Elacestrant

Addressing the clinical challenge of endocrine therapy resistance in advanced breast cancer, elacestrant, as the world's first approved oral selective estrogen receptor degrader (SERD) preparation, breaks the administration limitation that traditional SERDs require intramuscular injection. Its mechanism of action is to bind to the estrogen receptor (ER) with high affinity, induce conformational changes of the receptor and promote its degradation, thereby blocking the conduction of estrogen signaling pathway. At present, this drug is mainly indicated for adult patients with ESR1-mutated ER-positive, HER2-negative advanced or metastatic breast cancer who have progressed after prior endocrine therapy, providing a new treatment option for this population with poor prognosis.

The global market size related to elacestrant has exceeded 700 million US dollars in 2024, and the compound annual growth rate is expected to remain at around 22% by 2029. The growth drivers mainly come from the increased penetration rate of ESR1-mutated breast cancer screening and the upgraded recommendation of oral SERDs in clinical guidelines. In terms of competitive landscape, the original research product still occupies the main market share at present. More than 10 pharmaceutical companies around the world have launched generic drug research and development, and more than 8 domestic enterprises have submitted clinical applications for elacestrant API and preparations. As the core patents are approaching expiration, the market is expected to gradually enter the generic substitution stage in the next 2-3 years.

The original research enterprise of elacestrant is AstraZeneca, with the brand name Orserdu. Its core compound patent in the United States will expire in 2029, and the expiration date of its compound patent in China is 2030. The main approved dosage form at present is tablet, with three specifications including 50mg, 100mg and 150mg, which has been included in the FDA Reference Listed Drug Catalog. China NMPA approved the import and marketing of the original research preparation in 2023. In terms of domestic API registration, there is no approved A-status registration number as of now, and the API registrations of 5 enterprises are under approval. (Data as of August 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of elacestrant impurity reference standards, which can meet the qualitative and quantitative research needs of impurities in different R&D stages. Most products are in stock. Spot orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable support for pharmaceutical enterprises in API R&D, quality research and declaration work.