Shanghai Henlius Biotech, Inc. has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate a Phase 3 study to evaluate HLX22 (AC101) in combination with trastuzumab (Herceptin®?) and chemotherapy in 1st line HER2-positive advanced gastric cancer patients. Gastric/gastroesophageal junction (G/GEJ) cancer is one of the most common cancers and approximately 20% of these patients show HER2 amplification or overexpression. Despite the approval of Herceptin®?

(trastuzumab) in the US in 2010, the median overall survival of patients suffering from HER2+ gastric cancer remains limited. HLX22 (AC 101) is an innovative monoclonal anti-HER2-antibody, which was out-licensed by Alligator to the South Korean company AbClon Inc. in 2016, who sub-licensed the drug candidate to Henlius Biotech for clinical and commercial development in China. Alligator retains an ownership interest entitling the company to 35% of AbClon's income from the agreement with Henlius Biotech.