SAN FRANCISCO and SUZHOU, China , Sept. 26, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of various diseases, has announced a major milestone.
Innovent’s New Drug Application (NDA) for picankibart injection has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody is intended for the treatment of moderate to severe plaque psoriasis.
This approval marks a significant advancement in the field of biopharmaceuticals, as picankibart injection shows promise in effectively treating a chronic autoimmune skin condition that impacts millions of individuals worldwide.
Plaque psoriasis is a debilitating condition characterized by red, scaly patches on the skin that can cause discomfort and embarrassment for those affected. Current treatment options for moderate to severe cases are limited, often requiring a combination of therapies that may not be effective for all patients.
By targeting the IL-23p19 subunit, picankibart injection aims to address the underlying cause of plaque psoriasis, providing a more targeted and personalized approach to treatment. In clinical trials, the antibody has demonstrated efficacy in reducing symptoms and improving quality of life for patients, with a favorable safety profile.
The acceptance of Innovent’s NDA by the CDE signifies that picankibart injection has met the regulatory standards for safety, efficacy, and quality required for approval in China. This milestone paves the way for the potential availability of a new treatment option for individuals living with plaque psoriasis in the region.
Impact on Individuals:
For individuals living with moderate to severe plaque psoriasis in China, the acceptance of picankibart injection’s NDA could represent a significant breakthrough in their treatment journey. The availability of a targeted biologic therapy like picankibart injection may offer new hope for improved symptom management and overall quality of life.
Global Impact:
On a global scale, the acceptance of Innovent’s NDA for picankibart injection signifies a step forward in the development of innovative biopharmaceutical solutions for autoimmune conditions. The successful approval of this antibody in China may also open doors for regulatory submissions in other regions, potentially expanding access to novel treatment options for individuals with plaque psoriasis worldwide.
Conclusion:
The acceptance of Innovent’s NDA for picankibart injection is a significant achievement that highlights the ongoing advancements in biopharmaceutical research and development. This milestone not only offers new hope for individuals living with plaque psoriasis in China but also underscores the potential for global impact in the treatment of autoimmune diseases. As the field of biopharmaceuticals continues to evolve, innovative therapies like picankibart injection have the potential to revolutionize the way we approach and manage complex medical conditions.
