Jiangsu Hengrui Pharmaceutials Co., Ltd (SHA: 600276), a leading China-based pharmaceutical company, announced that the National Medical Products Administration (NMPA) has accepted its market filing for vunakizumab, an IL-17A monoclonal antibody (mAb), for the treatment of moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy.
Global IL-17A Products and Their Presence in China
Globally, IL-17A products include notable drugs such as Novartis’s Cosentyx (secukinumab), Eli Lilly’s Taltz (ixekizumab), and Biocad’s Efleira (netakimab). The first two have been approved in China and were included in the first batch of clinically urgently needed drugs in April and September 2019, respectively. Both Cosentyx and ixekizumab were subsequently added to the National Reimbursement Drug List (NRDL) in 2020 and 2021, highlighting their importance in psoriasis treatment.
Phase III Study Results for SHR-1314
The Phase III SHR-1314-301 study demonstrated pre-set superiority standards in terms of the primary endpoint in February 2023. The study enrolled 690 adult subjects with moderate to severe chronic plaque psoriasis, who were randomly assigned to receive SHR-1314 injection of 240mg or placebo treatment in a 2:1 ratio. The results indicated that at week 12, the primary and key secondary study endpoints were met, showing statistically significant and clinically meaningful improvements in plaque psoriasis compared to the placebo. Furthermore, SHR-1314 exhibited a good safety and tolerability profile in the long-term treatment of patients with moderate to severe chronic plaque psoriasis.-Fineline Info & Tech
