Core Viewpoint - The company’s subsidiary has received orphan drug designation from the FDA for WP203A (afamelanotide) to treat pemphigus, which is a rare autoimmune blistering disease [1][2]. Summary by Sections Qualification Recognition - The company submitted an application for orphan drug designation for WP203A to the FDA in August 2025, under application number DRU-2024-10630, and received confirmation of approval based on the Federal Food, Drug, and Cosmetic Act [1]. Drug Overview - Pemphigus is characterized by widespread blistering and erosion of the skin and mucous membranes, primarily affecting the elderly due to immune system dysfunction. Symptoms include severe itching, redness, and painful lesions, with the potential for life-threatening complications [1]. Impact of Orphan Drug Designation - The orphan drug designation for WP203A is expected to accelerate the company’s international drug development efforts. This designation provides various incentives, including tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [2].

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].