SHENZHEN, China, May 30, 2024 /PRNewswire/ -- On the 24th of May, Kexing Biopharm (688136.SH) announced that Shenzhen Kexing Pharmaceutical Co., Ltd., its wholly-owned subsidiary, recently received a Notice of Approval for Drug Clinical Trials from the National Medical Products Administration, approving its clinical trial application for GB08 injection solution developed independently by the company.
GB08 was developed using recombinant DNA technology, where the human growth hormone (hGH) gene was linked to a human IgG4-Fc segment gene for expression. GB08 shows significantly improved product safety, patience convenience and compliance. This product is the first Class I innovative drug independently developed by Kexing Biopharm since its listing on the STAR Market. It is a long-acting growth hormone developed to fulfill the clinical needs of patients with pediatric growth hormone deficiency syndrome. There are no long-acting growth hormone products in Fc-fusion format available in the current market. Hence, if launched successfully in the future, this product is expected to provide a new treatment option for pediatric patients with growth hormone deficiency syndrome.
Developed by Kexing Biopharm, GB08 is a long-acting growth hormone in the form of a Fc-fusion protein, representing a brand-new generation of long-acting protein drugs. Kexing Biopharm has delved into the R&D of recombinant protein drugs for over 20 years. In its R&D pipeline, a short-acting growth hormone received clinical trial approval last year, and the recent approval of the long-acting version of growth hormone for clinical trials signals another breakthrough for the company in the development of innovative drugs. This achievement not only helps Kexing Biopharm to further optimize its product structure, but it also marks an era when Kexing Biopharm has officially entered the long-acting growth hormone market through fully independent R&D. This accomplishment has also brought hope to patients worldwide, and Kexing Biopharm will leverage this product to tap the vast market potential for long-term profitability.
Against the backdrop of a significant demand gap for long-acting growth hormone products globally, the approval of Kexing Biopharm's clinical trial application for GB08 injection solution is of positive significance for the company's future development. It will particularly contribute to the "for global" strategy Kexing Biopharm has been promoting in recent years.