Oneness and Microbio (Shanghai) Co., Ltd. announced the Phase 1 clinical trial data of SNS812, a broad-spectrum antiviral siRNA for treatment of SARS-CoV-2 infection. Mass production date:NA. Effect on company finances and business: New drug name or code:SNS812.

Purpose: A. Treatment of COVID-19 infection. Information Website: Planned development stages: Phase II clinical trial/Phase III clinical trial/NDA (New Drug Application). Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Clinical Trial Design: Protocol TitleGA Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled SNS812 in Healthy Participants.

Study PurposeGA phase I clinical trial conducted at a single center in the United States using a randomized, controlled, and placebo-controlled design to evaluate the safety, tolerability, and pharmacokinetics of SNS812 in healthy subjects. Phase I clinical trial Phase I clinical trial, Investigational productGSNS812. IndicationGT treatment of COVID-19 infection, Endpoints: Primary endpointsG The safety and tolerability of SNS812.

The half-life in vivo was about 5-7 hours. The results indicate that SNS812 has good pharmacokinetic properties and will be helpful for the design and planning of phase II clinical trials in the future. Immunogenicity: No autoantibodies against SNS812 were produced after SNS812 administration.

Exploratory endpoint and the statistical results:NAd. Safety evaluation results:SNS812 at a dose of 1.2 mg/kg has good safety and tolerability in healthy subjects. The results of a single clinical trial (including the p value or whether there is statistical significance in primary, secondary endpoints) shall not be sufficient to reflect the success or failure of the new drug in the future development.

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