Positive Results for Tildrakizumab Phase Ⅲ Clinical Trial in China

Company News

China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Group’s innovative drug Tildrakizumab solution for injection (the “Product”)  obtained positive results of its Phase Ⅲ clinical trial in China (the “Trial”).

The Trial is a randomized, double-blind, placebo-controlled, multi-centre clinical trial, with 220 patients enrolled in total, aiming to evaluate the safety and efficacy of the Product for treatment of patients among the Chinese population with moderate-to-severe plaque psoriasis.The preliminary trial results demonstrated that comparing with placebo, the treatment of the Product for 12 weeks significantly increased the proportion of subjects who have achieved at least 75% of improvement in psoriasis area and severity index (PASI 75), which was vastly superior to placebo.

The Group will actively move forward the Product’s new drug application (NDA) in China.  

About Tildrakizumab solution for injection

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.  

Psoriasis is an autoimmune disease with complex causes, whereas IL-23 is regarded as one of important driving factors in the pathogenesis of it. There are more than 6.5 million people suffering from psoriasis in China with an incidence rate of 0.47%. About 30% of patients are with moderate-to-severe psoriasis, among them, nearly 62% are dissatisfied with existing treatment options. Tildrakizumab solution for injection is expected to be a safe, effective and the most cost-effective innovative monoclonal antibody targeting IL-23, benefiting more patients and their families in China.