On September 30, 2022, Suzhou Abogen Biosciences Co., Ltd. (Abogen) today announced that it has received emergency use authorization (EUA) from Indonesia’s Food and Drug Monitoring Agency (BPOM) for its COVID-19 vaccine，ARCoV(commercial name, AWcorna ) for both primary and booster doses in individuals aged 18 years or older. The vaccine, developed by the company with the People's Liberation Army (PLA) Academy of Military Sciences and Walvax Biotechnology Co., Ltd., is the first China-made mRNA vaccine authorized for use.
▲On September 30, 2022, Indonesia’s Food and Drug Monitoring Agency (BPOM) held a press conference to announce the approval of Abogen’s COVID-19 Vaccine.
BPOM based its recommendation on the totality of scientific evidence shared by the company. This included data analysis from a multi-center Phase 3 clinical trial enrolling more than 20,000 participants globally and follow-up clinical trials on the safety and immunogenicity of a third dose of heterologous boosting with AWcorna in Chinese adults. Other necessary information was fully taken into account in making this recommendation.
The clinical trials indicated that the vaccine has good efficacy in protecting against both the wild-type strain and Omicron variant strain (the Omicron variant) of COVID-19, along with a favorable safety profile consistent with another two major commercial mRNA COVID-19 vaccines in the global market. It also demonstrated a significant level of protection against mild to moderate symptoms.
Results from the clinical trial on heterologous boosting with AWcorna showed higher levels of neutralization and IgG antibodies against wide-type, Delta, and Omicron variants compared to homologous boosting. The research findings have been published in the journal "Cell Research".Indonesia is designated by the World Health Organization (WHO) as a hub for the supply of COVID-19 vaccines in Southeast Asia. Abogen also committed to bringing mRNA manufacturing to Indonesia through a Memorandum of Understanding (MoU) with PT Etana Biotechnologies Indonesia with the aim of building a state-of-the-art mRNA vaccine manufacturing facility in the country through technology transfer. This manufacturing facility, as the first of its kind in South East Asia, strives to equip the region with easily accessible capabilities for responding rapidly to pandemics. Furthermore, it will provide access to Abogen's expanding portfolio of mRNA therapeutic products that are currently in the developmental phase.
As a biotech company at the forefront of mRNA therapeutics and vaccines, Abogen has established its own industry-leading proprietary platform that is built upon continuous advances in mRNA science, delivery technology, and manufacturing. The platform has endowed the company with the capabilities to pursue a robust pipeline of novel therapeutic candidates and vaccines. AWCorna, as Abogen’s first product to receive EUA, establishes a firm groundwork for the future development of even more mRNA-based therapeutics for other infectious diseases than COVID-19, immuno-oncology, rare diseases, among others.
