Darolutamide

Prostate cancer is a malignant tumor of the genitourinary system with a high incidence in men, among which patients with castration-resistant prostate cancer (CRPC) have a high risk of disease progression and limited clinical treatment options. Darolutamide is a new generation of non-steroidal androgen receptor inhibitor. Compared with traditional AR inhibitors, its molecular structure is optimized, with higher affinity for androgen receptors. Meanwhile, it can effectively inhibit receptor nuclear translocation and downstream gene transcription, and has an extremely low blood-brain barrier penetration rate, resulting in fewer central adverse reactions. At present, this drug is mainly used to treat adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis, as well as in combination with docetaxel to treat adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). It can significantly prolong the metastasis-free survival and overall survival of patients, and improve their quality of life.

The global darolutamide market size maintains a steady growth trend. The global sales in 2023 were approximately USD 1.78 billion, and the compound annual growth rate from 2024 to 2030 is expected to remain around 15%. For the Chinese market, with the increase in the diagnosis and treatment penetration rate of nmCRPC and the expansion of medical insurance coverage, the domestic darolutamide market size in 2023 was approximately RMB 1.2 billion. In terms of the competitive landscape, the domestic market is still dominated by the original research product at present. A number of local pharmaceutical companies have deployed generic drug R&D, but no generic drug has been approved for marketing yet. In the future, with the expiration of patents, the entry of generic drugs will further improve the accessibility of the drug.

The original research enterprise of darolutamide is Bayer Pharmaceuticals, with the trade name Nubeqa®. Its core compound patent will expire in China in 2026, and the indication-related patents will expire in 2028. At present, the original research dosage form approved in China is tablet, with a specification of 300 mg, which has been included in the *Catalogue of Chemical Reference Preparations* issued by the National Medical Products Administration. Up to now, a number of domestic enterprises have submitted DMF registration applications for darolutamide API, some of which are in the registration status of A and can support the associated declaration of preparations. The original research preparation has been approved for marketing in China, and no generic preparation has been approved yet. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for darolutamide API, covering process impurities, degradation impurities and other full categories. Most products are in sufficient stock. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. In-stock orders placed before 16:00 can be shipped on the same day, which can efficiently meet various needs of pharmaceutical enterprises in the stages of R&D, quality research and declaration.