An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 Monotherapy, LBL-024 in Combination With LBL-007 or Toripalimab in Patients With Advanced Melanoma

This study is an open-label, multicenter phase Ib/II study to evaluate the efficacy and safety of LBL-024 monotherapy, LBL-024 in combination with LBL-007 or toripalimab in patients with advanced melanoma,To evaluate the preliminary efficacy and safety of LBL-024 monotherapy and combination therapy in patients with advanced melanoma.

开始日期2025-09-05

申办/合作机构

南京维立志博生物科技股份有限公司

NCT06010303

/ Active, not recruiting临床2期

A Phase 2, Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of LBL-007 in Combination With Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

This is a randomized, open-label study to compare how well LBL-007 works in combination with tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the first-line treatment in participants with inoperable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).

开始日期2023-11-08

申办/合作机构

BeOne Medicines Ltd.

NCT05909904

/ Active, not recruiting临床2期

A Randomized, Phase 2, Open-Label, Multi-Arm Study of Tislelizumab in Combination With Investigational Agents as First-Line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This study is designed to evaluate the efficacy and safety of tislelizumab and tislelizumab in combination with investigational agent(s) in first-line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

开始日期2023-07-21

申办/合作机构

BeOne Medicines Ltd.

100 项与艾克苏拜单抗相关的临床结果

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100 项与艾克苏拜单抗相关的转化医学

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100 项与艾克苏拜单抗相关的专利（医药）

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项与艾克苏拜单抗相关的文献（医药）

2026-02-17·CLINICAL CANCER RESEARCH

Anti–LAG-3 Antibody LBL-007 plus Tislelizumab and Chemotherapy as First-Line Therapy for Advanced Nasopharyngeal Carcinoma: A Multicenter Phase 2 Trial

Article

作者: Wang, Rensheng ; Qu, Song ; Chen, Xiaozhong ; Zhu, Haisheng ; Li, Jingao ; Chen, Gang ; Xiong, Hailin ; Gao, Jin ; Fan, Bin ; Chen, Wu ; Liu, Lei ; Han, Yaqian ; Tang, Wenjun ; Kang, Xiaoqiang ; Zhang, Li ; Huang, Xiaoming ; Yang, Kunyu ; Cai, Shengli ; Hu, Desheng ; Chen, Lisha ; Yang, Yunpeng ; Chen, Yu ; Sun, Dongchen

Abstract:

Purpose::

Prior studies reported synergistic antitumor activity by dual inhibition of lymphocyte activation gene-3 (LAG-3) and PD-1. This study investigated the activity, safety, and biomarker of LAG-3/PD-1 co-blockade plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).

Patients and Methods::

Previously untreated patients with RM-NPC received LBL-007 (anti–LAG-3), tislelizumab (anti–PD-1), and gemcitabine-cisplatin for four to six cycles, followed by maintenance therapy with LBL-007 and tislelizumab. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), duration of response (DoR), time to response, disease control rate (DCR), overall survival (OS), and safety. Biomarker analysis included LAG-3 and PD-L1 expression.

Results::

Forty-two patients were enrolled from 15 centers in China. With a median follow-up of 19.0 months, the ORR was 83.3% [95% confidence interval (CI), 68.6%–93.0%], and the DCR was 97.6% (95% CI, 87.4%–99.9%). The median PFS reached 15.8 months (95% CI, 9.9–not estimable); the 12-month PFS rate was 55.1% (95% CI, 41.7%–72.9%). The median DoR was 14.6 months (95% CI, 10.3–not estimable); the median OS was not reached. Grade 3 or higher treatment-related adverse events occurred in 37 patients (98.1%). No new safety signals were identified. In biomarker analysis, patients with dual-positive LAG-3/PD-L1 expression demonstrated more favorable outcomes than those lacking either biomarker, including a 12-month PFS rate of 65.0% versus 40.2% and median PFS of 16.0 versus 10.3 months.

