Paishuning (senaparib) / IMPACT Therap, Huadong Medicine - LARVOL DELTA

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

Unveiling the power of PARP inhibitors: a meta-analysis on newly diagnosed advanced ovarian cancer maintenance therapy. (PubMed, Expert Rev Anticancer Ther) - "Notably, senaparib showed superior PFS efficacy compared to veliparib and niraparib. PARPi showed efficacy in improving PFS as maintenance therapy for newly diagnosed advanced OC, although no OS advantage was observed. PROSPERO (CRD420251020275)."

Journal • Retrospective data • Review • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD

PARP Inhibitor Maintenance After First-Line Chemotherapy in Advanced-Stage Epithelial Ovarian Cancer: A Systematic Review and Meta-Analysis. (PubMed, JAMA Netw Open) - "Observed treatment efficacy and toxic effects varied across PARP inhibitor regimens; for example, the risk ratio for any recurrence or death in the overall study group ranged from 0.53 (95% CI, 0.40-0.70) for senaparib to 0.83 (95% CI, 0.68-1.00) for olaparib, while the risk ratio for high-grade adverse events ranged from 1.15 (95% CI, 0.64-2.06) for veliparib to 4.73 (95% CI, 2.77-8.07) for niraparib. In this study, no subgroup showed an association between first-line PARP inhibitor maintenance therapy in advanced-stage EOC and improved OS, and findings suggest that the consistency of associated PFS benefits may vary, particularly in homologous recombination proficient and BRCA wild type tumors. Variability in efficacy and toxic effects across subgroups and PARP inhibitor regimens underscores the importance of individualized treatment decisions."

Clinical • Journal • Retrospective data • Review • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD

Senaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer with Homologous Recombination Proficient and Exploration of Biomarkers (ChiCTR) - P4 | N=37 | Not yet recruiting | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

Biomarker • New P4 trial • Oncology • Ovarian Cancer • Solid Tumor • MUC16

Efficacy and safety of maintenance therapy with senaparib in patients with platinum-sensitive recurrent ovarian cancer previously treated with PARP inhibitors (ChiCTR) - P4 | N=40 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New P4 trial • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • BRCA • MUC16

Senaparib monotherapy for patients (pts) with BRCA1/2 mutated recurrent platinum-sensitive ovarian cancer (PSOC): Final analysis of study SABRINA (ESMO 2025) - P2 | "2 pts reported fatal TEAEs, 1 cerebral haemorrhage and 1 cerebral infarction, both of them were not related to senaparib. Conclusions Senaparib demonstrated clinically meaningful antitumor activity and manageable safety profile in BRCA1/2 mutated recurrent PSOC."

Clinical • Monotherapy • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2

PET imaging of PARP-1 expression using a novel 18 F-labeled probe based on Quinazoline-2,4(1 H,3 H)-dione Scaffold (EANM 2025) - "Based on the core binding structure of Senaparib, we aimed to synthesize a novel probe targeting PARP-1 for PET with high feasibility, high binding selectivity, and a favorable tumor-to-background ratio...Conclusion Photocatalytic radiofluorination enables the facile synthesis of a PARP-1-targeted probe with high specificity and favorable contrast. Further studies on treatment response prediction will be performed in preclinical models."

HRD • PARP1

A Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 to China Healthy Male Subjects (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Impact Therapeutics, Inc. | Not yet recruiting ➔ Completed

Trial completion • Solid Tumor

An BE Study to Compare 10mg & 20mg of IMP4297 Capsules in Healthy Chinese Subjects Under Fasting Condition (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Impact Therapeutics, Inc. | Not yet recruiting ➔ Completed

Trial completion • Solid Tumor

SABRINA: Study of IMP4297 in Patients With BRCA1/2 Mutation Ovarian Cancer (clinicaltrials.gov) - P2 | N=93 | Completed | Sponsor: Impact Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Aug 2022 ➔ Dec 2024

Trial completion • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2 • MUC16

An BE Study to Compare 10mg & 20mg of IMP4297 Capsules in Healthy Chinese Subjects Under Fed Condition (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Impact Therapeutics, Inc. | Not yet recruiting ➔ Completed

Trial completion • Solid Tumor

Combination Therapy of Senaparib and Bevacizumab for First-line Maintenance Therapy in Newly Diagnosed Advanced Homologous Recombination Proficient Ovarian Cancer Based on Exosome Protein Marker (clinicaltrials.gov) - P2 | N=37 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Oncology • Ovarian Cancer • Solid Tumor

Senaparib: First Approval. (PubMed, Drugs) - "Senaparib (®; Sainapali Jiaonang) is a novel PARP inhibitor that potently inhibits PARP1 and PARP2, which is being developed by IMPACT Therapeutics for the treatment of advanced ovarian cancer and small-cell lung cancer. This article summarizes the milestones in the development of senaparib leading to this first approval for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who achieved a complete or partial response to first-line platinum-based chemotherapy."

