San Diego, California--(Newsfile Corp. - October 4, 2026) - Recently, Kexing Biopharma (688136.SH) announced that its wholly owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd. ("Shenzhen Kexing"), has received a Notice of Approval for Drug Clinical Trials from China's National Medical Products Administration (NMPA), authorizing the initiation of clinical trials of GB20, a proprietary investigational anti-TL1A monoclonal antibody for inflammatory bowel disease (IBD).
Inflammatory bowel disease (IBD) is a chronic, relapsing inflammatory condition of the gastrointestinal tract that primarily comprises Crohn's disease and ulcerative colitis. IBD is typically lifelong and requires long-term management.
TL1A, a member of the tumor necrosis factor (TNF) superfamily, binds to death receptor 3 (DR3) and plays a central role in IBD pathogenesis. Targeting TL1A offers a dual mechanism of action-suppressing inflammation and delaying fibrosis, potentially supporting disease management across the full course of IBD and offering a differentiated therapeutic approach.
GB20 was developed using the company's proprietary KX-BODY antibody technology platform. AI-assisted drug design was used to identify key residues involved in binding between the anti-TL1A antibody and its target, and markedly improving early-stage R&D efficiency.
Preclinical findings for GB20 published in Frontiers in Immunology indicated a differentiated profile, including improvements in disease activity scores, colon morphology, and histopathologic signs of inflammatory injury, as well as a trend toward reduced intestinal fibrosis. GB20 also demonstrated a long half-life in pharmacokinetic studies, which could support longer dosing intervals in future clinical use, reduce injection frequency, and improve patient adherence.
In autoimmune diseases, in addition to GB20 (an anti-TL1A monoclonal antibody), the company is advancing several differentiated programs. These include GB19, an anti-BDCA2 monoclonal antibody for lupus that has received clearance to enter clinical trials from both the NMPA and the U.S. Food and Drug Administration (FDA); GB24, a bispecific antibody for IBD; GB12, a bispecific antibody targeting IL-4R and IL-31; and GB26, a bispecific antibody for systemic lupus erythematosus.
In recent years, the company has focused on oncology and autoimmune diseases and accelerated the development of more than 10 innovative drug programs. It is forming a staged pipeline that spans discovery, clinical development, and regulatory filing.
Alongside its commitment to internal innovation, Kexing Biopharm continues to expand its global presence. The company has established a sales presence in approximately 70 countries and regions. With established capabilities in overseas registration, market access, and commercialization, Kexing Biopharm aims to become an innovation-driven global biopharmaceutical company and bring more high-quality products to patients worldwide.
Contact:
Kexing Biopharm
Zheng Haiyan
zhenghaiyan@kexing.com
https://www.kexingbiopharm.com/
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