昂戈瑞西单抗(Ongericimab) - 药物靶点：PCSK9_在研适应症：杂合子家族性高胆固醇血症，复杂性血脂异常，原发性高胆固醇血症_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

重组人源化抗PCSK9单克隆抗体（上海君实）、重组人源化抗PCSK9单抗 (上海君实)、JS 002

+ [3]

靶点

PCSK9

作用方式

抑制剂

作用机制

PCSK9抑制剂(前蛋白转化酶枯草杆菌蛋白酶Kexin-9抑制剂)

治疗领域

内分泌与代谢疾病其他疾病遗传病与畸形+ [2]

在研适应症

杂合子家族性高胆固醇血症复杂性血脂异常原发性高胆固醇血症+ [3]

非在研适应症

晚期癌症动脉粥样硬化合并高脂血症

原研机构

上海君实生物医药科技股份有限公司

在研机构

上海君实生物医药科技股份有限公司

非在研机构-

权益机构

植恩生物技术股份有限公司

上海君实生物医药科技股份有限公司

最高研发阶段批准上市

首次获批日期

中国 (2024-10-09),

复杂性血脂异常原发性高胆固醇血症

最高研发阶段(中国)批准上市

特殊审评-

登录后查看时间轴

结构/序列

Sequence Code 524305457H

来源: *****

Sequence Code 524305458L

来源: *****

关联

10

项与昂戈瑞西单抗相关的临床试验

NCT07106034

/ Not yet recruiting临床2期IIT

Clinical Study of Second-Line Standard Therapy Combined With Ongericimab and Toripalimab in Patients With MSS/pMMR Colorectal Cancer Following First-Line Treatment Failure

The ONTOP study is a prospective, single-arm, open-label phase II clinical trial. A total of 32 patients with advanced MSS/pMMR colorectal cancer who have failed first-line treatment will receive second-line standard treatment combined with Ongericimab and toripalimab. Among them, patients who received irinotecan-containing treatment in the first line will be administered the regimen of Ongericimab + toripalimab + bevacizumab + FOLFOX. Patients who received oxaliplatin-containing treatment in the first line will be administered the regimen of Ongericimab + toripalimab + bevacizumab + FOLFIRI. Treatment will continue until disease progression, initiation of new anti-tumor treatment, active request of the subject, or determination by the investigator that study drug administration needs to be terminated. The primary study endpoint is the objective response rate (ORR), and the secondary study endpoints include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety, etc.

开始日期2025-08-31

申办/合作机构

上海市浦东医院

[+1]

NCT05859529

/ Completed临床1期

A Single-center, Randomized, Open-label, Parallel-controlled Study Was Conducted to Compare the Pharmacokinetics of JS002 When Delivered Subcutaneously Via a Prefilled Syringe Versus a Prefilled Autosyringe in Healthy Subjects

This study was a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects. Subjects were randomly assigned to 1 of 2 parallel treatment groups: treatment group A received a single subcutaneous injection of JS002 150 mg via PFS, and treatment group B received a single subcutaneous injection of JS002 150 mg via AI. Subjects were followed up to study day 85 for pharmacokinetic equivalence assessment of JS002. A total of 159 subjects were planned to be included in each group. After signing the informed consent form and completing the screening examination, subjects will be randomly assigned to treatment arm A or treatment arm B if eligible for inclusion.
The study period consisted of a screening period of up to 21 days and a follow-up period of 12 weeks (85 days). Subjects were admitted to the phase I clinical research unit the day before dose administration (day 1) and were not allowed to leave until all examinations and assessments were completed on day 6 after dose administration and were allowed to return to the clinical research center for follow-up visits on days 8,11,15,22,29,43,57,71, and 85.

开始日期2023-05-30

申办/合作机构

上海君实生物医药科技股份有限公司

NCT05621070

/ Recruiting临床3期

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.
In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.

