AiRuiYi (fluzoparib) / Jiangsu Hengrui Pharma - LARVOL DELTA

Efficacy and Safety of Fuzuloparib Combined with Bevacizumab as Maintenance Treatment in PARPi-Pretreated Platinum-Sensitive Recurrent Ovarian Cancer: A Phase II Study (ESMO 2025) - No abstract available

Clinical • P2 data • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor

A case report of advanced small intestinal stromal tumor with KIT gene mutation and BRCA2 deletion after multi-line treatments. (PubMed, Front Oncol) - "After initial surgery and adjuvant imatinib, the tumor recurred. Through comprehensive analysis of gene mutation profiles (KIT and HRR gene mutations, including BRCA2), a combination therapy of fluzoparib, pamiparib, and ripretinib was administered, stabilizing the patient's condition with significant efficacy. This case highlights the importance of genetic testing and personalized targeted treatment strategies for gastrointestinal stromal tumor (GIST) patients."

Journal • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Oncology • Sarcoma • BRCA2 • HRD • KIT

SYSKY-2023-1016-01: Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • BRCA

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P1/2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • BCL2

Fuzuloparib (FZPL) monotherapy or in combination with apatinib (APA) as first-line (1L) maintenance therapy in advanced ovarian cancer (OC): final analysis of the FZOCUS-1 trial (ESMO 2025) - No abstract available

Clinical • Combination therapy • Metastases • Monotherapy • Oncology • Ovarian Cancer • Solid Tumor

Real world clinical data analysis of fuzuloparib for the treatment of ovarian epithelial cancer patients (PubMed, Zhonghua Fu Chan Ke Za Zhi) - " The effectiveness of fuzuloparib in clinical application is generally consistent with other drugs in the same class, with good safety. This study provids new clinical evidence for the treatment of ovarian cancer with fuzuloparib."

Clinical data • Journal • Real-world evidence • Gynecology • Hematological Disorders • Leukopenia • Obstetrics • Oncology • Ovarian Cancer • Solid Tumor • Thrombocytopenia

[3-(Trifluoromethyl)-1H-1,2,4-triazol-5-yl]methylamine derivatives: synthesis, ways of modification and use for peptides labeling. (PubMed, Org Biomol Chem) - "In particular, 2-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[1,5-a]pyrazine (23) - a component in the synthesis of Fuzuloparib - was successfully obtained in good yields (56.4%). Finally, we showed that 2-(5-(aminomethyl)-3-(trifluoromethyl)-1H-1,2,4-triazol-1-yl)acetic acid hydrochloride (19) can be incorporated into short peptides using solid phase peptide synthesis, serving as a fluorinated Gly-Gly analogue for peptide 19F NMR studies."

Journal

Gene Expression Profiling for Predicting the Treatment Response of Patients with BRCA(wild type) or HRD- Platinum Sensitive Ovarian Cancer to Fuzuloparib Capsules (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Hefei Cancer Hospital, Chinese Academy of Sciences; Hefei Cancer Hospital, Chinese Academy of Sciences

New trial • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor

An Open-Label, Single-Center, Exploratory Phase Ⅱ Study of Fluzoparib With or Without Capecitabine as Maintenance Therapy for Recurrent or Metastatic Pancreatic Cancer (ChiCTR) - P=N/A | N=59 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

New trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Fluzoparib combination with temozolomide in recurrent extensive-stage small cell lung cancer,a prospective, single-arm, multi- Center Phase II clinical study (ChiCTR) - P2 | N=34 | Not yet recruiting | Sponsor: Zigong Fourth People's Hospital; Zigong Fourth People's Hospital

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=306 | Recruiting | Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd. | Trial completion date: Feb 2026 ➔ Feb 2027 | Trial primary completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

FZPL-Ⅲ-301-OC: A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients (clinicaltrials.gov) - P3 | N=252 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jun 2025

Platinum sensitive • Trial completion • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor • BRCA

Fluzoparib disrupts Golgi apparatus to inhibit O-GlcNAcylation and nuclear translocation of β-catenin to attenuate ovarian cancer invasion and metastasis. (PubMed, Int Immunopharmacol) - "Mechanistically, FZ disrupts the morphology and function of the Golgi apparatus, inhibits the O-GlcNAcylation of β-catenin, and promotes competitive phosphorylation of β-catenin, thereby preventing its translocation to the nucleus and ultimately inhibiting the invasion and metastasis of ovarian cancer. In summary, this study reveals that FZ disrupts the Golgi apparatus and inhibits the O-GlcNAcylation and nuclear translocation of β-catenin, thereby preventing the invasion and metastasis of ovarian cancer."

