Fosun Pharma (02196.HK) announced that the Shanghai Fosun Pharma (Group) Co., Ltd. (referred to as the 'Company'), Shanghai Henlius Biotech, and its subsidiaries (referred to as 'Henlius') independently developed Hansizhuo (i.e. SULIN monoclonal antibody injection, referred to as 'the drug') in combination with Pemiglemase and Carboplatin for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with negative epidermal growth factor receptor (EGFR) gene mutation and negative anaplastic lymphoma kinase (ALK) mutation. The new indication was recently approved by the National Medical Products Administration (NMPA).
Hansizhuo (i.e. SULIN monoclonal antibody injection) is an innovative anti-PD-1 monoclonal antibody independently developed by the Group (i.e. the Company and its subsidiaries/units, same below). In addition to the newly approved indication, as of the date of this announcement (December 3, 2024, same below), the drug has obtained related indications approved in China, including first-line treatment of non-squamous non-small cell lung cancer (NSCLC), extensive stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), etc. Furthermore, the Market Authorization Application (MAA) for the drug in the European Union was accepted by the European Medicines Agency (EMA) in March 2023, and received a positive evaluation opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September 2024. As of the date of this announcement, there are multiple combination therapies based on this drug undergoing clinical trials in various countries and regions globally.
