Monoclonal antibody drugs in development in China

With regard to current R&D progress and application situation of monoclonal antibody drugs in China, anti-PD-1 inhibitors applied for as Class 1 new drug have achieved the fastest progress: there have been 4 Chinese pharmaceutical enterprises that have filed the marketing applications therefor, wherein, the first indication applied for by Junshi Biosciences is melanoma, and the indication applied for by Innovent Biologics, Hengrui, and BeiGene is all classical Hodgkin's lymphoma.

In the field of monoclonal antibody biosimilars, data on the Drug Clinical Trial Registration and Information Publicity Platform show that 39 clinical trial projects of 17 pharmaceutical enterprises have entered Phase III clinical trials, involving 8 different therapeutic targets, wherein, Bio-Thera and Hisun Pharmaceutical have filed marketing applications for adalimumab, and Henlius, 3SBio, and Qilu Pharmaceutical have separately filed marketing applications for rituximab, trastuzumab, and bevacizumab. Many Chinese-produced blockbuster monoclonal antibody drugs are expected to be marketed in China in the following one to two years.

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