Kexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA

SHENZHEN, China, May 28, 2025 /PRNewswire/ -- On May 26th, Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previously received the clearance from U.S. Food and Drug Administration (FDA) for IND application on May 21st.

GB18 is an innovative biologic product developed for the treatment of cancer cachexia, a complication with a prevalence up to 40% to 70% among cancer patients. Currently, no specific biological therapies are available to address the condition, presenting vast market potential. Featuring a unique nanobody-Fc fusion molecular structure, the product demonstrates enhanced stability, bettered bioavailability, and significantly improved performance in inhibiting disease-associated signaling pathways.

Benchmarking against globally leading pipelines with the same target (GDF-15) and indication, Kexing Biopharm's GB18 features a special nanobody-Fc fusion structure (VHH-Fc), with the patents granted or applied for the molecule globally already. Last October, a research article of GB18's preclinical study was published in the renowned international academic journal mAbs, which demonstrated that GB18 effectively alleviated weight loss in cancer cachexia models, showing superior weight recovery and improved muscle fibers in both quantity and size compared to the comparator.

In cancer cachexia, the expression level of GDF-15 is significantly elevated, which is closely associated with tumor progression and the severity of cachexia. Therefore, targeting GDF-15 has emerged as a new strategy in addressing the clinical challenge of cancer cachexia. This recent FDA IND approval marks a significant milestone in the Company's globalization of innovative products.

Approximately millions advanced cancer patients annually in the world are suffering from cachexia. There is a significant unmet clinical need for the indication of cancer cachexia.Kexing Biopharm will remain steadfast in its mission to deliver "Precise Products, Predictable Effects, and Health Protection", with a focus on product quality and a commitment to scientific innovation, and improve the lives of patients worldwide.

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SOURCE Kexing Biopharm