HanAll Biopharma Subcutaneous Autoimmune Therapy 'HL161' Announces US Clinical Trial Plan

Partner Immunovant to Announce Clinical Plans Within the Year
Myasthenia Gravis Phase 3 Trial This Month, Thyroid Eye Disease Phase 3 Trial in Second Half

[Asia Economy Reporter Lee Gwan-joo] Immunovant, the US partner of HanAll Biopharma, disclosed the clinical plan for 'HL161 (Batoclimab),' a subcutaneous injection autoimmune therapeutic, on the 8th (local time).

HL161 is an autoimmune disease treatment antibody that HanAll Biopharma licensed out in 2017. The most advanced clinical trial, Phase 3 for myasthenia gravis, began this month, and topline results are expected to be available in 2024.

The clinical plan for thyroid eye disease (TED), which was temporarily halted last year, was also revealed. Immunovant obtained FDA approval for the Phase 3 clinical trial of HL161 for thyroid eye disease. The Phase 3 trial is expected to start in the second half of this year, with results anticipated in 2025.

There is also a plan to further expand HL161’s indications to provide broader treatment options for patients suffering from intractable diseases. By August, three additional indications, including warm autoimmune hemolytic anemia (WAIHA), will be added, and a Phase 3 clinical trial for one of these indications will commence.

Seungwon Jung, CEO of HanAll Biopharma, stated, "HL161 is administered subcutaneously, allowing patients to self-inject, which enhances convenience and reduces the need for frequent hospital visits, thereby lowering medical costs. We will continue to expand HL161’s indications to contribute to the lives of more patients."

This content was produced with the assistance of AI translation services.