(Yicai Global) June 8 -- Chinese scientists started the country’s first human clinical trials of a Covid-19 antibody drug yesterday, administering it to volunteers at a hospital in Shanghai.
Jointly developed by biotech firm Shanghai Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Sciences, JS016 is the first Covid-19 antibody drug to get the greenlight from the country’s National Medical Products Administration to proceed with clinical trials. The objectives of the trials will be to prevent disease in healthy people and to treat patients.
The development puts the relatively unknown Chinese drug developer and university research team up with pharmaceutical giants, including New Jersey-based Merck, New York-based Pfizer and Foster City, California-based Gilead Sciences, all racing to develop a cure for Covid-19.
Volunteers at Huashan Hospital, affiliated to Shanghai Fudan University, were administered the drug. The trials will use a randomized, double-blind, placebo-controlled research method to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of the drug in an unspecified number of healthy volunteers. Results are expected to be available before the end of next month.
It is also the world’s first trial of a SARS-CoV-2 antibody medicine in a healthy population after completing non-human primate experiments.
An antibody drug differs from a vaccine, which trains the body’s immune system to make its own antibodies, by selecting a particularly effective antibody, out of thousands that might be present in a patient, and mass manufacturing it. It is also more suitable for the prevention of the disease in key vulnerable groups such as medical staff and elderly people.
Due to a dearth of patients in China, Junshi has agreed to share patient data with US pharma giant Eli Lilly. Earlier this month, Eli Lilly began early stage studies in the US of an antibody drug on humans. Jointly developed with Canada’s AbCellera, the trials will test the safety and tolerability of the medicine in Covid-19 patients and the results are expected to be available by the end of the month.
Editors: Tang Shihua, Kim Taylor