Conclusions::

LBL-007 plus tislelizumab and chemotherapy shows promising clinical benefits and manageable toxicity as first-line therapy for RM-NPC. Dual-positive LAG-3/PD-L1 expression was associated with improved outcomes, supporting further exploration of this biomarker-defined subpopulation in randomized trials.

2025-05-01·Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology

[A novel fully human LAG-3 monoclonal antibody LBL-007 combined with PD-1 antibody inhibits proliferation, migration and invasion of tumor cells via blocking NF-κB pathway].

Article

作者: Zhou, Lijun ; Wu, Chenglin ; Zhou, Huinan ; Qin, Kewei ; Liu, Jianfei

Objective To investigate the effects of LBL-007, a novel fully human lymphocyte activation gene 3 (LAG-3) monoclonal antibody, in combination with programmed cell death protein 1 (PD-1) antibody, on the invasion, migration and proliferation of tumor cells, and to elucidate the underlying mechanisms. Methods Human lymphocyte cells Jurkat were co-cultured with A549 and MGC803 tumor cell lines and treated with the isotype control antibody human IgG, LBL-007, anti-PD-1 antibody BE0188, or tumor necrosis factor-alpha (TNF-α, the NF-κB signaling pathway agonist). Tumor cell proliferation was assessed using a colony formation assay; invasion was measured by Transwell^TM assay; migration was evaluated using a wound healing assay. Western blotting was employed to determine the expression levels of NF-κB pathway-related proteins: IκB inhibitor kinase alpha (Ikkα), phosphorylated Ikkα (p-IKKα), NF-κB subunit p65, phosphorylated p65 (p-p65), NF-κB Inhibitor Alpha (IκBα), phosphorylated IκBα (p-IκBα), matrix metalloproteinase 9 (MMP9), and MMP2. Results Compared with the control and IgG isotype groups, LBL-007 and BE0188 significantly reduced tumor cell proliferation, invasion, and migration. They also decreased the phosphorylation of p-IKKα, p-p65 and p-IκBα, and the expression of MMP9 and MMP2 of tumor cells in the co-culture system. The combined treatment of LBL-007 and BE0188 enhanced inhibitory effects. Treatment with the NF-κB signaling pathway agonist TNF-α reversed the suppressive effects of LBL-007 and BE0188 on tumor cell proliferation, invasion, migration, and NF-κB signaling. Conclusion LBL-007 and anti-PD-1 antibody synergistically inhibit the invasion, migration, and proliferation of A549 and MGC803 tumor cells by blocking the NF-κB signaling pathway.

Journal of Hematology & Oncology

Anti-LAG-3 antibody LBL-007 plus anti-PD-1 antibody toripalimab in advanced nasopharyngeal carcinoma and other solid tumors: an open-label, multicenter, phase Ib/II trial

Article

作者: Zhao, Yuan-Yuan ; Huang, Yan ; Kang, Xiao-Qiang ; Li, Gui-Ling ; Hu, De-Sheng ; Chen, Gang ; Wang, Hui-Li ; Cai, Sheng-Li ; Ba, Yi ; Fang, Wen-Feng ; Zhou, Ting ; Zhang, Ya-Xiong ; Lin, Jin-Guan ; Wang, Wei ; Sun, Dong-Chen ; Yang, Yun-Peng ; Zhu, Hai-Sheng ; Zhang, Li ; Deng, Chao ; Fu, Zhi-Chao ; Wang, Zhen ; Zhao, Hong-Yun ; Luo, Su-Xia

PURPOSE:

Open-label phase Ib/II study to investigate the safety and efficacy of LBL-007, an anti-LAG-3 antibody, plus toripalimab, an anti-PD-1 antibody, in patients with previously treated advanced nasopharyngeal carcinoma (NPC) and other solid tumors.

