NMPA approves IND for a Ph 2 Clinical Trial of Anti-HER2 mAb HLX22
“Shanghai Henlius Biotech, Inc. announced that the investigational new drug (IND) application for a phase 2 clinical trial of the company’s novel anti-HER2 monoclonal antibody (mAb), HLX22, in combination with trastuzumab and chemotherapy or combined with trastuzumab deruxtecan (T-DXd) has been approved by the China National Medical Products Administration (NMPA), for the treatment of HER2-expressing solid tumours. As a novel HER2-targeting mAb, HLX22 has a synergistic anti-tumor effect in combination with trastuzumab. The dual-HER2 blockade therapy has demonstrated anti-tumor efficacy and good safety in investigational studies for the first-line treatment of advanced gastric cancer. Therefore, Henlius intends to further explore the efficacy and safety of HLX22-based anti-HER2 therapies in various types of solid tumours, expected to bring clinical benefits to a wider group of patients with solid tumours.”
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