Tildrakizumab Being Granted an Approval for Drug Clinical Trial

Company News

Reference is made to the announcement of
China Medical System Holdings Limited dated 27 June 2019 (the “Previous
Announcement”) related to signing a License Agreement of Tildrakizumab (替拉珠單抗注射液) (the “Product”) for the treatment of psoriasis and psoriatic
arthritis with Sun Pharmaceutical Industries Ltd.. The Product is a humanized
lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of
interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor,
leading to inhibition of the release of pro-inflammatory cytokines and
chemokines. The Product has been approved for marketing in the U.S., Europe, Australia and Japan for treatment of adults
with moderate-to-severe plaque psoriasis who are candidates for systemic
therapy or phototherapy. 

The Company is pleased to announce that the
Product has been granted an approval for drug clinical trial issued on 18 August 2020 from the
National Medical Products Administration of the People’s Republic of China and agreed to carry out a randomized, double-blind, placebo-controlled, multi-center clinical
trial on the effect and safety of Tildrakizumab for treatment of patients among the
Chinese population with moderate-to-severe plaque
psoriasis. The Group is currently actively preparing for initiating the confirmatory
clinical trial of the Product.