Recently, the new drug application of Tildrakizumab solution for injection, the innovative biological product of China Medical System Holdings Limited (the “Group”), was approved in Hong Kong, China, with brand name of ILUMETRI.
The product is a novel monoclonal antibody targeting interleukin-23(IL-23) with an indication for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. The product has been approved for marketing in the U.S., Australia, European Union, Switzerland, Japan and Canada. The new drug application of the product in China was accepted by the National Medical Products Administration (NMPA) in October 2021.
The approval in Hong Kong marked another milestone in the commercialization of the product. It will provide a safe, effective and highly cost-effective monoclonal antibody treatment option for Hong Kong patients with moderate-to-severe plaque psoriasis .
The Group will continue to accelerate the clinical development and registration progress of innovative products to meet China’s unmet medical needs.