Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the dosing of the first patient in a global, multi-center Phase III study for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10). The study combines serplulimab with bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer (mCRC) in Japan, marking the Phase III segment of the global, multi-center Phase II/III ASTRUM-015 study.
HanSiZhuang, the inaugural innovative monoclonal antibody (mAb) developed by Henlius, has been approved by the National Medical Products Administration (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) since March 2022. The drug received approval in Indonesia for ES-SCLC in December 2023 and was recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) last month, indicating its potential for broader global reach.- Flcube.com
