On December 2, 2022, Dr. Min Hu, the Chief Medical Officer of Frontier Biotechnologies Inc. (the “Company”, stock code: (688221. SH) presented the latest clinical updates of COVID-19 small molecule treatment FB2001 (generic name: Bofutrelvir) for nebulized inhalation at the 2022 China Chemical Pharmaceutical CMC Innovation Summit.

Latest updates included:

1.    Data of SARS-CoV-2 Inhibitory effect: The company collaborated with Wuhan Institute of Virology, Chinese Academy of Sciences to evaluate the effect against mutant virus strains In vitro.

▷    FB2001 showed definite antiviral activity against Omicron BA.2 and BA.5 virus strains.

▷    Regarding the EC50 of the COVID-19 strains Alpha, Beta, Delta, and Omicron in Vero E6 cells, FB2001 is comparable to or better than Nirmatrelvir (Paxlovid)

2.    Phase I clinical trial of FB2001 for nebulized inhalation:

▷    This Phase I clinical trial was conducted in China. This study is a randomized, double-blind, placebo-parallel control with dose escalation design. Enrolled subjects were healthly men and women aged 18-60 years.

▷    According to the preliminary latest Phase I analysis, FB2001 nebulized aerosol formulary has a high concentration in the respiratory tract, demonstrating good clinical safety and tolerability and no dose-limiting toxicity (DLT).