Fulvestrant

Breast cancer is the malignant tumor with the highest incidence rate among women globally, of which approximately 70% are hormone receptor-positive (HR+) subtypes, and endocrine therapy is the core regimen for the long-term management of such patients. Fulvestrant, as a new class of selective estrogen receptor downregulator (SERD), has a different mechanism of action from traditional endocrine drugs. It can competitively bind to estrogen receptors, block receptor-mediated signaling pathways while promoting receptor degradation, and effectively inhibit tumor cell proliferation. Currently, it is mainly used for postmenopausal patients with HR+/HER2- advanced breast cancer who have progressed after prior endocrine therapy, and can also be used in combination with targeted drugs for first-line treatment, which can significantly prolong the progression-free survival of patients, and is an important option for endocrine therapy of advanced breast cancer.

At present, the global market size of fulvestrant is stable at around USD 1.5 billion, and the annual growth rate of the Chinese market remains at 12%-15%. In 2023, the sales of domestic sample hospitals exceeded RMB 1.2 billion. In terms of competitive landscape, the original research product has long occupied the major market share. With the expiration of patents, generic drugs from a number of domestic pharmaceutical companies have been approved for marketing and included in the national centralized procurement. The winning price has dropped by more than 80% compared with the original research, and the accessibility for patients has been greatly improved. The market share of generic drugs is increasing year by year, and the penetration of the primary market will become the main growth driver in the future.

The original research enterprise of fulvestrant is AstraZeneca, with the brand name Faslodex. The expiration date of its core compound patent in the United States is 2021, and the compound patent in China expired in 2020. The main dosage form approved for the original research is injection, with the specification of 5ml:0.25g, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. Up to now, nearly 20 Chinese enterprises have completed the registration of fulvestrant API with the CDE and obtained the A status, and fulvestrant for injection from the original research manufacturer and a number of generic manufacturers has been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for fulvestrant API, and most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance needs of pharmaceutical enterprises in the process of R&D, quality research and production.