The company's wholly-owned subsidiary, Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd., has obtained a Drug Clinical Trial Approval Notice from the National Medical Products Administration.
The approval is for the clinical trial of HY-1016 Sustained-Release Injection (project R&D code "HY-1016") intended for the treatment of endometriosis.
Dienogest is a highly selective progesterone receptor agonist. It functions in endometriosis by inhibiting the hypothalamic-pituitary-ovarian axis to reduce endogenous estradiol production, thereby suppressing estradiol's stimulatory effect on both normal and ectopic endometrial tissue.
With continuous administration, dienogest creates an endocrine environment of low estrogen and high progesterone, leading to decidualization of endometrial tissue and a subsequent reduction in endometriotic lesions.
The HY-1016 Sustained-Release Injection represents a new formulation and a novel route of administration containing dienogest. The aim is to reduce the dosing frequency for long-term treatment of endometriosis patients without compromising clinical efficacy or introducing significant new safety risks, thereby improving patient compliance with the medication regimen.