US FDA Approved Jemincare to Initiate Clinical Trial of Neutralizing Antibody JMB2002

SHANGHAI, April 2, 2021 /PRNewswire/ -- On March 31, 2021, Jemincare group announced that their anti-SARS-CoV-2 neutralizing antibody, JMB2002, independently developed by Jemincare Shanghai Research Center, was approved by FDA for clinical trial in the United States.

Preclinical data showed that JMB2002 can precisely occupy 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, and has 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) .

In February of this year, Jemincare researchers published  on bioRxiv website 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". The preprint paper reported that 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 that of prototype S1, indicating that JMB2002 would likely keep the neutralize potency against the South Africa and UK mutants. In the latest lab study, JMB2002 also showed 7-fold higher affinity to S1 RBD of Brazilian variant compared to prototype S1 RBD, suggesting that JMB2002 would also likely retain the neutralize potency against the Brazilian variant.

In the middle of January, 2021, Jemincare has initiated the phase I clinical trial of Chinese healthy subjects. Dosing of all cohorts is completed in the phase I clinical trial in China. Now, JMB2002 was approved by FDA for clinical trial in US, that 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.

As one of the top pharmaceutical groups in China, Jemincare Group, has focused on the R&D of new drugs with pipeline for treating diseases in cancer, central nervous system, respiratory system, cardiovascular and cerebrovascular systems. Jemincare has established its Research Center in Shanghai Zhangjiang Science City and has recruited over 400 R&D scientists for development of innovative drugs including biologics, novel small molecules, novel drug delivery system, generic drugs and traditional Chinese medicines.

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