GI Innovation Registers Japanese Patent for Allergy Treatment 'GI-301'

[Asia Economy Reporter Lee Gwanju] GI Innovation announced on the 18th that the substance patent for its main pipeline allergy treatment 'GI-301' has been granted in Japan.

GI-301, being developed as a next-generation allergy treatment, is a dual-fusion protein combining the extracellular domain (ECD) of the ‘FcεRIα’ chain, which binds to immunoglobulin E (IgE), with long-acting Fc technology. Compared to existing drugs, it offers superior IgE inhibition effects, minimizes the risk of anaphylaxis, and is designed for use in children as well.

GI-301 was licensed out to Yuhan Corporation in 2020 for a total of 1.4 trillion KRW (global rights excluding Japan), including an upfront payment of 20 billion KRW and future milestones. However, GI Innovation retains the rights for Japan, and with this patent registration, it plans to accelerate contacts with pharmaceutical companies within Japan for technology transfer in the Japanese market.

Japan is considered a major market for allergic diseases such as rhinitis, asthma, and atopic dermatitis. The market size includes approximately 1 trillion KRW for pollen allergies, 3 trillion KRW for asthma and chronic obstructive pulmonary disease (COPD), and 400 billion KRW for atopic dermatitis.

GI-301 is currently undergoing Phase 1 clinical trials with Yuhan Corporation (YH35324) in healthy individuals with atopy or subjects with mild allergic diseases. Both companies are discussing specific progress through a joint development committee and are following a step-by-step process. The results of the Phase 1 trial are expected to be obtained within this year.

Lee Byung-geon, Chairman of GI Innovation, stated, “As allergic diseases are expanding in Asian countries, Japan forms the largest market among them. In particular, more than one in four people suffer from pollen allergies caused by cedar trees and others,” adding, “Starting with the registration of the Japanese patent for GI-301, we will do our best to achieve additional technology transfers in the Japanese region.”

Meanwhile, GI Innovation completed its preliminary review request for KOSDAQ listing in April. Additionally, the global large-scale Phase 1/2 clinical trials of the immuno-oncology drug GI-101 are progressing smoothly, and research and development of follow-up pipelines such as new immuno-oncology drugs and metabolic diseases are underway.