Drugs / Endostar
last change 10 days ago re-read 8 days ago

Endostar

Protein / enzyme biologic

Developed for
non-small cell lung carcinoma · nasopharyngeal carcinoma · colorectal cancer · esophageal cancer · gastric cancer · lung cancer · soft tissue sarcoma · esophageal squamous cell carcinoma
+26 more · T-cell non-Hodgkin lymphoma · acral lentiginous melanoma · breast cancer · cervical cancer · cervical carcinoma · cutaneous melanoma · digestive system neoplasm · hepatocellular carcinoma · lung adenocarcinoma · lung neoplasm · melanoma · metastatic malignant neoplasm in the brain · nasopharyngeal neoplasm · neuroblastoma · non-small cell squamous lung carcinoma · osteosarcoma · pancreatic neoplasm · peripheral T-cell lymphoma, not otherwise specified · peritoneal neoplasm · pleural neoplasm · portal vein thrombosis · radiation pneumonitis · small cell lung carcinoma · squamous cell lung carcinoma · colorectal neoplasm · pleural disorder
Investigated by
Jiangsu Simcere Pharmaceutical Co., Ltd. · Fudan University · Simcere Pharmaceutical Co., Ltd · Zhejiang Cancer Hospital · The First People's Hospital of Lianyungang · First Affiliated Hospital of Guangxi Medical University
+68 more · Nanjing NingQi Medicine Science and Technology Co., Ltd. · Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd · Affiliated Hospital of North Sichuan Medical College · Jiangsu Cancer Institute & Hospital · Jiangxi Provincial Cancer Hospital · Peking University Cancer Hospital & Institute · Peking University Third Hospital · The Affiliated Hospital of Xuzhou Medical University · Tianjin Medical University Cancer Institute and Hospital · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Xinqiao Hospital of Chongqing · Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Anhui Chest Hospital · Beijing 302 Hospital · Beijing Chest Hospital · Beijing Shijitan Hospital, Capital Medical University · Beta Pharma, Inc. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · China International Medical Foundation · China Medical University, China · China Three Gorges University, Yichang, China · China-Japan Friendship Hospital · Chinese PLA General Hospital · Chinese Society of Clinical Oncology · Dalian municipal central hospital affiliated of dalian medical university · Dong Wang · Eastern Hepatobiliary Surgery Hospital · Fourth Affiliated Hospital of Guangxi Medical University · General Hospital of Shenyang Military Region · Guangxi Ruikang Hospital · Guilin Medical College · Liaoning Cancer Hospital & Institute · LiuZhou People's Hospital · Liuzhou Workers' Hospital · Mianyang Central Hospital · Nanjing First Hospital, Nanjing Medical University · Panjin Liaohe Oilfield Gem Flower Hospital · Peking Union Medical College Hospital · Peking University · Peking University First Hospital · Peking University International Hospital · Peking University People's Hospital · Peng Yuan · Qianfoshan Hospital · Qingdao Hiser Medical Group · Second Affiliated Hospital of Xi'an Jiaotong University · Second Hospital of Shanxi Medical University · Shandong Cancer Hospital and Institute · Shanghai 411 hospital · Shanghai Jiao Tong University School of Medicine · Shanghai Tong Ren Hospital · Shengjing Hospital · Tang Xushan · Tang-Du Hospital · The Affiliated Changzhou Tumor Hospital of Suzhou University · The Affiliated Hospital Of Guizhou Medical University · The First Affiliated Hospital of Dalian Medical University · The First Affiliated Hospital with Nanjing Medical University · The Second Affiliated Hospital of Dalian Medical University · Third Affiliated Hospital of Guizhou Medical University · Xiangya Hospital of Central South University · Xiansheng Pharmaceutical Company · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Xuzhou Medical University · Yong Chen · Yong Zhang,MD · Yuhong Li · Zhejiang University

