Guide: About to Submit Marketing Application
Recently, Health Yuan Pharmaceutical Group announced that the Phase III clinical trial of "Recombinant Anti-Human IL-17A/F Humanized Monoclonal Antibody Injection" (LZM012), jointly developed by Livzon MabPharm, a holding subsidiary of Livzon Group (which is a holding subsidiary of Health Yuan), and Beijing Xinkanghe Biomedical Technology Co., Ltd., has reached the primary study endpoint.
According to the announcement, this Phase III clinical study is a multi-center, randomized, double-blind, positive-controlled (secukinumab) clinical trial conducted in patients with moderate-to-severe plaque psoriasis. The primary endpoint is the proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 100 at week 12 (PASI 100 response rate).
The study results showed that the primary efficacy endpoint of the study was met. At week 12, the PASI 100 response rate was 49.5% for LZM012 and 40.2% for the control group (secukinumab), indicating that LZM012 is not inferior to secukinumab and even superior to it.
For the key secondary efficacy endpoint, the PASI 75 response rate at week 4 was 65.7% for LZM012 and 50.3% for the control group secukinumab, showing that LZM012 takes effect faster; the PASI 100 response rates at week 52 in the LZM012 320mg Q4W and 320mg Q8W maintenance treatment groups were 75.9% and 62.6% respectively, indicating that psoriasis patients can continuously obtain increased benefits.
Meanwhile, LZM012 has an overall good safety profile, and the incidence of common adverse events is comparable to that of various adverse events in the control group.
Psoriasis is a chronic, systemic, immune-mediated inflammatory skin disease, affecting approximately 125 million people worldwide and more than 6.5 million people in China. Its typical symptoms are red patches on the skin covered with silvery white scales, often accompanied by comorbidities such as arthritis, diabetes, and hypertension. As a chronic non-communicable disease, the comorbidities of psoriasis have been listed by the World Health Organization as a major health threat.
In recent years, biological agents have become one of the main treatment methods for moderate-to-severe plaque psoriasis. Among them, the overexpression of the cytokine interleukin-17A (IL-17A) is closely related to the pathogenesis of psoriasis. Targeting this target, Novartis developed the first IL-17-targeting drug, secukinumab. Since its approval for marketing in 2014, the sales of this drug have been rising, with annual sales exceeding 6 billion US dollars in 2024.
In China, secukinumab was approved for marketing in March 2019 under the trade name Cosentyx. In 2024, the sales of this drug were approximately 3 billion yuan.
Figure : Domestic Sales of Secukinumab Image
Source: Yaozhi Data
In addition, two domestic IL-17A drugs, furmonertinib from Hengrui and serilicimab from Zhixiang Jintai, were approved for marketing last year, bringing new treatment options for domestic psoriasis patients.
Conclusion
LZM012 is head-to-head superior to Cosentyx, and the Phase III clinical trial shows its superiority, which is expected to change the pattern of the domestic psoriasis drug market and become a new generation of leading products.
The announcement shows that Livzon Group has recently submitted a pre-licensing application to the NMPA for the indication of LZM012 in the treatment of adult moderate-to-severe plaque psoriasis, to promote the marketing process of LZM012.
