Drug intelligence / Profile preview

Baituowei

Development stage
Phase 3
Lead developer
Luye Pharma
Modality
Small Molecules, Biodegradable Polymers → Polymer-based Nanoparticles → Nanoparticles → Drug Delivery Systems
Administration
Subcutaneous
01

Overview

Baituowei is a long-acting, sustained-release **microsphere formulation of goserelin acetate** for injection, developed by Luye Pharma Group. It is the world's first and only approved microsphere formulation of goserelin. The drug acts as a **gonadotropin-releasing hormone (GnRH) agonist**, used primarily for **androgen deprivation therapy (ADT) in prostate cancer** and for **hormonal therapy in premenopausal and perimenopausal women with breast cancer**. Its microsphere-based delivery system allows for steady release of the active ingredient, better control over testosterone levels, reduced injection site reactions compared to the reference drug, and improved patient compliance through an ultra-thin injection needle. It was approved by China’s National Medical Products Administration (NMPA) in June 2023 for prostate cancer and in September 2023 for breast cancer[1][2][3][5][7][9][10].

Brand names
Baituowei
Other names
Goserelin microspheres for injectionGoserelin acetate sustained-release microspheres for injection
02

Targets

GnRHR (Gonadotropin-releasing hormone receptor)

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