China-based Impact Therapeutics has announced receiving marketing clearance from the National Medical Products Administration (NMPA) for its senaparib to be used as maintenance therapy in adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The clearance is for patients who have achieved complete or partial remission with first-line platinum-based chemotherapy.
Senaparib: Drug Profile
Senaparib is Impact’s in-house developed PARP1 inhibitor, featuring a unique structure that allows it to be highly active both in vitro and in vivo. The drug demonstrates high targeting selectivity and a wide safety window, making it a promising candidate for the treatment of advanced ovarian cancers.
PLAMES Study Results
The NMPA’s endorsement of senaparib was based on results from the PLAMES study. The study showed that maintenance therapy with senaparib significantly prolonged the median progression-free survival (mPFS) of patients with advanced ovarian cancer (not achieved vs 13.6 months, HR 0.43, P<0.0001). Importantly, patients benefited from the drug regardless of their BRCA gene expression status. Furthermore, senaparib was well-tolerated and demonstrated controllable safety.
Market and Distribution Agreement
In December 2023, China-based Huadong Medicine Co., Ltd (SHE: 000963) secured the rights to market and promote senaparib in mainland China through a pact with Impact. This strategic move aims to enhance the drug’s market reach and improve access for patients in need.
Strategic Implications
The marketing clearance of senaparib by the NMPA is a significant milestone for Impact Therapeutics. It underscores the company’s commitment to advancing innovative cancer therapies and enhancing patient outcomes. By bringing senaparib to the Chinese market, Impact and Huadong Medicine aim to address significant unmet medical needs in the treatment of advanced ovarian cancers, contributing to the broader goal of improving cancer care.-Fineline Info & Tech
