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It is perhaps not surprising that Shanghai Junshi Biosciences has postponed some clinical trials to prioritize its Covid-19 antibody, partner of Eli Lilly. But what wasted their time is almost certain to raise eyebrows: The company has spent months finding enough monkeys to test the experimental drug on.
Junshi’s plight highlights a serious, though often overlooked, challenge that besets the entire biomedical research enterprise. Testing a molecule in non-human primates is often a crucial final step before it can be transferred to the clinic, but a confluence of factors has resulted in a shortage in the United States and Europe, as drug makers ‘were trying to implement their experimental programs. testing at record speed.
Junshi’s chief operating officer Feng Hui told investors on a call on Friday that the shortage was acute between February and June, when biotechnology competed with other companies and institutes.
But the problem remains unresolved. Just days ago, the European Animal Research Association drew attention to “a growing shortage of purpose-bred macaque monkeys” used in Covid-19 and other vital research.
One of the main bottlenecks is the way China, the main source of monkeys for medical research, has banned the export of breeding establishments since early 2020, citing concerns over the spread of the coronavirus.
“The current embargo is now starting to have serious consequences for research in Europe and the rest of the world,” the group wrote in a statement. Kirk Leech, the executive director, added: “Monkeys play a vital role in the development of vaccines, such as those for Covid-19, and urgent international cooperation is needed to lift the ban.”
In a letter urging WHO to intervene, EARA argued that “while the suspension was prudent at the time, it has become clear that animals exported from China have a very low risk of transmitting any communicable disease.” Research monkeys, they added, are also subject to strict handling and transport rules, including quarantine and personal protective equipment requirements.
Still, those facing the challenge are not optimistic that the problem will be resolved soon. As the Atlantic reported in August, Bioqual – which has done primate research for Moderna’s vaccine and several other Covid-19 players – said that while it was initially able to reuse some animals from non-pathological studies, the ‘supply had been exhausted.
The new macaques also cost $ 10,000, which is double the original price.
“This may be just the start,” said R. Keith Reeves, a Harvard virologist working on HIV. Atlantic. “And I think we are all preparing for significant delays.”
For his part, Junshi has conducted human tests of his antibody. The results of a recent study testing it in combination with bamlanivimab, the antibody developed by Eli Lilly and AbCellera, impressed analysts and paved the way for an emergency use authorization application. The FDA has granted an EUA for bamlanivimab.
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