Innovent Biologics Accepts New Drug Application for picankibart injection
Thursday, September 26, 2024
Innovent Biologics has announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for picankibart injection, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, for the treatment of moderate to severe plaque psoriasis.
Developed independently with proprietary intellectual property rights, picankibart (IBI112) is a monoclonal antibody designed to target the IL-23p19 subunit, effectively blocking IL-23 from binding to receptors on the cell surface. This mechanism offers promising treatment potential for psoriasis, ulcerative colitis, and other autoimmune diseases.
In a registrational Phase 3 clinical trial, picankibart became the first IL-23p19 antibody to demonstrate that over 80% of participants achieved a PASI 90 score after 16 weeks of treatment. Additionally, it boasts the longest maintenance dosing interval among its class, with a regimen of once every 12 weeks.
Picankibart is expected to provide comprehensive benefits for Chinese patients with moderate to severe plaque psoriasis, including the clearance of skin lesions, improved convenience of medication, and enhanced quality of life.
Psoriasis, a chronic and incurable condition, affects patients both physically and mentally, significantly impacting their quality of life. Effective treatment options are crucial to managing the disease, reducing related comorbidities, ensuring long-term therapeutic success, and improving overall patient well-being. IL-23p19-targeted antibodies, such as picankibart, have demonstrated significant advantages in maintaining long-term efficacy and treatment convenience, as evidenced by clinical trials.
Source: prnasia.com