Journal • Fallopian Tube Cancer • Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Small Cell Lung Cancer • Solid Tumor • PARP2

A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients with Advanced Solid Tumors (ANZCTR) - P1 | N=30 | Completed | Sponsor: IMPACT Therapeutics Australia Pty Ltd | Recruiting ➔ Completed

Trial completion • Breast Cancer • Ovarian Cancer • Prostate Cancer • Solid Tumor • BRCA

A Bioequivalence Study to Compare Senaparib Manufactured at 2 Sites in Healthy Subjects in Fasting State (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Impact Therapeutics, Inc.

New P1 trial • Solid Tumor

FLAMES: A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer (clinicaltrials.gov) - P3 | N=404 | Active, not recruiting | Sponsor: Impact Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Jun 2026

Enrollment closed • Monotherapy • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor • BRCA • MUC16

An Bioequivalence Study to Compare 10mg & 20mg of Senaparib Capsules in Healthy Chinese Subjects Under Fasting Condition (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Impact Therapeutics, Inc.

New P1 trial • Solid Tumor

Discovery and development of a potent and highly selective ATR inhibitor IMP9064 (AACR 2025) - P1/2 | "IMP9064 has entered a phase 1/2 study to evaluate the safety and efficacy either as monotherapy or in combination with PARP inhibitor Senaparib in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT05269316). The recommended phase 2 dose (RP2D) has been determined and IMP9064 is currently in expansion studies for selected tumors."

Colorectal Cancer • Oncology • Solid Tumor • PKMYT1

Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=61 | Recruiting | Sponsor: Impact Therapeutics, Inc. | Phase classification: P1 ➔ P1/2 | Trial completion date: Jul 2025 ➔ Dec 2026 | Trial primary completion date: Jul 2025 ➔ Dec 2026

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

Multifunctional nanoparticle-mediated targeting of metabolic reprogramming and DNA damage response pathways to treat drug-resistant triple-negative breast cancer. (PubMed, J Control Release) - "Herein, a P-gp-inhibiting and GSH-responsive multifunctional drug carrier targeting integrin αvβ3 was synthesised for the delivery of Lonidamine-prodrug (M1, glycolysis inhibitor) and Senaparib (Se, Poly [ADP-ribose] polymerase inhibitor). Experimental results show that iPR@M1/Se nanoparticles effectively promote dendritic cell maturation and T lymphocyte activation, which elicits long-term immune memory responses, and prevents tumour recurrence and lung metastasis. Therefore, these multifunctional nanoparticles have great potential and provide a clinically relevant and valuable option for Olaparib-resistant TNBC."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CGAS • HRD • STING

Duplexed CeTEAM drug biosensors reveal determinants of PARP inhibitor selectivity in cells. (PubMed, J Biol Chem) - "Our results reveal that most PARPi are equipotent for both PARPs, including the next-generation drug, senaparib. However, benzimidazole carboxamide (niraparib) derivatives demonstrated PARP1-selective tendencies, while pthalazinones (olaparib) favored PARP2. AZD5305, a reported PARP1-selective inhibitor with characteristics of both series, was the exception and appears ∼1600-fold more potent towards PARP1. In agreement with current understanding, we see that trapping-associated S/G2-phase transitions positively correlate with PARP1/2 binding potency, while some potent binders, such as veliparib, did not - likely reflecting their allosteric influence on DNA retention...The PARP1/2 CeTEAM platform thus provides a structural roadmap for the development of selective PARPi and should facilitate the discovery of targeted therapies. Furthermore, our results highlight that multiplexing CeTEAM biosensors and layered genetic perturbations can systematically profile determinants of..."

Journal • Oncology • PARP2

Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting ➔ Recruiting

Enrollment open • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

Senaparib Approved by NMPA for 1L Maintenance Therapy in Ovarian Cancer (PRNewswire) - "IMPACT Therapeutics...is pleased to announce that Senaparib Capsules has received marketing authorization in China from National Medical Products Administration (NMPA) as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy....The approval is based on FLAMES Study....The results of FLAMES Study showed that Senaparib demonstrated significant improvement in median PFS compared to placebo (PFS not reached vs 13.6 months, HR 0.43, P < 0.0001), irrespective of BRCA status."

China approval • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

Results from the first-in-human study of ATR inhibitor, IMP9064 monotherapy dose escalation in patients with advanced solid tumors (ESMO 2024) - P1 | "Here reports the results of Part 1 from the phase 1/2 study. The study consists of 4 parts: dose-escalation and dose-expansion of IMP9064 monotherapy and combination with senaparib (PARPi). IMP9064 has demonstrated a favorable safety profile and preliminary clinical efficacy signal and sustained clinical benefit in late-stage AST, which warrants further development of IMP9064. After RP2D is determined in May, enrollment in an expansion cohort will proceed."

Clinical • Metastases • Monotherapy • P1 data • Biliary Cancer • Cholangiocarcinoma • Endometrial Cancer • Gastrointestinal Cancer • Leiomyosarcoma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Uterine Corpus Leiomyosarcoma

Study of Senaparib in Combination With Temozolomide (clinicaltrials.gov) - P2 | N=18 | Not yet recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

New P2 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor