Wednesday, May 31, 2023
On May 30, China Medical System Holdings Limited (“CMS” or the “Group”) announced that on 26 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 indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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.
Psoriasis is an autoimmune disease with complex causes, where IL-23 is regarded as one of the important driving factors of the pathogenesis of psoriasis. 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.
It took only 14 months from obtaining the approval for the drug clinical trial to submitting the NDA for ILUMETRI in China, with the enrollment of 220 subjects completed in only 2.5 months (which included the Spring Festival), highlighting CMS’s highly efficient clinical development capabilities supported by its commercialization strength.
ILUMETRI is CMS’s second innovative drug approved to be marketed in China in 2023, following the recent approval of Methotrexate Injection. CMS has invested in, and collaborated with, innovative companies globally over the last 5 years to jointly develop innovative products with academic value and differentiated advantages, in order to meet unmet clinical needs and enhance the accessibility of global innovative drugs for Chinese patients. Starting from 2023, CMS’s innovation development is stepping into the harvest period.
ILUMETRI has been approved for marketing in the Hong Kong Special Administrative Region of China in April 2022. Tildrakizumab Injection has also been approved for marketing in the U.S., EU, Japan, UK, Switzerland, Canada, Australia and other countries/regions.
