恩沃利单抗(Envafolimab) - 药物靶点：PDL1_在研适应症：结直肠癌，MSI-H 实体瘤，非小细胞肺癌_专利_临床

A Phase II, Open-label, Multicenter, Randomized Controlled Clinical Trial Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment.

This study is a multicenter, prospective, randomized controlled Phase II clinical trial. The primary endpoint is to evaluate the efficacy and safety of regorafenib combined with envafolimab compared to physician's choice in patients with metastatic gastrointestinal stromal tumors harboring KIT exon 17 mutations who have failed standard treatments.

开始日期2025-07-30

申办/合作机构

北京大学

NCT06959693

/ Not yet recruiting临床2/3期IIT

mFOLFOX and Cetuximab - β With or Without Envafolimab for MSS, RAS/BRAF Wild - Type Advanced Unresectable CRC: Prospective, Randomized, Controlled Phase Ⅱ/Ⅲ Trial

This is a prospective randomized controlled Phase Ⅱ/Ⅲ Clinical study to evaluate the clinical efficacy and safety of Envafolimab combining with Cetuximab -β and mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)

开始日期2025-06-01

申办/合作机构

中山大学

NCT04910386

/ Not yet recruiting临床2期

A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers

开始日期2025-06-01

申办/合作机构

四川思路康瑞药业有限公司

100 项与恩沃利单抗相关的临床结果

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100 项与恩沃利单抗相关的转化医学

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100 项与恩沃利单抗相关的专利（医药）

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47

项与恩沃利单抗相关的文献（医药）

2025-09-01·JOURNAL OF CONTROLLED RELEASE

A super-long-acting anti-PD-L1 nanobody fused to elastin-like polypeptide for triple-negative breast cancer immunotherapy

Article

作者: Gao, Weiping ; Yang, Zhaoying ; Zhang, Fan ; Sun, Yuanzi ; Yao, Qiongqiong

The limited tumor penetration of monoclonal antibodies or the rapid renal clearance of nanobodies hamper their application in cancer immunotherapy. Through genetic engineering, we fuse a thermosensitive elastin-like polypeptide of ELP(V) with a nanobody of KN035 that binds specifically to human programmed cell death protein ligand 1 (PD-L1) to generate a conjugate of KN035-ELP(V) for triple-negative breast cancer (TNBC) therapy. The high affinity of KN035-ELP(V) enables it to efficiently block the interaction of PD1 and PD-L1. A single intraperitoneal administration of KN035-ELP(V) leads to the in situ generation of a sustained-release depot, showing a circulating half-life that is 276.4-fold and 5.1-fold longer than those of KN035 and KN035 fused with fragment crystallizable (KN035-Fc), respectively. Additionally, KN035-ELP(V) outperforms KN035 and KN035-Fc in term of accumulation and penetration in tumor tissue. Compared to KN035 and KN035-Fc treatments, a single injection of KN035-ELP(V) induces a durable and efficient antitumor immunity in TNBC-bearing mice, resulting in improved anti-tumor efficacy with reduced adverse effects. Therefore, KN035-ELP(V) is promising as a super-long-acting anti-PD-L1 nanobody for efficient cancer immune checkpoint blockade therapy.

2025-06-01·Thoracic Cancer

Safety and Efficacy of the First Subcutaneous ICI, Envafolimab, in the Treatment of Advanced Lung Cancer Patients: A Real‐World Study

Article

作者: Zhang, JieLi ; Wang, Hanping ; Yang, Yulong ; Zhang, Xiaotong ; Rui, Meng ; Si, Xiaoyan ; Zhou, Yunzhi ; Zhang, Li ; Zhao, Qiuhong ; Wang, Mengzhao ; Dou, Zixuan ; Cui, Xiaoxia ; Wang, Li

ABSTRACT:

Background:

Envafolimab is a novel immune checkpoint inhibitor (ICI) with several advantages due to its subcutaneous administration. Phases I and II randomized controlled trials have demonstrated promising efficacy in treating colorectal and gastric cancer. However, the safety and efficacy of Envafolimab in patients with advanced lung cancer remain to be investigated.

Methods:

This retrospective, multicenter, open‐label, single‐arm cohort study examined real‐world medical data from patients treated at four medical centers to assess the safety and efficacy of Envafolimab in treating patients with advanced lung cancer. The primary safety outcome was Envafolimab‐related treatment‐emergent adverse events (TEAEs) and immune‐related adverse events (irAEs). The primary efficacy outcomes included overall survival (OS) and progression‐free survival (PFS). Then, the relationship between clinical parameters and prognosis was investigated using univariate and multivariate regression analyses. Furthermore, the impact of tumor EGFR driver mutation status and PD‐L1 expression on prognosis was explicitly explored in patients with nonsmall‐cell lung cancer (NSCLC).