Journal • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • CTNNB1

A Phase II Clinical Study to Evaluate the Efficacy and Safety of Flazoparib Combined With Temozolomide After the Completion of Standard Concurrent Chemoradiotherapy (CCRT) in Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Tongji Hospital

New P2 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=25 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Neoadjuvant Treatment of Ovarian Cancer With Fluazoparib in Combination With Apatinib (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P2 trial • Oncology • Ovarian Cancer • Solid Tumor

Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer (clinicaltrials.gov) - P3 | N=424 | Recruiting | Sponsor: Tongji Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Ovarian Cancer • Solid Tumor

A Study of SHR3680 in Combination With SHR3162 in the Treatment of mCRPC (clinicaltrials.gov) - P2 | N=20 | Terminated | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | N=144 ➔ 20 | Active, not recruiting ➔ Terminated; The sponsor's R&D strategy is adjusted.

Enrollment change • Trial termination • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

EFFICACY AND SAFETY OF HETROMBOPAG FOR PARP INHIBITOR-INDUCED THROMBOCYTOPENIA: A PHASE II OPEN-LABEL, PROSPECTIVE TRIAL (EHA 2025) - "PARPi treatments included fuzuloparib (11.8%), olaparib (23.5%), and niraparib (64.7%). Hetrombopag demonstrated promising efficacy in platelet recovery and favorable tolerability in patients with PARPi-induced thrombocytopenia, enabling uninterrupted PARPi therapy. These results suggest that hetrombopag may be a viable treatment option for managing thrombocytopenia in patients receiving PARPi."

Clinical • P2 data • Cervical Cancer • Fatigue • Hematological Disorders • Oncology • Ovarian Cancer • Solid Tumor • Thrombocytopenia

Hepatitis B virus core protein promotes liver cancer progression by stabilizing CANX and suppressing IRF7 transcription. (PubMed, Acta Pharmacol Sin) - "We showed that a candidate compound fluzoparib effectively suppressed HBC-positive liver cancer cells in vitro and in vivo. Overall, this study underscores the crucial role of CANX and its regulatory mechanisms in promoting HBC-mediated liver cancer progression and reveals the therapeutic potential of targeting CANX in HBV infection-caused liver cancer."

Journal • Hepatitis B • Infectious Disease • Liver Cancer • Oncology • Solid Tumor • Targeted Protein Degradation • CANX • HDAC3 • IRF7

Bioanalytical assay for the quantification of rucaparib in rat plasma using UPLC-MS/MS: development, and validation for interaction with myricetin. (PubMed, Front Pharmacol) - "In this study, acetonitrile was used as the protein precipitant, and fuzuloparib was used as the internal standard (IS). The results of the drug-drug interaction (DDI) study showed that myricetin had no significant effect on the pharmacokinetic parameters of rucaparib, which indicating that the clinician did not need to adjust the dosage of rucaparib when it was used in combination. The UPLC-MS/MS method developed in this study was successfully used for the determination of the plasma concentrations of rucaparib orally administered in rats, which provided a reference for DDI studies and clinical pharmacokinetic studies of rucaparib."

Journal • Preclinical • Oncology • Ovarian Cancer • Solid Tumor • BRCA

Neoadjuvant SNF Precision Therapy Phase III (clinicaltrials.gov) - P3 | N=404 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Safety and effectiveness of fuzuloparib in patients with ovarian cancer: A nationwide, multicenter, prospective real-world study. (ASCO 2025) - P=N/A | "This is the first large-scale real-world study assessing the safety and effectiveness of fuzuloparib. In the real-world setting, fuzuloparib shows favorable safety, with no new safety signals. The effectiveness outcomes align with trends observed in key clinical trials."

Clinical • Real-world • Real-world evidence • Anemia • Fallopian Tube Cancer • Leukopenia • Oncology • Ovarian Cancer • Solid Tumor • Thrombocytopenia

Phase Ib/II study of fluzoparib in combination with dalpiciclib in patients with locally advanced or metastatic sarcoma. (ASCO 2025) - P2 | "This novel combination therapy of CDK4/6 inhibitor and PARP inhibitor showed manageable toxicity that could provide a strategy for advanced or metastatic sarcoma. Part 2 to evaluate safety and efficacy is currently recruiting pts. TRAEs with an incidence of ≥30% and any grade ≥3 TRAEs."

Clinical • Combination therapy • Metastases • P1/2 data • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Sarcoma • Solid Tumor • Thrombocytopenia • HRD