Shanghai Henlius Biotech Inc. (HKG: 2696) has received market approval from the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) for its anti-PD-1 monoclonal antibody, HanSiZhuang (serplulimab). This approval allows the drug to be used in the treatment of extensive-stage small-cell lung cancer (ES-SCLC). Henlius is collaborating with Indonesia’s PT Kalbe Genexine Biologics to develop and commercialize HanSiZhuang across 22 countries.
HanSiZhuang is Henlius’s first innovative monoclonal antibody and has already been approved by China’s National Medical Products Administration (NMPA) for various indications, including MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC). The drug is also being investigated in combination therapies for a broader range of indications.
In November 2022, parent company Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196; SHA: 600196) secured exclusive commercialization rights for HanSiZhuang in the United States. Following this, Fosun Pharma partnered with US CRO Syneos Health (Nasdaq: SYNH) for US development in January 2023. Additionally, Henlius licensed the drug to PT Kalbe Genexine Biologics for select Southeast Asian markets in September 2019, with the agreement expanded in August 2023 to include the Middle East and North Africa. Recently, India-based Intas Pharmaceuticals Ltd acquired exclusive development and commercialization rights for HanSiZhuang in Europe and India through a EUR 185 million deal finalized in late October.- Flcube.com
