HanAll Biopharma Partner Immunovant Reveals Additional Indications for 'HL161'

[Asia Economy Reporter Lee Gwanju] HanAll Biopharma announced on the 8th that its global partner Immunovant revealed two new indications for the subcutaneous injection autoimmune disease therapeutic antibody drug 'HL161 (generic name Batoclimab)'.

On the 7th (local time), Immunovant announced through a conference call that in addition to the ongoing clinical developments for myasthenia gravis (MG), thyroid eye disease (TED), and warm autoimmune hemolytic anemia (WAIHA), it will also expand clinical development for chronic inflammatory demyelinating polyneuropathy (CIDP) and Graves' disease.

Chronic inflammatory demyelinating polyneuropathy is an autoimmune disease in which autoantibodies damage the myelin sheath of peripheral nerves, causing symptoms such as numbness or paralysis in the hands and feet. Graves' disease is caused by autoantibodies continuously stimulating the thyroid gland, leading to excessive secretion of thyroid hormones, and in severe cases, complications such as swelling in the front of the neck or protruding eyes may occur.

For chronic inflammatory demyelinating polyneuropathy, a Phase 2b clinical trial is planned to start in the second half of this year, with results expected in the first half of 2024. For Graves' disease, a Phase 2 clinical trial will begin early next year, with results expected in the second half of the same year. Additionally, a Phase 3 clinical trial for myasthenia gravis has already started in June this year, and a Phase 3 trial for thyroid eye disease is also scheduled to begin within this year.

Pete Salzman, CEO of Immunovant, said, "Both new indications are autoimmune diseases caused by autoantibodies attacking the body itself. We believe that this expansion of indications will be an opportunity to demonstrate our confidence that Batoclimab will establish itself as an important therapeutic strategy for various intractable autoimmune diseases."

Seungwon Jung, CEO of HanAll Biopharma, emphasized, "If the development of the two additional indications proceeds as planned, the subcutaneous injection product will be the first to be launched in the chronic inflammatory demyelinating polyneuropathy area, and in the Graves' disease area, it is expected to be the first-in-class drug within the same class. We will lead efforts to further expand Batoclimab's indications and provide effective treatment options to patients with intractable autoimmune diseases worldwide."