EMA Validates Marketing Authorization Application for Henlius' HANSIZHUANG (Serplulimab)

SHANGHAI, March 23, 2023 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the European Medicines Agency (EMA) has validated the application for its self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab), in combination with chemotherapy (carboplatin and etoposide), for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The European Commission (EC) previously granted Orphan Drug Designation (ODD) to HANSIZHUANG for the treatment of small cell lung cancer (SCLC).

"HANSIZHUANG is Henlius' first innovative mAb, as well as the first and only anti-PD-1 therapy approved for treatment of SCLC, which has benefited 13,000 SCLC patients in China. Since launched in March 2022, it has been approved for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer and ES-SCLC in China," said Jason Zhu, President of Henlius. "HANSIZHUANG is steadily making its way from China to Europe and the U.S. Previously, we had Zercepac^® approved in over 30 countries including the European Union. We hope HANSIZHUANG will further open that market and spur global expansion as we seek to benefit more patients."

The regulatory application is based on data from ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre phase 3 clinical study, which evaluated the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with ES-SCLC. The study has set up 128 sites in various countries including China, Poland, Turkey, and Georgia, and enrolled 585 subjects, among whom 31.5% were White. The results were presented in oral at the 2022 ASCO annual meeting and was then published in the JAMA (impact factor of 157.3), demonstrating the high level of academic acclaim on a global scale.

In 2022, HANSIZHUANG was also granted ODD by the U.S. FDA for the treatment of SCLC. The ODD granted by the FDA is beneficial for the continuous development of HANSIZHUANG and the enjoyment of certain policy support in terms of registration and commercialization in the U.S. Based on the positive feedback of FDA Biologics license Application (BLA) submission for HANSIZHUANG for the treatment of ES-SCLC and the discussion results of the FDA's Class C consultation meeting, Henlius initiated a bridging head-to-head trial in U.S. patients with ES-SCLC to evaluate the efficacy of HANSIZHUANG, which propels the product towards U.S. market approval further.