Kexing Biopharm Co.,Ltd. (688136.SH) has announced that its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has received the Clinical Trial Approval Notice issued by the National Medical Products Administration for the company's self-developed innovative biologic, GB20 Injection.

The drug approval permits the commencement of clinical trials for GB20 Injection, a humanized monoclonal antibody targeting tumor necrosis factor superfamily member 15, also known as TL1A. The therapy is designed to specifically bind to TL1A, thereby interrupting the cascade of intestinal inflammation and reducing mucosal damage in the gut, with the intended use being the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn's disease.

Preclinical studies have demonstrated that the molecular profile of GB20 Injection exhibits robust activity both in vitro and in vivo. In animal models, the drug effectively alleviated IBD symptoms and improved intestinal function and microstructure, with anti-inflammatory and anti-fibrotic efficacy surpassing that of competing benchmark products. Additionally, the molecule has been engineered for extended half-life, resulting in favorable pharmacokinetic and pharmacodynamic properties. This modification provides the potential for developing a highly concentrated formulation, which could reduce dosing frequency and thereby enhance patient compliance.