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HanAll Biopharma Announces Orphan Drug Designation for Batoclimab in Japan for Active Thyroid Eye Disease
Batoclimab receives Orphan Drug Designation in Japan, advancing treatment for active Thyroid Eye Disease (TED). Batoclimab, subcutaneous formulation, offers the potential for at-home administration, improving patient convenience and accessibility. Phase 3 study to confirm the potential of batoclimab to address unmet needs of patients with TED in process, with top-line results expected in the 2H 2025. SEOUL, South Korea, March 17, 2025 /PRNewswire/ -- HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, announced that Batoclimab, an anti-FcRn treatment being developed for a range of autoimmune diseases, has received Orphan Drug Designation (ODD) from the Ministry of Health, Labor and Welfare (MHLW) in Japan for active Thyroid Eye Disease (TED).