Anhui Anke Biotechnology (300009.SZ): AK2024 injection clinical trial approved

Anhui Anke Biotechnology (300009.SZ) announced that the company has received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration regarding the "AK2024 Injection". The National Medical Products Administration has approved the company to conduct clinical trials of this product as a single drug in HER2-positive advanced solid tumors. The announcement shows that AK2024 is an anti-HER2 antibody that was selected using a functional detection method based on trastuzumab, with synergistic anti-tumor activity. It selectively acts on the extracellular site of human epidermal growth factor receptor-2 (HER2), with antigen recognition sites different from those of trastuzumab or pertuzumab. Preclinical studies have shown that AK2024 can inhibit the proliferation of HER2-positive tumor cells, synergize with trastuzumab, and have better synergistic anti-tumor effects than pertuzumab.