Trials 67 · started per year

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT04942301 Jul → Dec 2021 non-small cell lung carcinoma Jiangsu Simcere Pharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 1 NCT02652234 Aug 2015 → Jun 2016 non-small cell lung carcinoma Jiangsu Simcere Pharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 1 NCT01531790 Sep 2011 → Dec 2012 non-small cell lung carcinoma Jiangsu Simcere Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 251 trials · 1 met primary
Phase 2 NCT07818304 Oct 2026 → Apr 2028 expected non-small cell lung carcinoma The First People's Hospital of Lianyungang Not yet recruiting No outcome recorded
Phase 2 NCT06965231 Jan 2025 → Dec 2028 expected acral lentiginous melanoma Fudan University Recruiting No outcome recorded
Phase 2 NCT06301828 Feb 2024 → Jun 2025 digestive system neoplasm Nanjing First Hospital, Nanjing Medical University Unknown No outcome recorded
Phase 2 NCT06055816 Oct 2023 → May 2026 overdue nasopharyngeal carcinoma Zhejiang Cancer Hospital Active not recruiting No outcome recorded
Phase 2 NCT05529355 Sep 2022 → Sep 2023 non-small cell lung carcinoma Anhui Chest Hospital Unknown No outcome recorded
Phase 2 NCT05298020 Apr → Dec 2022 pancreatic neoplasm The Affiliated Hospital of Xuzhou Medical University Unknown No outcome recorded
Phase 2 NCT05203276 Mar 2022 → May 2024 lung neoplasm The First People's Hospital of Lianyungang Unknown No outcome recorded
Phase 2 NCT05177237 Jul 2021 → Dec 2024 nasopharyngeal carcinoma Jiangxi Provincial Cancer Hospital Unknown No outcome recorded
Phase 2 NCT05574998 Feb 2021 → Feb 2024 non-small cell lung carcinoma Qianfoshan Hospital Unknown No outcome recorded
Phase 2 NCT04699214 Sep 2020 → Aug 2023 soft tissue sarcoma Yong Chen Unknown No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03588494 Aug 2018 → Sep 2019 — Affiliated Hospital of North Sichuan Medical College Unknown No outcome recorded
Phase 34 trials
Phase 3 NCT02907710 Oct 2016 → Nov 2018 nasopharyngeal carcinoma First Affiliated Hospital of Guangxi Medical University Unknown No outcome recorded
Phase 3 NCT02579564 Oct 2016 → Jun 2018 non-small cell lung carcinoma Xinqiao Hospital of Chongqing Unknown No outcome recorded
Phase 3 NCT02283476 Nov 2014 → Nov 2017 lung cancer Jiangsu Simcere Pharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 3 NCT02008422 Aug 2013 → May 2016 gastric cancer Tang Xushan Unknown No outcome recorded
Phase 46 trials
Phase 4 NCT05782764 Jun 2023 → May 2025 non-small cell squamous lung carcinoma Xuzhou Medical University Unknown No outcome recorded
Phase 4 NCT04164797 Nov 2019 → Jul 2021 esophageal cancer Second Affiliated Hospital of Xi'an Jiaotong University Unknown No outcome recorded
Phase 4 NCT02513342 Mar 2015 → Oct 2017 squamous cell lung carcinoma Nanjing NingQi Medicine Science and Technology Co., Ltd. Unknown No outcome recorded
Phase 4 NCT02513355 Feb 2015 → Nov 2017 non-small cell lung carcinoma Nanjing NingQi Medicine Science and Technology Co., Ltd. Unknown No outcome recorded
Phase 4 NCT01028729 Sep 2009 → Jul 2011 non-small cell lung carcinoma Simcere Pharmaceutical Co., Ltd Unknown No outcome recorded
Phase 4 NCT00813332 Oct 2008 → Oct 2009 non-small cell lung carcinoma Simcere Pharmaceutical Co., Ltd Unknown No outcome recorded
Phase not applicable2 trials
— NCT04274270 Apr 2020 → Jan 2022 — Peking University Third Hospital Unknown No outcome recorded
— NCT04063449 Aug 2019 → Jun 2020 non-small cell lung carcinoma Dong Wang Unknown No outcome recorded
Comparator or background therapy5 trials
Phase 2 NCT04472806 Background Jun 2020 → Jun 2022 mucosal melanoma Fudan University Unknown No outcome recorded
Phase 2 NCT03649945 Comparator Nov 2018 → Nov 2020 esophageal cancer First Affiliated Hospital of Guangxi Medical University Unknown No outcome recorded
Phase 2 NCT01549093 Comparator Aug 2011 → Jul 2016 non-small cell lung carcinoma Hunan Province Tumor Hospital Unknown No outcome recorded
Phase 3 NCT04914598 Comparator Jul 2021 → Feb 2025 overdue pleural disorder Jiangsu Simcere Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 3 NCT02748772 Comparator Jan 2016 → Dec 2017 colorectal neoplasm The First People's Hospital of Hefei Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2025-12-16 Jiangsu Simcere Pharmaceutical Co., Ltd. Regulatory Simcere Zaiming Announces Inclusion of Enzeshu® (Suvemcitug for Injection) in China’s 2025 National Medical Insurance Drug List simcere.com ↗
Another key product of Simcere Zaiming, Endostar® (Recombinant Human Endostatin Injection), has also been successfully transitioned to the conventional (non-negotiated) category of the National Medical Insurance Drug List.
2023-06-06 Jiangsu Simcere Pharmaceutical Co., Ltd. Results Simcere Zaiming showcases the latest R&D progress on its debut at 2023 ASCO annual meeting simcere.com ↗
In the real-world scenario, endostatin combination with PD-1 antibody plus chemotherapy obtained encouraging efficacy and favorable safety in advanced or metastatic NSCLC.
2022-06-07 Jiangsu Simcere Pharmaceutical Co., Ltd. Results Latest Clinical Data regarding ENDOSTAR and Trilaciclib Presented at the 2022 ASCO simcere.com ↗
ORR and DCR was 53% and 93% in Cohort 1 (CR, 0; PR, 8; SD, 6; PD,1) and 39% and 86% in Cohort 2 (CR 0; PR 11; SD, 13; PD, 4), respectively.
2021-05-26 Jiangsu Simcere Pharmaceutical Co., Ltd. Results Simcere Will Announce Progress of Multiple Clinical Research on Antitumor Drugs at the 2021 ASCO Annual Meeting Endostar®(Recombinant Human Endostatin Injection) Envafolimab (KNO35) simcere.com ↗
The ORR, DCR and median PFS were 34%, 73% and 8.2 (95% CI 6.0-13.7) months, respectively.

