Kexing Biopharm (688136.SH): GB20 Injection Receives Drug Clinical Trial Approval Notice

Kexing Biopharm (688136.SH) announced that recently, its wholly-owned subsidiary Shenzhen Kexing Pharmaceutical Co., Ltd. ("Shenzhen Kexing") received a Drug Clinical Trial Approval Notice issued by the National Medical Products Administration. The NMPA approved Shenzhen Kexing's independently developed TL1A monoclonal antibody innovative drug "GB20 Injection" to conduct clinical trials. GB20 Injection is a humanized monoclonal antibody targeting tumor necrosis factor superfamily member 15 (TNFSF15, also known as TL1A). It can specifically bind to TL1A, block the intestinal inflammatory cascade, and reduce intestinal mucosal inflammatory damage. It is intended for the treatment of inflammatory bowel disease (including ulcerative colitis and Crohn's disease). Preclinical studies have shown that the molecule of GB20 Injection has good in vitro and in vivo activity, can effectively alleviate IBD symptoms and improve intestinal function and microstructure in animal models, and its anti-inflammatory and anti-fibrotic efficacy is superior to comparator competing products. GB20 Injection has undergone long-acting modification and has good PK/PD properties, with the potential to develop high-concentration formulations, which is expected to reduce clinical dosing frequency and improve patient compliance.