China-based Kexing Pharmaceutical (SHA: 688136) announced that its oral small-molecule COVID-19 drug SHEN26, co-developed with Shenzhen Antaiwei Biopharmaceutical Co., Ltd, has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials.
Drug Profile
SHEN26 is a novel coronavirus polymerase (RdRp) inhibitor that blocks viral nucleic acid synthesis. In vitro studies showed the drug’s EC50 against the Omicron variant was 13nM, with inhibitory activity 103 times that of remdesivir. In vivo, 50 mg/kg of SHEN26 demonstrated efficacy equivalent to 200 mg/kg of molnupiravir.
Preclinical Results
In a K18-hACE2 mouse model infected with COVID-19, SHEN26 significantly reduced lung virus titers, improved lung lesions, and alleviated tissue damage. Safety data indicated a low risk of off-target effects, with negative results for teratogenicity and mutagenesis, highlighting a high therapeutic index.-Fineline Info & Tech
