HanAll Biopharma Autoimmune Disease Treatment Designated as Rare Drug in Japan

Orphan Drug Designation Granted in Japan
Batoclimab Recognized for Thyroid Eye Disease Treatment Potential

HanAll Biopharma announced on the 4th that 'Batoclimab (HL161BKN)', being developed as a treatment for autoimmune diseases, has received Orphan Drug Designation (ODD) for Thyroid Eye Disease (TED) from the Japanese Ministry of Health, Labour and Welfare (MHLW).

Orphan Drug Designation is granted to drugs intended for the treatment and prevention of rare diseases, where the patient population is fewer than 50,000 and the drug meets criteria such as patient numbers, unmet medical needs, and development feasibility. It is estimated that about 35,000 patients currently suffer from Thyroid Eye Disease in Japan. Drugs designated as orphan drugs are granted exclusivity rights for up to 10 years from the date of marketing approval and receive tax benefits and other incentives.

Batoclimab is an antibody drug with a mechanism that removes pathogenic autoantibodies causing autoimmune diseases in the body. In particular, it is being developed in a subcutaneous (SC) formulation to allow patients to self-administer, which is expected to significantly improve patients' quality of life.

Currently, HanAll Biopharma, together with Immunovant, is developing Batoclimab for various autoimmune diseases including myasthenia gravis (MG), thyroid eye disease (TED), and chronic inflammatory demyelinating polyneuropathy (CIDP). In Japan, a Phase 3 clinical trial evaluating the efficacy and safety of Batoclimab for thyroid eye disease is underway, with topline results expected to be announced in the second half of this year.

Seungwon Jung, CEO of HanAll Biopharma, stated, "This orphan drug designation is a result of HanAll Biopharma’s research and development capabilities and the strong competitiveness of the HL161 pipeline in the Japanese market," adding, "Batoclimab is being administered directly by patients at home from the clinical stage, and we expect it to be approved as a treatment that can be self-administered without medical professional monitoring."