Innovent Announces NMPA Acceptance of NDA for Picankibart (Anti-IL-23p19 Antibody) for Treating Moderate to Severe Plaque Psoriasis
SAN FRANCISCO and
This NDA acceptance is based on positive results from the Phase 3 registrational clinical study CLEAR-1 (NCT05645627) in Chinese patients with moderate to severe plaque psoriasis. The study successfully met its primary and all key secondary endpoints in
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About Psoriasis
Psoriasis is a chronic, recurrent, inflammatory and systemic disease included by genetic and environmental factors, affecting individuals of all ages and genders. It typically presents as scaly erythema or plaques, with non-infections, localized or widespread distribution. As a life-long noninfectious condition, psoriasis is notoriously difficult to treat. The disease can be categorized into psoriasis vulgaris (including guttate psoriasis and plaque psoriasis), pustular psoriasis, erythrodermic psoriasis and arthropathic psoriasis. Approximately 80%~90% of patients have plaque psoriasis, with nearly 30% of the cases being moderate to severe. Global psoriasis prevalence varies significantly, with over 7 million patients in
About Picankibart (IBI112)
Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent with proprietary intellectual property rights. This product specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors. Picankibart has the potential to offer a more effective treatment option for patients with psoriasis, ulcerative colitis or other autoimmune diseases.
Currently, multiple clinical studies of Picankibart are underway, including:
- Phase 3 study conducted in patients with moderate to severe plaque psoriasis (CLEAR-1), which has reached the study endpoints in
May 2024 ; - Phase 3 study conducted in patients with moderate to severe plaque psoriasis with randomized withdrawal and re-treatment;
- Phase 2 study in patients with moderate to severe plaque psoriasis who were previously treated with biologics;
- Phase 2 study in patients with moderate to severe active ulcerative colitis;
In
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte,
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).
Forward-looking statement
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