Results:

The cohort comprised 58 patients with a median follow‐up time of 8.3 months (from March 1, 2022, to March 7, 2024). Envafolimab‐related TEAEs and irAEs were observed in 53.4% and 27.6% of patients, respectively. No specific clinical factors were identified as being associated with irAEs. The median OS was 8.5 months (95% confidence interval [CI] 6.2–10.8), and the median PFS was 6.1 months (95% CI 3.8–8.3). For 47 patients with NSCLC, factors including ECOG PS > 2 (HR: 2.91, p = 0.015), Stage IV tumor (HR: 3.43, p = 0.043), and nonfirst‐line Envafolimab treatment (HR: 3.27, p = 0.026) were associated with poor prognosis.

Conclusion:

Envafolimab demonstrates a tolerable safety profile and favorable efficacy. With its subcutaneous formulation, Envafolimab shows promising potential for treating advanced lung cancer.

2025-04-01·HEPATOLOGY

A randomized phase 2b study of subcutaneous PD-L1 antibody ASC22 in virally suppressed patients with chronic hepatitis B who are HBeAg-negative

Article

作者: Xie, Qing ; Yang, Yongfeng ; Fu, Lei ; Wu, Jinzi J. ; Mao, Qianguo ; Chen, Yongping ; Cui, Yimin ; Xie, Yao ; Qian, Jiandan ; Guo, Xiaolin ; Zhang, Qin ; Wang, Guiqiang ; Chen, Xinyue ; Lu, Jiajie ; Hou, Jinlin ; Gu, Ye ; Hu, Guoxin ; Yan, Yuemei ; Zou, Guizhou

Background and Aims::

Studies have shown that blocking the programmed cell death-1/programmed cell death ligand 1 pathway may lead to a potential cure for HBV infections. ASC22 (envafolimab) is a humanized, single-domain programmed cell death ligand 1 antibody administered subcutaneously. This study aimed to evaluate the efficacy and safety of ASC22 in virally suppressed patients with chronic hepatitis B on nucleos(t)ide analogs.

Approach and Results::

This randomized, single-blind, phase IIb trial enrolled patients with chronic hepatitis B in 2 cohorts for a 24-week treatment with ASC22 or placebo (PBO) once every 2 weeks and 24-week follow-up. In total, 60, 59, and 30 patients were treated with 1.0, 2.5 mg/kg ASC22, and PBO, respectively. The mean changes in HBsAg from baseline at weeks 24 and 48 were −0.309 (p < 0.001) and −0.272 (p < 0.023) log10 IU/mL in the 1.0 mg/kg ASC22 group, −0.231 (p = 0.007) and −0.205 (p = 0.12) log10 IU/mL in the 2.5 mg/kg ASC22 group, and −0.003 and −0.063 log10 IU/mL in the PBO group, respectively (intent-to-treat population). Three out of 10 patients with baseline HBsAg levels ≤100 IU/mL in the 1.0 mg/kg group obtained on-treatment HBsAg loss. Most adverse events were mild (97.9%). There were no study drug–related serious adverse events in the 1.0 mg/kg ASC22 group.

Conclusions::

Subcutaneous administration of 1.0 mg/kg ASC22 once every 2 weeks for 24 weeks was shown to be safe and well-tolerated in virally suppressed patients with chronic hepatitis B on nucleos(t)ide analogs and can induce HBsAg decline, especially in patients with HBsAg ≤100 IU/mL.

