HanAll Biopharma said it has applied for a phase 3 trial of the autoimmune disease drug HL161 (ingredient: batoclimab) in Japan.

In a public disclosure on Friday, HanAll said it submitted Clinical Trial Notification (CTN) for the phase 3 study of HL161 to treat myasthenia gravis (MG) in Japan.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is expected to announce its decision on the trial approval within 45 days.

If the trial is authorized, HanAll plans to evaluate subcutaneous injection of batoclimab in 15 patients with MG at six medical institutions in Japan. The study will take 24 weeks from the administration to the observation.

The market is paying keen attention to the upcoming study because Immunovant, a partner company of HanAll, will conduct it.

HanAll has the right to commercialize and sell batoclimab in Japan.

The phase 3 study will be part of Immunovant’s global HL161 trial, HanAll said.

Immunovant, which has the right to commercialize and sell HL161 in the global market except for Korea, Japan, and China, is testing batoclimab (Immunovant’s pipeline name: IMVT-1401) in the phase 3 study in 210 patients with MG in 18 countries, including Canada, the U.S., Australia, and Europe.

Observers raised the possibility that HanAll and Immunovant may sign a deal for HL161 sales in Japan, but HanAll refused to comment.

“Batoclimab’s mechanism of action improves the symptoms of MG patients by reducing pathogenic antibodies in the body,” HanAll said in the public filing. “We expect it could be a new treatment option for patients with MG who lack an effective treatment.”

“Depending on the study results, we will push for approval as a new MG treatment in Japan,” the company added.