Korean companies bid to break AZ’s monopoly with FcRN drug

HanAll in Phase III trial for batoclimab…Phase I trial also ongoing for a new drug candidate Handok introduces Vyvgart from Argenx…for exclusive supply in Korea

HanAll in Phase III trial for batoclimab…Phase I trial also ongoing for a new drug candidate

New FcRN drug to compete with C5 complement inhibitors like Ultromiris

With new FcRn antibody drugs secured by Korean pharmaceutical companies demonstrating efficacy in myasthenia gravis, these new FcRn antibody drugs are expected to rise as a competitor to C5 complement inhibitors such as AstraZeneca’s Ultromiris and Soliris that currently occupy the market in Korea.

 

to industry sources on the 27th, Handok is preparing to apply for marketing authorization of its new FcRn antibody drug Vyvgart (efgartigimod).

 

The company had signed an agreement with the Belgian company Argenx for the marketing authorization, reimbursement, and exclusive distribution of Vyvgart in Korea.

 

Vyvgart is a human Immunoglobulin G1 (IgG1) antibody fragment that binds to the neonatal.

 

Fc receptors (FcRn).

 

The mechanism of action reduces and blocks the circulation of IgG antibodies that cause diseases.

 

FcRn binds to IgG antibodies, preventing them from being destroyed in the lysosome.

 

Vyvgart is currently approved as a treatment for adult patients with generalized myasthenia gravis in the U.S., Europe, the U.K., Israel, and China.

 

In the Phase III ADAPT trial, a significant 68% of anti-AChR antibody-positive gMG patients responded to Vyvgart therapy, compared to 30% of patients on placebo on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale during the first treatment cycle.

 

Furthermore, patients who were treated with Vyvgart showed an improvement over those who received a placebo on the Quantitative Myasthenia Gravis (QMG) scale.

 

Also, Argenx received approval for the subcutaneous formulation of its Vyvgart from the US FDA.

 

In clinical trials, the subcutaneous injection formulation of Vyvgart reduced average IgG by 66.4% on the 29th day, which was higher than the 62.2% achieved using the existing intravenous injection formulation of Vyvgart.

 

On the 23rd, Mirae Asset researcher Seung-min Kim selected FcRn antibody treatment as the most promising candidate for immune and inflammatory diseases in his 2024 Pharmaceutical Bio Outlook Report.

 

Researcher Kim said that the FcRn antibody drug Vyvgart has the potential to become a blockbuster and that HanAll Biopharma, which is developing a treatment in the same class, also deserves attention.

 

HanAll in Phase III trial for batoclimab…achieved positive results in the Phase I IMVT-1402 trial

HanAll Biopharma is also developing a subcutaneous injection dosage formulation of its GcRn antibody treatment candidate, batoclimab (HL161).

 

Its licensed partner in China, Harbour BioMed, is conducting clinical trials on the candidate to confirm the potential of batoclimab as a treatment for various autoimmune diseases.

 

HanAll Biopharma obtained positive Phase III trial results with batoclimab in China in March.

 

The trial was conducted by its Chinese partner Harbour BioMed on 132 patients with myasthenia gravis.

 

In the trial, patients were randomly assigned to two groups and evaluated the candidate’s symptom improvement effect and safety at each designated cycle.

 

Results showed that batoclimab met its primary endpoint and demonstrated statistically significant improvement over placebo.

 

Also, batoclimab achieved the key secondary endpoints.

 

It showed consistent safety and tolerability with the previous Phase II trial, and there were no newly discovered adverse reactions.

 

Also, HanAll Biopharma is setting out to receive US approval with its US partner Immunovant.

 

In addition to batoclimab, which is currently in the later stage of clinical trials, a Phase I trial is underway for IMVT-1402, another new FcRn antibody drug candidate.

 

According to the interim results of the Phase I trial that was released last September, IMVT-1402 decreased blood IgG concentration, the efficacy endpoint, by 63%, and no decrease in albumin, a safety indicator, was observed.

 

The ongoing Phase I trial administered IMVT-1402 and placebo as a subcutaneous injection formulation to randomly assigned healthy adults, in increased dosages for each patient group with single or repeated administrations.

 

HanAll Biopharma plans to develop IMVT-1402 to target various autoimmune diseases in addition to myasthenia gravis.

 

No.1 drug for myasthenia gravis in Korea is Ultomiris IV When introduced, the FcRn antibody treatments are expected to compete fiercely with existing AstraZeneca treatments in the market.

 

AstraZeneca had successfully acquired Alexion, a rare disease specialized company that developed the C5 complement inhibitors Soliris (eculizumab) and Ultomiris (ravulizumab), which are treatments for myasthenia gravis.

 

Currently, the domestic market is dominated by AstraZeneca's Ultomiris.

 

The drug absorbed most of the market share that had been previously occupied by Soliris.

 

According to the market research institution IQVIA, Ultomiris recorded KRW 43.2 billion in sales last year.

 

This year, it raised KRW 37.8 billion by Q3.

 

Soliris recorded sales of KRW 10.1 billion last year and KRW 6.5 billion through Q3 this year.

 

Based on the performance, AstraZeneca is evaluated to have successfully made the switch from Soliris to Ultomiris.

 

Soliris, which is indicated both for paroxysmal nocturnal hemoglobinuria (PNH) and myasthenia gravis, had maintained its first place in the market for a long time, but then, a change in the market was detected with the full-scale introduction of Ultomiris in 2021.

 

Ultomiris succeeded in increasing the dosing interval while maintaining its effect compared with Soliris.

 

The dosing interval for Ultomiris has been extended to once every 8 weeks compared to Soliris, which is administered intravenously once every 2 weeks.

 

However, no subcutaneous injection formulation currently exists in the field, so the new FcRn antibody treatments are expected to have high marketability.