HanAll Biopharma Secures Orphan Drug Status for Batoclimab in Japan for Thyroid Eye Disease

Batoclimab, an innovative treatment developed by HanAll Biopharma Co., Ltd., has been recognized with Orphan Drug Designation in Japan for addressing active Thyroid Eye Disease (TED). This recognition by the Ministry of Health, Labor and Welfare (MHLW) acknowledges the potential of Batoclimab as a significant therapeutic advancement for this rare autoimmune disorder that affects around 35,000 individuals in Japan.

Thyroid Eye Disease, also known as Graves' orbitopathy, is a debilitating condition predominantly affecting those with hyperthyroidism or Graves' disease. It manifests in symptoms such as painful eye bulging, double vision, and in severe cases, vision loss, greatly impacting daily life and psychological well-being. With limited treatment options available for moderate to severe TED, there is a pressing need for effective therapies that can improve patient outcomes and quality of life.

Batoclimab is a monoclonal antibody targeting the neonatal Fc receptor (FcRn), which is integral in recycling IgG antibodies. By inhibiting FcRn, Batoclimab reduces harmful IgG antibody levels, offering a potential therapeutic option for various IgG-mediated autoimmune diseases. Uniquely developed as a subcutaneous formulation, Batoclimab allows for self-administration at home, thereby enhancing patient convenience and treatment accessibility.

HanAll Biopharma, in collaboration with its licensing partners, is actively conducting a Phase 3 study on Batoclimab for TED, with patient enrollment taking place in Japan. The goal is to establish the treatment's efficacy and safety as a promising new solution for those suffering from TED. The top-line results from this study are anticipated in the second half of 2025, which will be crucial in confirming Batoclimab's potential to address the unmet needs of TED patients.

Sean Jeong, CEO of HanAll Biopharma, expressed enthusiasm about the Orphan Drug Designation, highlighting the milestone as a critical step towards making Batoclimab available to patients in need. This designation underscores the innovative potential of Batoclimab to significantly impact the lives of individuals dealing with TED.

HanAll Biopharma is a global biopharmaceutical entity with a longstanding commitment to developing pioneering medicines for diseases with substantial unmet needs. Over the past five decades, the company has been actively involved in producing pharmaceutical products in various therapeutic areas, including endocrine, circulatory, and urologic diseases. More recently, HanAll has expanded its research and development focus to include immunology, oncology, neurology, and ophthalmology.

The pipeline of products under development at HanAll includes not only Batoclimab but also other promising treatments such as HL161ANS for Graves' Disease and Rheumatoid Arthritis, HL036 for dry eye disease, and HL192 aimed at Parkinson’s Disease. Each of these developments reflects HanAll's mission to introduce impactful medicines and improve patient lives globally.

With Batoclimab positioned as a potential game-changer in the treatment of Thyroid Eye Disease, the ongoing research and studies will play a pivotal role in determining its future role in medical care. As the Phase 3 trial progresses, the medical community and patients alike await the forthcoming results with hope for a brighter future in managing TED.