Covid-19 roundup: Serum Institute eyes Africa for global expansion — report; Junshi antiviral hits primary endpoint in late-stage trial
After Serum Institute CEO Adar Poonawalla announced last month that the world’s largest vaccine maker stopped producing doses of Covid-19 vaccines back in December, the institute is looking to expand.
The CEO told Reuters Monday that the company is considering establishing its first manufacturing plant in Africa in its next step toward global expansion after successfully mass producing and selling hundreds of millions of Covid-19 vaccine doses out of its India-based facilities.
Reuters noted that Africa was the only continent that did not have its own manufacturing capabilities for COVID shots, and Poonawalla did not act shy about his ambitions for the vaccine maker.
“It’s never been a better time to be a vaccine manufacturer. I’m looking at expanding our manufacturing across the globe,” Poonawalla said in an interview at the World Economic Forum in Davos, adding, “There are some great countries out there: South Africa, Rwanda, you know, to name a few that we’re looking at.”
Poonawalla said he was meeting some African officials while in Davos to discuss his plans. And when asked about possible investments, Poonawalla said a project like this would typically require at least a ballpark figure of $300 million.
Poonawalla’s plans put him in direct competition with Moderna, which has also been looking at establishing its own vaccine manufacturing site in Africa. Modern entered a memorandum of understanding with the Kenyan government earlier this year for its first manufacturing facility on the continent.
Junshi, Vigonvita’s Covid-19 drug hits primary endpoint in PhIII trial
Junshi Biosciences has been working on co-developing an oral Covid-19 drug alongside Chinese biotech Vigonvita Life Sciences— and as of this week, the drug met the primary endpoint in a registration trial.
The biotech announced that the oral nucleoside analog candidate, called VV116, reached the primary endpoint of “time to sustained clinical recovery” in a head-to-head battle with Pfizer’s Paxlovid pill for “early treatment of mild to moderate Covid-19.”
Junshi also added that it will communicate with a regulatory authority regarding an NDA submission “soon” because of the readout — but no other details on timing were provided.
The collaboration between JunTop Biosciences — a Junshi subsidiary — and Vigonvita started back in September, when they signed a development agreement to jointly work on both clinical development and commercialization.
The “cooperation territory” that the two biotechs agreed to is the whole world, excluding 31 countries, such as 19 in the Middle East, and Russia.
According to Junshi, several clinical studies for patients with mild to moderate and moderate to severe Covid-19 are in progress, and some other multi-center, international Phase III trials will be underway. If those international trials pan out, it could be the in-road to nab approval in countries such as the US, as the FDA has put its foot down on China-only data for cancer drugs, although it remains unknown if that new policy extends to Covid-19 too.