Kexing Biopharm’s GB18 Receives FDA Approval for Tumor Cachexia Clinical Trial

Kexing Biopharm's GB18 Receives FDA Approval for Tumor Cachexia Clinical Trial

China-based Kexing Biopharm Co., Ltd. (SHA: 688136) announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed GB18 as a treatment for tumor cachexia. This marks a significant milestone in the development of novel therapies for this debilitating condition.

GB18 Mechanism and Structure
GB18 is a novel medicine targeting growth differentiation factor 15 (GDF15). It features a unique Fc fusion nanobody structure design, which not only improves the stability and bioavailability of the drug but also significantly enhances its performance in inhibiting signal pathway transmission. Preclinical data showed that GB18 had significant differentiation advantages.

Preclinical Results
In vivo experiments demonstrated that by blocking the GDF15 signaling pathway, GB18 effectively reversed weight loss caused by tumor cachexia. It also significantly increased the muscle and fat weight of model animals and improved the quality of muscle fibers. The experimental results showed that cachexia animals treated with GB18 exhibited stronger exercise ability and similar energy metabolism indicators to normal animals compared to the control group.-Fineline Info & Tech