METHODS:

Patients with advanced tumors refractory to prior standard therapies were enrolled. In phase Ib, patients received LBL-007 200 mg or 400 mg and toripalimab 240 mg intravenously once every 3 weeks. In phase II, all patients received LBL-007 at the recommended phase II dose (RP2D) and toripalimab 240 mg intravenously once every 3 weeks. The primary end points were safety in phase Ib and objective response rate (ORR) in phase II. The exploratory end point was the predictive capability of LAG-3 and PD-L1 expression for efficacy.

RESULTS:

Between November 30, 2021, and December 1, 2023, 80 patients were enrolled, including 30 (37.5%) with NPC and 50 (62.5%) with other tumors. Median follow-up was 26.0 months. In Phase Ib, LBL-007 was administered at 200 mg to four patients and 400 mg to six patients, with no dose-limiting toxicities observed. Therefore, the 400 mg dose of LBL-007 was established as the RP2D and administered to 70 patients in phase II. Nine (11.3%) of 80 patients had grade 3 or 4 treatment-related adverse events, the most common of which included anemia (2.5%), hyponatremia (2.5%), increased alanine aminotransferase (2.5%), increased aspartate aminotransferase (1.3%), and fatigue (1.3%). Eight patients (10.0%) had treatment-related serious adverse events. No treatment-related deaths were reported. In immunotherapy-naive NPC patients (n = 12), ORR was 33.3%, disease control rate (DCR) was 75%, and median progression-free survival (PFS) was 10.8 months (95% CI, 1.3 to not estimated). In IO-treated NPC patients (n = 17), ORR was 11.8%, DCR was 64.7%, and median PFS was 2.7 months (95% CI, 1.4 to 4.9). For other tumors, ORRs were 15.8% in immunotherapy-naive patients and 3.7% in immunotherapy-treated patients. Patients with ≥ 2 + LAG-3 expression had a higher ORR of 28.0%, compared to 7.7% in those with < 2 + LAG-3 expression.

CONCLUSION:

LBL-007 plus toripalimab exhibited a manageable safety profile in patients with advanced solid tumors and demonstrated promising antitumor activity in NPC, especially in immunotherapy-naive patients. These findings warrant further validation in future studies.

