MPACT Therapeutics (07630.HK), a commercial-stage biotechnology company focused on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality mechanisms, together with global specialty pharmaceutical company Pharmanovia,jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a Marketing Authorisation (MA) for the medicinal product Sepalna® (senaparib) intended for the maintenance treatment of advance epithelial ovarian, fallopian tube and primary peritoneal cancer.

Following the CHMP’s recommendation for approval, senaparib will be submitted to the European Commission (EC) for final decision. Once approved by the EC, senaparib will be authorized for marketing in all EU Member States and European Economic Area (EEA) countries.

The positive opinion from CHMP is primarily based on the results of the pivotal Phase III FLAMES¹ study. The FLAMES study is a Phase III, randomized, double-blind, placebo-controlled, multicenter trial to evaluate the efficacy and safety of senaparib versus placebo as the maintenance treatment for subjects with advanced (FIGO Stage III-IV) Ovarian Cancer (OC) who are in response (complete or partial) following first-line (1L) platinum-based chemotherapy. In the FLAMES study, senaparib as 1L maintenance monotherapy reduced the risk of progression or death versus placebo in a broad patient population with advanced OC, irrespective of BRCA mutation status and with consistent benefits observed between homologous recombination subgroups. Notably, at the prespecified interim analysis, the median PFS was NR with senaparib versus 13.6 months with placebo (HR = 0.43, 95% CI 0.32-0.58; p<0.0001). Senaparib was associated with a 57% reduction in the risk of progression or death compared with placebo.

In July 2026, IMPACT entered into an exclusive partnership with Pharmanovia. Under the licensing agreement, IMPACT has granted Pharmanovia exclusive manufacturing, development and commercialisation rights for senaparib as maintenance monotherapy for advanced epithelial high-grade ovarian, fallopian tube and primary peritoneal cancer across 66 countries, including all 27 European Union member states, as well as the United Kingdom, Norway, Iceland, Switzerland, Liechtenstein, Australia, New Zealand and countries in the Middle East and North Africa.

Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT, commented: "The positive opinion from EMA CHMP is a critical step towards market authorization by the EC, marking a significant milestone not only for senaparib and IMPACT Therapeutics, but also for the global footprint of innovative Chinese-originator biotech companies. We look forward to the final decision by the EC, and we will continue to work closely with our partner Pharmanovia to efficiently advance access to senaparib across the licensed territories in Europe, the Middle East, North Africa, Australia and New Zealand, accelerating the global reach of this innovative Chinese-originated drug to benefit more patients worldwide."

Dr. Stephan Eder, Chief Executive Officer, Pharmanovia, added: "Our partnership combines IMPACT’s scientific expertise with our launch and market expertise. The CHMP’s positive opinion marks an important next step in the regulatory process for this medicine. Our focus is now on using our market access, medical and launch capabilities to bring senaparib as a novel treatment option to patients in our territories.