万邦德子公司产品获美国FDA孤儿药认定

Core Viewpoint - Wanbangde's subsidiary has received orphan drug designation from the FDA for WP203A (afamelanotide) to treat pemphigus, a rare autoimmune blistering disease, which may accelerate the company's international drug development efforts [1][3]. Group 1: FDA Orphan Drug Designation - The FDA granted orphan drug status to WP203A for the treatment of pemphigus, providing various incentives for drug development, including tax credits for clinical trial costs and a seven-year market exclusivity post-approval [1][2]. - Wanbangde submitted the orphan drug designation application for WP203A on August 2025, which was confirmed by the FDA [2]. Group 2: Mechanism and Current Treatment Landscape - Afamelanotide acts as a synthetic agonist of the MC1R receptor, demonstrating anti-inflammatory and immunomodulatory effects, and has been successfully used in treating erythropoietic protoporphyria (EPP) [2]. - Current treatments for pemphigus primarily include systemic corticosteroids and monoclonal antibodies, which have high relapse rates and severe side effects, indicating an unmet clinical need [2]. Group 3: Future Development and Uncertainties - Following the orphan drug designation, Wanbangde must conduct clinical trials for WP203A in accordance with FDA regulations, with uncertainties surrounding trial approval, results, and subsequent market application [3].