项与艾克苏拜单抗相关的新闻（医药）

2026-01-19

·搜狐新闻

协同出击，“双免疫检查点+化疗”一线方案可显著延长晚期鼻咽癌患者生存期！丨今日前沿

近日，中山大学肿瘤防治中心张力、杨云鹏教授团队在美国癌症研究协会官方杂志《临床癌症研究》(Clinical Cancer Research)杂志在线发表了题为“抗LAG-3单抗（LBL-007）联合抗PD-1单抗（替雷利珠单抗）及吉西他滨-顺铂化疗一线治疗复发或转移性鼻咽癌”的II期多中心临床研究成果。研究结果显示，LAG-3/PD-1联合阻断+化疗展现出显著的抗肿瘤活性和良好的安全性，为鼻咽癌一线治疗提出了“双免疫检查点+化疗”的创新策略。机制协同：构建“双免疫+化疗”一线治疗新策略近年来，多项III期临床研究已确立PD-1抗体联合吉西他滨-顺铂化疗为复发/转移性鼻咽癌的一线标准方案。然而，该方案的中位无进展生存期（PFS）通常在9~12个月，疾病长期控制仍不理想，亟需探索更有效的治疗策略。既往研究表明，鼻咽癌作为一种EB病毒相关肿瘤，其肿瘤微环境中存在大量处于“激活-耗竭状态”的 CD8⁺ T细胞，常同时高表达 PD-1、LAG-3 等抑制性免疫检查点。单一阻断PD-1难以充分逆转T细胞耗竭，而LAG-3与PD-1在功能上具有协同抑制作用，为双靶点联合阻断提供了理论支持。基于上述临床与理论依据，本研究首次系统性评估LAG-3/PD-1双重免疫阻断联合化疗在复发/转移性鼻咽癌中的疗效、安全性及潜在生物标志物。临床实证：显著延长PFS期与持久的疾病控制本研究是一项开放标签、多中心的II期临床试验，共纳入42例未经系统治疗的复发或转移性鼻咽癌患者。所有患者接受抗LAG-3单抗（LBL-007）+抗PD-1单抗（替雷利珠）+吉西他滨-顺铂方案治疗4~6个周期，随后进入LBL-007联合替雷利珠维持治疗。研究显示，客观缓解率（ORR）达83.3%，疾病控制率（DCR）达97.6%，中位无进展生存（PFS）期达15.8个月，中位总体生存（OS）期尚未达到，12个月总体生存率为85.6%（图1）。值得关注的是，超过一半的应答患者缓解持续时间超过12个月，提示该方案具有更持久的疾病控制潜力。图1. LBL-007联合替雷利珠单抗+化疗在复发/转移性鼻咽癌一线治疗中展现出显著抗肿瘤活性转化探索：生物标志物指导下的精准分层与安全性在生物标志物分析方面，研究发现LAG-3与PD-L1在鼻咽癌中普遍高表达，且二者具有明确的预测价值。LAG-3/PD-L1双阳性患者，中位无进展生存期达16.0个月，12个月无进展生存率为65.0%；非双阳性患者，中位无进展生存期仅10.3个月，12个月无进展生存率40.2%（表1）。这一发现提示，LAG-3/PD-L1双阳性人群可能是双靶点联合阻断治疗的主要获益人群，为未来精准分层和个体化治疗提供了重要依据。表1. 不同LAG-3/PD-L1表达状态下患者的疗效比较在安全性方面，本研究总体耐受性良好。治疗相关≥3级不良事件主要与化疗相关，如白细胞减少、粒细胞减少和贫血等。免疫相关不良事件发生率为23.8%，未观察到新的安全信号。综上，本研究系统性揭示了LAG-3/PD-1双免疫检查点阻断联合化疗在复发/转移性鼻咽癌一线治疗中的显著疗效与可控安全性，尤其在LAG-3/PD-L1双阳性人群中展现出治疗潜力。未来，围绕该方案的随机对照研究及精准分层策略值得进一步深入探索，有望为鼻咽癌患者提供新的治疗选择。中山大学肿瘤防治中心张力教授、杨云鹏主任医师为该论文的共同通讯作者。孙东晨医师、陈港副主任医师、福建省肿瘤医院陈誉主任医师、广西医科大学附属肿瘤医院曲颂主任医师、四川大学华西医院刘磊教授为该论文的共同第一作者。专家介绍张力教授通讯作者中山大学肿瘤防治中心内科主任导师、博士生导师、二级教授、肺癌首席专家国家杰出医师国家重点研发计划“肺癌精准医学研究” 项目首席科学家中国临床肿瘤学会（CSCO）免疫治疗专家委员会主任委员CSCO非小细胞肺癌专家委员会、肿瘤支持与康复治疗专家委员会副主任委员中国抗癌协会（CACA）肿瘤药物临床研究专业委员会主任委员CACA小细胞肺癌专业委员会副主任委员广东省医学会《临床研究学分会》主任委员以第一或通讯作者身份在NEJM、Lancet、JAMA、BMJ、Nature Review Clinical Oncology、Nature Medicine、Cancer Cell等杂志发表论文杨云鹏教授通讯作者中山大学肿瘤防治中心主任医师、博士生导师、内科副主任中国临床肿瘤学会免疫治疗专家委员会秘书长中国抗癌协会青年理事会理事中国抗癌协会小细胞肺癌专业委员会常务委员广东省抗癌协会化疗委员会青委会主任委员广东省抗癌协会肿瘤免疫治疗专业委员会副主任委员/候任主任委员清华校友总会生物医药学院分会理事国家科技重大专项课题负责人以第一或通讯作者身份在NEJM, Lancet, Lancet Oncology, Lancet Respiratory Medicine, Cancer Cell 等杂志发表论文通讯员丨中山大学肿瘤防治中心郑敏姗陈鋆文朝阳周昕熙返回搜狐，查看更多

