Junshi Bio: Preparing for the international multi-center phase II/III clinical trial of new crown oral medicine

The Paper's reporter Li Xiaoxiao

The new crown oral drug VV116 is expected to apply for listing in the second half of the year?

On January 17, Junshi Bio (688180. SH；01877. HK) responded to the surging news reporter on the above news that its oral nucleoside new crown drug VV116 was authorized to use in Uzbekistan in December 2021, and is currently promoting clinical trials in China at the same time, and is preparing for international multi-center Phase II/III clinical trials.

VV116 was jointly developed by the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, the Wuhan Institute of Virology of the Chinese Academy of Sciences, the Xinjiang Institute of Physics and Chemistry Technology of the Chinese Academy of Sciences, the Wangshan Wangshui, and the Central Asia Drug Research and Development Center of the Chinese Academy of Sciences. In October 2021, Junshi Biotech announced that it has reached a cooperation with Wangshan Wangshui to jointly undertake the clinical development and industrialization of the drug worldwide.

On January 17, it was reported that VV116, the only small molecule drug approved to enter clinical trials in China, will start the listing (NDA) application as soon as it passes the clinical trial within this year. For the listing application time of VV116, Junshi Bio did not directly respond in the above response.

In addition to VV116 oral small molecule drugs, the other two are JS016 and JS026, both of which are neutralizing antibody therapies. It is worth mentioning that JS016 has been approved for emergency use in the United States. At the end of November 2021, Li Ning, CEO of Junshi Bio, said in an interview with the surging news reporter: "JS016's international multi-center clinical research has accumulated a certain experience base for us, hoping to help us promote the overseas clinical trial of VV116 faster." ”

For the advantages of small molecule drugs such as VV116, Li Ning said that compared with antibody drugs, the production cost and production difficulty of small molecule drugs, especially oral small molecule drugs, are relatively low, and the mode of administration is convenient, so it has outstanding advantages in accessibility, but further scientific demonstration of each path is needed in terms of efficacy and safety.

As of the close of trading on January 17, Junshi Bio A shares were quoted at 84.96 yuan / share, up 11.06%, with a market value of 77.38 billion yuan; Hong Kong stocks were quoted at 59 Hong Kong dollars / share, up 14.67%, with a market value of 53.73 billion Hong Kong dollars.

Responsible Editor: Yes Winter Photo Editor: Le Yu Feng

Proofreader: Yan Zhang