HanAll Biopharma receives Orphan Drug Designation in Japan for Batoclimab for thyroid eye disease

(Image Credit: AdobeStock/Koshiro K)

HanAll Biopharma received Orphan Drug Designation (ODD) from the Ministry of Health, Labor and Welfare (MHLW) in Japan for Batoclimab, an anti-FcRn treatment being developed for a range of autoimmune diseases and active thyroid eye disease (TED). The ODD is awarded to drugs and biologics intended to treat rare diseases affecting less than 50,000 people in Japan, with eligibility based on certain criteria, such as patient population size, medical needs, and the feasibility and possibility of development.

Now, approximately 35,000 people in Japan are affected by TED. “We are thrilled to have received Orphan Drug Designation for Batoclimab in Japan, marking an important milestone in our efforts to bring this promising treatment to patients in need,” Sean Jeong, CEO of HanAll Biopharma, said. “This designation highlights the potential impact Batoclimab could have on the lives of patients with TED. We remain dedicated to advancing the development of this treatment and are focused on bringing it closer to the market.”

Batoclimab is a monoclonal antibody aimed to target and inhibit FcRn, which has a crucial ability to recycle IgG antibodies. The new treatment selectively binds FcRn, reducing the levels of harmful IgG antibodies and offering the potential to treat a variety of IgG-mediated autoimmune diseases. It is also expected to allow patients to administer the treatment at home, allowing for convenience and accessibility.

Besides TED, Batoclimab is being studied globally for conditions like generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves’ disease. HanAll is also conducting a Phase 3 study of the treatment in active TED, aiming to confirm the efficacy and safety of Batoclimab as a potential new treatment for patients with TED.

Reference:

1. HanAll Biopharma Announces Orphan Drug Designation for Batoclimab in Japan for Active Thyroid Eye Disease. HanAll Biopharma. Accessed March 17, 2025. https://www.hanall.com/board_view.php?bo_table=press&idx=101