Cetrorelix

In the clinical advancement of assisted reproductive technology, the controlled ovarian hyperstimulation process is often faced with the interference of premature luteinizing hormone surge, which may lead to oocyte retrieval failure and decreased pregnancy rate. The advent of cetrorelix provides a precise solution to this clinical pain point. As a gonadotropin-releasing hormone (GnRH) antagonist, it competitively binds to GnRH receptors on the surface of pituitary cells to rapidly and reversibly inhibit the secretion of endogenous gonadotropins, eliminating the initial stimulation period required by agonist drugs. It can significantly shorten the ovulation induction cycle and reduce the risk of ovarian hyperstimulation syndrome. It is mainly used for controlled ovarian stimulation in assisted reproductive technology, and can also be used for the treatment of sex hormone-dependent diseases such as endometriosis and uterine fibroids. The applicable population covers women of childbearing age receiving in vitro fertilization assisted pregnancy and patients with related gynecological diseases.

The global cetrorelix market size was approximately USD 420 million in 2023, and the compound annual growth rate from 2024 to 2030 is expected to maintain at around 6.8%. The growth momentum mainly comes from the rising global infertility rate, the increasing penetration rate of assisted reproduction, and the expanding demand for gynecological disease treatment. The Chinese market accounts for approximately 18% of the global share. In the current competitive landscape, the original research product still accounts for about 60% of the market share, and 3 domestic pharmaceutical companies have obtained the approval documents for generic drug preparations. As the centralized procurement policy extends to the field of assisted reproductive drugs, the substitution space for generic drugs is continuously releasing.

The original research enterprise of cetrorelix is Merck Serono, and the original research brand name is "Cetrotide". Its core compound patent expired in China in 2021. The main dosage form approved for the original research product is cetrorelix for injection, with a specification of 0.25 mg per vial. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also listed as a reference preparation by the FDA. As of May 2025, there are a total of 7 cetrorelix API registration information on the platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, among which 3 are in the status of "A" (approved for use in marketed preparations). Multiple domestic manufacturers have obtained approval for the marketing of generic cetrorelix for injection. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of cetrorelix impurity reference standards, which can meet the impurity research requirements of different process routes. All products comply with the relevant regulatory requirements of the Chinese Pharmacopoeia and the FDA. Most products are available from stock, and in-stock orders placed before 16:00 can be shipped on the same day, helping pharmaceutical companies efficiently complete API R&D, quality research and registration declaration work.