Sunshine Biopharma Inc (SBFM)

[MJP2020]

This is the time frame for Regeneron: https://www.regeneron.com/covid19

“We are using our end-to-end antibody technologies to develop REGN-COV2*, our novel anti-viral antibody cocktail that is being studied for its potential both to treat people with COVID-19 and to prevent SARS-CoV-2 infection. Our COVID-19-related discovery efforts started in early 2020, when we began producing hundreds of virus-neutralizing antibodies in our genetically-engineered mice and identifying similarly-performing antibodies from human COVID-19 survivors. By June, we had moved the two potent antibodies (REGN10933 and REGN10987) that form REGN-COV2 antibody therapy into cell production lines for large-scale manufacturing purposes and begun clinical trials. In September, we announced early data showing the effect of our antibody cocktail on viral load and symptoms in 275 non-hospitalized COVID-19 patients. In early October, we submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for REGN-COV2 antibody combination therapy (REGN10933 and REGN10987).”

I believe by early 2020 they mean in March. SBFM applied for the patent in May 2020. So we are probably one or two months behind from Regeneron. I also believe SBFM already performed the mice trial as they released a PR stating they found the lead compound. The next PR will be that they are done with mice trial and are now manufacturing the drug for human trials. If everything goes similar to Regeneron, SBFM should be done by human trials and apply for FDA in November or December.

Anticipated Supply of REGN-COV2

“We are actively working to maximize production capacity of REGN-COV2 and ensure it reaches as many people as possible in the United States and around the world, should ongoing clinical trials be successful and regulatory approvals are granted. We are manufacturing and providing REGN-COV2 antibody combination therapy to the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Department of Defense. Under our agreement with the U.S. government for the initial doses of REGN-COV2 antibody combination therapy, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.

We are also collaborating with Roche to significantly increase the global supply of REGN-COV2, with both companies dedicating a certain manufacturing capacity to REGN-COV2 each year. This is expected to increase existing capacity by at least three and a half times, with the potential for even further expansion. If approved, Regeneron will distribute REGN-COV2 in the U.S. (beyond the initial U.S. Government supply) and Roche will be responsible for distribution outside the U.S.”

Regeneron can only produce 300,000 doses!! They had to be partnered with Roche. So the next PR from SBFM will definitely be their partnership with a big pharma to supply their drug IMO.

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