Oneness Biotech Co., Ltd. announced that it has submitted an IND to US FDA for a phase II clinical trial on the broad-spectrum anti-SARS-CoV-2siRNA (SNS812) co-developed with Microbio (Shanghai) Co. Ltd. Product:SNS812, a broad-spectrum siRNA against SARS-CoV-2 virus. Mass production date:NA.

Effect on company finances and business: New drug name or code:SNS812. Purpose: A. Treatment for COVID-19 infection. The phase I study of SNS812 has been completed in the US, obtaining comprehensive pharmacokinetic parameters and preliminary validation of its safety in humans.

An IND application for the phase II study in treating COVID-19 infection has been submitted to explore the efficacy, safety, tolerability, and pharmacokinetic characteristics of SNS812 in patients with COVID-19. File application/approved/disapproved/Each of clinical trials (include interim analysis): submit an IND application to the US FDA for Phase II clinical trial. Once disapproved by competent authority or each of clinical trials (include interim analyses) results less than statistically significant sense, the risks and the associated measures the Company may occur: Not applicable.

After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable. Accumulated investment expenditure incurred: No disclosure of investment expenditure at the moment in consideration of future marketing strategies and to protect the interests of the company and investors. Upcoming development plan:phase II /III clinical trial A. Scheduled completion date: The actual schedule will depend on the progress of the US FDA review.

Estimate responsibilities: SNS812, an broad-spectrum antiviral siRNA for COVID-19, is developed jointly by Oneness Biotech Co., Ltd., and Microbio (Shan Shanghai) Co., Ltd. Market: Based on the data published on May 17, 2023, severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) has infected more than 766 million people worldwide and caused more than 6.93 million deaths. With the occurrence of vaccine breakthrough and repeated COVID-19 infections caused by new variants, it is anticipated that the future new variants will lead to periodic global epidemics. The emergence of the Omicron variant has highlighted not only the rapid mutation rate of the SARS-CoV-2 virus, but also its astonishing global transmission speed.

SNS812 has the potential to be an anti-coronavirus drug unaffected by viral mutations, allowing for long-term usage. While the annual number of flu patients worldwide ranges from 10 to 20 million, with up to 40 million during pandemics, Roche's Tamiflu has generated over $1 billion in annual revenue. However, given the significantly higher infectivity of the SARS-CoV-2 virus, with over 150 million people infected annually and the number of infections continuing to rise, the market for COVID-19 treatments is predicted to surpass that of traditional flu drugs, reaching $16.2 billion by 2031, according to the well-known analytical firm Transparency Market Research.