Kissei Initiates Phase III Clinical Trial for GnRH antagonist Linzagolix in Japanese Patients with uterine fibroids

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan, Chairman and CEO: Mutsuo Kanzawa,"Kissei") announces that Kissei initiates a Japanese Phase III clinical trial for GNRH antagonist linzagolix (KLH-2109) in uterine fibroids.

Uterine fibroids are benign tumors that develop in the smooth muscles that make up the myometrium and grow in a sex hormone-dependent manner, and the most common symptoms are hypermenorrhea and associated anemia, dysmenorrhea, pressure symptoms, pain, and infertility. Hypermenorrhea and chronic pain symptoms have also been reported to have a significant impact on patients' quality of life.

The efficacy and safety of oral linzagolix in patients with uterine fibroids with hypermenorrhea will be investigated in a double-blind study using a GnRH agonist as a control, and the efficacy and safety of oral linzagolix in patients with uterine fibroids with hypermenorrhea and pain will be investigated in a double-blind study using a placebo-controlled study.

Kissei strives to provide contribute to patients with uterine fibroids through the development of linzagolix.

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About Linzagolix（KLH-2109）
Linzagolix is a novel, orally administered GnRH receptor antagonist. Linzagolix acts by antagonizing the GnRH receptor in the pituitary gland, ultimately reducing estrogen production by the ovaries. In November 2015, Kissei licensed out exclusive rights to develop and market in countries excluding part of Asia such as Japan to ObsEva. ObsEva has conducted clinical development of Linzagolix for uterine fibroids and endometriosis. ObsEva has obtained marketing authorization from European Commission for uterine fibroids on June 14, 2022 and from MHRA in the United Kingdom on June 27, 2022. In the United States, the New Drug Application for Linzagolix for uterine fibroids is under review by the Food and Drug Administration. Phase III trials of linzagolix are being conducted for endometriosis in Europe and the United States, and linzagolix has completed Phase II clinical trials in Japan. In Asia, Kissei licensed out rights to develop and market in China to Bio Genuine in September 2021, and is now in preparation to start clinical trials.

About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is traded under the ticker symbol "OBSN".
For more information, please visit https://www.obseva.com/

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.