(From left) BG Rhee, chairman of GI Innovation, Atsushi Sugita, CEO of Maruho 

GI Innovation, an innovative new drug development company, announced on 16th October that it succeeded in out-licensing as worth up to 221M USD in totaling upfront, development and commercial milestones to Maruho, a leading dermatology company which was founded 1915 in Japan.

Under the terms of agreement, GI Innovation is eligible to receive non-refundable upfront payments, along with development and commercial milestone payments, and royalties on further sales of GI-301 in Japan. Maruho will lead both the clinical development and commercialization efforts for GI-301 within the Japan market. 

Founded in 1915, Maruho leads Japan in research and development, manufacturing and commercialization of dermatological products, which include treatments for Atopic dermatitis, Hyperhidrosis, Psoriasis, Acne, and Herpes zoster. Prescription drugs for skin disease make up almost 96% of its net sales, which were approximately 95.39 billion yen(consolidated) in its fiscal year ended September 30, 2022. In addition, Maruho is actively advancing its clinical development initiatives across various pipelines and expanding its sales through strategic alliance with prominent global big pharmaceutical companies.

The successful out-licensing of GI-301 was made possible by its demonstrated effectiveness, surpassing that of its blockbuster competitors.

GI-301 is a bispecific fusion protein, comprising FcεRIα extracellular domain of IgE binding site, With long-acting technology. Its exceptional IgE blocking effectiveness was validated through non-human primate experiments and a phase 1a clinical trial. As a result, GI-301 showed great potential in addressing a variety of allergic diseases.

"Given the unique nature of the Japanese allergic market, characterized by a substantial demand for a variety of allergy treatments, several Japanese pharmaceutical companies have shown strong interest in GI-301," said Myung Ho Jang, the CSO of GI Innovation. "We are pleased to announce that we have selected Maruho, Japan's leading clinical and commercial specialist in dermatological diseases, as our partner. 

The successful out-licensing deal between GI innovation and Maruho sets the stage for YUHAN to capitalize on the global out-licensing rights for GI-301(YH35324), particularly given the significant population of allergic patients in Japan. 

BG Rhee, the Chairman of GI Innovation, expressed, "We look forward to strengthening our clinical collaboration with Maruho in Japan to help those who suffer from allergic diseases around the world. We are committed to working closely with Yuhan to navigate the global licensing deal of GI-301(YH35324) going forward."

GI Innovation executed global license agreement for GI-301(YH35324), excluding Japan, with YUHAN for 1,037M USD, and the phase 1b of domestic clinical trial is currently underway.