Shanghai Junshi Biosciences (Junshi Bio) [1877:HK] released a statement on June 7 that its neutralizing monoclonal antibody (McAb) to the novel coronavirus, namely JS016, has obtained approval to enter the phase I clinical trial stage, as reported by STCN on June 8. The antibody is co-developed by the Institute of Microbiology of the Chinese Academy of Sciences (CAS) and the company. The phase I clinical trial is a randomized, double-blind, and placebo-controlled study on healthy people, conducted in Huashan Hospital affiliated to Fudan University, which will evaluate antibody's safety level and tolerance on humans.
This is the world's first anti-novel coronavirus neutralizing antibody clinical trial on healthy subjects after the completion of non-human primate (NHP) trials, and the earliest antibody entering the clinical trial stage in China. Junshi Bio said that it had completed the pre-clinical studies required for the Investigational New Drug (IND), which showed the candidate could preemptively bind to the coronavirus, thereby blocking it from entering into host cells and replicate. Earlier, on June 1, Eli Lilly and Company [LLY:US] announced that the antibody to the novel coronavirus, LY-CoV555, jointly developed with AbCellera, launched clinical trials on human bodies. However, the drug had not been tested rigorously on animals before starting human tests. After the above news came out, Junshi Bio’s stock price once peaked at HKD59.80 per share on June 8, which was closed at HKD43.50 on June 5.