Recently, Joincare Pharmaceutical Group Industry Co., Ltd. issued an announcement stating that the Phase III clinical trial of "Recombinant Humanized Anti-Human IL-17A/F Monoclonal Antibody Injection" (LZM012), jointly developed by Livzon Monoclonal Antibody, a controlled subsidiary of Livzon Pharmaceutical Group (itself a controlled subsidiary of Joincare), and Beijing Xinkanghe Biomedical Technology Co., Ltd., had reached its primary study endpoint.

According to the announcement, this Phase III clinical study was a multicenter, randomized, double-blind, active-controlled (secukinumab) trial conducted among patients with moderate-to-severe plaque psoriasis. The primary endpoint was the proportion of subjects achieving a 100% reduction in the Psoriasis Area and Severity Index (PASI 100 response rate) at Week 12.

The study results demonstrated that the primary efficacy endpoint was met. The PASI 100 response rate at Week 12 was 49.5% for LZM012, compared to 40.2% for the control group (secukinumab), indicating that LZM012 was non-inferior and superior to secukinumab.

For the key secondary efficacy endpoint, the PASI 75 response rate at Week 4 was 65.7% for LZM012, compared to 50.3% for the control group, suggesting a faster onset of action for LZM012. At Week 52, the PASI 100 response rates for the LZM012 maintenance treatment groups receiving 320 mg every 4 weeks (Q4W) and 320 mg every 8 weeks (Q8W) were 75.9% and 62.6%, respectively, demonstrating sustained and improving benefits for psoriasis patients.

Additionally, LZM012 exhibited a favorable overall safety profile, with the incidence of common adverse events comparable to that in the control group.

Psoriasis, commonly known as psoriasis vulgaris, is a chronic, systemic, immune-mediated inflammatory skin disease affecting approximately 125 million people worldwide, with over 6.5 million patients in China. It is characterized by red skin plaques covered with silvery-white scales and is often associated with comorbidities such as arthritis, diabetes, and hypertension. As a chronic non-communicable disease, its comorbidities have been identified by the World Health Organization as a major health threat.

In recent years, biologics have become one of the primary treatment options for moderate-to-severe plaque psoriasis. Overexpression of the cytokine interleukin-17A (IL-17A) is closely linked to the pathogenesis of psoriasis. Novartis developed the first IL-17-targeted drug, secukinumab, which has seen its sales surge since its approval in 2014, exceeding $6 billion in annual sales in 2024.

In China, secukinumab, marketed under the brand name Cosentyx, was approved for use in March 2019. In 2024, the drug generated sales of approximately RMB 3 billion.

Furthermore, two Chinese IL-17A inhibitors, Hengrui's vunakizumab and ZhiXiang JinTai's selicitumab, were approved for marketing last year, offering new treatment options for Chinese psoriasis patients.

Conclusion

LZM012, in a head-to-head comparison with Cosentyx, demonstrated superior efficacy in its Phase III clinical trial and is poised to reshape the Chinese psoriasis drug market, potentially becoming a new leading product.

The announcement also revealed that Livzon Pharmaceutical Group has recently submitted a pre-marketing authorization application communication request to the National Medical Products Administration (NMPA) for LZM012 for the treatment of adult patients with moderate-to-severe plaque psoriasis, advancing the drug's path to market approval.

Source: https://news.yaozh.com/archive/45814.html