Raloxifene

For the high risks of osteoporosis and breast cancer among postmenopausal women, selective estrogen receptor modulators (SERMs) are core drug categories with dual prevention and treatment values, and raloxifene is a representative variety of this class of drugs. Its mechanism of action is different from that of traditional estrogen replacement therapy. It can exert estrogen-like effects in bone tissues and the cardiovascular system, promote the increase of bone mineral density and reduce the risk of fractures. Meanwhile, it exhibits estrogen antagonistic effects in breast and uterine tissues, and will not increase the risk of mammary gland and endometrial hyperplasia. It is mainly used for the prevention and treatment of osteoporosis in postmenopausal women, and can also be used for the prevention of invasive breast cancer in high-risk postmenopausal women.

The global market size of raloxifene has long been stable at around USD 320 million, and the growth rate of the Chinese market has remained at 7.2% in recent years. The core driving factors are the continuous rise in the prevalence of postmenopausal osteoporosis, and the continuous release of patients' dual demands for bone health and tumor prevention. In terms of the competitive landscape, the original research product still accounts for about 26% of the market share, and domestic generic drugs have been launched in batches after passing the consistency evaluation. In the 2022 provincial-level centralized procurement, the average price of raloxifene was reduced by 48%, which further improved clinical accessibility, and the demand of downstream preparation enterprises for cost-effective and compliant API has continued to expand.

The original research enterprise of raloxifene is Eli Lilly and Company, and the original brand name is Evista. Its US compound patent expired in 2013, and its core Chinese patent expired in 2014. The main dosage form of the original research product is tablet, with a specification of 60mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparation Catalogue. At present, there are more than 10 raloxifene API registration numbers on the API registration platform of China's Center for Drug Evaluation (CDE), many of which are in status A (already used in marketed preparations), and multiple domestic manufacturers have obtained approval for the marketing of 60mg raloxifene tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of raloxifene impurity reference standards, covering the whole chain of synthetic starting materials, intermediates and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and can meet the quality research needs of the whole process of API R&D, registration and production.