开始日期2023-02-03

申办/合作机构

上海君实生物医药科技股份有限公司

100 项与昂戈瑞西单抗相关的临床结果

登录后查看更多信息

100 项与昂戈瑞西单抗相关的转化医学

登录后查看更多信息

100 项与昂戈瑞西单抗相关的专利（医药）

登录后查看更多信息

5

项与昂戈瑞西单抗相关的文献（医药）

2025-08-01·ATHEROSCLEROSIS

Efficacy and safety of ongericimab in Chinese statin-intolerant patients with primary hypercholesterolemia or mixed dyslipidemia: a randomized, placebo-controlled phase 3 trial

Article

作者: Li, Lipeng ; Shao, Cong ; Zhang, Shanchun ; Ma, Jinxia ; Pei, Zhaohui ; Cheng, Zhifeng ; Hao, Yu ; Yang, Keping ; Yang, Haibo ; Ji, Yuan ; Shao, Chunli ; Li, Hua ; Tang, Yi-da ; Li, Yang ; Zhang, Yumin ; Zheng, Yang ; Wang, Gaopin ; Shi, Xiaoxia ; Zhang, Mengqi ; Zhang, Shu

BACKGROUND AND AIMS:

Several protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to significantly reduce low-density lipoprotein cholesterol (LDL-C) levels in statin-intolerant patients, but none have been verified in Chinese patients. This study aimed to evaluate the efficacy and safety of ongericimab, a novel PCSK9 monoclonal antibody, in Chinese statin-intolerant patients with primary hypercholesterolemia or mixed dyslipidemia.

METHODS:

This was a randomized, multicenter, double-blind, placebo-controlled phase 3 study designed to enroll 120 statin-intolerant adult patients. Eligible patients were randomly assigned in a 2:1 ratio to receive ongericimab 150 mg or placebo subcutaneously every 2 weeks for 12 weeks in the double-blind treatment period, followed by 40 weeks of ongericimab treatment during the open-label period. The primary endpoint was a percentage change in LDL-C from baseline to week 12. The key secondary endpoints included percentage change from baseline to week 12 in non-high density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC), and lipoprotein(a) [Lp(a)].

RESULTS:

From February 6, 2023, to September 23, 2024, a total of 139 patients were enrolled. The least-squares (LS) mean difference between ongericimab and placebo groups in LDL-C from baseline to week 12 was -66.2 % (95 % CI: 74.2 %, -58.2 %; p < 0.0001), with reductions sustained up to week 52. Ongericimab also significantly reduced levels of non-HDL-C, ApoB, TC, and Lp(a). The overall incidence of treatment-emergent adverse events was comparable between the ongericimab and placebo groups.

CONCLUSION:

Ongericimab significantly reduced LDL-C as well as other atherogenic lipid levels and was well tolerated in Chinese statin-intolerant patients with primary hypercholesterolemia or mixed dyslipidemia.

CLINICAL TRIAL REGISTRATION:

http://www.

CLINICALTRIALS:

gov; Unique Identifier: NCT05621070.

2025-04-01·ATHEROSCLEROSIS

Efficacy and safety of ongericimab in Chinese patients with heterozygous familial hypercholesterolemia: A randomized, double-blind, placebo-controlled phase 3 trial

Article

作者: Zhang, Mengqi ; Lin, Jie ; Xu, Guangma ; Hao, Yu ; Huang, Wei ; Yan, Peishi ; Han, Xuebin ; Tang, Yida ; Yu, Jianjun ; Qiao, Ping ; Chen, Jie ; Yao, Zhuhua ; Chen, Jiyan ; Wang, Minghui ; Peng, Daoquan ; Ma, Xueping ; Ji, Yuan ; He, Yongming ; Wang, Gaopin ; Ma, Changsheng

BACKGROUND AND AIMS:

Heterozygous familial hypercholesterolemia (HeFH) is a prevalent autosomal dominant disorder of lipid metabolism but severely underdiagnosed and undertreated in China. This phase 3 trial aims to evaluate the efficacy and safety of ongericimab, a novel monoclonal antibody that targets proprotein convertase subtilisin/kexin type 9 (PCSK9), in Chinese patients with HeFH.

