Qilu Pharmaceutical's Ganirelix Acetate Injection (Baoyuntai®) Approved for Market Launch

Beijing News reporter Zhang ZhaohuiAugust 7Qilu Pharmaceutical announced that its fertility drug, Ganirelix Acetate Injection (brand name: Baoyun Tai), has been approved for marketing. The drug is mainly used in women undergoing controlled ovarian stimulation (COS) protocols as part of assisted reproductive technology (ART) to prevent premature luteinizing hormone (LH) surges.

In recent years, the childbearing age of eligible women in China has been gradually postponed, the prevalence of reproductive-related diseases has been increasing year by year, and the number of women receiving assisted reproductive treatment has been growing annually. Ganirelix acetate is a synthetically produced peptide drug, belonging to the gonadotropin-releasing hormone (GnRH) antagonist class. It competitively blocks the GnRH receptors and their transduction pathways on pituitary gonadotropin cells, thereby inhibiting the secretion of gonadotropins.

The BaoYunTai approved this time by Qilu Pharmaceutical is packaged in a pre-filled syringe, offering more accurate dosing, simpler operation steps, lower risk of liquid contamination, and a smaller overall package size for easier transportation and storage. Additionally, BaoYunTai has dual filings in China and the US, and its marketing application was accepted by the U.S. Food and Drug Administration (FDA) in 2023.

Public information shows that the original research drug of Ganirelix Acetate is Merck's Orgalutran, which was launched in China in June 2013. The Ganirelix Acetate Injection produced by Zhengda Tianqing was the first generic version to be launched in 2018.

In 2022, the sales of Ganirelix Acetate Injection in public medical institutions exceeded 170 million yuan, and its sales have maintained a growth trend since it was launched in China a few years ago. To date, apart from Qilu Pharmaceutical, only four companies have been approved in China, including Merck (imported), Chia Tai Tianqing, Suzhou Erye Pharmaceutical, and Nanjing Jianyou Biochemical Pharmaceutical.

Proofread by Zhai Yongjun