A Chinese COVID-19 drug candidate is undergoing clinical trials in the United States after receiving approval from the U.S. Food and Drug Administration (FDA), the drugmaker said on Wednesday.
Clinical research permits for the drug, coded DC402234, were sought from both China's National Medical Products Administration and the U.S. FDA in July 2020, the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences (CAS), the major developer of the drug, said in a statement.
Researchers commenced phase-1 clinical trials for the drug on Monday at a clinical research center of New Jersey-based Frontage Laboratories, Inc., according to the institute.
The drug is a novel compound designed and synthesized based on the crystal structure of the coronavirus' main protease, a key enzyme that plays a pivotal role in mediating viral replication and transcription. Preclinical research showed that the compound exhibited potent inhibitory activity against the protease and good antiviral activity in cell culture.
Good pharmacokinetic properties -- how a drug is absorbed and moves through the body, and its safety in animal trials -- also suggested the potential for further clinical tests, the statement read.
The results were reported in a paper titled "Structure-based design of antiviral drug candidates targeting the SARS-CoV-2 main protease," published as the cover story for the journal Science in June 2020.
The patented drug was jointly developed by researchers from the ShanghaiTech University and the Wuhan Institute of Virology under the CAS.