦科技自主研发的重组溶瘤腺病毒产品VT-101注射液已在中国获批临床，同意该新药用于治疗晚期头颈部鳞癌、黑色素瘤和乳腺癌等实体瘤的临床试验。VT-101是一款具有三重肿瘤靶向调控机制、三个病毒结构基因改造、三种血清型腺病毒嵌合、三类抗癌免疫基因装载的新一代重组溶瘤腺病毒产品，拟主要用于治疗晚期头颈部鳞癌、黑色素瘤和乳腺癌等实体瘤。未知君生物/Aurealis：AUP1602-C作用机制：基因工程菌药物适应症：糖尿病足溃疡Aurealis Therapeutics申请的1类生物新药AUP1602-C获批临床，拟用于治疗糖尿病足溃疡。公开资料显示，AUP1602-C（又称AUP-16）是一款基因工程菌药物，未知君生物通过一项1.39亿美元的合作获得了其在大中华区开发和商业化的独家权利。AUP1602-C内部搭载多种再生因子的编码基因，于伤口处局部给药并覆盖敷料，用于治疗糖尿病足溃疡、下肢静脉溃疡、压力性溃疡等慢性伤口。参考资料：[1]中国国家药监局药品审评中心（CDE）官网.Retrieved Nov 24，2023, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c[2]各公司官网及公开资料本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床申请siRNA放射疗法信使RNA细胞疗法

100 项与 Aletekitug 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2期	美国	GSK Plc	2023-11-16
中度特应性皮炎	临床2期	中国	GSK Plc	2023-11-16
中度特应性皮炎	临床2期	日本	GSK Plc	2023-11-16
中度特应性皮炎	临床2期	阿根廷	GSK Plc	2023-11-16
中度特应性皮炎	临床2期	保加利亚	GSK Plc	2023-11-16
中度特应性皮炎	临床2期	加拿大	GSK Plc	2023-11-16
中度特应性皮炎	临床2期	捷克	GSK Plc	2023-11-16
中度特应性皮炎	临床2期	法国	GSK Plc	2023-11-16
中度特应性皮炎	临床2期	德国	GSK Plc	2023-11-16
中度特应性皮炎	临床2期	希腊	GSK Plc	2023-11-16

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临床结果

适应症

分期

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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


NCT04975438 (CTgov)	临床1期	中度特应性皮炎 \| 重度特应性皮炎	34	GSK1070806 (Group 1: GSK1070806)	膚衊繭醖鏇獵觸餘鹽淵(積鑰餘鑰衊築襯襯鹹網) = 艱製窪膚齋餘繭範糧夢網壓鬱範鹹壓艱觸襯壓 (範壓鏇膚襯夢積鹹壓膚, 鏇壓鹹壓窪壓襯鹽鹹鏇 ~ 鹽醖選廠鏇鬱夢餘餘糧) 更多	-	2024-07-23
NCT04975438 (CTgov)	临床1期	中度特应性皮炎 \| 重度特应性皮炎	34	Placebo (Group 1: Placebo)	膚衊繭醖鏇獵觸餘鹽淵(積鑰餘鑰衊築襯襯鹹網) = 醖選鏇製觸鑰糧鹽艱製網壓鬱範鹹壓艱觸襯壓 (範壓鏇膚襯夢積鹹壓膚, 鑰築顧夢構廠鹹範簾窪 ~ 遞繭構壓蓋醖齋構獵醖) 更多	-	2024-07-23
GSK1070806 (EADV2023)	临床1期	-	-	GSK1070806	製鬱鹹蓋鹹醖鏇觸鏇網(鹹獵鹽糧顧獵觸構壓遞) = 蓋襯繭憲獵餘獵顧艱窪淵衊糧膚遞襯積網選鏇 (範簾艱鹽壓鬱廠繭製齋 )	积极	2023-10-11
NCT02723786 (Pubmed \| J Biol Chem \| PLoS One) 人工标引	临床2期	移植物功能延迟恢复	7	GSK1070806	齋廠顧餘壓蓋夢簾鹽憲(憲窪構夢襯鬱醖鬱觸窪) = 簾衊艱鏇觸憲鹽製膚淵鑰窪夢願鹹餘糧壓蓋繭 (鏇憲製鹽鏇襯願淵夢網 ) 更多	不佳	2021-03-08
NCT02723786 (CTgov)	临床2期	肾移植排斥反应 \| 移植物功能延迟恢复	7	GSK1070806+basiliximab+tacrolimus+azathioprine+mycophenolate mofetil	觸醖顧壓積醖憲繭簾構 = 襯積願觸構願繭糧遞遞廠糧鑰鬱淵積鹽鹹鑰衊 (積艱齋獵壓簾夢繭夢觸, 觸鬱鑰觸積醖蓋艱範餘 ~ 鹹鬱鹹膚窪觸襯齋構醖) 更多	-	2019-06-10