临床2期免疫疗法临床结果临床3期

2026-01-15

·百度百家

鼻咽癌治疗再提速：LAG-3抗体LBL-007Ⅱ期数据登上《Clinical Cancer Research》

日前，国际肿瘤学权威期刊《Clinical Cancer Research》在线发表了江北新区南京生物医药谷企业维立志博自主研发的1类新药LAG-3抗体艾克苏拜单抗（LBL-007）联合替雷利珠单抗和化疗，针对既往未经治疗的复发或转移性鼻咽癌（R/M NPC）患者的Ⅱ期临床研究结果。中山大学肿瘤防治中心张力教授和杨云鹏主任医师为共同通讯作者，数据披露后即引发广泛关注。 1.1 ◆ 关键指标全线领先确认的客观缓解率（ORR）83.3% 疾病控制率（DCR）97.6% 中位无进展生存期（mPFS）15.8个月中位缓解持续时间（mDoR）14.6个月中位总生存期（mOS）虽尚未成熟，但已展现延长趋势与单用替雷利珠单抗加化疗的历史对照（ORR 69.5%，mPFS 9.2个月，mDoR 8.5个月）相比，三项核心指标全面提高，为晚期鼻咽癌患者带来显著生存获益。继此前研究成果发表于《Journal of Hematology & Oncology》后，LBL-007再度以第一作者身份登上《Clinical Cancer Research》，标志着国际学术界对其疗效与科学价值的双重肯定。维立志博首席医学官表示，未来将持续深化临床布局，加速创新疗法的转化落地，让更多突破性成果尽快惠及全球患者。 3.1 ◆ 全人源IgG4，靶向LAG-3“黄金位点” 艾克苏拜单抗是靶向LAG-3的全人源IgG4单克隆抗体，也是截至2024年11月全球临床进度前三的LAG-3单抗（剔除已上市产品）。其独特表位设计可高亲和力阻断LAG-3与全部四种已知免疫抑制配体的结合，诱导细胞内吞并下调表面LAG-3表达，进一步切断免疫抑制回路。 3.2 ◆ 临床前数据优于“同类标杆” 与已上市LAG-3抗体relatlimab相比，艾克苏拜单抗在动物模型中展现更强的肿瘤生长抑制与疗效优势，为后续临床转化奠定坚实基础。 3.3 ◆ 联合PD-1，协同抗癌“1+12” 在多项瘤种中，艾克苏拜单抗联合PD-1抑制剂均表现出良好的协同效应与可控的安全性。在鼻咽癌这一“免疫沙漠”型肿瘤中，其疗效尤为突出，有望成为标准疗法之外的新选择。随着Ⅱ期数据解锁，维立志博已启动针对LBL-007联合方案的Ⅲ期注册研究，计划在全球范围内进一步验证其疗效与安全性。若Ⅲ期结果持续优异，艾克苏拜单抗或将成为R/M NPC的一线治疗选项，让晚期患者也能获得长期生存甚至治愈的可能。

