Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a leading pharmaceutical company in China, has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang, in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
HanSiZhuang, which first gained marketing approval in China in March 2022, has since accumulated four indication approvals, including its use in 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). In a significant move last year, exclusive development and commercialization rights for the drug were licensed to Intas Pharmaceuticals Ltd, an India-based pharmaceutical company, for distribution in Europe and India.- Flcube.com