Yingpai Pharmaceutical-B (07630): Senapalil received positive feedback from CHMP and is expected to be used for first-line maintenance treatment of advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer

Zhitong Finance App News, Yingpai Pharmaceutical-B (07630) issued an announcement. The European Medicines Agency (EMA) Commission for Human Medicines (CHMP) has passed a positive opinion recommending approval of the marketing license (MA) for the drug Sepalna® (Senapali). The drug is intended for maintenance treatment of advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer.

After approval of the CHMP proposal, Senapali will be submitted to the European Commission (EC) for a final decision. Once approved by the European Commission, Senapali will be approved for sale in all EU member states and European Economic Area countries.

The CHMP's positive opinion is mainly based on the results of the key Phase III FLAMES study. The FLAMES study is a multicenter, randomized, double-blind, placebo-controlled phase III trial to evaluate the efficacy and safety of maintenance treatment with senapalil versus placebo for first-line (1L) platinum-containing chemotherapy (complete remission or partial remission) in advanced (FIGO stage III-IV) epithelial high-grade ovarian cancer (OC), fallopian tube cancer, and primary peritoneal cancer. In the FLAMES study, for a broad group of patients with advanced ovarian cancer, senapali as a 1L maintenance monotherapy reduced the risk of disease progression or death compared to placebo, and was not affected by BRCA mutation status, and consistent benefits were observed among homologous recombinant subgroups. Notably, in the predetermined midterm analysis, median progression-free survival was not achieved in the senapali group, while the placebo group was 13.6 months (risk ratio = 0.43, 95% confidence interval 0.32-0.58; p<0.0001). Compared to placebo, senapalil reduced the risk of disease progression or death by 57%. The above FLAMES study results were published in “Nature Medicine” in May 2024.

Dr. Choi Sui-hung, CEO of the company, said, “The positive opinion of EMA CHMP is a key step towards marketing approval by the European Commission. This is an exciting and important milestone for both the drug Senapali, the British School itself, and the internationalization of independent innovative drugs in China. We are very much looking forward to EC's final approval results, and will continue to work closely and efficiently with our partner Pharmanovia to make every effort to promote the accessibility of Senapali in authorized regions such as Europe, the Middle East, North Africa, Australia and New Zealand, and accelerate the spread of this innovative drug developed in China to the global market and benefit more global patients.”

Dr. Stephan Eder, CEO of Pharmanovia, added: “This partnership combines British research expertise with our commercial listing and market operation experience. The CHMP's positive opinion marks an important next step in the regulatory process for the drug. Our current focus of work is to provide patients in authorized regions with senapalil as a new treatment option based on our market access, medical affairs, and commercial marketing capabilities.”