Yuhan Corp. announced Wednesday it has licensed GI Innovation’s next-generation allergy treatment pipeline in a deal that could potentially total $1.2 billion.

“I am very pleased by this collaboration with GI Innovation to develop the next-generation allergy treatment across all four major allergic diseases; allergic asthma, chronic urticaria, atopic dermatitis and food allergy, improving the lives of pediatric and adult patients who suffer from allergies” said Yuhan President and CEO Lee Jung-hee.

Under the deal, Yuhan has global rights, excluding Japan, to develop and commercialize GI-301. GI Innovation will collaborate on the development.

Yuhan will pay an upfront, nonrefundable $17 million to GI Innovation, and pay additional royalties upon milestone achievements. The deal could reach $1.2 billion in case of the completion of development and successful commercialization.

Most allergic reactions are induced by histamine. When a person is exposed to allergy triggers, their body produces immunoglobulin E. When this allergen-bound IgE activates the Fc receptors on the mast cell and basophil, histamine is created. 

Currently, Xolair is the only existing IgE antibody approved by the US Food and Drug Administration.

In 2019, Xolair raked in an annual revenue of 4 trillion won ($3.3 billion) despite the fact that its patent expired the previous year.

Unlike Xolair which is an antibody treatment, GI-301 is a fusion protein treatment that has shown higher inhibition of IgE in animal testing compared to Xolair, according to GI Innovation. GI-301 is specifically designed to minimize the risk of anaphylaxis, the most common side effect of anti-IgE drugs, it added.

Yuhan said it anticipates GI-301 to become an unprecedented treatment for asthma, atopy and food allergy, given that Xolair and other anti-IgE drugs under development have failed to demonstrate efficacy in clinical studies in atopic patients with higher serum IgE levels.

GI Innovation, founded in 2017, is preparing to issue an initial public offering in the tech-heavy Kosdaq market within this year.

The company’s founder and CEO Nam Su-youn was formerly the head of research at Yuhan. She had been one of the key people responsible for Yuhan’s trillion-won-worth license-out of lazertinib to Janssen.

For GI-301, GI Innovation has contract manufacturing deal signed with DM Bio, which has manufacturing facility that abides by Japanese drug authority Pharmaceuticals and Medical Device Agency’s standards.

GI-301 will enter phase 1 clinical trials in Korea in September.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)