Recently, China Medical System’s innovative drug ILUMETRI (Tildrakizumab Injection) has issued its first prescriptions for psoriasis patients who meet the treatment requirements in multiple hospitals located in different Chinese cities, including the Dermatology Hospital of the Chinese Academy of Medical Sciences, the Third Affiliated Hospital of Sun Yat-sen University, the Dermatology Hospital of Southern Medical University, and the First People’s Hospital of Foshan City. With the official launch of ILUMETRI’s nationwide drug supply, ILUMETRI officially stepped into large-scale clinical application, providing better choices for the long-term treatment and disease management among psoriasis patients in China.
On May 26, 2023, ILUMETRI (Tildrakizumab Injection) was approved for marketing by the National Medical Products Administration of China for the treatment of adult patients who have moderate to severe plaque psoriasis and are suitable for systemic therapy or phototherapy. On December 13th, the “National Catalogue of Medicines for Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance (2023) ” was released, and ILUMETRI was successfully included in Class B of the National Medical Insurance Catalogue, further improving its accessibility and affordability.
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. Thereby leading to inhibition of the release of pro-inflammatory cytokines and chemokines. 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. The maintenance period of ILUMETRI requires only 4 administrations per year, which may lead to higher patient compliance.
The Dermatology Hospital of the Chinese Academy of Medical Sciences has issued the first prescription for ILUMETRI (Tildrakizumab Injection)
After obtaining approval in China, various business departments of CMS worked together, with strong support from the governments and partners at all levels, to achieve the rapid import of the first batch of commercial products of ILUMETRI. On December 13th, the first prescriptions of ILUMETRI issued simultaneously in Nanjing, Guangzhou, and Foshan, which marks the official launch of its large-scale clinical applications. CMS will actively promote the implementation and admission of medical insurance for ILUMETRI, carry out relevant academic exchange activities, and achieve full channel commercial coverage, providing safe, effective, and long-term treatment options for adult patients with moderate to severe plaque psoriasis in China.
ILUMETRI (Tildrakizumab Injection, a p19 subunit monoclonal antibody specifically targeting IL-23)
As an open platform enterprise that links pharmaceutical innovation and commercialization, and controls the full lifecycle management of products, CMS is based on its own commercialization capabilities and clinical resources with economies of scale. It extensively cooperates with global source innovation forces to jointly develop innovative pharmaceutical products with academic value and differentiation advantages, enhancing the accessibility of Chinese patients to global innovative drugs. After over five years of investment layout and R&D promotion, in 2023, three innovative products of CMS were successfully approved to be launched in China. Two innovative products are in the NDA process in China, and over ten innovative products are steadily advancing China’s registered clinical trials, mainly focused on RCT, in order to continuously produce innovative pharmaceutical products guided by differentiated clinical value.
CMS always persists in benefiting patients. Since the beginning of this year, 5 drugs of CMS, including ILUMETRI (Tildrakizumab Injection), has been added/renewed to National Reimbursement Drug List, which will further improve the accessibility and affordability of high-quality drugs and benefit more domestic patients.
Psoriasis is an autoimmune disease with a complex etiology, and IL-23 is considered an important driving factor in the pathogenesis of psoriasis. The incidence rate of psoriasis in China is about 0.47%, and the number of patients is more than 7 million, of which about 57% have developed into moderate and severe.