Cretostimogene Grenadenorepvec(Cretostimogene Grenadenorepvec) - 药物靶点：CSF-2R_在研适应症：非肌层浸润性膀胱肿瘤，肌层浸润性膀胱癌_专利_临床

概要

基本信息

药物类型

溶瘤病毒

别名

CG 0070、CG-0070、CG0700

靶点

CSF-2R

作用方式

刺激剂

作用机制

CSF-2R刺激剂(粒细胞 - 巨噬细胞集落刺激因子受体复合体刺激剂)

治疗领域

肿瘤泌尿生殖系统疾病

在研适应症

非肌层浸润性膀胱肿瘤肌层浸润性膀胱癌

非在研适应症

浸润性膀胱癌非肌层浸润性膀胱尿路上皮癌乳头状原位癌+ [2]

原研机构

在研机构

非在研机构

Kissei Pharmaceutical Co., Ltd.FUJIFILM Diosynth Biotechnologies Texas LLC

权益机构

Kissei Pharmaceutical Co., Ltd.

乐普生物科技股份有限公司

Cell Genesys, Inc.

+ [5]

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评突破性疗法 (美国)、快速通道 (美国)、突破性疗法 (中国)

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结构/序列

Sequence Code 563340306

关联

13

项与 Cretostimogene Grenadenorepvec 相关的临床试验

NCT07283835

/ Recruiting临床2期

A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of CG0070 Injection in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer

This study aims to evaluate the efficacy and safety of CG0070 injection in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.

开始日期2025-12-04

申办/合作机构

乐普生物科技股份有限公司

NCT06567743

/ Recruiting临床2期

A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.

开始日期2024-09-16

申办/合作机构

CG Oncology, Inc.

NCT06253845

/ Active, not recruiting临床1期IIT

A Phase 1b, Single Arm Study of CG0070 After Transurethral Resection in Patients With Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

Investigators will evaluate the safety of CG0070 for the treatment of patients with Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).

开始日期2024-03-01

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

100 项与 Cretostimogene Grenadenorepvec 相关的临床结果

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100 项与 Cretostimogene Grenadenorepvec 相关的转化医学

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100 项与 Cretostimogene Grenadenorepvec 相关的专利（医药）

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18

项与 Cretostimogene Grenadenorepvec 相关的文献（医药）

2026-01-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Oncolytic virotherapy: Molecular mechanisms, delivery strategies, and translational insights

Review

作者: Xavier, Pedro Luiz Porfirio ; Fukumasu, Heidge ; Nunes, Alanne Tenório ; Qazi, Talal Jamil

Despite major gains with immunotherapy, many tumors remain non-responsive because of poor antigen release and a suppressive tumor microenvironment (TME). Oncolytic virotherapy (OVT) directly lyses cancer cells and secondarily inflames the TME via immunogenic cell death and type I interferon (IFN-I) signaling. Here we present primary clinical and preclinical evidence on (i) mechanisms that govern OV selectivity and immune priming, (ii) genetic engineering strategies linked to clinical signals, and (iii) translational lessons across species, with emphasis on companion-animal oncology as a bridge to human trials. We highlight trials where OVs prime checkpoint response (e.g., DNX-2401→pembrolizumab in recurrent glioblastoma) and where vector design (e.g., TK-deleted vaccinia, CG0070) or payloads (e.g., IFNβ, NIS) drive measurable benefit. We conclude with actionable priorities, patient selection by IFN-pathway competence, receptor-tropism panels, and rational OV-ICI sequencing, to accelerate durable responses.

2025-11-01·CURRENT OPINION IN UROLOGY

Oncolytic virus therapy for nonmuscle-invasive bladder cancer: current status and future directions

Review

作者: Kitamura, Hiroshi ; Nishiyama, Naotaka

Purpose of review:

Nonmuscle-invasive bladder cancer (NMIBC) patients with BCG-unresponsive disease have limited treatment options beyond radical cystectomy. With ongoing BCG shortages and the urgent need for bladder-preserving alternatives, this review examines the emerging role of oncolytic virus therapy as a novel intravesical treatment approach for this challenging patient population.

