Senaparib is a PARP 1/2 inhibitor used to treat ovarian cancer. Credit: Jo Panuwat D/Shutterstock.

IMPACT Therapeutics has received the China National Medical Products Administration (NMPA) marketing authorisation for Senaparib capsules to treat ovarian cancer.

The authorisation allows the therapy to be used as a single agent for the maintenance treatment of adult individuals with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who showed a response after first-line platinum-based chemotherapy.

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Senaparib, a poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor developed by the company, stands out due to its unique molecular structure, which ensures high activity, selectivity, and a broad safety margin.

The approval is supported by the outcomes from the randomised, placebo-controlled Phase III FLAMES study that assessed the therapy’s safety and efficacy.

In the study, subjects with advanced ovarian cancer who had responded to chemotherapy showed a significant improvement in median progression-free survival (PFS) when treated with the therapy against placebo.

Its safety profile was also found to be tolerable, with no significant safety concerns identified.

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Both homologous recombination deficiency (HRD)-positive and HRD-negative subjects’ groups benefited from Senaparib maintenance therapy, suggesting its potential as a standard of care for first-line maintenance therapy in patients with newly diagnosed ovarian cancer.

In December 2023, the company partnered with Huadong Medicine subsidiary, Zhongmei Huadong Pharmaceutical, for the commercialisation of the therapy in mainland China.

IMPACT Therapeutics CEO Dr Sui Xiong Cai stated: “It is our great pleasure to share with you the successful approval of Senaparib for the Chinese market, which is another strong proof of the excellence of IMPACT’s in-house synthetic lethality research and development (R&D) platform and the R&D execution team.

Leveraging Huadong Medicine’s extensive commercial experiences in promoting novel therapeutics, we hope that Senaparib will reach more ovarian cancer patients soon and bring new treatment options for first-line maintenance therapy in advanced ovarian cancer.”