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.
– CMS is pleased to announce the NDA of Tildrakizumab Injection under the brand name of ILUMETRI, a monoclonal antibody specifically targeting the p19 subunit of IL-23, has been approved in China. ILUMETRI is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
– The extended study of ILUMETRI’s 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.
– ILUMETRI will synergize with CMS Aesthetics’ marketed products, Hirudoid, Aethoxysklerol and pipeline products, to solidify comprehensive competitiveness of CMS in the dermatology field.
– This is CMS’s second innovative drug approved for marketing in China this year following the approval of Methotrexate Injection.
ILUMETRI 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. 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.
CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet healthcare needs. In 2022, the Group recorded a turnover of RMB9,150 million; in the case that all medicines were directly sold by the Group, the turnover reached RMB10,498 million. Profit for the year reached RMB3,276 million.
CMS focuses on developing first- or best-in-class innovative products and has made the layout of 30 differentiated pipeline products with strong market potential. CMS deeply engages in specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to strengthen the competitiveness of its cardio-cerebrovascular/gastroenterology business, and independently operated dermatology and medical aesthetic business, and ophthalmology business, whilst enhancing the scale and efficiency. CMS also entered into the Southeast Asian market to create new opportunities to further enhance the sustainable development of the Group.
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China Medical System Holdings Ltd.