565

项与恩沃利单抗相关的新闻（医药）

2025-08-05

·生物制品圈

康宁杰瑞PD-L1/αvβ6双抗ADC创新药申报临床

8月4日，康宁杰瑞宣布，公司自主研发的PD-L1/αvβ6双特异性抗体偶联药物（ADC）JSKN022新药临床试验（IND）申请，已获中国国家药品监督管理局药品审评中心（CDE）正式受理，即将开展用于晚期恶性实体瘤的首次人体临床研究。 JSKN022是康宁杰瑞基于糖基定点偶联平台开发的创新双抗ADC药物，可同时识别并结合肿瘤细胞表面的PD-L1与αvβ6整合素。康宁杰瑞以自主研发的恩沃利单抗为基础，创新性地将免疫（IO）机制与ADC技术相结合。该药物采用糖基定点偶联技术，提高了稳定性和均一性。通过可裂解连接子将拓扑异构酶Ⅰ抑制剂T01精准偶联至抗体上，提高疗效。该药物与任一靶点结合后通过靶点介导的内吞作用进入到溶酶体中，可切割的连接子在组织蛋白酶B等蛋白水解酶的作用下裂解，定点释放出具有细胞毒性的拓扑异构酶I抑制剂（T01），既可直接诱导抗原阳性细胞凋亡，又可穿透细胞膜在抗原阴性细胞中触发旁观者效应，实现双重抗肿瘤效果。该产品有望为PD-1/PD-L1抑制剂耐药或治疗无效的癌症患者提供全新的治疗选择。临床前数据显示，JSKN022在体外和体内模型中，对整合素αvβ6和/或PD-L1表达阳性的肿瘤细胞具有抗肿瘤活性。JSKN022有望为PD-1/PD-L1抑制剂耐药或治疗无效的肿瘤（如非小细胞肺癌、头颈部鳞状细胞癌、结直肠癌等）患者提供新的治疗选择。 JSKN022的该项1期临床研究将在标准治疗失败的晚期恶性实体瘤患者中评估其安全性、耐受性、药代动力学（PK）/药效学（PD）特征以及抗肿瘤活性，并确定最大耐受剂量（MTD）和/或推荐2期剂量（RP2D）。参考资料：[1]康宁杰瑞PD-L1/αvβ6双抗ADC创新药JSKN022临床试验申请获受理. From https://www.prnasia.com/story/498549-1.shtml 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

抗体药物偶联物临床1期临床申请

2025-08-05

·医药观澜

速递丨康宁杰瑞PD-L1/αvβ6双抗ADC创新药申报临床

8月4日，康宁杰瑞宣布，公司自主研发的PD-L1/αvβ6双特异性抗体偶联药物（ADC）JSKN022新药临床试验（IND）申请，已获中国国家药品监督管理局药品审评中心（CDE）正式受理，即将开展用于晚期恶性实体瘤的首次人体临床研究。 JSKN022是康宁杰瑞基于糖基定点偶联平台开发的创新双抗ADC药物，可同时识别并结合肿瘤细胞表面的PD-L1与αvβ6整合素。康宁杰瑞以自主研发的恩沃利单抗为基础，创新性地将免疫（IO）机制与ADC技术相结合。该药物采用糖基定点偶联技术，提高了稳定性和均一性。通过可裂解连接子将拓扑异构酶Ⅰ抑制剂T01精准偶联至抗体上，提高疗效。该药物与任一靶点结合后通过靶点介导的内吞作用进入到溶酶体中，可切割的连接子在组织蛋白酶B等蛋白水解酶的作用下裂解，定点释放出具有细胞毒性的拓扑异构酶I抑制剂（T01），既可直接诱导抗原阳性细胞凋亡，又可穿透细胞膜在抗原阴性细胞中触发旁观者效应，实现双重抗肿瘤效果。该产品有望为PD-1/PD-L1抑制剂耐药或治疗无效的癌症患者提供全新的治疗选择。临床前数据显示，JSKN022在体外和体内模型中，对整合素αvβ6和/或PD-L1表达阳性的肿瘤细胞具有抗肿瘤活性。JSKN022有望为PD-1/PD-L1抑制剂耐药或治疗无效的肿瘤（如非小细胞肺癌、头颈部鳞状细胞癌、结直肠癌等）患者提供新的治疗选择。 JSKN022的该项1期临床研究将在标准治疗失败的晚期恶性实体瘤患者中评估其安全性、耐受性、药代动力学（PK）/药效学（PD）特征以及抗肿瘤活性，并确定最大耐受剂量（MTD）和/或推荐2期剂量（RP2D）。参考资料：[1]康宁杰瑞PD-L1/αvβ6双抗ADC创新药JSKN022临床试验申请获受理. From https://www.prnasia.com/story/498549-1.shtml免责声明：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。

