Hanall Biopharma Receives Approval for Phase 3 Clinical Trial of Myasthenia Gravis Treatment in Japan

[Asia Economy Reporter Chunhee Lee] HanAll Biopharma announced on the 20th that its autoimmune disease treatment candidate ‘HL161 (substance name Batoclimab)’ has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for a Phase 3 clinical trial for myasthenia gravis in Japan.

This clinical trial is part of the global Phase 3 trial being conducted by Immunovant, the U.S. partner company that licensed the global commercialization and sales rights of HL161 excluding Korea, Japan, and China, since 2017. The multinational trial is being conducted in a total of 18 countries including Japan, Canada, the United States, Australia, and Europe, targeting a total of 210 patients. During the initial 12-week induction period, patients with myasthenia gravis are divided into two groups receiving Batoclimab (680 mg, 340 mg) and a placebo group to induce rapid symptom improvement. This is followed by a 12-week maintenance period during which a low dose of Batoclimab 340 mg is administered to measure the maintenance effect of the treatment. The actual clinical trial is scheduled to begin in the second half of this year, and depending on the clinical results, HanAll plans to apply for approval of Batoclimab as a new drug for the treatment of myasthenia gravis in Japan.

The company explained that Batoclimab is expected to become an important treatment option for patients in Japan as the first subcutaneous injection (SC) therapy in the neonatal Fc receptor (FcRn) class to enter the Japanese market. According to the Japanese Ministry of Health, Labour and Welfare, there are approximately 22,000 patients suffering from myasthenia gravis in Japan, but effective treatments are still lacking.

Seungwon Jung, CEO of HanAll Biopharma, said, “HanAll is doing its best to provide effective treatments to autoimmune disease patients worldwide by developing Batoclimab together with our partners. In particular, Japan is a region where HanAll holds the distribution rights, making it strategically important for the commercialization of Batoclimab.”