临床2期临床结果临床3期

2026-01-12

·科创江北

北岸的“学霸”属性，又又又更新了！

上周的北岸创新氛围又“拉满”了从地下数十米的智能盾构“最强大脑” 到呵护人类与宠物健康的最新药物再到登上国际顶刊的科研突破 …… 各条战线捷报频传仿佛能听到这片创新热土上 “咚咚”作响的强劲心跳以废治废！中国石化南化公司这项技术全国一等奖！近日，中国石化南化公司申报的“硫基自养反硝化污水高效脱氮技术研发及应用”项目，荣获中华环保联合会科学技术奖一等奖。该项突破性技术以“硫”治“氮”，为化工、冶金等行业高硝态氮废水治理提供了高效低成本的解决方案，也为长江生态保护注入了创新动力。这项技术核心是“以废治废，变堵为疏”。传统工艺需要额外添加碳源，好比给微生物“喂饭”，成本高且可能带来新污染。而南化研发的硫基自养反硝化生物膜技术，是利用废水中本身的硫元素或硫酸根作为“能量”，驱动特定的微生物群落，将硝态氮直接转化成氮气。这样，既无需外加碳源，从源头大幅降低了运行成本，而且微生物群落更稳定，能耐受复杂恶劣的水质环境，脱氮效率更高、更稳定。全域智能新进化！四维智联 AI舱泊融合技术登顶高工金球奖定义座舱智能新标杆近日，以“「全域智能」新进化”为主题的2025（第九届）高工智能汽车年会暨高工金球奖颁奖典礼在上海举行。四维智联凭借自主研发的“AI舱泊一体解决方案（融合域控标准级舱泊版AF2SP）”，荣获高工金球奖“年度技术突破奖”，该奖项是对公司在跨域融合架构与AI原生交互领域所展现的技术前瞻性与工程化落地能力的权威认可。此次获奖的AI舱泊一体解决方案，基于高性能SA8255P芯片平台，采用4V12U多模态感知架构，支持10路摄像头输入及“一机多屏”沉浸式联动。其核心突破在于，在单一域控制器中深度融合了大模型驱动的AI Agent、游戏级实时3D HMI与全场景泊车功能，并通过硬件资源共享与跨域调度优化，为主流价位车型提供可进化、体验连贯的智能座舱解决方案。 Nature子刊！澄实生物联合南农大发表突破性成果近日，澄实生物与南京农业大学合作团队在国际权威期刊Nature旗下子刊《npj Vaccines》在线发表研究论文《Next-generation mRNA vaccines eliciting robust protection against multidrug-resistant Enterobacteriaceae》。该研究成功开发出一种能广谱靶向多重耐药肠杆菌科细菌的下一代mRNA疫苗，为应对全球抗生素耐药危机提供了全新的预防解决方案，标志着mRNA技术正式迈入抗细菌感染新阶段。核心研究结果证实：高效表达与分泌：mRNA疫苗在体外实验中表现出极高的抗原表达水平和稳定的分泌能力。显著广谱交叉保护：不仅可有效防护肺炎克雷伯菌，还对肠出血性大肠杆菌（EHEC）、沙门氏菌、福氏志贺氏菌等多种重要肠杆菌科病原体产生显著交叉保护。大幅降低细菌载量与组织损伤：接种后，小鼠肺部及肠道细菌载量最高降低约180倍，并显著减轻器官病理损伤。国内首个！新区造！近日，由中铁十四局大盾构公司研发的、国内首个超大规模的大盾构领域混合专家模型“深远大模型”，通过了中国信息通信研究院组织的“可信AI大语言模型”专项评估，并获4+级评级，这是国内首个获国家级权威认证的盾构垂域大模型。作为中铁十四局“数智盾构3.0”体系的核心引擎，“深远大模型”参数规模超2000亿，是国内首个超大规模大盾构领域混合专家模型。