METHODS:

Patients who have been diagnosed with definite HeFH according to Dutch Lipid Clinical Network criteria and receiving stable and optimized lipid-lowering therapy were enrolled. A total of 135 patients were randomly assigned in a 2:1:2:1 ratio to receive either ongericimab 150 mg or matching placebo every 2 weeks (Q2W), or ongericimab 450 mg or matching placebo every 4 weeks (Q4W) for 24 weeks. Patients were stratified according to the use of high-intensity statins. The primary endpoint was the percentage change in LDL-C from baseline to week 24.

RESULTS:

Our findings demonstrated that treatment with ongericimab resulted in a significant reduction in LDL-C at week 24. The least-squares mean difference was -69.4 % (95 % confidence interval [CI]: -80.9 %, -57.9 %; p < 0.0001) for the ongericimab 150 mg Q2W group, and -80.6 % (95 % CI: -92.1 %, -69.1 %; p < 0.0001) for ongericimab 450 mg Q4W group compared to respective matching placebo groups. Meanwhile, ongericimab also favorably altered other lipid parameters. A similar incidence of adverse events was observed in the ongericimab and placebo groups.

CONCLUSIONS:

Ongericimab administered at either 150 mg Q2W or 450 mg Q4W for 24 weeks, significantly reduced LDL-C levels and was well-tolerated in Chinese patients with HeFH.

CLINICAL TRIAL REGISTRATION:

http://www.

CLINICALTRIALS:

gov; Unique Identifier: NCT05325203.

2024-09-01·NUTRITION METABOLISM AND CARDIOVASCULAR DISEASES

Efficacy and safety of ongericimab given by prefilled syringe or autoinjector in primary hypercholesterolemia and mixed hyperlipidemia

Article

作者: Ji, Xianyou ; Wang, Gaopin ; Wu, Yanqing ; Pei, Zhaohui ; Bai, Xuelian ; Cheng, Zhifeng ; Huang, Zhouqing ; Zhao, Yi ; Yang, Keping ; Wang, Minghui ; Zhao, Wang ; Zhao, Shuiping

BACKGROUND AND AIMS:

Limited evidence exist regarding the association between ongericimab, a novel recombinant humanized anti-PCSK9 monoclonal antibody, and primary hypercholesterolemia and mixed dyslipidemia. This study aimed to evaluate the efficacy and safety of ongericimab administered by prefilled syringe (PFS) or autoinjector (AI) in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia on stable optimized lipid-lowering therapy.

METHODS AND RESULTS:

A total of 255 patients on stable optimized lipid-lowering therapy were randomized in a 2:1:2:1 ratio to receive PFS for the subcutaneous injection of ongericimab 150 mg every 2 weeks (Q2W) or a matching placebo, or AI for the subcutaneous injection of ongericimab 150 mg Q2W or a matching placebo. The primary efficacy endpoint was the percent change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to week 12. Safety was also evaluated. At week 12, the least squares mean percent changes were -72.7% (3.9%) for PFS and -71.1% (3.8%) for AI (all P < 0.001) compared to respective matching placebo groups. Beneficial effects were also seen for all secondary lipid parameters, notably with robust reduction in Lp (a). Treatment-emergent adverse events (TEAEs) and serious AEs with ongericimab were reported in 46.2% and 2.4% of patients, compared to 44.2% and 3.5% with placebo.

CONCLUSION:

In Chinese patients with primary hypercholesterolemia and mixed dyslipidemia, a 12-week treatment regimen with ongericimab administered by PFS or AI significantly reduced LDL-C and other lipid parameters, proving to be safe and well tolerated. Patients experienced consistent effects from PFS or AI devices.

CLINICAL TRIAL REGISTRATION:

CTR20220027; January 11, 2022; http://www.chinadrugtrials.org.cn/index.html.

