#Japan #Seoul #HanAll Biopharma #Thyroid Eye Disease #Batoclimab

HanAll Biopharma Announces Major Milestone for Batoclimab

On March 6, 2025, HanAll Biopharma Co., Ltd. made an exciting announcement regarding its noteworthy drug, Batoclimab. The Ministry of Health, Labor, and Welfare (MHLW) in Japan has officially granted Orphan Drug Designation (ODD) for Batoclimab, specifically aimed at treating active Thyroid Eye Disease (TED). This designation is crucial as it underscores the drug's potential impact on a population that is often underserved in terms of treatment options.

Understanding Thyroid Eye Disease (TED)

Thyroid Eye Disease, also identified as Graves' orbitopathy, is a rare and severe autoimmune disorder. It mainly affects individuals with hyperthyroidism or Graves' disease and can result in debilitating symptoms such as bulging eyes, discomfort, double vision, and in severe cases, loss of vision. These symptoms can greatly restrict daily activities—patients struggle with simple tasks like reading, driving, and even engaging socially due to concerns over their appearance and the psychological impact of the disease.

It is estimated that around 35,000 people in Japan suffer from TED, a figure that highlights the necessity for effective treatment options. Currently, many existing treatments are inadequate for those experiencing moderate to severe forms of the disease.

What is Batoclimab?

Batoclimab is a monoclonal antibody designed to block FcRn, a receptor that recycles IgG antibodies in the body. By inhibiting FcRn, Batoclimab aims to reduce harmful IgG antibody levels, thus addressing various autoimmune diseases. The drug is being developed in a subcutaneous formulation, allowing patients the convenience of at-home administration. This feature is designed to improve accessibility, making it easier for patients to manage their treatment without frequent hospital visits.

HanAll Biopharma is pursuing a global Phase 3 clinical trial for Batoclimab, which includes patient enrollment in Japan. This study aims to confirm the drug's efficacy and safety as a novel treatment for TED, with expected top-line results anticipated in the second half of 2025.

Company Commitments

Sean Jeong, MD, MBA, the CEO of HanAll Biopharma, expressed excitement about receiving the Orphan Drug Designation, labeling it as a significant milestone for the company and the patients who could benefit from Batoclimab. Jeong emphasized HanAll's dedication to advancing the treatment and bridging the gap between development and market availability.

The Road Ahead

With the Orphan Drug Designation now in place, HanAll Biopharma is poised to make significant advancements in the treatment of Thyroid Eye Disease. The ongoing Phase 3 study will play a crucial role in assessing Batoclimab's potential to fill the urgent needs of TED patients. As the company continues to navigate the challenges of clinical development, the focus remains on delivering innovative solutions that can significantly enhance the quality of life for those affected by this debilitating disorder.

For further updates and detailed information, interested parties can connect with HanAll Biopharma through their official website or follow them on LinkedIn.