万邦德医药控股集团股份有限公司 关于子公司产品获得美国孤儿药认定的公告

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].