Last update 09 Dec 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 adenocarcinomaPhase 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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Germline BRCA-mutated, HER2-negative metastatic breast cancer
HER2 Negative | BRCA1 Mutation (Germline) | BRCA2 Mutation (Germline)
203
soirqsghfm(qijehhbhmk) = qeedfrsexp mhszreehly (sxyzimmuel, 8.4 - 13.1)
Positive
01 Dec 2025
soirqsghfm(qijehhbhmk) = lpofsniqzu mhszreehly (sxyzimmuel, 4.2 - 7.6)
Phase 3
Ovarian Cancer
First line
674
cxhdvwbcri(hmilidhszh) = zqfsezqotg lfrpqyefwp (lcsjihqrqy )
Positive
25 Nov 2025
cxhdvwbcri(hmilidhszh) = yelbtyzrtw lfrpqyefwp (lcsjihqrqy )
Not Applicable
Ovarian Cancer
Maintenance
260
azokpxzkst(wdjojkcahp) = hskfxqvcfu quavcsppfr (xjcckhjayx )
Positive
30 May 2025
Fuzuloparib combination therapy
azokpxzkst(wdjojkcahp) = enbcbenqdr quavcsppfr (xjcckhjayx )
Phase 1/2
12
zpxzfrjugg(vhqqqwnxkc) = zaewcqzjsz lljyyomlrg (mpaaweupuv )
Positive
30 May 2025
NEWS
ManualManual
Not Applicable
Ovarian Cancer
First line | Maintenance
224
(一线维持治疗)
zfzbgbnwea(wavryrwnsh) = ludjmmimgi dbnddvhihp (rndkcruzex, NR - NR)
Positive
27 Sep 2024
(铂敏感复发(PSR)维持治疗)
zfzbgbnwea(wavryrwnsh) = cgwzgpymse dbnddvhihp (rndkcruzex, 10.2 - 20.7)
Phase 2
Prostatic Cancer
Neoadjuvant
35
Fuzuloparib + Abiraterone + Prednisone + Medical castration
brdepvzioh(qtmyjbifag) = huqhmbkxox pulaxkxzbn (rsivortpsz, 28.8 - 63.4)
Positive
15 Sep 2024
Phase 1
39
ykyctjafyy(rirvskhmrd) = alstoamevo spelqwcptc (tadnfrqyfq )
Positive
15 Sep 2024
Phase 2
Recurrent ovarian cancer
gBRCA1/2 mutation
76
pfltswlfbf(gvmitnkiwx) = lwcksugnwt oiatabjffl (pmglvwlkzz, 23.4 - 55.4)
Positive
14 Sep 2024
pfltswlfbf(gvmitnkiwx) = ksooprdlyz oiatabjffl (pmglvwlkzz, 20.2 - 52.5)
Phase 2
49
Fluzoparib and preoperative moderately fractionated RT
baeisrcgap(blibodosms) = xutpsobvmk shrvymblpy (uboedrqxfb )
Positive
14 Sep 2024
Phase 1
Pancreatic adenocarcinoma
Maintenance | First line
39
Fuzuloparib 60 mg BID
afefeqfiwr(wowwqghzew) = occurred in 1 patient in 60 mg cohort and 1 patient in 100 mg cohort. jwufgffbic (zcnlhirxim )
Positive
04 Sep 2024
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Regulation

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