AiRuiYi (fluzoparib) / Jiangsu Hengrui Pharma - LARVOL DELTA

Radiosynthesis and PET evaluation of [18F]Fuzuloparib as a PARP-targeted imaging agent in breast cancer. (PubMed, Eur J Med Chem) - "[18F]Fuzuloparib showed high tumor accumulation (peak 9.06 ± 0.31 %ID/g at 2 h) and sustained intratumoral retention (7.12 ± 0.31 %ID/g at 6 h), underscoring its potential as a promising PET imaging agent. These preclinical findings highlight the potential of [18F]Fuzuloparib as a robust non-invasive imaging agent for identifying PARP-overexpressing malignancies, with implications for optimizing PARP inhibitor therapy and forecasting therapeutic response."

Journal • Breast Cancer • Oncology • Solid Tumor • PARP1

A Phase II Study of Induction with Immunotherapy, Targeted Therapy, and Chemotherapy, Followed by Maintenance with Immunotherapy, Targeted Therapy, and a PARP Inhibitor in Platinum-Resistant Ovarian Cancer (ChiCTR) - P=N/A | N=32 | Not yet recruiting | Sponsor: First Hospital Of Nanping; First Hospital Of Nanping

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

Clinical Study of Fluzoparib Combined with Dalpiciclib and Endocrine Neoadjuvant Therapy for gBRCA-Mutated HR+/HER2- Early-Stage Breast Cancer (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Harbin Medical University Affiliated Cancer Hospital; Harbin Medical University Affiliated Cancer Hospital

New trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • HER-2

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Bevacizumab as Maintenance Treatment in PARPi-Pretreated Platinum-Sensitive Recurrent Ovarian Cancer: A Phase II Study [WITHDRAWN] (ESMO 2025) - No abstract available

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

Clinical evaluation of combined programmed cell death protein 1 inhibitor and poly(ADP-ribose) polymerase inhibitor in metastatic castration-resistant prostate cancer patients: Insights from a real-world study. (PubMed, Curr Urol) - "This open-label, single-arm, prospective study enrolled patients with mCRPC who had experienced disease progression after docetaxel and at least 2 lines of next-generation hormonal agents to receive camrelizumab (PD-1 inhibitor) and fluzoparib (PARPi). None of the patients discontinued treatment because of treatment-related AEs. This real-world study demonstrated that the combination of a PD-1 inhibitor and PARPi exhibited sustained antitumor activity with an acceptable safety profile in the fourth-line treatment of patients with mCRPC."

Journal • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy and safety profiles of PARP inhibitors in Chinese patients with metastatic breast cancer: A multi-center real-world study (ESMO 2025) - "Results 62 MBC patients treated with olaparib (n = 55), talazoparib (n = 4), pamiparib (n = 2) and fluzoparib (n = 1) were analyzed. Conclusions PARPis showed promising PFS and tolerable toxicity in the real-word treatment of Chinese patients with metastatic breast cancer. Legal entity responsible for the study The authors."

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2 • CDK12 • CHEK1 • HER-2 • HRD • PALB2 • RAD51C

Live from ESMO | Hengrui Debuts Exhibition Booth with Landmark Data Showcasing Pharma’s Emerging Innovation Power (The Manila Times) - "This year, the company unveiled 46 studies across 14 innovative therapeutic programs, including nine oral presentations, two mini oral sessions, and four late-breaking abstracts (LBAs), underscoring its global R&D strength. These data highlight the company's commitment to multi-cancer coverage and multi-mechanism innovation in oncology."

Clinical data • Gastrointestinal Cancer • Head and Neck Cancer • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer

FLUZOPARIB COMBINED WITH ORAL ETOPOSIDE IN ALTERNATING MAINTENANCE THERAPY FOR NEWLY DIAGNOSED ADVANCED OVARIAN CANCER (FARE TRIAL): A PROSPECTIVE, SINGLE-ARM, PHASE II STUDY (IGCS 2025) - "At interim analysis, a total of 14 participants received treatment, including 4 patients (28.6%) with BRCA1/2 mutations, 8 patients (57.1%) with wild-type BRCA1/2, and 2 patients (14.3%) with unknown BRCA1/2 status, 9 patients (64.3%) were homologous recombination deficiency (HRD) -positive, 2 (14.3%) were HRD-negative, and 3 (21.4%) had undetermined HRD status. Among them, 5 patients (35.7%) were diagnosed with FIGO IV Stage, and 9 patients (64.3%) with FIGO III Stage. Median follow-up duration was 26.5 months."

Clinical • Metastases • P2 data • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2

Jiangsu Hengrui Pharmaceuticals…announced today that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for fluzoparib capsules in combination with abiraterone and prednisone/prednisolone (flcube.com) - "The indication targets first‑line metastatic castration‑resistant prostate cancer (mCRPC) patients with DNA damage repair (DDR) gene‑defect positive (DDR+) status."

