Japan’s PMDA clears CTN for Ph 3 MRCT of Serplulimab Combo in patients with 1L mCRC
“Shanghai Henlius Biotech announced that the clinical trial notification (CTN) for phase 3 international multicenter clinical study (ASTRUM-015) of Henlius’ self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency. The study has previously completed dosing of the first subject in China, and the regulatory registration and clinical development is advancing efficiently in more countries and regions around the world.”
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