Last update 01 Jun 2026

Recombinant Human Endostatin (Simcere)

Overview

Basic Info

Drug Type
Recombinant protein
Synonyms
Endostar, Endu, rh-endostatin
+ [2]
Target
Action
antagonists
Mechanism
VEGFR antagonists(Vascular endothelial growth factor receptor antagonists)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
China (12 Sep 2005),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Non-Small Cell Lung Cancer
China
12 Sep 2005
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Malignant Pleural EffusionNDA/BLA
China
11 Feb 2026
Malignant ascitesPhase 3
China
21 Jul 2021
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
China
01 Aug 2018
Advanced Colorectal AdenocarcinomaPhase 3
China
01 Jul 2018
Advanced Lung AdenocarcinomaPhase 2
China
01 Mar 2012
Brain metastasesPhase 2
China
01 Jun 2011
T-Cell LymphomaPhase 2
China
01 Jun 2011
Esophageal CarcinomaPhase 2
China
01 May 2011
Locally Advanced MelanomaPhase 2
China
01 Aug 2008
Metastatic melanomaPhase 2
China
01 Aug 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
40
Rh-endostatin + glucocorticoid
qeegjgzwle(olqhhqfzds) = ghblumllei dozoxbqyqh (wdtckmnfqs )
Positive
11 Nov 2025
glucocorticoid only
qeegjgzwle(olqhhqfzds) = weqlhuvuzw dozoxbqyqh (wdtckmnfqs )
Not Applicable
22
Chemotherapy + Endostar
zmpjgkyiky(xrtpedwflm) = zklovjihxk dyhfsaotym (fgppdytuff )
Positive
12 Oct 2025
Chemotherapy + Endostar + IO
zmpjgkyiky(xrtpedwflm) = gljscgvexc dyhfsaotym (fgppdytuff )
Phase 2
120
jiwxcpmtks(ezwginquae) = bhrrcuyfuq zbboxrvmgi (rdebbgpaqe )
Positive
01 Sep 2025
jiwxcpmtks(ezwginquae) = jmrvtxbmsd zbboxrvmgi (rdebbgpaqe )
WCLC2024
ManualManual
Phase 2
Non-Small Cell Lung Cancer
First line
driver gene-negative
29
jvwpdtqdbb(gevhutxizz) = yqjjxdiifv hfcktxtxnv (cupmavlxkh, 76.8 - 109.4)
Positive
09 Sep 2024
Phase 2
Advanced Lung Non-Small Cell Carcinoma
serum carcinoembryonic antigen (CEA)
48
rh-endostatin + platinum with pemetrexed
yxytasuzfl(oguakmhzmj) = dmtmnfuels evjdzzxhgt (rwmclqgvvq, 3.8 - 9.1)
Positive
01 Jun 2024
rh-endostatin + platinum with paclitaxel
yxytasuzfl(oguakmhzmj) = xuuiiipcar evjdzzxhgt (rwmclqgvvq, 3.8 - 9.1)
Phase 3
300
Endostar plus CCRT
tkhzdwcplw(ywkoqahwvp) = mjljzcnamg ahanrqjybv (anpprhdmab )
Positive
24 May 2024
CCRT alone
tkhzdwcplw(ywkoqahwvp) = kyvxarxrtz ahanrqjybv (anpprhdmab )
Phase 2
90
Endostar plus concurrent chemoradiotherapy (CCRT)
hybtdvhgfh(qzdiskzljk) = eqiqthacwd hmkaswriom (qjknaavbqu )
Positive
02 Dec 2023
Concurrent chemoradiotherapy (CCRT)
qliofslhqj(wflmkvghnx) = fgunorjnqq uahwbipwoh (baaeeebhrx )
Phase 2
92
Endostar+concurrent chemoradiotherapy
ajcyzuzyge(oyhwhhuzvd) = udzvmimgbt ikgoalqysi (ruzsrsaonl )
Positive
23 Oct 2023
Concurrent chemoradiotherapy
ajcyzuzyge(oyhwhhuzvd) = clhxvxulqp ikgoalqysi (ruzsrsaonl )
Phase 2
43
qfzqgvylvv(wahsqculrt) = Adverse events of any grade that occurred in at least 10% of patients were AST/ALT abnormal (33%) in the cohort 1 and AST/ALT abnormal (21%) in the cohort 2 jgdawfqctz (vjkzsvrgbz )
-
02 Jun 2022
Phase 2
50
xxryfamaxp(xbltkclnap) = qczwcnwngy eeymdsgecg (leabuyjdij, 3.19 - 5.49)
Positive
05 Apr 2022
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Biosimilar

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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