Kexing Biopharm (688136.SH) subsidiary GB19 injection I phase clinical trial completed the first participant enrollment.

Kexing Biopharm (688136.SH) announced that its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., successfully completed the first participant dosing in the Phase I clinical trial of the innovative drug "GB19 Injection" targeting BDCA2 (blood dendritic cell antigen 2) developed independently by the company. The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics of GB19 Injection in healthy participants and participants with systemic lupus erythematosus in China. It is reported that the GB19 Injection project targets BDCA2, a specific surface marker expressed on plasmacytoid dendritic cells (pDC), and its mechanism of action differs significantly from existing clinical drugs targeting the B-cell pathway. By specifically binding to BDCA2, GB19 can inhibit the production of type I interferon by pDC cells, thereby intervening in the abnormal activation loop between innate and adaptive immunity. Preclinical studies of GB19 have shown good in vitro activity, immunogenicity, high bioavailability, maintenance of target inhibition for over 90 days, excellent safety profile, and potential to provide a new treatment option for patients with various interferon pathway-related autoimmune diseases such as cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE).