Kexing Biopharm's GB18 Project Gains IND Approval from NMPA and FDA

Kexing Biopharm's GB18 Project Secures IND Application Approval

On May 26, Kexing Biopharm (688136.SH) announced that it received approval for its Investigational New Drug (IND) application for the innovative product, GB18, from the National Medical Products Administration (NMPA). This important milestone comes just days after the U.S. Food and Drug Administration (FDA) granted IND clearance for the same project on May 21.

About GB18

GB18 is poised to make a significant impact in the medical field, specifically in the area of cancer cachexia—a condition that affects 40% to 70% of cancer patients. Currently, there are no targeted biological therapies available for this debilitating condition, making GB18's development crucial. Its unique nanobody-Fc fusion molecular structure offers improved stability, bioavailability, and performance in combating disease-associated signaling pathways.

Kexing Biopharm's GB18 is designed to target GDF-15, a protein whose elevated levels are associated with tumor progression and the severity of cachexia. By addressing this, the company is exploring a new strategy in tackling the clinical challenges posed by cancer cachexia.

Recent studies highlight the efficacy of GB18, demonstrating its potential in alleviating weight loss in cancer cachexia models. The results, published last fall in the esteemed journal mAbs, showcased GB18's effectiveness in promoting weight recovery and enhancing muscle fibers compared to existing treatment options.

Significance of the IND Approval

The recent FDA IND approval is more than just a regulatory achievement; it signifies Kexing Biopharm's commitment to globalizing innovative healthcare products. The approval also reflects the increasing recognition of the urgent need for treatments addressing cancer cachexia, a condition affecting millions of advanced cancer patients every year.

As Kexing Biopharm celebrates this milestone, the company reinforces its mission to provide