HanAll Biopharma Secures Orphan Drug Designation in Japan for Batoclimab to Treat Thyroid Eye Disease

HanAll Biopharma has received Orphan Drug Designation (ODD) from the Ministry of Health, Labor and Welfare (MHLW) in Japan for Batoclimab, an anti-FcRn monoclonal antibody developed for autoimmune diseases, including active thyroid eye disease (TED). The ODD status, granted to treatments targeting rare diseases affecting fewer than 50,000 patients in Japan, facilitates expedited development and regulatory support for promising therapies.

A Major Step in TED Treatment in Japan

Currently, approximately 35,000 individuals in Japan are affected by TED, an autoimmune condition that leads to inflammation and damage to eye tissues. With limited treatment options available, the ODD designation reinforces Batoclimab’s potential to address an unmet medical need.

Sean Jeong, CEO of HanAll Biopharma, expressed optimism about the milestone: “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. 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.”

How Batoclimab Works

Batoclimab is designed to inhibit the neonatal Fc receptor (FcRn), a protein that regulates the recycling of immunoglobulin G (IgG) antibodies. By selectively binding to FcRn, Batoclimab lowers harmful IgG antibody levels, offering potential benefits for various IgG-mediated autoimmune diseases. A key advantage of Batoclimab is its expected ability to be self-administered at home, improving patient convenience and accessibility.

Broad Research and Development Efforts

Beyond TED, HanAll Biopharma is investigating Batoclimab for several autoimmune diseases, including:

       • Generalized Myasthenia Gravis (gMG)

       • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

       • Graves’ Disease

The company is also conducting a Phase 3 clinical trial to evaluate the safety and efficacy of Batoclimab in patients with active TED. These efforts align with HanAll’s commitment to pioneering innovative treatments for autoimmune diseases.

What’s Next for Batoclimab?

With its ODD status, Batoclimab may benefit from regulatory incentives in Japan, such as priority review, tax credits, and extended market exclusivity upon approval. HanAll Biopharma continues to advance its clinical research, aiming to bring Batoclimab to market as a transformative therapy for TED and other autoimmune conditions.