Recent findings:

Multiple oncolytic viral platforms have entered clinical trials for NMIBC treatment, demonstrating promising efficacy and safety profiles. Cretostimogene grenadenorepvec has shown exceptional results in a phase 3 trial, achieving 74.5% complete response rates with durable responses exceeding 27 months in BCG-unresponsive carcinoma in situ. Combination therapy with pembrolizumab further enhanced efficacy, with a 57.1% complete response rate at 12 months and no progression to muscle-invasive disease. Other viral platforms, including herpes simplex, coxsackie, and measles viruses, have demonstrated preliminary antitumor activity with favorable safety profiles. These agents utilize three mechanisms of action: selective viral replication, direct oncolysis, and immune system activation.

Summary:

Oncolytic virus therapy represents a paradigm shift toward an effective bladder-preserving treatment for BCG-unresponsive NMIBC. With phase 3 data supporting regulatory approval pathways, these therapies are poised to become new standards of care, offering hope for improved outcomes while avoiding radical surgery.

2025-11-01·CURRENT OPINION IN UROLOGY

Gene-mediated therapy for BCG-unresponsive nonmuscle-invasive bladder cancer: mechanisms, clinical evidence, and practical implementation

Review

作者: Teoh, Jeremy Yuen-Chun ; Leung, David Ka-Wai ; Wong, Chris Ho-Ming ; Gontero, Paolo

Purpose of review:

Gene therapy has emerged as an attractive bladder-sparing strategy for patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle-invasive bladder cancer (NMIBC), addressing a therapeutic gap for those ineligible for or declining radical cystectomy. This review aims to describe the recent advances in gene-mediated therapies for BCG-unresponsive NMIBC.

Recent findings:

The bladder's unique anatomy with direct intravesical access and capacity for high local exposure with minimal systemic absorption provides an ideal context for gene delivery. Advances in barrier modulation with Syn3 and vector engineering have enabled efficient delivery. Adenoviral vectors as illustrated by the FDA-approved nadofaragene firadenovec (Adstiladrin), and other platforms, such as the conditionally replicating oncolytic adenoviruses (cretostimogene, CG0070), are maturing. Combination regimens of gene therapy and immune checkpoint inhibitors have shown additive or synergistic activity, deepening durability of gene therapy. Novel advancements including urinary and plasma tumor DNA are emerging as predictive biomarkers to guide patient selection, monitor minimal residual disease, and trigger early salvage.

Summary:

Gene-mediated therapy is gradually advancing NMIBC care, with expanding indications and potent combinations positing itself to improve bladder preservation and long-term outcomes.

202

项与 Cretostimogene Grenadenorepvec 相关的新闻（医药）

2025-12-19

·证券之星

乐普生物-B（02157.HK）：12月19日南向资金增持11.6万股

证券之星消息，12月19日南向资金增持11.6万股乐普生物-B（02157.HK）。近5个交易日中，获南向资金增持的有4天，累计净增持36.28万股。近20个交易日中，获南向资金减持的有11天，累计净减持413.05万股。截至目前，南向资金持有乐普生物-B（02157.HK）4.57亿股，占公司已发行普通股的25.3%。乐普生物科技股份有限公司是一家主要从事医药产品销售及新药研发的公司。该公司聚焦于肿瘤治疗领域，尤其是靶向治疗及免疫治疗。该公司致力于通过抗体药物偶联物（ADC）技术开发平台开发创新型ADC。该公司的临床阶段候选药物涵盖靶向疗法药物和一种免疫治疗药物，具体包括MRG003、MRG002、CMG901、MRG004A、CG0070、MRG006A、MRG007、CTM012等。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。

抗体药物偶联物免疫疗法

2025-12-19

·证券之星

乐普生物-B（02157.HK）12月19日收盘涨5.23%，主力资金净流入89.44万港元

证券之星消息，截至2025年12月19日收盘，乐普生物-B(02157.HK)报收于5.43港元，上涨5.23%，成交量808.3万股，成交额4362.42万港元。资金流向数据方面，12月19日乐普生物-B主力资金净流入89.44万港元，超大单资金净流入69.55万港元，大单资金净流入19.89万港元，中单资金净流入941.44万港元，小单资金净流入55.95万港元。投行对该股的评级以增持为主，近90天内共有1家投行给出增持评级，近90天的目标均价为10.38港元。国泰海通证券股份有限公司最新一份研报给予乐普生物-B增持评级，目标价10.38港元。乐普生物科技股份有限公司是一家主要从事医药产品销售及新药研发的公司。该公司聚焦于肿瘤治疗领域，尤其是靶向治疗及免疫治疗。该公司致力于通过抗体药物偶联物（ADC）技术开发平台开发创新型ADC。该公司的临床阶段候选药物涵盖靶向疗法药物和一种免疫治疗药物，具体包括MRG003、MRG002、CMG901、MRG004A、CG0070、MRG006A、MRG007、CTM012等。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。

