SBP GROUP (01177): The clinical trial application for TQF6422 injection "ActRII A/B monoclonal antibody" has been approved by NMPA.

SBP GROUP (01177) announced that its subsidiary, Chongqing Zhifei Biological Products Co., Ltd. (Zhengda Tianqing), has independently developed the national Class 1 innovative drug TQF6422 injection (ActRII A/B monoclonal antibody), which has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China to conduct clinical research. It is intended for weight management in adult patients with obesity or those who are overweight with at least one weight-related comorbidity. TQF6422 is a fully human IgG1 monoclonal antibody targeting ActRII A/B. By specifically binding to ActRII A/B receptors, it effectively blocks signal transduction mediated by activin, myostatin, and other ligands, promoting skeletal muscle growth while enhancing lipolysis, thus achieving a dual effect of "fat loss and muscle gain." ActRII mainly includes two subtypes, ActRII A and ActRII B, primarily found in adipose and muscle cells. In adipose cells, after activin ligands bind to ActRII receptors, they promote lipid storage and visceral fat accumulation, serving as key drivers of visceral fat accumulation and the formation of obesity. In muscle cells, ligands such as activin and myostatin directly inhibit muscle growth through their action on ActRII receptors, leading to muscle atrophy. Blocking this signaling can inhibit atrophy and promote muscle mass increase. Therefore, targeting the ActRII pathway has the potential to simultaneously improve fat mass and lean body mass.