AiRuiYi (fluzoparib) / Jiangsu Hengrui Pharma - LARVOL DELTA

Radiotherapy combined with fluzopanib and abiraterone acetate tablets (II) treatment for mCRPC (ESMO Asia 2025) - P2 | "This study aims to explore the potential efficacy and safety of the combination of fluzoparib (PARPi), abiraterone acetate (II), and radiotherapy as first-line treatment for patients with mCRPC. This multicenter, open-label, single-arm, phase II clinical study conducted in China included 40 previously untreated mCRPC (metastatic castration-resistant prostate cancer) patients aged ≥18 years. This study is currently in active enrollment stage."

Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma (SPARE-03) (clinicaltrials.gov) - P2 | N=52 | Completed | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting ➔ Completed | N=100 ➔ 52 | Trial completion date: Dec 2026 ➔ Dec 2024 | Trial primary completion date: Apr 2026 ➔ Dec 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Sacituzumab Govitecan Combined with Anti-angiogenic Therapy and Radiotherapy in a BRCA1-Mutated Triple-Negative Breast Cancer Patient with Multiple Recurrences: A Case Report (SABCS 2025) - P2 | "She underwent left modified radical mastectomy, followed by 8 cycles of adjuvant chemotherapy (epirubicin + cyclophosphamide, followed by paclitaxel)...In December 2020, right chest wall recurrence was found, treated with local extended resection in January 2021, and followed by one-year oral capecitabine.In June 2023, she developed lung metastases (germline BRCA1 mutation),then enrolled in an IIT trial (NCT05085626) where she received Fluzoparib + Chidamide, achieving partial response (PR) with a progression-free survival (PFS) of 14 months...She declined brain surgery and received Bevacizumab + Trastuzumab Deruxtecan...Treatment with SG in combination with Anlotinib was initiated, accompanied by concurrent WBRT during the first cycle... This case report highlights the potential efficacy of SG in combination with anti-angiogenic therapy and radiotherapy in treating BRCA1-mutated TNBC patients with multiple recurrences and brain metastases. However, further studies..."

Case report • Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • HER-2 • HRD • PGR

Poly (ADP-ribose) polymerase (PARP) inhibitors approved for the treatment of cancer. (PubMed, Pharmacol Res) - "The FDA has approved four PARP inhibitors (olaparib, rucaparib, niraparib, and talazoparib) for the treatment of ovarian, breast, prostate, and pancreatic cancer...The Chinese NMPA has approved three PARP antagonists (fuzuloparib, pamiparib, senaparib) for the treatment of ovarian cancer. All seven of these drugs are orally bioavailable and fall within the criteria of Lipinski's rule of five. Drug resistance develops in most PARP-inhibitor-treated cancer patients within one or two years."

Journal • Review • Breast Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HRD

Precision neoadjuvant treatment with Artificial Intelligence assisted subtyping in HR+/HER2- breast cancer: a randomized, open-label, phase 2 trial FASCINATE-N (SABCS 2025) - P2 | "Precision treatments included six cycles of dalpicilib (CDK4/6 inhibitor) plus endocrine therapy every 4 weeks for endocrine-based group and six cycles of targeted therapy (SHR-1316 [PD-L1 inhibitor] for SNF2, fuzuloparib [PARP1 inhibitor] for SNF3 and apatinib [VEGFR inhibitor] for SNF4) plus nab-paclitaxel and carboplatin every 4 weeks for targeted-based group. NET plus CDK4/6 inhibitor was verified to replace chemotherapy with better tolerance in the endocrine-base group while precision therapy was proved promising clinical activity and manageable safety profile in the targeted-based group. (ClinicalTrials.gov: NCT05582499)."

Clinical • IO biomarker • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • SMARCA2

Fuzuloparib with or without apatinib as maintenance therapy in newly diagnosed, advanced ovarian cancer (FZOCUS-1): A multicenter, randomized, double-blind, placebo-controlled phase 3 trial. (PubMed, CA Cancer J Clin) - "Although poly(adenosine diphosphate-ribose) polymerase inhibitors (PARPis) and bevacizumab were approved as first-line maintenance for advanced ovarian cancer (OC), evidence comparing this combination with PARPi monotherapy, especially in BRCA-mutated/homologous recombination-deficient (HRD) patients, is lacking. Adding apatinib to fuzuloparib did not prolong PFS among homologous recombination-deficient patients. There was a PFS benefit trend among homologous recombination-proficient patients who received combination therapy compared with those who received monotherapy."

Clinical • Journal • P3 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

Fuzuloparib with or without apatinib in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations (FABULOUS): interim analysis of a multicentre, three-arm, open-label, randomised, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Fuzuloparib, either as monotherapy or in combination with apatinib, provided statistically significant improvements in progression-free survival compared with chemotherapy in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations, presenting as new treatment options."

Clinical • Journal • P3 data • P3 data: top line • Breast Cancer • Cardiovascular • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hypertension • Oncology • Septic Shock • Solid Tumor • BRCA1 • BRCA2 • HER-2

Treatment of HRD-positive elderly ovarian cancer patient: a case report. (PubMed, Anticancer Drugs) - "Fluzoparib, the domestically developed PARPi in China, has demonstrated significant efficacy in BRCA-mutated ovarian cancer. In the field of supportive care, megestrol acetate (MA) is recommended as the first-line preferred therapeutic agent for cancer-related anorexia by major guidelines, though its role in first-line ovarian cancer therapy remains unexplored, and evidence for its combination with PARPi is lacking...Imaging assessments revealed significant tumor reduction without disease progression or grade ≥3 adverse events observed throughout follow-up. This case highlights the potential of combining PARPi and hormone therapy as a 'chemotherapy-free' precision treatment model for elderly and HRD-positive ovarian cancer patients, offering a promising strategy to balance efficacy and tolerability in a population traditionally underserved by conventional regimens."

Journal • Anorexia • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA • BRCA2 • HRD

Experimental study on the treatment of norepinephrine transporter-overexpressing pheochromocytomas and paragangliomas: a synthetic lethality strategy combining 131I-MIBG with PARP inhibitors. (PubMed, Front Oncol) - "This study aims to investigate the therapeutic potential of 131I-MIBG and the PARP inhibitor fluzoparib monotherapies and their combination on two distinct PC12-derived stable cell lines: PC12-NET cells and PC12-NET-SDHB cells...The specificity of PC12-NET cells to the 131I-MIBG was confirmed through desipramine inhibition assays...The combined of 131I-MIBG with PARP inhibitor demonstrated a synergistic antitumor effect in PC12-NET cells. While PC12-NET-SDHB cells display comparable sensitivity to 131I-MIBG as PC12-NET cells, they exhibited heightened responsiveness to PARP inhibitor treatment."

Journal • Oncology • Solid Tumor • SDHB

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