抗体药物偶联物临床申请临床2期临床1期

2025-08-04

·药研网

康宁杰瑞：全球首创 PD-L1/αvβ6 双抗ADC新药临床试验申请获受理

8月4日，康宁杰瑞生物制药宣布，其自主研发的PD-L1/αvβ6双抗ADC（JSKN022）新药临床试验（IND）申请已获国内CDE正式受理，即将开展用于晚期恶性实体瘤的首次人体临床研究。JSKN022是一种全球首创的双靶点抗体偶联药物（ADC），同时靶向PD-L1和整合素αvβ6。康宁杰瑞以自主研发的恩沃利单抗（Envafolimab）为基础，创新性地将免疫（IO）机制与ADC技术相结合。该药物采用糖基定点偶联技术，提高了稳定性和均一性。通过可裂解连接子将拓扑异构酶Ⅰ抑制剂T01精准偶联至抗体上，提高疗效。据其新闻稿，目前全球范围内尚无靶向整合素αvβ6或PD-L1的ADC上市，相关在研药物均处于临床研究阶段。临床前数据显示，JSKN022在体外和体内模型中，对整合素αvβ6和/或PD-L1表达阳性的肿瘤细胞具有抗肿瘤活性。JSKN022有望为PD-1/PD-L1抑制剂耐药或治疗无效的肿瘤（如非小细胞肺癌、头颈部鳞状细胞癌、结直肠癌等）患者提供新的治疗选择。JSKN022的该项Ⅰ期临床研究将在标准治疗失败的晚期恶性实体瘤患者中评估其安全性、耐受性、药代动力学（PK）/药效学（PD）特征以及抗肿瘤活性，并确定最大耐受剂量（MTD）和/或推荐II期剂量（RP2D）。截止收盘，康宁杰瑞股票上涨1.38%。End声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，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/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾1港股创新药走出至暗时刻2License-out潮来袭：谁是下一个出海爆款?3高盛发声：中国创新药价值重估时代来临

抗体药物偶联物临床1期临床申请临床2期

100 项与恩沃利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15769

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
结直肠癌	中国	四川思路康瑞药业有限公司	2021-11-24
MSI-H 实体瘤	中国	四川思路康瑞药业有限公司	2021-11-24

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
非小细胞肺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2023-11-27
非小细胞肺癌IIIB期	临床3期	中国	四川思路康瑞药业有限公司	2023-11-17
局部晚期直肠癌	临床3期	中国	浙江大学医学院附属邵逸夫医院（浙江省邵逸夫医院）	2023-04-01
胆管癌	临床3期	中国	四川思路康瑞药业有限公司	2018-04-16
胆管癌	临床3期	中国	苏州康宁杰瑞生物科技有限公司	2018-04-16
转移性胆道癌	临床3期	中国	四川思路康瑞药业有限公司	2018-04-16
转移性胆道癌	临床3期	中国	苏州康宁杰瑞生物科技有限公司	2018-04-16
转移性胆囊癌	临床3期	中国	苏州康宁杰瑞生物科技有限公司	2018-04-16
转移性胆囊癌	临床3期	中国	四川思路康瑞药业有限公司	2018-04-16
晚期胆道癌	临床3期	-	思路迪生物医药（上海）有限公司	-

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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