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 74 sources stand behind the page.

FieldValueCited text
Known as Endostar “This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin (Endostar®) works in treating patients with advanced stage non-small cell lung...” NCT02375022 ↗
74

“The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer...” NCT02283476 ↗

“Camrelizumab (SHR-1210) Combined With Endostar for First-line Treatment in Subjects With Advanced Squamous Non-small Cell Lung Cancer (NSCLC)” NCT04303130 ↗

“Rh-Endostatin (Endostar®) Continuous Intravenous Infusion” NCT03706703 ↗

NCT04063449 ↗

NCT01002092 ↗

NCT02665702 ↗

NCT02907710 ↗

NCT04472806 ↗

NCT00842491 ↗

NCT05203276 ↗

Show 64 more sources

Known as Endostar (a recombinant human endostatin) “Endostar (a recombinant human endostatin)” NCT00853684 ↗
Known as human recombinant endostatin “Endostar (human recombinant endostatin)” NCT02513355 ↗
Known as recombinant human endostatin “NSCLC patients with grade 2 or higher RP were enrolled and randomly assigned into 2 groups: recombinant human endostatin (Rh-endostatin) group (Rh-endostatin + glucocorticoid)...” PMID 41014160 ↗ Nov 2025
8

“To evaluate the effectiveness, safety and tolerability of Endostar (recombinant human endostatin) combined with AI chemotherapy” NCT04699214 ↗

“Endostar-Recombinant human endostatin injection is injected by 30mg continuous intravenous injection pump,d1-d7.” NCT02513342 ↗

“Endostar ® (recombinant human endostatin) continuous intravenous infusion” NCT02749526 ↗

“endostar (recombinant human endostatin)” NCT00842491 ↗

“Endostar (Recombinant Human Endostatin)” NCT00813449 ↗

“recombinant human endostatin (Endostar)” NCT05574998 ↗

“Recombinant human endostatin (Endostar)” NCT06965231 ↗

“Recombinant Human Endostatin(Endostar)” NCT00813137 ↗

Known as Recombinant Human Endostatin Injection “Endostar(Recombinant Human Endostatin Injection)” NCT00708812 ↗
Known as rh recombinant endostatin “Endostar(rh recombinant endostatin) plus Docetaxel” NCT00813332 ↗
Known as Rh-endostatin “This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin (Endostar®) works in treating patients with advanced stage non-small cell lung...” NCT02375022 ↗
4

“NSCLC patients with grade 2 or higher RP were enrolled and randomly assigned into 2 groups: recombinant human endostatin (Rh-endostatin) group (Rh-endostatin + glucocorticoid)...” PMID 41014160 ↗ Nov 2025

“The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer...” NCT02283476 ↗

“Endostar™ (rh-endostatin, YH-16) is a new recombinant human endostatin developed by Medgenn Bioengineering Co. Ltd., Yantai, Shandong, P.R.China.” PMID 21108883 ↗ Aug 2005

“Rh-Endostatin (Endostar®) Continuous Intravenous Infusion” NCT03706703 ↗

Known as Rh-endostatin Injection “Endostar® (Rh-endostatin Injection) may have anti-tumor activity by against vascular endothelial growth factor for initial treatment.” NCT00912392 ↗
Known as YH-16 “Endostar™ (rh-endostatin, YH-16) is a new recombinant human endostatin developed by Medgenn Bioengineering Co. Ltd., Yantai, Shandong, P.R.China.” PMID 21108883 ↗ Aug 2005
Action Inhibit “a inhibitor of angiogenesis” NCT00595972 ↗
Modality Protein / enzyme biologic “Recombinant Human Endostatin” NCT00813137 ↗
Route Intravenous “Endostar 15mg iv drip D1\~7, D15\~21” NCT00813137 ↗