SHANGHAI, August 15th, 2025 - IMPACT Therapeutics (“IMPACT”), a biotechnology company focused on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, is pleased to announce that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Senaparib, a next-generation PARP1/2 inhibitor discovered and developed by IMPACT, as a first-line maintenance treatment for advanced ovarian cancer.  

This milestone follows Senaparib’s approval by the China National Medical Products Administration (NMPA) in January 2025 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.

This MAA submission is based on the randomized, double-blind, placebo-controlled, multicenter phase III FLAMES study (FLAMES Study). The results of the FLAMES Study showed that Senaparib demonstrated significant improvement in median progression-free survival (mPFS) compared to placebo, irrespective of BRCA status. Meanwhile, Senaparib was well-tolerated with a manageable safety profile. The results were published in May 2024 in the internationally renowned medical journal Nature Medicine.¹

Dr. Sui Xiong Cai, CEO of IMPACT, said: “We are delighted that the MAA for Senaparib has been accepted by the EMA. This marks a pivotal milestone in Impact’s journey toward globalization. With this acceptance, we anticipate expedited entry into overseas markets to deliver this innovative therapy to patients worldwide.”

About Ovarian Cancer

Ovarian cancer is one of the most common lethal female reproductive malignancies. According to GLOBOCAN 2020 data, the global incidence of ovarian cancer is amounted to 310,000 cases and mortality is amounted to 210,000.² Due to the insidious and non-specific early symptoms of ovarian cancer, about 80% of patients are already in advanced stage when they are diagnosed, and the 5-year survival rate is only 40%.³ Although ovarian cancer may be resolved after initial platinum-based chemotherapy, most patients face recurrence, highlighting a significant unmet clinical need for treatment in the ovarian cancer patient population.⁴ In recent years, PARP inhibitors have transformed the therapeutic landscape for ovarian cancer, with maintenance therapy extending the duration of sustained remission after platinum-based chemotherapy and delaying disease recurrence.⁵

- This material is intended to provide cutting-edge information, and is not meant to promote any products or serve as clinical medication guidance.

- If you wish to obtain specific disease diagnosis and treatment information, please follow the advice and guidance of medical and healthcare professionals.

About the FLAMES Study

The FLAMES Study (IMP4297-301, NCT04169997) is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study designed to evaluate the efficacy and safety of Senaparib as a single-agent maintenance treatment for patients with FIGO Stage III-IV ovarian cancer who have achieved a complete response (CR) or partial response (PR) following first-line platinum-based chemotherapy. The results of the 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. Senaparib demonstrated a tolerable safety profile, with no noticeable safety issues. ¹ The results also indicated that both homologous recombination deficiency (HRD) positive and HRD negative populations derived benefit from Senaparib maintenance therapy, highlighting the potential of Senaparib for broad clinical application. The results of this study will strongly support Senaparib as the Standard of Care for first-line maintenance therapy in patients with newly diagnosed ovarian cancer. The top-line results of the study were initially presented as a late-breaking oral presentation at ESMO in 2023 and at CSCO 2024, and published in the international renowned medical journal Nature Medicine. ¹

About Senaparib (派舒宁®)

Senaparib is a potent and novel PARP 1/2 inhibitor discovered and developed by IMPACT. Its unique molecular structure provides high in vitro and in vivo activity, exceptional target selectivity and wide safety window. Senaparib’s approval by the NMPA was supported by the FLAMES Study.

About IMPACT Therapeutics

IMPACT Therapeutics is a globally focused, innovation-driven biotechnology company at the commercial stage, and one of the few biotechnology companies worldwide dedicated to the discovery and development of novel precision oncology therapeutics based on the synthetic lethality approach. IMPACT’s vision is to build a leading global synthetic lethality franchise that delivers better targeted cancer therapies and makes a meaningful impact on the treatment of solid tumors. IMPACT’s pipeline is among the most advanced in the synthetic lethality field globally, with product candidates designed to address significant unmet medical needs and poised to set new standards of care.

IMPACT’s pipeline includes the PARP1/2 inhibitor Senaparib (IMP4297), ATR inhibitor (IMP9064), Wee1 inhibitor (IMP7068), PARP1 selective inhibitors (IMP1734 and IMP1707, co-developed with Eikon Therapeutics), and multiple other synthetic lethality target inhibitors.

For additional information, please visit www.impacttherapeutics.com

IMPACT Therapeutics Contact:

+86 21 6841 1121

IR@impacttherapeutics.com 

PR@impacttherapeutics.com

References

1.Nature Medicine | Volume 30 | June 2024 | 1612–1621

2.Sung H, et al. CA Cancer J Clin. 2021; 71(3):209-49

3. Morgan RJ Jr, et al. J Natl Compr Canc Netw. 2016; 14:1134-63.

4. Jayson GC, et al. Lancet. 2014;384(9951):1376–88.

5. Khalique S, et al. Curr Opin Oncol. 2014;26(5):521–8.