On December 28, in Xijing Hospital, the dosing of first subject has been completed in China’s registration bridging trial for Tildrakizumab, the blockbuster innovative drug of China Medical System Holdings Limited, representing a significant progress after the product received its China IND approval in August this year.
The trial is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial, and its primary objective is to assess the effectiveness of 12 weeks treatment of Tildrakizumab in patients with moderate-to-severe chronic plaque psoriasis as compared to placebo. With Xijing Hospital (The First Affiliated Hospital of Air Force Medical University of People’s Liberation Army of China) as the leading hospital, the trial is planned to enroll 220 subjects and be conducted in around 21 centers nationwide. The principal investigators of the trial include Dr. Wang Gang, the President of Chinese Dermatologist Association, Vice Chairman of Chinese Society of Dermatology and Vice President of Asian Society for Psoriasis, Dr. Gao Xinghua, the Chairman- designate of Chinese Society of Dermatology and President-designate of Chinese Dermatologist Association, Dr. Xu Jinhua, Vice Chairman of Chinese Society of Dermatology and the Leader of Key Clinical Specialty Construction Project of Ministry of Health, and other nation-wide well-known experts in the field of dermatology and psoriasis.
A Monoclonal Antibody Specifically Targeting IL-23
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.