Yuhan Corporation's Allergy Treatment New Drug 'YH35324' Receives Approval for Phase 1 Clinical Trial Plan

Yuhan Corporation CI (Photo by Yuhan Corporation)

[Asia Economy Reporter Lee Chun-hee] Yuhan Corporation's new allergy treatment drug candidate 'YH35324' has received approval from the Ministry of Food and Drug Safety (MFDS) for its Phase 1 clinical trial plan (IND).

Yuhan Corporation announced on the 19th that the MFDS approved the Phase 1 clinical trial plan (IND) for YH35324, which is being developed as a treatment for various immunoglobulin E (IgE)-mediated allergic diseases such as chronic urticaria, atopic dermatitis, severe asthma, and food allergies, as of the 16th. Yuhan plans to conduct a multi-center clinical trial domestically starting in the second half of this year.

YH35324 is the alpha domain of the IgE receptor FcεR1, which plays a key role in allergic reactions in basophils and mast cells in the human body. Compared to other IgE receptors, it has relatively high binding affinity and is evaluated as a fusion protein drug candidate capable of inhibiting receptor binding of autoantibodies (anti-FcεR1α IgG).

Yuhan Corporation acquired the technology for YH35324 from the domestic bio-venture GI Innovation in July last year and secured it as a new drug pipeline, conducting joint research and development.

Yuhan expects YH35324 to have excellent efficacy duration by applying technology that increases its in vivo half-life. Additionally, it is designed not to bind to FcγR receptors, minimizing the risk of anaphylactic shock, a representative side effect of existing IgE antibody-based drugs.

Regarding IgE inhibition effects, preclinical studies using a monkey model confirmed that YH35324 has superior IgE inhibition compared to 'Xolair,' an IgE antibody drug with annual global sales of 4 trillion KRW.

The upcoming study is a first-in-human (FIH) Phase 1 clinical trial administering YH35324 to humans for the first time. It will evaluate adverse reactions, pharmacokinetic characteristics, and pharmacodynamic properties such as blood IgE concentration in healthy individuals and patients with mild allergic diseases.

A Yuhan Corporation official stated, "With the approval of this Phase 1 clinical trial plan, we have officially started clinical development," adding, "Recruitment of trial subjects is scheduled to begin in the second half of this year, and through this trial, we expect to confirm the safety and IgE inhibition effects of YH35324."