HanAll Biopharma (KRX: 009420.KS) today announced that its Chinese partner, Harbour BioMed, had initiated the first dosing of patient of HL161 (INN: Batoclimab) in both myasthenia gravis (MG) and Immune thrombocytopenic purpura (ITP).
HL161 is a novel antibody drug for treating autoimmune diseases by inhibiting FcRn, which plays a role of prolonging the half-life of the IgG antibody, thus promoting breakdown of pathogenic autoantibodies in the system. In 2017, HanAll Biopharma licensed rights to develop and commercialize HL161 in the North American, Central and South American, European, Middle Eastern, and North African regions to Roivant Sciences of Switzerland (currently its subsidiary, Immunovant), and for the China region (including Hong Kong, Taiwan, and Macao) to Harbour BioMed of China. Since then, the three companies have been accelerating global clinical development of HL161 through cooperation based on a global alliance.
For HL161, a global clinical trial is being conducted across countries in five indications, such as myasthenia gravis, immune thrombocytopenic purpura, thyroid eye disease, warm antibody autoimmune hemolytic anemia, and neuromyelitis optica spectrum disorder, along with clinical trials in China. With the mechanism of action to break down and remove autoantibodies, HL161 is expected to be a multilayer drug to treat various autoimmune diseases.
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PrevHL161 (batoclimab) Demonstrated Positive Top-line Results in Phase 2 Clinical Trial in Myasthenia Gravis