Tildrakizumab Being Granted an Approval for Drug Clinical Trial
2020-08-19 19:43

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 (ÌæÀ­Öé†Î¿¹×¢ÉäÒº) (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.