Launch of YSELTY® (generic name linzagolix) for uterine fibroid treatment in Europe

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa; "Kissei") announced today that Theramex (UK), to which Kissei licensed out its technology for Linzagolix (generic name, development number in Japan: KLH-2109), a uterine fibroid treatment discovered and developed by Kissei, has made its first commercial sale of the drug in Germany.

YSELTY^® is a GnRH receptor antagonist that antagonizes GnRH at GnRH receptors in the pituitary gland and suppresses the secretion of gonadotropin, a gonadotropic hormone, thereby decreasing estrogen production in the ovary and improving bleeding and pain symptoms in patients with uterine fibroids. Phase III clinical trials conducted in the U.S. and Europe confirmed the efficacy of the product not only in combination with Add-back therapy but also in the non-combination group, and in June 2022, the European Commission (EC), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and other regulatory agencies granted marketing approval for the indication of moderate to severe uterine fibroids in adult women of reproductive age. YSELTY^® is a GnRH antagonist that can be used for uterine fibroid patients who cannot take hormonal agents, providing a new treatment option tailored to individual patient conditions and needs.
We expect that YSELTY^® will be available in many countries in the territory licensed to Theramex through Theramex, a global specialty pharmaceutical company dedicated to women and their health.

The agent is being developed for the treatment of uterine fibroids and endometriosis in Japan, and it is being developed by out-licensed companies such as Theramex Inc, overseas. We are committed to making efforts to ensure that this drug will contribute widely to improve the QOL of patients around the world.

The impact of this matter on our earnings forecast has already been incorporated in the consolidated earnings forecast for the full fiscal year ending March 31, 2025, which was announced on May 7, 2024.

《 Reference 》

About linzagolix (development number in Japan: KLH-2109)
Linzagolix is a novel orally available GnRH (gonadotropin-releasing hormone) antagonist discovered and developed by Kissei, which antagonizes GnRH at the GnRH receptor in the pituitary gland and reduces estrogen production in the ovaries by suppressing the secretion of the gonadotropin, a gonadotrophic hormone.
In Asia, in September 2021, Kissei granted Bio Genuine (China) the exclusive rights to develop and market the drug in China, and the drug is under development. In Taiwan, Synmosa BioPharma (Taiwan) has filed for approval, and in South Korea, JW Pharma (South Korea) is preparing to start development.
In Japan, Kissei is conducting Phase III clinical trials for uterine fibroids, and has completed Phase II clinical trials for endometriosis.

About Theramex
Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women at different stages of their lives by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause, and osteoporosis. Theramex's commitment is to listen to and understand its patients, serve their needs, and offer healthcare solutions to help improve their lives. Theramex's vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through different stages of their life.

For further information on Theramex, please visit their website (https://www.theramex.com/).

About Uterine Fibroid
Uterine fibroid is a benign tumor that develops in the smooth muscle that makes up the uterine myometrium and grows in a sex hormone-dependent manner. Its typical symptoms are excessive menstruation and associated anemia, dysmenorrhea, pressure symptoms, pain, and infertility. Hypermenorrhea and chronic pain symptoms have been reported to have a significant impact on patients' QOL.

About Add-back therapy
This is a treatment that replenishes estrogen (hormonal agents) exogenously to alleviate drug-induced bone density loss and other side effects.