2025-12-17

·搜狐新闻

乐普生物-B（02157.HK）：12月17日南向资金增持112.98万股

证券之星消息，12月17日南向资金增持112.98万股乐普生物-B（02157.HK）。近5个交易日中，获南向资金减持的有2天，累计净减持299.52万股。近20个交易日中，获南向资金减持的有13天，累计净减持1265.75万股。截至目前，南向资金持有乐普生物-B（02157.HK）4.55亿股，占公司已发行普通股的25.2%。乐普生物科技股份有限公司是一家主要从事医药产品销售及新药研发的公司。该公司聚焦于肿瘤治疗领域，尤其是靶向治疗及免疫治疗。该公司致力于通过抗体药物偶联物（ADC）技术开发平台开发创新型ADC。该公司的临床阶段候选药物涵盖靶向疗法药物和一种免疫治疗药物，具体包括MRG003、MRG002、CMG901、MRG004A、CG0070、MRG006A、MRG007、CTM012等。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

抗体药物偶联物免疫疗法

100 项与 Cretostimogene Grenadenorepvec 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
非肌层浸润性膀胱肿瘤	临床3期	美国	CG Oncology, Inc.	2020-10-27
非肌层浸润性膀胱肿瘤	临床3期	日本	CG Oncology, Inc.	2020-10-27
非肌层浸润性膀胱肿瘤	临床3期	澳大利亚	CG Oncology, Inc.	2020-10-27
非肌层浸润性膀胱肿瘤	临床3期	韩国	CG Oncology, Inc.	2020-10-27
非肌层浸润性膀胱肿瘤	临床3期	中国台湾	CG Oncology, Inc.	2020-10-27
乳头状原位癌	临床3期	美国	CG Oncology, Inc.	2014-03-01
膀胱尿路上皮癌	临床3期	美国	CG Oncology, Inc.	2014-03-01
浸润性膀胱癌	临床2期	美国	CG Oncology, Inc.	2014-03-01
肌层浸润性膀胱癌	临床1期	美国	CG Oncology, Inc.	2020-10-26
非肌层浸润性膀胱尿路上皮癌	临床1期	美国	Cell Genesys, Inc.	2005-04-01

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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


