The board of directors of Shanghai Henlius Biotech, Inc. announced that, recently, the supplemental new drug applications of HANDAYUAN (adalimumab injection) which is independently developed by the Company for the new indications of polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn's disease and pediatric Crohn's disease have been accepted by the National Medical Products Administration (the NMPA). HANDAYUAN is a biosimilar of adalimumab independently developed by the Company, which was approved by the NMPA for marketing in mainland China (excluding Hong Kong, Macau and Taiwan regions, the same as below) in December 2020. As of the date of this announcement, the indications of HANDAYUAN approved in mainland China are: rheumatoid arthritis; (2) ankylosing spondylitis; (3) plaque psoriasis; and (4) uveitis.

The applications add the indications of polyarticular juvenileidiopathic arthritis, pediatric ploriasis, Crohn's Disease and pediatric Crohn's disease, of which the originator adalimumab has been approved in mainland China. The extrapolation of these indications is mainly based on: (1) the proven similarity conclusion between HANDAYUAN and the original drug; (2) the same or similar mechanisms of action between the extrapolated indications and the indication in clinical comparative study; and (3) the selection of sensitive population and appropriate indication for key clinical trials, with substantial safety and immunogenicity data. The extrap isolation of these indications is in compliance with the requirements of the Technical Guidelines for R&D and Evaluation of Biosimilars (Trial), Clinical Trial Guidelines for Adalimumab Injection Biosimilars, the Technical Guidelines for Similarity Evaluation and Indication Extrapolation of Biosimilars and other regulations and policies in China for extrapolation of indication.