September 2, 2021

Licensing Agreement for GnRH Antagonist Linzagolix with Bio Genuine in China

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano; Chairman and CEO: Mutsuo Kanzawa) announced that it has entered into a license agreement with Bio Genuine (Head Office: People's Republic of China, CEO: Baohua Ji) to license development and commercialization rights in China for the GnRH antagonist linzagolix that was discovered by Kissei.

By executing this agreement, in China, Bio Genuine will develop and commercialize linzagolix. Kissei will receive an upfront payment and milestone payments based on the progress of the development and commercialization conducted by Bio Genuine and will supply the drug substance to Bio Genuine.

Linzagolix is a novel, orally administered GnRH (gonadotropin releasing hormone) receptor antagonist. Linzagolix acts by antagonizing GnRH at the GnRH receptor in the pituitary gland and consequently suppressing the secretion of gonadotropin. Ultimately reducing estrogen production at the ovaries, it improves symptoms of uterine fibroids and endometriosis.

Kissei has conducted clinical development for lizagolix in Japan, and our overseas partner ObsEva is under NDA and phase-III stage for the indications of uterine fibroids and endomteriosis respectively. ObsEva announced the acceptance of a Marketing Authorization Application to the European Medicines Agency (EMA) for linzagolix for the treatment of uterine fibroids in November 2020.

Kissei focuses on drug discovery, research and development of new drugs. In collaboration with partner companies, Kissei will contribute to the health of people around the world through developing novel drugs.

The upfront income is triggered by this agreement, and it has neglible effects on Kissei's consolidated business forecasts for the fiscal year ending in March 2022.


About development status of Linzagolix (generic name)

Linzagolix is a novel, orally administered GnRH receptor antagonist. Kissei has conducted clinical trials for the indications of endomteriosis in Japan. Overseas, in November 2015, Kissei granted ObsEva exclusive worldwide rights on linzagolix, excluding Asia such as Japan. ObsEva is a biopharmaceutical company focused on the development and commercialization for novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy.

About Bio Genuine
Bio Genuine continues to introduce a competitive portfolio of therapeutic programs aiming at bringing more solutions to China's healthcare. Their experienced team has secured partnerships with leading global biopharmaceutical companies to generate a broad pipeline of potentially innovative, marketed products and product candidates. Bio Genuine's vision is to become a leading biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to positively impact women's health area.