HanAll Biopharma HL161, Targeting 'First and Best' in FcRn Inhibitor Market

The 'neonatal Fc receptor (Fc neonatal receptor·FcRn) inhibitor' is emerging as a key mechanism in the treatment of autoimmune diseases. Amid this, HanAll Biopharma's FcRn inhibitors 'HL161 (Batoclimab)' and 'HL161ANS (IMVT-1402)' are showing promising results in major clinical trials, increasing the possibility of being the 'best in class' and 'first in class.'

According to the bio industry on the 21st, the strength of FcRn inhibitors lies in their ability to selectively inhibit 'IgG,' the antibody that causes autoimmune diseases. This allows a single drug to enter various autoimmune disease markets.

Batoclimab, an FcRn inhibitor developed by HanAll Biopharma, demonstrated superior efficacy compared to existing FcRn inhibitors in a recently announced Phase 3 clinical trial. In the primary endpoint, MG-ADL (a score quantifying symptoms of myasthenia gravis), the high dose (680 mg) showed an average decrease of 5.6 points, and the low dose (340 mg) showed an average decrease of 4.7 points. Considering that competitors’ clinical trials showed MG-ADL improvement results ranging from 3.8 to 4.7 points, this is a meaningful figure.

Exterior view of Hanall Biopharma headquarters. Photo by Hanall Biopharma

The most notable aspect of this clinical trial is the reduction level of autoantibodies in the blood. Since IgG autoantibodies are the main cause of autoimmunity, the rate of IgG reduction is regarded as a key indicator to gauge the therapeutic effect of the drug. Batoclimab demonstrated the highest effect among drugs in the same class at the high dose and equivalent efficacy compared to competitors at the low dose.

These clinical achievements further highlight the potential of the follow-up pipeline HL161ANS. HL161ANS maintains a similar level of IgG reduction effect as Batoclimab but is characterized by having less impact on cholesterol and albumin levels. This is a factor that can provide a strategic advantage in chronic autoimmune diseases requiring long-term high-dose treatment.

In some autoimmune diseases such as rheumatoid arthritis (RA), the 'dose-dependent' characteristic of FcRn inhibitors is emphasized. Dose dependency means that as the administered dose of the drug increases, the reduction in blood IgG concentration becomes greater, and accordingly, the improvement effect on clinical symptoms becomes more pronounced.

For example, the competing substance 'Nipocalimab' confirmed the correlation between IgG reduction and symptom improvement in a Phase 2 clinical trial targeting rheumatoid arthritis patients but did not secure statistical significance. Subsequently, high-dose clinical trials have not been conducted due to safety and other reasons.

A HanAll Biopharma official stated, "HL161ANS possesses structural competitiveness with three weapons: 'high concentration, high efficacy, and high convenience,' and we plan to continuously grow it as a pipeline that can set new standards in the rapidly growing FcRn inhibitor market."

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