Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biotech company from China, has announced the first international shipment of its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab), from Shanghai Pudong Airport to Indonesia. HanSiZhuang, the inaugural innovative monoclonal antibody (mAb) developed by Henlius, has gained approval from the National Medical Products Administration (NMPA) in China for the treatment of microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small-cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC).
The drug received regulatory approval in Indonesia for the treatment of ES-SCLC in December 2023. Henlius had previously licensed the drug to PT Kalbe Genexine Biologics for distribution in agreed Southeast Asian countries back in September 2019, with the deal being expanded in August 2023 to encompass the Middle East and North Africa. The company is now strategizing to pursue market approval for HanSiZhuang across 22 emerging markets, broadening its global reach and impact.- Flcube.com
