By Fineline Cube 
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced that it has received clinical trial approval from the regulatory body in Germany for its HER2-targeted monoclonal antibody (mAb) HLX22. The drug, in-licensed from AbClon, Inc., will be tested in a global, multi-center Phase III study. The trial will evaluate HLX22 in combination with trastuzumab plus chemotherapy for first-line treatment of HER2-positive locally advanced or metastatic gastroesophageal junction and gastric cancer.
HLX22 Development and Orphan Drug Designation
HLX22 is being developed to treat gastric cancer, breast cancer, and other solid tumors. In March of this year, the drug was granted Orphan Drug Designation (ODD) in the US for the treatment of gastric cancer. This designation underscores the potential of HLX22 to address unmet medical needs in rare diseases, particularly in the treatment of gastric cancer.-Fineline Info & Tech