Ganirelix

For gonadotropin-releasing hormone (GnRH) antagonist drugs commonly used clinically in the field of assisted reproduction, ganirelix has become one of the core drugs for controlled ovarian stimulation protocols due to its clinical advantages of reversible action and controllable adverse reactions. As a synthetic decapeptide compound, it can rapidly inhibit the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) by competitively binding to GnRH receptors on the pituitary cell membrane, effectively preventing premature ovulation during in vitro fertilization and helping infertile women of childbearing age adjust their ovulation cycles. It can also be used for the treatment of hormone-dependent diseases such as endometriosis and precocious puberty, and the applicable population covers women receiving assisted reproductive technology and some patients with endocrine diseases requiring hormone regulation.

The global market size of ganirelix-related preparations was approximately USD 1.27 billion in 2023, with a stable compound annual growth rate of 7.2% from 2019 to 2023. Driven by the rising demand for assisted reproduction and the expansion of medical insurance coverage in the domestic market, the terminal sales of public medical institutions exceeded RMB 1.8 billion in 2023, with a compound growth rate of more than 14% in the past three years. In terms of the competitive landscape, the original research product still accounts for about 42% of the market share, and generic preparations from 3 domestic enterprises have passed the consistency evaluation. As it was included in the procurement catalog of the seventh batch of national centralized drug procurement, the substitution rate of generic drugs is continuing to rise.

The original research enterprise of ganirelix is Merck Sharp & Dohme, and the original brand name is Orgalutran. The core compound patent expired in 2020 in the United States and Europe, and the core compound patent in China expired in 2021. The originally marketed dosage form is injection, with a conventional specification of 0.25mg/0.5ml, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA reference preparation catalogue. In terms of domestic API registration, 5 enterprises have completed the registration of ganirelix API in CDE with the status of A (can be used in marketed preparations), and the registration of another 2 enterprises is under review; a total of 6 ganirelix injection products, including the original research one, have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for ganirelix API, covering a total of 16 process impurities and degradation impurities. Most of the products are in stock, and in-stock products ordered before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can meet the reference standard needs of enterprises in the whole process from API R&D, quality research to marketing application.