NCT04891198 (ASCO2025) 人工标引	临床2期	晚期恶性实体瘤 TMB-High	70	Envafolimab (tTMB≥13 mut/Mb)	夢範願衊艱壓鬱餘網夢(醖壓構簾憲齋網顧夢齋) = 鹽窪壓醖齋艱壓簾艱積鑰窪顧觸構遞廠艱窪簾 (憲範夢網構糧齋膚蓋鑰, 15.6 ~ 55.3) 更多	积极	2025-05-30
NCT04891198 (ASCO2025) 人工标引	临床2期	晚期恶性实体瘤 TMB-High	70	Envafolimab (tTMB<13 mut/Mb)	夢範願衊艱壓鬱餘網夢(醖壓構簾憲齋網顧夢齋) = 鹹鏇餘遞鑰獵蓋憲蓋選鑰窪顧觸構遞廠艱窪簾 (憲範夢網構糧齋膚蓋鑰, 0.5 ~ 14.8) 更多	积极	2025-05-30
ChiCTR2100044981 (ASCO2025)	临床2期	广泛期小细胞肺癌一线	32	Envafolimab + Carboplatin + Etoposide	繭鹹糧蓋範壓鏇鹹醖餘(獵積醖鑰選壓網醖獵鏇) = 糧顧憲糧齋蓋壓鬱積繭夢齋遞糧鑰壓繭夢鏇選 (襯範構製醖糧糧糧觸蓋, 4.83 ~ 7.67) 更多	积极	2025-05-30
ASCO2025	N/A	晚期恶性实体瘤 dMMR \| microsatellite instability high (MSI-H)	17	Envafolimab monotherapy	構鏇顧鹽壓觸觸襯網襯(簾窪顧選顧淵醖鏇壓選) = 顧齋憲製窪糧製獵衊淵醖衊鬱夢鹽網顧蓋齋糧 (餘鏇鏇選廠艱艱顧壓積 ) 更多	积极	2025-05-30
NCT05828381 (Phase II study, ASCO2025)	临床2期	局部晚期食管鳞状细胞癌新辅助	32	Envafolimab + Albumin-bound Paclitaxel + Cisplatin	壓願夢獵鏇窪醖夢廠網(觸範醖顧願廠鏇糧顧衊) = One patient occurred cerebral hemorrhage 簾鏇膚膚醖衊鬱選鑰願 (選窪艱齋壓願鹽鬱觸遞 ) 更多	积极	2025-05-30
NCT05243355 (ASCO2025)	临床2期	鳞状非小细胞肺癌一线	33	Envafolimab + Rh-endostatin + Paclitaxel + Cisplatin	網繭選壓艱夢餘淵餘遞(衊選齋廠餘製鹽憲鹹壓) = 艱選鹽膚鏇願齋鏇製積顧製鑰範顧夢製襯鏇構 (觸餘廠選憲顧範簾範範, 43.0% ~ 83.3%) 更多	积极	2025-05-30
NCT06030934 (ASCO_GI2025) 人工标引	临床2期	晚期胃食管交界处腺癌二线 Microsatellite Stable (MSS) \| HER2 Negative	30	Envafolimab + Lenvatinib + Albumin Paclitaxel (Pts who never received PD-1 or PD-L1 inhibitors before)	範網蓋繭廠憲構顧製製(艱築壓膚網窪衊製壓網) = 簾鹹廠糧壓淵鹽築願範網壓鬱鏇膚鏇淵築範膚 (鹽餘獵鹹顧憲淵鏇餘餘 ) 更多	积极	2025-01-23
NCT06030934 (ASCO_GI2025) 人工标引	临床2期	晚期胃食管交界处腺癌二线 Microsatellite Stable (MSS) \| HER2 Negative	30	Envafolimab + Lenvatinib + Albumin Paclitaxel (Pts have failed first-line PD-1 antibody combined chemotherapy, with optimal efficacy as or above stable disease)	範網蓋繭廠憲構顧製製(艱築壓膚網窪衊製壓網) = 窪鹽繭觸製淵鑰襯簾齋網壓鬱鏇膚鏇淵築範膚 (鹽餘獵鹹顧憲淵鏇餘餘 ) 更多	积极	2025-01-23
NCT05529355 (ESMO_ASIA2024) 人工标引	临床2期	非小细胞肺癌末线 \| 二线	20	Envafolimab 150mg + Chemotherapy/Anti-VEGF	艱選衊繭繭蓋廠獵鹽鹽(簾糧觸製鹹獵艱壓窪憲) = 艱艱鏇構壓鏇製觸廠遞糧範醖憲淵築廠襯膚築 (遞鹹顧衊網遞選選積餘 ) 更多	积极	2024-12-07
ChiCTR2200055407 (Pubmed)	临床2期	肝细胞癌一线	36	仑伐替尼+恩沃利单抗	齋觸衊艱鹹鹹壓壓願鹽(顧齋遞觸遞簾選憲蓋鬱) = 鏇鏇觸築壓網製鏇鏇遞廠獵壓遞繭衊鑰艱製襯 (鹹憲糧齋廠齋範衊築範 ) 更多	积极	2024-12-01
NCT05243355 (WCLC2024) 人工标引	临床2期	鳞状非小细胞肺癌一线	26	Envafolimab	顧網觸廠衊糧鬱壓鏇網(積廠鑰築艱夢築獵鬱蓋) = 積廠壓壓壓衊製膚簾淵願鏇餘淵膚鬱築獵範鏇 (鹹鏇構襯選鑰遞選簾鬱 ) 更多	积极	2024-09-09
WCLC2024 人工标引	临床2期	非小细胞肺癌一线 driver gene-negative	29	EnvafolimabRh-endostatin	壓鏇蓋鏇範繭壓顧餘鹽(製餘襯遞衊築獵鬱襯繭) = 遞糧範餘齋鹽獵築鹽餘窪襯簾遞鬱鬱鏇鑰簾鏇 (選積鬱範醖鬱蓋餘夢鏇, 76.8 ~ 109.4) 更多	积极	2024-09-09