Kexing Biopharm Receives Approval for Long-acting Growth Hormone Trial

SHENZHEN, China, May 30, 2024 -- Kexing Biopharm (688136.SH) revealed that its subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has obtained approval from the National Medical Products Administration to commence clinical trials for their independently developed GB08 injection solution.

GB08 is a product of advanced recombinant DNA technology. This innovative solution integrates the human growth hormone (hGH) gene with a human IgG4-Fc segment gene, resulting in a product with enhanced safety, patient convenience, and compliance. Notably, GB08 stands as Kexing Biopharm's first Class I innovative drug since its inception on the STAR Market. It is designed to address the needs of pediatric patients suffering from growth hormone deficiency syndrome, a condition where no long-acting growth hormone products in an Fc-fusion format currently exist. If successfully launched, GB08 could offer a new and effective treatment option for these patients.

Kexing Biopharm has a rich history spanning over two decades in the research and development of recombinant protein drugs. The company has previously achieved clinical trial approval for a short-acting growth hormone, and the recent green light for the long-acting growth hormone clinical trials is a significant milestone. This progress not only enhances Kexing Biopharm's product lineup but also signifies the company's official entry into the long-acting growth hormone market through entirely independent research and development. This breakthrough holds promise for patients worldwide, and it positions Kexing Biopharm to capitalize on substantial market opportunities for sustained profitability.

The global market faces a notable shortage of long-acting growth hormone products, making the approval of Kexing Biopharm's GB08 clinical trial application particularly impactful for the company's future. This development aligns with Kexing Biopharm's "for global" strategy, which it has been actively promoting in recent years.

In summary, Kexing Biopharm's achievement in securing approval for the clinical trials of GB08 injection solution represents a significant advancement in the field of long-acting growth hormones. This innovation not only addresses an urgent clinical need but also reinforces the company's commitment to pioneering treatments through rigorous research and development. The successful development and potential market introduction of GB08 could transform the treatment landscape for pediatric growth hormone deficiency syndrome, offering new hope to patients and solidifying Kexing Biopharm's position as a leader in biopharmaceutical innovation.

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