BRIEF—Henlius' serplulimab approved in Indonesia

Shanghai Henlius Biotech has announced that PT Kalbio Global Medika, the subsidiary of Henlius' partner PT Kalbe Genexine Biologics (KGbio), has received the relevant registration certificates issued by Indonesia’s National Agency for Drug and Food Control for the approval of Henlius’ self-developed and manufactured anti-PD-1 monoclonal antibody (MAb) Hansizhuang (serplulimab) in Indonesia under the trade name Zerpidio for the treatment of extensive stage small cell lung cancer (ES-SCLC).

This is the first time the product has been successfully approved for marketing in an overseas market, and it has become the first China anti-PD-1 MAb successfully approved for marketing in Southeast Asia.

Currently, Henlius, the biotech arm of China’s Fosun Pharma, is joining hands with KGbio for the development and commercialization in 22 countries, and the approval is expected to bring Hansizhuang/Zerpidio to more patients in Indonesia.