Chinese pharmaceutical company Jemincare group reported on Friday the receipt of US FDA approval for its anti-SARS-CoV-2 neutralizing antibody, JMB2002, for clinical trial in the US.

This antibody was independently developed by Jemincare Shanghai Research Center.

Based on preclinical data, the company said JMB2002 occupies the key epitope of the receptor binding domain (RBD) on the S1 subunit of the SARS-CoV-2 with human angiotensin-converting enzyme II (hACE2) binding interface, with strong binding and blocking activities to the spike glycoproteins of mutant viruses including the South African mutant (B.1.351), the UK mutant (B.1.1.7) and the Brazilian mutant (P.1) .

The company added that it has published a paper entitled "A human antibody with blocking activity to RBD proteins of multiple SARS-CoV-2 variants including B.1.351 showed potent prophylactic and therapeutic efficacy against SARS-CoV-2 in rhesus macaques" on the bioRxiv website.

According to Jemincare, JMB2002 showed 6.8-fold and 1.9-fold higher binding affinity to SARS-CoV-2 S1 mutant proteins of South African mutant and UK mutant respectively in comparison to prototype S1. JMB2002 showed seven fold higher affinity to S1 RBD of Brazilian variant compared to prototype S1 RBD. JMB2002 would likely retain the neutralize potency against the Brazilian variant, added the company.

Under the company's prior phase I clinical trial in Chinese healthy subjects, the dosing of all cohorts is completed in the phase I clinical trial in China. JMB2002 would add an option for prophylactic and therapeutic intervention of SARS-CoV-2 utilizing JMB2002 to slow down the transmission of currently emerged SARS-CoV-2 variants and that would likely result in more efficient control of the COVID-19 pandemic.