Chongqing Genrix Bio Secures NMPA Approval for GR2303, a Novel TL1A‑Targeting Antibody in IBD

China‑based Chongqing Genrix Biopharmaceutical Co., Ltd. (SHA: 688443) announced that its Class 1 biological product GR2303 has received approval from the National Medical Products Administration (NMPA) to initiate clinical trials for the treatment of inflammatory bowel disease (IBD).

How GR2303 Works

• Target: Recombinant fully human monoclonal antibody against tumor necrosis factor‑like ligand 1A (TL1A).
• Mechanism: Binds TL1A, preventing its interaction with death receptor 3 (DR3) and blocking downstream signaling.
• Result: Suppression of pro‑inflammatory cytokines—TNF‑α, IL‑17, IFN‑γ—leading to reduced intestinal inflammation.

Strategic Significance

• First‑In‑Class IBD Therapy – Addresses a growing unmet need for patients who do not respond to conventional anti‑TNF agents.
• Domestic Development – Highlights China’s expanding biopharmaceutical innovation pipeline.
• Clinical Pathway – Phase I/II trials will evaluate safety, tolerability, and early efficacy in ulcerative colitis and Crohn’s disease cohorts.

Next Steps

1. Regulatory Filing – Submit detailed clinical protocol to NMPA for approval.
2. Patient Recruitment – Begin enrollment across multiple Chongqing and Shanghai centers.
3. Data Readiness – Leverage preclinical safety data to accelerate trial initiation.-Fineline Info & Tech