依托语音智能交互技术，该模型可精准理解用户意图、自动拆解施工任务，通过快速检索海量分布式数据，融合知识图谱对掘进参数、沉降数据、历史案例等多源信息进行综合研判，构建起“实时数据+专家经验+行业知识+模型算法”四位一体的技术体系。这一创新突破，让盾构施工风险管控从“被动应对”实现向“主动预控”的跨越式升级，为工程施工提供前瞻性决策支撑。目前，该模型及应用体系已在杭州萧山机场线钱塘江隧道工程成功试点，凭借精准的风险预判与高效的决策辅助，取得显著应用成效。重磅刊发！维立志博鼻咽癌新药临床价值再获国际瞩目日前，国际肿瘤学领域权威期刊《Clinical Cancer Research》在线发表了维立志博（股票代码：9887.HK）自主研发的1类新药LAG-3抗体艾克苏拜单抗（LBL-007）联合替雷利珠单抗和化疗在既往未经治疗的复发或转移性鼻咽癌（R/M NPC）患者中的Ⅱ期临床研究结果。中山大学肿瘤防治中心张力教授和杨云鹏主任医师为论文的通讯作者。研究结果显示，经确认的ORR为83.3%，DCR为97.6%。中位无进展生存期(mPFS)为15.8个月，中位缓解持续时间(mDoR)为14.6个月，中位总生存期(mOS)尚未成熟。LBL-007联合替雷利珠单抗加化疗相比替雷利珠单抗联合化疗(ORR 69.5%，mPFS 9.2个月，mDoR 8.5个月；NCT03924986)，ORR、mPFS、mDoR均明显提高。孤儿药+1！融捷康创新药获美国FDA资格认定日前，融捷康宣布，其自主研发的创新型药物RJK-RT2831获得美国食品药品监督管理局（FDA）授予的孤儿药资格认定（Orphan Drug Designation，ODD），用于治疗急性髓系白血病（AML）。融捷康RT2831项目（RJK-RT2831）为通过靶向恶性血液肿瘤细胞表面特异性抗原的双特异性纳米抗体药物，在非临床研究中显示出了优秀的安全性和药效潜力。目前，该项目正在中国地区开展I期临床研究。急性髓系白血病（AML）患者仍存在巨大未满足的医疗需求，RJK-RT2831有望给AML患者带来新型治疗选择和更大临床获益。RJK-RT2831获得该认定后将有利于后续在美国的研究、开发、注册及商业化等方面获得相关政策支持，包括研发费用资助、临床研究费用税收减免、处方药用户费用豁免、加速上市审评审批等，进一步推动产品的国际临床开发和商业化进程，让该产品早日惠及全球AML患者。朗博特 “氟雷拉纳咀嚼片” 获批国家二类新兽药证书近日，农业农村部发布第986号公告，朗博特研发的“氟雷拉纳咀嚼片”获批国家二类新兽药证书。截止目前，朗博特集团共累计获批国家新兽药14项；其中，国家二类新兽药4项，三类1项，四类3项，五类6项。氟雷拉纳咀嚼片主要用于治疗犬体表的跳蚤(猫栉首蚤)和蜱虫(长角血蜱和血红扇头蜱)感染。其主要成分氟雷拉纳是一种异噁唑啉类的杀虫剂和杀螨剂，通过拮抗y-氨基丁酸受体和谷氨酸受体门控氯离子通道，使氯离子无法渗透进入突触后膜，干扰神经系统的跨膜信号传递，导致昆虫神经系统紊乱，进而死亡。氟雷拉纳与狄氏剂不具有交叉耐药性。来源 | 南京新闻、南京智能制造产业园、南京生物医药谷、南京江北新区产业技术研创园编辑 | 高雅发布 | 李澜审核 | 韩晨微信改版了现在能不能刷到我们的推送全凭缘分所以大家记得把科小创“星标3连”呀 ▽

