On December 24, CDE's website revealed that LIVZON PHARMA (01513), in collaboration with Xinkanghe Biotech, has submitted an application for the market approval of LZM012/XKH004 (Lekangqituzumab) for the treatment of plaque psoriasis. Lekangqituzumab is an IL-17A/IL-17F monoclonal antibody introduced by LIVZON PHARMA from Xinkanghe Biotech. It targets both homodimers IL-17A-A and IL-17F-F, as well as the heterodimer IL-17A-F. LIVZON MONOCLONAL BIOTECH, a subsidiary of LIVZON PHARMA, holds exclusive global rights for the development, registration, production, sales, and sublicensing of this product.

In July this year, LIVZON PHARMA announced that Lekangqituzumab (320mg, administered every four weeks) met the primary endpoint in a Phase III clinical trial for moderate-to-severe plaque psoriasis patients, with or without psoriatic arthritis, compared to secukinumab (300mg, every four weeks). The results showed that at week 12, the proportion of patients achieving PASI 100 was 49.5% in the Lekangqituzumab group versus 40.2% in the secukinumab group, demonstrating non-inferiority and superiority. In terms of safety, Lekangqituzumab exhibited a favorable overall safety profile, with adverse event rates comparable to those in the control group.