NANJING, China and BASILDON, UK — September 18, 2026
IMPACT Therapeutics and Pharmanovia announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending marketing authorization for Sepalna® (senaparib) as maintenance treatment for advanced high-grade epithelial ovarian, fallopian tube and primary peritoneal cancer. The recommendation will now be reviewed by the European Commission, which will make the final decision. If approved, senaparib would be authorized across EU Member States and European Economic Area countries for the proposed indication.
FLAMES Phase 3 Study Supports First-Line Maintenance Use
The positive CHMP opinion is primarily supported by results from the pivotal Phase 3 FLAMES1 study, a randomized, double-blind, placebo-controlled trial evaluating senaparib as first-line maintenance monotherapy in patients with advanced FIGO Stage III-IV ovarian cancer who achieved a complete or partial response following platinum-based chemotherapy. Senaparib reduced the risk of disease progression or death compared with placebo across the broad study population, regardless of BRCA mutation status and with consistent effects across homologous recombination subgroups. At the prespecified interim analysis, median progression-free survival was not reached with senaparib compared with 13.6 months with placebo, corresponding to a 57% reduction in the risk of progression or death (HR 0.43; 95% CI 0.32–0.58; p<0.0001).
Pharmanovia Holds Rights Across 66 International Markets
The CHMP recommendation advances an exclusive partnership between IMPACT Therapeutics and Pharmanovia established in July 2026. Under the agreement, Pharmanovia holds exclusive manufacturing, development and commercialization rights for senaparib as maintenance monotherapy across 66 countries, including all 27 EU Member States, the United Kingdom, Norway, Iceland, Switzerland, Liechtenstein, Australia, New Zealand and markets across the Middle East and North Africa. The partnership combines IMPACT’s development and scientific capabilities with Pharmanovia’s regional market access, medical and commercialization infrastructure as the companies prepare for potential regulatory approval.
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Senaparib Expands Global Development of Chinese-Originated Therapy
The European regulatory milestone expands the potential international reach of senaparib, which was developed by IMPACT Therapeutics as a targeted anticancer therapy based on synthetic lethality mechanisms. Following a potential European Commission approval, Pharmanovia plans to use its market access and launch capabilities to support availability across the licensed territories. IMPACT said the CHMP recommendation represents an important step in expanding the global footprint of Chinese-originated biotechnology innovation, while the companies continue preparations for potential commercialization of senaparib in ovarian, fallopian tube and primary peritoneal cancers.
Source :IMPACT Therapeutics, press release
