Japanese Regulators Grant Orphan Drug Status to HanAll’s Batoclimab in Active Thyroid Eye Disease

South Korea’s HanAll Biopharma announced March 6 that Japanese regulators had granted orphan drug designation to batoclimab, a subcutaneous anti-FcRn treatment being developed for autoimmune diseases, including active thyroid eye disease (TED).

HanAll said it expects that patients will be able to self-administer batoclimab at home, improving convenience and accessibility. Amgen’s Tepezza (teprotumumab), the only approved drug treatment for TED, requires eight intravenous infusions.

HanAll, with licensing partners Harbour Biomed and Immunovant, is conducting a Phase III study of batoclimab in active TED.

TED is characterized by a range of severe symptoms, including eye bulging, pain, double vision, and, in some cases, vision loss.

HanAll is also advancing HL036 (tanfanercept), a TNF inhibitor protein in Phase III study in the US and China for dry eye.