Inetetamab Approved Naked monospecific

Inetetamab, a trastuzumab analog which has the exact F(ab’)2 of trastuzumab fused to a different IgG1 Fc allotype that differs from trastuzumab by two amino acid variation (Zhang et al. A new anti-HER2 antibody that enhances the anti-tumor efficacy of trastuzumab and pertuzumab with a distinct mechanism of action https://www.sciencedirect.com/science/article/pii/S0161589019307552) The Fab domain of inetetamab is identical with trastuzumab, but whose amino acid sequence at positions 359 (D359, aspartic acid) and 361 (L361, leucine) is different from trastuzumab [E359 (glutamate) and M361 (methionine), respectively] in the constant region of the heavy chain of the Fc domain. Inetetamab is a “mimetic combination” of an anti-HER2 monoclonal antibody, which is a drug independently developed by Sunshine Guojian for anti-HER2 treatments, leveraging on its own platform technology. It is also a project under the 863 Program, the National Major Scientific and Technological Special Project for “Significant New Drugs Development” and the key science and technological project for Shanghai and was granted with a priority review status. An in vitro research has shown that [Wang Xiaowen et al., Chinese Pharmaceutical Journal, 2015, 50 (12)] the Fab region of Inetetamab is consistent with trastuzumab. With the engineered Fc region and optimized production process, it has a stronger ADCC effect, which better achieves the therapeutic goal of the anti-HER2 monoclonal antibody. In addition to directly inhibiting proliferation and growth of tumor cells by blocking the pathway of HER2, the Fab region of Inetetamab can also induce the ADCC effect, recognizing and killing tumor cells through the immune system.