171

项与昂戈瑞西单抗相关的新闻（医药）

2025-11-07

·证券之星

君实生物（01877.HK）11月7日收盘跌5.62%，主力资金净流入444.95万港元

证券之星消息，截至2025年11月7日收盘，君实生物(01877.HK)报收于24.52港元，下跌5.62%，成交量588.92万股，成交额1.47亿港元。资金流向数据方面，11月7日君实生物主力资金净流入444.95万港元，超大单资金净流入751.06万港元，大单资金净流出306.11万港元，中单资金净流出2552.16万港元，小单资金净流出630.14万港元。投行对该股的评级以跑赢行业(OUTPERFORM)为主，近90天内共有2家投行给出跑赢行业(OUTPERFORM)评级，近90天的目标均价为35.49港元。中金公司最新一份研报给予君实生物跑赢行业(OUTPERFORM)评级，目标价36.98港元。上海君实生物医药科技股份有限公司是一家主要从事创新驱动生物制药业务的中国公司。该公司主营业务为创新药物的发现、临床研究和开发。该公司的主要产品包括特立普珠单抗注射液、依替维单抗、阿达木单抗注射液等用于治疗恶性肿瘤、自身免疫系统疾病、慢性代谢疾病、神经系统疾病和感染性疾病的药物。该公司还从事重组人源化抗PCSK9单克隆抗体注射液等药物的临床研发。该公司主要为国内外市场提供产品。以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成投资建议。

IPO

2025-11-04

·搜狐新闻

君实生物（01877.HK）：11月4日南向资金增持119.3万股

证券之星消息，11月4日南向资金增持119.3万股君实生物（01877.HK）。近5个交易日中，获南向资金减持的有3天，累计净减持72.32万股。近20个交易日中，获南向资金减持的有14天，累计净减持520.1万股。截至目前，南向资金持有君实生物（01877.HK）1.48亿股，占公司已发行普通股的57.03%。上海君实生物医药科技股份有限公司是一家主要从事创新驱动生物制药业务的中国公司。该公司主营业务为创新药物的发现、临床研究和开发。该公司的主要产品包括特立普珠单抗注射液、依替维单抗、阿达木单抗注射液等用于治疗恶性肿瘤、自身免疫系统疾病、慢性代谢疾病、神经系统疾病和感染性疾病的药物。该公司还从事重组人源化抗PCSK9单克隆抗体注射液等药物的临床研发。该公司主要为国内外市场提供产品。以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成投资建议。返回搜狐，查看更多

IPO

2025-11-04

·证券之星

君实生物（01877.HK）11月4日收盘跌2.17%，主力资金净流出1200.75万港元

证券之星消息，截至2025年11月4日收盘，君实生物(01877.HK)报收于26.12港元，下跌2.17%，成交量240.98万股，成交额6332.97万港元。资金流向数据方面，11月4日君实生物主力资金净流出1200.75万港元，超大单资金净流出569.59万港元，大单资金净流出631.17万港元，中单资金净流出473.36万港元，小单资金净流入67.28万港元。投行对该股的评级以买入为主，近90天内共有3家投行给出买入评级，近90天的目标均价为35.49港元。中金公司最新一份研报给予君实生物跑赢行业(OUTPERFORM)评级，目标价36.98港元。上海君实生物医药科技股份有限公司是一家主要从事创新驱动生物制药业务的中国公司。该公司主营业务为创新药物的发现、临床研究和开发。该公司的主要产品包括特立普珠单抗注射液、依替维单抗、阿达木单抗注射液等用于治疗恶性肿瘤、自身免疫系统疾病、慢性代谢疾病、神经系统疾病和感染性疾病的药物。该公司还从事重组人源化抗PCSK9单克隆抗体注射液等药物的临床研发。该公司主要为国内外市场提供产品。以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成投资建议。

