In May 2023, the New Drug Application (NDA) of Tildrakizumab Injection under the brand name of ILUMETRI has been approved by the National Medical Products Administration of China (NMPA). ILUMETRI is a humanized lgG1/κ 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. ILUMETRI has patents on composition and formulation in China.
The results of the extended study of its Phase III clinical trial in China demonstrated that the primary efficacy assessment indicator PASI 75 response rate continued to increase over treatment time. The PASI 75 response rate reached a high level after 28 weeks of treatment with ILUMETRI and maintained at 91.3% at week 52, and ILUMETRI showed good long-term safety and tolerance. ILUMETRI only needs to be administered 4 times a year during maintenance treatment period, which may bring higher patient compliance.
The incidence of psoriasis in China is about 0.47%, with the number of patients exceeding 7 million, of which more than 30% have developed into moderate-to-severe disease. ILUMETRI will provide moderate-to-severe plaque psoriasis patients with a safe and effective treatment option.