NCT04452591 (BOND-003, AUA2025 \| Company_Website) 人工标引	临床3期	非肌层浸润性膀胱肿瘤	110	Intravesical Cretostimogene Grenadenorepvec	窪齋鹹襯艱襯壓襯醖簾(鹹願築構鑰網蓋鬱製遞) = 網簾鹹壓蓋膚鹹繭夢觸餘鏇糧製範憲壓積積構 (艱鑰鏇衊範獵獵蓋淵憲, 52.4 ~ 73.7) 更多	积极	2025-05-01
NCT04452591 (BOND-003, Company_Website) 人工标引	临床3期	非肌层浸润性膀胱肿瘤	112	Cretostimogene Grenadenorepvec	願鏇艱醖願鬱醖膚鑰餘(衊遞鑰淵網選齋網構範) = 顧淵鏇餘艱觸顧憲範齋鏇衊積醖淵廠繭簾繭夢 (窪範襯顧膚鹹鹹蓋構淵, 65.4 ~ 82.4) 更多	积极	2024-12-05
NCT04387461 (CORE-001, ASCO2024) 人工标引	临床2期	非肌层浸润性膀胱肿瘤 alterations in the retinoblastoma pathway \| GM-CSF transgene \| viral receptor expression ... 更多	35	Cretostimogene grenadenorepvec + Pembrolizumab	遞鹹構襯衊構鹹醖觸艱(蓋鑰觸蓋襯選觸選顧齋) = 廠網夢餘網廠選築鏇顧築鏇壓廠遞衊顧壓鬱廠 (鏇糧廠遞醖簾繭願艱遞, 40 ~ 73) 更多	积极	2024-05-24
NCT04452591 (BOND-003, Company_Website) 人工标引	临床3期	非肌层浸润性膀胱肿瘤	112	Cretostimogene monotherapy	鬱糧積獵鬱餘觸簾鹹鏇(繭鏇醖糧襯蓋艱構鑰鑰) = 餘鏇衊鬱鬱憲築淵鬱餘廠積窪淵憲遞齋鬱網顧 (餘艱襯窪廠蓋簾顧積製, 65 ~ 83) 更多	积极	2024-05-03
NCT04452591 (BOND-003, NEWS) 人工标引	临床3期	非肌层浸润性膀胱肿瘤	66	cretostimogene grenadenorepvec	構簾壓網繭醖選選餘獵(選襯醖齋壓醖鹽構齋鹽) = 衊膚糧齋網鹹廠遞獵顧醖繭願築顧鹹鑰鹹願鏇 (衊衊鹽艱鬱製鹹簾積願, 63 ~ 85) 更多	积极	2023-12-07
NCT04610671 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	非肌层浸润性膀胱肿瘤新辅助	21	CG 0070+Nivolumab	鬱範遞餘艱簾鹽夢鹽襯(鑰窪窪膚襯鹹獵衊築鹽) = 顧壓鏇鏇選艱製範夢夢觸願餘願網廠蓋襯遞觸 (積網遞構夢餘醖範選膚 ) 更多	积极	2023-05-31
NCT04387461 (CORE1, AUA2023)	临床2期	非肌层浸润性膀胱肿瘤 mutated or deficient RB	35	CG0070	選鏇鏇簾選窪遞範淵襯(鏇壓鬱觸鑰築廠壓鑰鏇) = 鑰顧鑰鏇積鹹築窪觸艱廠衊糧糧壓夢襯襯窪選 (鑰鏇廠製願鹽夢衊餘簾 ) 更多	-	2023-04-01
NCT04387461 (CORE1, AUA2023)	临床2期	非肌层浸润性膀胱肿瘤 mutated or deficient RB	35	Pembrolizumab	夢積願範遞窪顧範壓繭(襯窪鑰艱獵顧淵廠廠獵) = 蓋窪襯廠顧糧夢壓齋鹽築鬱獵衊廠齋蓋繭鹽襯 (簾膚餘繭廠製鑰顧構遞 ) 更多	-	2023-04-01
NCT04387461 (CORE1, BusinessWire) 人工标引	临床2期	非肌层浸润性膀胱肿瘤	32	pembrolizumab+CG0070	積壓齋鏇網膚鹽遞窪齋(鹹醖積壓顧鏇齋選鏇遞) = 構顧鑰醖顧選鏇選遞顧觸繭選簾淵糧鹽醖觸顧 (糧鏇繭選願廠糧壓鹽顧 ) 更多	积极	2022-11-10
NCT04452591 (AACR2022)	临床3期	非肌层浸润性膀胱肿瘤	110	CG0070	餘築蓋壓顧鏇淵製淵醖(簾廠糧鬱鹹獵築壓製獵) = 願範觸網選衊簾選範築獵繭衊構繭衊廠製艱鏇 (鑰簾選艱淵夢顧餘醖遞 )	-	2022-06-15
NCT04387461 (CORE1, AACR2022)	临床2期	非肌层浸润性膀胱肿瘤	35	CG0070	選壓醖廠積襯夢鑰襯壓(構觸顧淵積網憲鹹觸憲) = 製觸顧觸膚積觸鏇顧齋襯鏇範鬱構廠簾積憲積 (糧淵餘網艱網衊鬱遞憲 ) 更多	-	2022-06-15
NCT04387461 (CORE1, AACR2022)	临床2期	非肌层浸润性膀胱肿瘤	35	Pembrolizumab	選壓醖廠積襯夢鑰襯壓(網艱網觸簾繭積築簾觸) = 壓齋選廠觸糧鬱齋構顧鬱鹽積製衊艱艱鑰構選 (夢膚積衊衊醖憲顧醖鹹 ) 更多	-	2022-06-15