Kexing Biopharm Obtained IND Approval for Its Self-developed GB05 from U.S. FDA

SHENZHEN, China, Feb. 14, 2025 /PRNewswire/ -- Kexing Biopharm Co., Ltd. (Stock Code: 688136.SH) recently announced that the Investigational New Drug Application (IND) of GB05, Human Interferon α1b Inhalation Solution, a self-developed product by the Company's wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has been approved by the United States Food and Drug Administration (FDA), and this approval allows Shenzhen Kexing to initiate its proposed clinical trials in the US. The proposed indications are pediatric lower respiratory tract infections caused by respiratory syncytial virus (RSV), such as pneumonia and bronchiolitis. This significant breakthrough in antiviral drug development brings new hope to the treatment of RSV infections in children globally.

RSV is one of the most causative viruses for acute respiratory infections in infants. Children under the age of five are particularly vulnerable, and the situation is even worse for infants and children with underlying health conditions, who are likely to suffer severe pneumonia when infected. There is yet no effective anti-viral drugs targeting RSV approved globally. GB05, Human Interferon α1b Inhalation Solution, is specifically formulated for pediatric use: it incorporates a mutation to increase stability, is formulated with low human albumin content for increased safety and lower cost, and in inhaled regimen, the active ingredient can be delivered directly to the infection site for better efficacy and reduced side effects. In addition, inhalation delivery enhances pediatric patients' compliance compared to subcutaneous injection. In summary, the safety, efficacy and compliance of GB05 have been significantly improved. Currently, phase III clinical trials for GB05 are on going in China.

Kexing Biopharm has been deeply engaged in antiviral, oncology, and immunology areas, keeping refining and balancing its product pipeline. The approval of GB05 for clinical trials in both China and the US is not only a reflection of Kexing Biopharm's prowess in innovative R&D, but also an important achievement after years of efforts in antiviral area. Besides GB05, Kexing Biopharm is also gaining progress in the development of other innovative medicines. For instance, Kexing is actively working on a new biological entity, GB08, a long-acting growth hormone in the form of an Fc-fusion protein. Meanwhile, the IND applications of GB18 indicated for cancer cachexia (a nanobody targeting GDF-15) are about to be submitted in both China and the US within this year.

In recent years, Kexing Biopharm's R&D pipeline becomes more focused, and the R&D investment is more precise and targeted. Its innovation capability has attracted attention from peers and venture capitals at home and abroad. In the future, Kexing will adhere to the platform-based development strategy driven by innovation and internationalization, bringing more breakthroughs on the road of innovation.

SOURCE Kexing Biopharm