SHENZHEN, China, May 28, 2025 — Kexing Biopharm (688136.SH) announced on May 26th that its independently developed innovative product, GB18, has received approval for its Investigational New Drug (IND) application from the National Medical Products Administration (NMPA). Prior to this, the U.S. Food and Drug Administration (FDA) had also cleared GB18’s IND application on May 21st.
GB18 is an innovative biologic designed to treat cancer cachexia, a complication affecting 40% to 70% of cancer patients. Currently, there are no specific biological therapies available for this condition, indicating a substantial market opportunity. The product features a unique nanobody-Fc fusion molecular structure, which enhances stability and bioavailability, and significantly improves its ability to inhibit disease-associated signaling pathways.
Compared to leading global pipelines targeting GDF-15 for the same indication, Kexing Biopharm’s GB18 utilizes a special nanobody-Fc fusion structure (VHH-Fc), with patents already granted or applied for globally. In October, a preclinical study of GB18 was published in the international academic journal *mAbs*, demonstrating that GB18 effectively reduced weight loss in cancer cachexia models, showing superior weight recovery and improved muscle fibers in quantity and size compared to the comparator.
In cancer cachexia, GDF-15 expression levels are significantly elevated and closely linked to tumor progression and cachexia severity. Consequently, targeting GDF-15 has become a novel approach to addressing cancer cachexia. The recent FDA IND approval signifies a key achievement in the company’s innovative product globalization strategy.
Millions of advanced cancer patients worldwide suffer from cachexia annually, representing a significant unmet clinical need. Kexing Biopharm remains committed to its mission of delivering “Precise Products, Predictable Effects, and Health Protection,” emphasizing product quality, scientific innovation, and improving patient lives globally.
SOURCE Kexing Biopharm
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