China filing • Castration-Resistant Prostate Cancer

Case Report: Fluzoparib combined Exemestane in gBRCA2-mutated HR+/HER2- advanced breast cancer. (PubMed, Front Pharmacol) - "The patient achieved a remarkably prolonged progression-free survival (PFS) of 37 months on this combination therapy, representing the longest period of disease control in her metastatic course. Although eventual progression occurred (new axillary lymph node metastasis and suspected hepatic recurrence), this case demonstrates the exceptional efficacy and durable disease control achievable with Fluzoparib plus Exemestane in a pretreated patient with gBRCA2-mutated HR+/HER2-advanced breast cancer, highlighting a promising therapeutic approach for this molecularly defined population."

Journal • Breast Cancer • Hematological Disorders • Hepatocellular Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • BRCA2 • ER • HER-2

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) - P3 | "Grade >=3 TRAEs (mostly hematologic) were reported by 48.7%, 45.7%, and 7.4% of pts in the FZPL+APA, FZPL, and placebo group. Table: 1063O Efficacy summary FZPL+APA (N = 269) FZPL (N = 269) Placebo (N = 136) Overall population mPFS, mo (95% CI) 26.9 (20.3, 36.6) 29.9 (22.1, 36.1) 11.1 (8.3, 16.6) HR, vs placebo (95% CI) 0.57 (0.44, 0.75) 0.58 (0.44, 0.75) HR, vs FZPL (95% CI) 1.04 (0.83, 1.32) HRD, including BRCAm (n=486) mPFS, mo (95% CI) 34.1 (22.4, 41.2) 35.8 (27.3, NR) 16.6 (8.3, 31.1) HR, vs placebo (95% CI) 0.67 (0.48, 0.93) 0.62 (0.45, 0.87) HR, vs FZPL (95% CI) 1.09 (0.83, 1.44) HRP (n=118) mPFS, mo (95% CI) 16.6 (10.2, 22.1) 11.0 (6.5, 16.6) 5.5 (3.3, 13.8) HR, vs placebo (95% CI) 0.51 (0.30, 0.86) 0.68 (0.40, 1.15) HR, vs FZPL (95% CI) 0.73 (0.45, 1.19) Conclusions Adding antiangiogenic APA to FZPL did not enhance PFS among HRD pts in the 1L maintenance setting, while HRP pts showed PFS benefit trend with FZPL+APA compared to FZPL alone."

Clinical • Combination therapy • Metastases • Monotherapy • Oncology • Ovarian Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

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

Preoperative Conventionally vs. Moderately Fractionated Radiotherapy for Non-Metastatic Soft Tissue Sarcoma: The Physician- and Patient-Reported Outcome (ASTRO 2025) - "Materials/ Preoperative VMAT of 50Gy/25f with concurrent and sequential Anlotinib (12mg QD) or Apatinib (500mg QD), or 43.5Gy/15f with Fluzoparib (100mg Bid) were given for CF or MF groups. For patients with non-metastatic STS, whether CF or MF- RT was used, or whether TKIs or PARP inhibitors were added, there were no significant differences in resection rates or MWCs rate. However, it should be noted that patients in the MF group had slower recovery of QOL, with function items being worse than those in the CF-RT group."

Clinical • Metastases • Patient reported outcomes • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Continuous response to maintenance fuzuloparib for germline BRCA2- mutated metastatic pancreatic adenocarcinoma: a case report and literature review. (PubMed, Front Pharmacol) - "Despite showing improved efficacy and a more favorable safety profile compared to olaparib in preclinical studies, clinical evidence for its application in pancreatic adenocarcinoma harboring gBRCAm remains limited...This case underscores the important role of biomarker-directed therapy in pancreatic adenocarcinoma and fuzuloparib may represent a potential PARP inhibitor option for maintenance treatment in pancreatic adenocarcinoma with gBRCAm. However, large-scale randomized controlled trials are needed to validate these results."

Journal • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • BRCA • BRCA2

Case Report: Multimodal management of a rare pediatric astroblastoma using proton beam therapy and Gamma Knife radiosurgery-a case report and literature review. (PubMed, Front Oncol) - "Following the discovery of a BRCA2 mutation, the PARP inhibitor fluzoparib was administered, which was associated with temporary disease stabilization...This case suggests that leveraging the tissue-sparing benefits of initial PBT may enable effective salvage SRS for managing residual or recurrent high-grade pediatric astroblastoma. Furthermore, it highlights the potential role of molecular profiling to guide targeted therapies in these rare tumors."

Journal • Glioma • Oncology • Pediatrics • BRCA2

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

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

A Study on the Use of Fluzoparib Combined With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: Xijing Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • BRCA

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

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