SEOUL, South Korea – Hanall Biopharma (KRX: 009420) announced today that its investigational autoimmune disease treatment, Batoclimab (HL161BKN), has been granted Orphan Drug Designation (ODD) by the Japanese Ministry of Health, Labour and Welfare (MHLW).

Orphan Drug Designation is granted to therapies that address rare diseases affecting fewer than 50,000 people in Japan, while also demonstrating significant unmet medical need and development potential. This designation provides several benefits, including up to 10 years of market exclusivity upon approval and various tax incentives.

Batoclimab received ODD for the treatment of thyroid eye disease (TED), a debilitating autoimmune condition affecting an estimated 35,000 people in Japan.

Batoclimab is a novel antibody therapy designed to eliminate pathogenic autoantibodies, the root cause of many autoimmune diseases. It is being developed as a subcutaneous (SC) injection, allowing for convenient self-administration by patients, which is expected to significantly improve their quality of life.

"We are thrilled to receive this Orphan Drug Designation from the Japanese MHLW," said [CEO Name], CEO of Hanall Biopharma. "This recognition underscores the potential of Batoclimab to address the unmet needs of patients with thyroid eye disease in Japan. We are committed to working closely with the regulatory authorities to bring this innovative treatment to patients as quickly as possible. We expect Batoclimab to be approved as a self-administered treatment without the need for in-person monitoring, given its established clinical safety profile with patients self-administering the drug at home throughout clinical trials."

This ODD marks a significant milestone in the development of Batoclimab and reinforces Hanall Biopharma's commitment to developing innovative therapies for patients with autoimmune diseases.

About Hanall Biopharma

Hanall Biopharma (KRX: 009420) is a global biopharmaceutical company committed to developing innovative therapies for patients with autoimmune diseases and other unmet medical needs. The company's pipeline includes a diverse portfolio of novel biologics and small molecules, including Batoclimab, an anti-FcRn antibody being developed for the treatment of various autoimmune diseases.

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