Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new market filing for its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), seeking approval for use in combination with chemotherapy for first-line non-squamous non-small cell lung cancer (nsqNSCLC). The filing, accepted for review by the National Medical Products Administration (NMPA), marks the fifth indication approval filing for the drug in China.
HanSiZhuang, the first innovative monoclonal antibody (mAb) developed by Henlius, has already been approved by the NMPA for the treatment of 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 is also under development in combination with other treatments for a similar range of indications.
Parent company Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196; SHA: 600196) entered into a licensing agreement with Henlius in November 2022, securing exclusive commercialization rights to the drug in the United States. Fosun Pharma partnered with US CRO Syneos Health (NASDAQ: SYNH) for local development in January 2023. Henlius licensed the drug to PT Kalbe Genexine Biologics for agreed Southeast Asian countries in September 2019, with the deal expanded in August 2023 to cover the Middle East and North Africa. India-based Intas Pharmaceuticals Ltd obtained exclusive development and commercialization rights to the drug in Europe and India through an EUR 185 million deal signed in late October.- Flcube.com
