Recently, the Recombinant Five-antigen Staphylococcus Aureus Vaccine (rFSAV), a Class 1.1 New Drug co-developed by Chengdu Olymvax Biopharmaceuticals Inc. (hereinafter referred to as "Olymvax") and the Army Medical University, has achieved significant progress. The enrollment of all subjects in Phase III clinical trial has been completed, marking that the research and development of the product has entered into the sprint stage.
Over Ten Years of Research and Development: Breakthrough of Technology Having Laid a Leading Advantage
rFSAV has been developed for over 10 years and has established multiple key technologies and industrialization platform. It is the vaccine of its kind with the most targeted components in the world and the only vaccine undergoing clinical trial phase III with a globally leading research and development progress. The vaccine started clinical trials in June 2016 and has successfully completed clinical trial phase I and phase II. The summary report of clinical trial Phase II shows that rFSAV has good safety when administered to the target population of orthopedic surgery aged 18 to 70 years old in China; specific antibody levels reache peak from Day10 to Day14 after the first dose of immunization, indicating good immunogenicity of the vaccine. The clinical trial phase III adopts an internationally recognized multicenter, randomized, double-blind, placebo-controlled research protocol, which is simultaneously conducted at over 60 clinical centers across China, aiming to evaluate the protective efficacy, safety, and immunogenicity of the vaccine in the target population of orthopedic surgery.
Filling the Clinical Gap: Solving Global Healthcare Challenges
The Staphylococcus aureus is a highly drug-resistant pathogen (superbug) that causes hospital-acquired infections. It can lead to serious complications such as purulent arthritis, osteomyelitis, sepsis, acute pneumonia, endocarditis, and can also cause systemic lethal infections such as scald like skin syndrome and toxic Hooke's syndrome, contributing to over 1.1 million deaths worldwide each year. So far, there is no vaccine available for drug-resistant Staphylococcus aureus infection globally. If rFSAV is successfully developed, it is expected to fill this important clinical gap and make significant contributions to global public health challenges.
Innovation-driven Development: Building a Leading Enterprise in Superbug Vaccines
As a pioneer in the development of "superbug" vaccines in China, Olymvax has always adhered to an innovation-driven development strategy. Olymvax has established a comprehensive research and development system for superbug vaccines, and continues to carry out innovative vaccine research and development for multiple drug-resistant bacteria. In the future, the company will fully promote the clinical trial phase III research of rFSAV, aiming to achieve a breakthrough from 0 to 1 in the prevention and control of superbug infections，and provide innovative and high-quality solutions for important global health issues.