September 29, 2021 (Shanghai, China) - Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the China National Medical Products Administration (NMPA) approved an IND application for SHR7280, enabling a multi-center, open-label, Phase II study to be initiated. This study is to evaluate the efficacy, safety, and tolerability of SHR7280 for the prevention of premature ovulation in women undergoing assisted reproductive technology (ART). Currently, no oral gonadotropin-releasing hormone (GnRH) agonist or antagonist is approved worldwide to prevent premature ovulation.

ARTs such as in vitro fertilization (IVF) expanded opportunities for the treatment of infertility. Controlled ovarian hyperstimulation (COH) is a crucial step of IVF to obtain a sufficient number of oocytes. In this process, ovarian stimulation medications may trigger premature luteinizing hormone (LH) surge, which may lead to IVF failure. The GnRH agonist or antagonist reduces the occurrence of premature LH surge, thereby preventing premature ovulation and improving the success rate of IVF.

About Infertility

Infertility is a global health issue affecting millions of people of reproductive age worldwide. Infertility is the third common disease after tumors and cardiovascular diseases. According to World Health Organization (WHO), infertility affects approximately 15% of couples globally, amounting to around 48 million couples.

About SHR7280

SHR7280 is an investigational oral GnRH antagonist that competitively binds to the GnRH receptor and inhibits the synthesis and secretion of gonadotropin such as LH and follicular stimulating hormone (FSH). The preliminary data from three Phase I studies demonstrated that SHR7280 was well tolerated with a good safety profile. To date, much lower incidences of hot flushes, headache, and nausea have been observed, which confers best-in-class potential and may allow a wider range of indications.

SHR7280 is also currently being developed for the treatment of endometriosis, prostate cancer, and other gynecological diseases.

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 21st among the top 1,000 global pharma companies in 2020. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.

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Email: bd@hengrui.com

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