疫苗信使RNA

100 项与艾克苏拜单抗相关的药物交易

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研发状态

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
肿瘤	临床3期	美国	BeOne Medicines Ltd.	2019-12-19
肿瘤	临床3期	中国	BeOne Medicines Ltd.	2019-12-19
肿瘤	临床3期	日本	BeOne Medicines Ltd.	2019-12-19
肿瘤	临床3期	澳大利亚	BeOne Medicines Ltd.	2019-12-19
肿瘤	临床3期	法国	BeOne Medicines Ltd.	2019-12-19
肿瘤	临床3期	意大利	BeOne Medicines Ltd.	2019-12-19
肿瘤	临床3期	马来西亚	BeOne Medicines Ltd.	2019-12-19
肿瘤	临床3期	新西兰	BeOne Medicines Ltd.	2019-12-19
肿瘤	临床3期	波兰	BeOne Medicines Ltd.	2019-12-19
肿瘤	临床3期	韩国	BeOne Medicines Ltd.	2019-12-19

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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


NCT05577702 (BGBLC202, WCLC2025)	临床2期	非小细胞肺癌新辅助	121	Tislelizumab (PD-L1 TC ≥50%, TIS (anti-PD-1))	壓醖網鏇糧構網蓋構鑰(襯網築顧鑰構獵簾廠鏇) = 齋積鹹顧範網衊構糧遞廠醖鏇積壓選鹽遞憲築 (選鹹遞襯鏇艱鬱繭憲繭 ) 更多	积极	2025-09-08
				Tislelizumab+OciperlimabTislelizumab+Ociperlimabociperlimab (anti-TIGIT) (PD-L1 TC ≥50%, TIS plus ociperlimab (anti-TIGIT))	壓醖網鏇糧構網蓋構鑰(襯網築顧鑰構獵簾廠鏇) = 製顧鏇簾艱廠餘糧餘觸廠醖鏇積壓選鹽遞憲築 (選鹹遞襯鏇艱鬱繭憲繭 ) 更多
NCT05516914 (LBL-007, ASCO2025)	临床2期	复发性鼻咽癌一线 \| 维持	42	LBL-007 600 mg	簾淵鹹繭廠衊夢鬱艱鑰(膚鬱淵鬱糧壓襯醖觸壓) = 16 patients (38.1%) experienced LBL-007 treatment related SAEs 鑰蓋鹽積遞夢憲觸鑰選 (窪範醖鑰顧積膚觸餘齋 ) 更多	积极	2025-05-30
NCT05516914 (ASCO2024) 人工标引	临床1/2期	晚期恶性实体瘤 \| 晚期鼻咽癌一线	63	LBL-007 tislelizumab	積鹽壓艱網醖艱觸鹹製(鹹選膚範顧襯夢襯醖鏇) = None 築鬱廠鬱繭獵鬱積醖醖 (壓遞壓構鬱選鹹選齋窪 ) 更多	积极	2024-05-24
				LBL-007 tislelizumabcisplatin
NCT05102006 (AACR2024) 人工标引	临床1/2期	肿瘤	80	LBL-007 20ToripalimabToripalimab 240 mg	壓醖齋鹽鏇壓襯構夢簾(憲簾願窪壓蓋鬱夢鏇鹽) = 簾簾襯鏇淵鬱鑰繭鏇鑰壓壓艱願壓衊積願顧願 (範獵網製憲淵範觸襯糧 ) 更多	积极	2024-04-05
NCT04640545 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	局部晚期黑色素瘤	110	Toripalimab+LBL-007	願繭壓壓窪選鹹鹹觸顧(鏇鹽積製願夢襯醖糧觸) = 齋齋繭壓艱願窪鬱顧糧窪廠遞觸糧構構餘膚繭 (鬱構獵衊夢蓋餘繭憲醖 ) 更多	积极	2023-05-26
				Toripalimab+Axitinib+LBL-007	願繭壓壓窪選鹹鹹觸顧(鏇鹽積製願夢襯醖糧觸) = 糧衊膚鏇淵製遞淵壓選窪廠遞觸糧構構餘膚繭 (鬱構獵衊夢蓋餘繭憲醖 ) 更多
NCT04640545 (ASCO2022)	临床1期	不可切除的黑色素瘤	37	LBL-007	網築觸築構夢糧範糧選(壓積顧齋淵夢觸選衊壓) = 壓襯構糧選鑰鑰艱顧糧憲網構繭夢網糧簾夢夢 (願鬱窪網蓋齋簾鏇鏇艱 )	-	2022-06-02
				Toripalimab	網築觸築構夢糧範糧選(壓積顧齋淵夢觸選衊壓) = 獵艱醖鹹獵餘壓鏇餘齋憲網構繭夢網糧簾夢夢 (願鬱窪網蓋齋簾鏇鏇艱 )