Home » EMA Validates Marketing Authorization Application for Henlius’ HANSIZHUANG (Serplulimab)

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

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

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SHANGHAI, March 24, 2023 (Reuters) /PRNewswire/

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

“HANSIZHUANG is Henlius’ first innovative mAb and the first and only anti-PD-1 therapy approved for the treatment of SCLC, which has already benefited 13,000 SCLC patients in China. Since its launch in March 2022 approved in China for the treatment of MSI-H solid tumors, non-small cell squamous cell lung cancer and ES-SCLC,” said Jason Zhu, President of Henlius. “HANSIZHUANG is on the way from China to Europe and the USA. Previously, we had Zercepac® approved in over 30 countries including the European Union. We hope that HANSIZHUANG will further open this market and drive global expansion so that more patients can benefit from it.”

The filing is based on data from ASTRUM-005, a randomized, double-blind, placebo-controlled, international, multi-center, Phase 3 clinical trial evaluating the efficacy and safety profile of the PD-1 inhibitor serplulimab plus chemotherapy versus placebo plus chemotherapy as first-line therapy Patients with ES-SCLC were studied. The study set up 128 sites in different countries, including China, Poland, Turkey and Georgia, and enrolled 585 subjects, 31.5% of whom were white. The results were presented orally at the 2022 ASCO Annual Meeting and subsequently in the journal JAMA (Impact Factor 157.3), demonstrating the high level of scientific recognition on a global scale.

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In 2022, HANSIZHUANG received ODD approval from the US Food and Drug Administration for the treatment of SCLC. The ODD granted by the FDA is beneficial for the continued development of HANSIZHUANG and the receipt of certain policy support related to approval and commercialization in the United States. Based on the positive feedback on the FDA’s submission of a Biologics License Application (BLA) for HANSIZHUANG for the treatment of ES-SCLC and the discussion results of the FDA’s Class C Consultative Meeting, Henlius has submitted a head-to-head bridging study US patients with ES-SCLC initiated to evaluate the efficacy of HANSIZHUANG, further advancing the product toward US market approval.

View original content: https://www.prnewswire.com/news-releases/ema-validiert-antrag-auf-marktzulassung-fur-henlius-hansizhuang-serplulimab-301780587.html

Press contact:

Bella Zhou,
+86-13917530919

Original content by: Henlius, transmitted by news aktuell

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