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Chinese biopharmaceutical firm Junshi Biosciences has dosed the first healthy volunteer in the Phase I clinical trial of its SARS-CoV-2 neutralising antibody, JS016.
The first participant has been treat at Huashan Hospital, which is affiliated to Fudan University in China. JS016 is said to be the first SARS-CoV-2 neutralising antibody to advance into trials in China.
Junshi Biosciences is developing the antibody candidate in alliance with US-based Eli Lilly. Junshi is responsible for clinical development in China, while Lilly will carry out clinical development in all other countries worldwide.
JS016 was initially co-developed by the Chinese company and Institute of Microbiology, Chinese Academy of Sciences (IMCAS). It was discovered through the screening of blood samples from recovered Covid-19 patients.
In a preclinical study, JS016 was found to exhibit high specific affinity to the SARS-CoV-2 receptor-binding domain (RBD) on the spike protein and blocked the virus from entering host cells.
A separate study demonstrated the candidate’s ability to protect rhesus monkeys against Covid-19.
IMCAS researcher Dr Yan Jinghua said: “Preclinical studies have shown that JS016 has strong neutralising and blocking ability, as well as prophylactic and treatment effect. We anticipate that JS016 could be further tested in clinical trials.”
The randomised, double-blind and placebo-controlled Phase I trial will assess the safety, tolerability, pharmacokinetic, and immunogenicity of JS016 in healthy participants.
If Phase I data reveals that if the antibody can be safely administered, the company will advance the candidate into the next phase of testing to assess its ability to prevent and treat Covid-19.
Clinical study head researcher professor Zhang Wenhong said: “Neutralising antibodies can precisely target the SARS-CoV-2 virus, which may quickly prevent the virus from replicating in the human body.
“We hope to demonstrate the safety and tolerability of JS016 in Phase I and provide supporting data for additional clinical trials.”
Earlier this month, Eli Lilly started dosing participants in the Phase I trial of antibody therapy LY-CoV555, which is intended to treat Covid-19 infection.