China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for its drug candidate RAY1216, a 3CL protease (3CLpro) inhibitor. The drug is set to be assessed as a treatment for mild to moderate COVID-19.
Mechanism of Action and Preclinical Results
RAY1216 targets the main protease of the novel coronavirus, inhibiting the cleavage of the virus precursor protein and blocking virus replication to achieve a therapeutic effect. Preclinical studies have shown that the drug demonstrates significant inhibitory activities against five different variants of the novel coronavirus, including the wild strain, Alpha, Beta, Delta, and Omicron (including BA.1, BA.5, BF.7, etc.), on par with Paxlovid.
Phase III Study Results and Clinical Benefits
The approval is based on a randomized, double-blinded, placebo-controlled Phase III study, which enrolled 1,359 patients aged 18-75 years who tested positive for SARS-CoV-2 infection within 120 hours before randomization. The results indicated that the primary efficacy endpoint was achieved, and the time from 11 symptoms to continuous clinical recovery was significantly shortened compared to the placebo group. Importantly, RAY1216 does not require the combination of ritonavir, allowing it to significantly shorten the clinical recovery time of patients with COVID-19 infection, reduce viral load, and avoid potential clinical restrictions and safety risks associated with ritonavir combination therapy.-Fineline Info & Tech
