Microbio Group held an international press conference yesterday (9th), announcing the successful unblinding of Phase II clinical trial results for its nucleic acid-based COVID-19 treatment, SNS812. According to their plan, Oneness Biotech, a subsidiary of Microbio Group, will first apply for Emergency Use Authorization (EUA) in Taiwan from the Ministry of Health and Welfare this year and will initiate global licensing discussions with international pharmaceutical companies.
Shu-Ling Cheng, General Manager of Oneness Biotech, stated that while the COVID-19 pandemic has passed its peak, the virus continues to evolve. SNS812, co-developed by Oneness Biotech and Microbio Shanghai, has completed its Phase II clinical trial with 135 patients with mild to moderate infections, following the international standards required by the U.S. Food and Drug Administration (FDA).
Cheng emphasized that the trial demonstrated three key advantages of SNS812 over other COVID-19 treatments. First, it helps alleviate patients' breathing difficulties. Second, it addresses symptoms like loss of smell and taste. Third, it significantly reduces the time for patients to test negative after being positive for the virus.
Microbio Group aims to complete the Clinical Study Report (CSR) for the Phase II trial by October of this year and submit it to the U.S. FDA for review. If approved, the company plans to apply for EUA in Taiwan and other countries, including the U.S., later this year.
In addition to pursuing EUA applications in multiple countries, Cheng highlighted that Microbio Group is in talks with major international pharmaceutical companies for global market licensing. This includes collaboration on Phase III clinical trials and efforts to have SNS812 recognized as an emergency treatment for COVID-19 by the World Health Organization (WHO) and key nations.
Pan-Chyr Yang, Academician of Academia Sinica and Chief Scientific Advisor for Oneness Biotech, noted that data from the Worldometer website shows that global COVID-19 infections have reached 700 million, with over 7 million deaths.
Although the pandemic has peaked, the U.S. Health Resources and Services Administration (HRSA) predicts that COVID-19 will continue to infect 1.1 billion people annually. In February of this year, WHO officials stated that actual global infection numbers may be two to twenty times higher than reported by individual countries and that the virus will persist and continue to mutate.
Yang pointed out that there are currently four main drugs used to treat COVID-19 globally, none of which have fully addressed the safety and efficacy concerns in combating the virus's impact on humans. While Paxlovid, developed by Pfizer, has limited effectiveness and notable side effects, it still generated over $2 billion in sales in the first half of 2024, underscoring the massive demand for COVID-19 treatments.
Resource (mandarin): 中天新冠藥將申請上市 同步啟動國際大廠授權
