Innovent to Submit IL-23 Psoriasis Drug to Chinese Regulators Following Phase 3 Success

1. Phase 3 Success: Innovent's picankibart (IBI112) has met all primary and key secondary endpoints in the CLEAR-1 phase 3 registrational study for moderate to severe plaque psoriasis in Chinese subjects.
2. Regulatory Submission: Innovent plans to submit a new drug application (NDA) for picankibart to the Center for Drug Evaluation (CDE) of the National Medical Product Administration (NMPA) in China.
3. Efficacy: The study showed that 80.3% of subjects achieved PASI 90 and 93.5% achieved a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16, with strong efficacy maintained through week 52.
4. Safety Profile: The overall safety profile of picankibart was favorable, with no new safety signals identified compared to previous clinical studies.
5. Competitive Landscape: Picankibart is an IL-23p19 targeted antibody, which has advantages in maintaining long-term efficacy and medication convenience compared to existing treatments.
6. Potential Impact: If approved, picankibart could provide a differentiated treatment option for Chinese patients with psoriasis, improving their quality of life and clinical outcomes.