IPO

100 项与昂戈瑞西单抗相关的药物交易

登录后查看更多信息

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
杂合子家族性高胆固醇血症	中国	上海君实生物医药科技股份有限公司	2025-05-20
复杂性血脂异常	中国	上海君实生物医药科技股份有限公司	2024-10-09
原发性高胆固醇血症	中国	上海君实生物医药科技股份有限公司	2024-10-09

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
纯合子家族性高胆固醇血症	申请上市	中国	上海君实生物医药科技股份有限公司	2023-04-26
家族性混合型高脂血症	临床3期	中国	上海君实生物医药科技股份有限公司	2020-12-23
晚期结直肠腺癌	临床2期	中国	上海君实生物医药科技股份有限公司	2025-08-31
家族性高胆固醇血症	临床2期	中国	上海君实生物医药科技股份有限公司	2020-08-19
动脉粥样硬化	临床2期	中国	上海君实生物医药科技股份有限公司	2019-05-23
合并高脂血症	临床2期	中国	上海君实生物医药科技股份有限公司	2019-05-23
晚期癌症	临床1期	中国	上海君实生物医药科技股份有限公司	2022-02-10
高胆固醇血症	临床1期	中国	上海君实生物医药科技股份有限公司	2017-12-11

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05325203 (Pubmed \| Atherosclerosis \| NEWS) 人工标引	临床3期	杂合子家族性高胆固醇血症	135	OngericimabOngericimab 150 mg Q2W	鬱鏇鹹構鬱鏇觸範製觸(願淵獵衊鏇鬱蓋齋憲壓) = 積網鹽簾鑰壓願襯鹹積衊構糧觸願鏇簾餘糧網 (構蓋憲積繭襯願鹽築襯 )	积极	2025-04-01
				Placebo Q2W	-
NCT04781114 (JS002-003, Pubmed) 人工标引	临床3期	血脂障碍 \| 原发性高胆固醇血症追加	806	Ongericimab 150 mg every 2 weeks	鏇網簾襯構夢艱淵壓蓋(築淵衊繭壓憲壓鑰夢窪) = 觸蓋鬱餘膚鏇鑰觸獵選繭窪鏇憲憲窪觸憲襯餘 (觸網襯簾鹹鹹願餘積簾, −70.3 ~ −64.4) 更多	积极	2024-06-04
				Placebo every 2 weeks	鏇網簾襯構夢艱淵壓蓋(築淵衊繭壓憲壓鑰夢窪) = 憲艱簾糧鑰艱願網鏇壓繭窪鏇憲憲窪觸憲襯餘 (觸網襯簾鹹鹹願餘積簾, −3.7 ~ 4.5) 更多
CTR20220027 (Literature) 人工标引	临床3期	原发性高胆固醇血症 \| 家族性混合型高脂血症	255	Ongericimab 150 mg Q2W by prefilled syringe	構廠衊積積遞廠蓋願衊(遞壓鬱餘膚壓選鏇蓋獵) = 鏇繭蓋膚遞膚觸願齋窪廠齋鑰繭願鹽繭顧壓鹽 (蓋膚窪齋製鬱選鹽積膚 ) 更多	积极	2024-04-23
				Ongericimab 150 mg Q2W by autoinjector	構廠衊積積遞廠蓋願衊(遞壓鬱餘膚壓選鏇蓋獵) = 遞襯製築艱衊膚醖鏇壓廠齋鑰繭願鹽繭顧壓鹽 (蓋膚窪齋製鬱選鹽積膚 )
NCT04781114 (NEWS) 人工标引	临床3期	复杂性血脂异常 \| 原发性高胆固醇血症	802	昂戈瑞西单抗 150 mg Q2W	選遞製鹽夢蓋鹹壓遞餘(醖艱餘憲窪製繭膚願觸): Difference(%) = -67.74 (95% CI, -72.5 ~ -63.0), P-Value = 0.0001 更多	积极	2023-11-14
				Placebo 150 mg Q2W