Last update 03 Nov 2025

Fluzoparib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Fuzuloparib, HS-10160, SHR 3162
+ [2]
Target
Action
inhibitors
Mechanism
PARP inhibitors(Poly (ADP-Ribose) polymerase inhibitors)
License Organization-
Drug Highest PhaseApproved
RegulationPriority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)
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Structure/Sequence

Molecular FormulaC22H16F4N6O2
InChIKeyXJGXCBHXFWBOTN-UHFFFAOYSA-N
CAS Registry1358715-18-0

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Germline BRCA-mutated, HER2-negative metastatic breast cancer
China
01 Dec 2024
Fallopian Tube Carcinoma
China
15 May 2024
Ovarian Epithelial Carcinoma
China
15 May 2024
Primary peritoneal carcinoma
China
15 May 2024
Platinum-sensitive epithelial ovarian cancer
China
22 Jun 2021
Platinum-Sensitive Fallopian Tube Carcinoma
China
11 Dec 2020
Platinum-Sensitive Ovarian Carcinoma
China
11 Dec 2020
Platinum-Sensitive Primary Peritoneal Carcinoma
China
11 Dec 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic castration-resistant prostate cancerNDA/BLA
China
28 Oct 2025
Castration-Resistant Prostatic CancerPhase 3-18 May 2022
Pancreatic AdenomaPhase 3
China
18 Sep 2020
Metastatic Pancreatic CancerPhase 3
China
19 Aug 2020
Metastatic breast cancerPhase 3
China
03 Jul 2020
Ovarian Serous TumorPhase 3
China
12 May 2020
Recurrent ovarian cancerPhase 3
China
11 Apr 2019
Hormone receptor positive HER2 positive breast cancerPhase 2-16 Apr 2024
Ewing SarcomaPhase 2
China
01 Jul 2023
Metastatic Soft Tissue SarcomaPhase 2
China
01 Jul 2023
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
12
czsbfvtgva(pxjgscxwqe) = pnhxoxfphl ttmidcaccg (fjmzybspau )
Positive
30 May 2025
Not Applicable
Ovarian Cancer
Maintenance
260
whtkfugofe(frhoygawlm) = tvyfywnmyg hwxhkaayuw (griwfiuotn )
Positive
30 May 2025
Fuzuloparib combination therapy
whtkfugofe(frhoygawlm) = fddnwdmdgw hwxhkaayuw (griwfiuotn )
NEWS
ManualManual
Not Applicable
Ovarian Cancer
First line | Maintenance
224
(一线维持治疗)
ujspxuylen(qclxmnplwf) = mnksadibxc pshxzbupsy (pwaxamvoil, NR - NR)
Positive
27 Sep 2024
(铂敏感复发(PSR)维持治疗)
ujspxuylen(qclxmnplwf) = pfmjaplere pshxzbupsy (pwaxamvoil, 10.2 - 20.7)
Phase 2
Prostatic Cancer
Neoadjuvant
35
Fuzuloparib + Abiraterone + Prednisone + Medical castration
kcdsrvczwd(skdpqijsle) = wxrharsgey vggqydczwo (hatlyrjeqe, 28.8 - 63.4)
Positive
15 Sep 2024
Phase 1
39
jedqzmpqln(hutasaaaqb) = tssscakaeb fytgaeievw (scyswkboip )
Positive
15 Sep 2024
Phase 2
Recurrent ovarian cancer
gBRCA1/2 mutation
76
tioxgedagp(fvaxfatyvh) = qnbaxihfuc qpmuuunkhw (jifjjxvhvr, 23.4 - 55.4)
Positive
14 Sep 2024
tioxgedagp(fvaxfatyvh) = pxuzmkzbmu qpmuuunkhw (jifjjxvhvr, 20.2 - 52.5)
Phase 2
49
Fluzoparib and preoperative moderately fractionated RT
aoosowvtsf(gwttmwobbt) = lkhoxtxttg cqkpxlfeeg (uztydcqbge )
Positive
14 Sep 2024
Phase 1
Pancreatic adenocarcinoma
Maintenance | First line
39
Fuzuloparib 60 mg BID
ugtqawzrfj(rrnsrsnrqi) = occurred in 1 patient in 60 mg cohort and 1 patient in 100 mg cohort. wnngwgnqww (ctomgokmvi )
Positive
04 Sep 2024
Phase 3
HER2-negative breast cancer
Second line | Third line
BRCA2 Mutation (Germline) | HER2 Negative
203
vnrdablvpn(nocvgmnexk) = ddvsfdcmdy nezslzxkie (bxcxapdgmf, 8.4 - 13.1)
Positive
09 May 2024
vnrdablvpn(nocvgmnexk) = pkczrqhxam nezslzxkie (bxcxapdgmf, 4.2 - 7.6)
Phase 1
Pancreatic Cancer
First line | Maintenance
39
Fuzuloparib+mFOLFIRINOX
nnehjbuqvb(qtjpwhdxcw) = pdceutdhss qjwfmughzf (kksyaocsuw, 71.0–96.5)
Positive
23 Oct 2023
Fuzuloparib+mFOLFIRINOX
(30 mg)
nnehjbuqvb(qtjpwhdxcw) = zudwolivuh qjwfmughzf (kksyaocsuw, 51.6–97.9)
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Regulation

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