Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan to conduct a global, multi-center Phase III study. The study will evaluate the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10) in combination with bevacizumab and chemotherapy for first-line metastatic colorectal cancer (mCRC), as part of the Phase III of the global, multi-center Phase II/III ASTRUM-015 study.
Prior results from Phase II of the ASTRUM-015 study have demonstrated that the combination of serplulimab and bevacizumab with chemotherapy can enhance progression-free survival and other efficacy indicators in previously untreated mCRC patients, including those with microsatellite stable (MSS) type mCRC, with manageable safety. The first patient dosing in the Phase III of the ASTRUM-015 study has been completed in China, and the clinical filing process in other regions worldwide is progressing efficiently.
HanSiZhuang, the first 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 is also being developed in combination with other treatments, aiming to cover a similar range of indications.- Flcube.com
