Leuprorelin

In the clinical treatment of hormone-dependent diseases such as prostate cancer and endometriosis, gonadotropin-releasing hormone (GnRH) agonists are the core drugs for long-term management, and leuprorelin is a representative variety of this class of drugs. It continuously down-regulates pituitary GnRH receptors and inhibits gonadal hormone secretion, leading to the atrophy of hormone-dependent tumors or lesions. It is applicable to patients with prostate cancer, central precocious puberty, endometriosis, uterine fibroids, etc. It can also be used for down-regulation therapy in assisted reproductive technology, which can effectively reduce the demand for surgical intervention and greatly improve the quality of life of patients.

The global market size of leuprorelin has been stable at more than US$ 3 billion in recent years, and the market size in China exceeded RMB 4.5 billion in 2023, with a compound annual growth rate maintained at around 8%. As this drug belongs to polypeptide API with high barriers to synthesis process, the current market competition pattern is relatively concentrated. The original manufacturer dominates the high-end market, and only a few domestic enterprises with accumulation of polypeptide synthesis technology have the marketing qualification for generic drugs. As the relevant indications are included in the medical insurance reimbursement scope, the clinical demand continues to be released, and the space for domestic substitution of APIs and preparations is gradually expanding.

The original research enterprise of leuprorelin is Takeda Pharmaceutical Company Limited of Japan, and the original brand name is "Enantone". Its core compound patent has expired. The core patent in the US market expired in 2015, and the original compound patent in China expired in 2009. The main dosage forms of the original marketed products include sustained-release microspheres for injection, covering two specifications of 3.75mg (1-month dosage form) and 11.25mg (3-month dosage form), which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA reference preparation catalogue. Up to now, the leuprorelin APIs of multiple enterprises in China have obtained A status through CDE registration, and domestic generic drug preparations have also been approved for marketing by multiple manufacturers. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for leuprorelin API. Most products are in stock, and in-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable material basis support for enterprises' process research and development, quality research and registration declaration.