By Fineline Cube 
China‑based Chongqing Genrix Biopharmaceutical Co., Ltd. (SHA: 688443) announced today that its telikibart (GR1802) injection has successfully completed a Phase 3 clinical trial in adults with moderate‑to‑severe atopic dermatitis (AD). The study met its primary endpoint, prompting the company to submit a marketing‑approval application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The CDE has already accepted the filing, marking a significant regulatory milestone for Genrix.
What Is Telikibart?
- Mechanism of Action – Telikibart is a recombinant, fully human monoclonal antibody that targets the IL‑4Rα subunit. By binding to IL‑4Rα on the cell surface, it blocks the interaction of both IL‑4 and IL‑13, the key cytokines driving the Th2‑mediated inflammatory cascade.
- Downstream Effects – Inhibition of IL‑4/IL‑13 signaling prevents STAT6 phosphorylation and CD23 upregulation, thereby dampening the characteristic skin inflammation seen in AD.
- Development Portfolio – Beyond AD, telikibart is in Phase 3 trials for chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and allergic rhinitis; Phase 2 for asthma; and Phase 1b/2 for pediatric AD.
Regulatory and Commercial Implications
- CDE Acceptance – The NMPA’s acceptance of the application signals a clear path toward rapid market entry in China, where atopic dermatitis affects an estimated 12‑15 % of adults.
- Competitive Landscape – Telikibart offers a distinct therapeutic profile compared with existing biologics (dupilumab, tralokinumab) by targeting the shared IL‑4Rα receptor, potentially providing broader efficacy across IL‑4/IL‑13‑driven diseases.
- Future Pipeline – Successful approval will strengthen Genrix’s position in the growing dermatology biologics market and create a platform for further antibody development using its proprietary recombinant technology.
Looking Ahead
Genrix plans to launch telikibart in the Chinese market within the next 12–18 months, pending final regulatory review. The company is also exploring collaborations to expand telikibart’s indications globally, leveraging its robust Phase 3 data set and the expanding unmet need for targeted AD therapies.-Fineline Info & Tech