Completion of All Subject Enrollment in China Registration Trial of China Medical System (00867)í»s Innovative Drug Tildrakizumab
2021-03-11 21:33

On March 11, the China registration bridging Phase III trial of China Medical Systemí»s blockbuster innovative drug Tildrakizumab has completed the enrollment of all subjects. Since the first subject was enrolled on 28 December 2020, 332 psoriasis patients have been strictly screened at 19 research centers nationwide, and all the 220 subjects have been enrolled successfully within only 2.5 months (including the Spring Festival and other holidays), which proved the Groupí»s ability to quickly enroll subjects for clinical trials by leveraging its professional sales and promotion network as well as its expert resources.

About Product

Tildrakizumab is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of IL-23 and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. Currently, the product has been approved for marketing in the U.S. under the brand name of ILUMYATM, for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and also been approved for commercialization in Europe, Australia and Japan.

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. The most common form, affecting about 90 percent of people living with psoriasis, is plaque psoriasis. Tildrakizumab 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.