Health
HanAll Biopharma Announces Orphan Drug Designation for Batoclimab in Japan for Active Thyroid Eye Disease
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).
About this update from Hanall Biopharma Co., Ltd.
[{"type":"list","items":[{"val":[{"type":"text","content":"Batoclimab receives Orphan Drug Designation in Japan, advancing treatment for active Thyroid Eye Disease (TED).","length":111,"tagName":"p"}]},{"val":[{"type":"text","content":"Batoclimab, subcutaneous formulation, offers the potential for at-home administration, improving patient convenience and accessibility.","length":135,"tagName":"p"}]},{"val":[{"type":"text","content":"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.","length":160,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":406,"olType":false},{"type":"text","content":"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).","length":456,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/HanAll Biopharma)","displaySize":"","headline":null,"caption":"(PRNewsfoto/HanAll Biopharma)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":187,"url":"https://media.zenfs.com/en/prnewswire.com/0cc8ecae6863fff8d346f06850545b9d"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/YfO2k__VF4JGMYGt4Jg1yQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTMzMDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/0cc8ecae6863fff8d346f06850545b9d","width":400,"height":187}},"href":"https://mma.prnewswire.com/media/1806733/logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The Orphan Drug Designation (ODD), granted by the MHLW, is awarded to drugs and biologics intended to treat rare diseases affecting fewer than 50,000 people in Japan, with eligibility based on criteria such as patient population size, medical needs, and the feasibility of development, and possibility of development[1]. Currently, it is estimated that approximately 35,000 people in Japan are affected by TED.[2] ","length":413,"tagName":"p"},{"type":"text","content":""We are thrilled to have received Orphan Drug Designation...