Darolutamide tablets (darolutamide) listing status and price

Darolutamide tablets (Darolutamide), trade name: "Nobego", is a new type of androgen receptor inhibitor, mainly used to treat prostate cancer. The drug was jointly developed by Germany's Bayer and Finland's Orion and was first approved for marketing in the United States in 2019. In February 2021, the State Food and Drug Administration approved darotamide to be marketed in China for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of metastasis, providing more options for domestic prostate cancer treatment.

After being launched in China, darotamide was included in the national medical insurance directory at the end of 2021, which greatly reduced patients' medication burden. The initial market price of the drug was relatively high, with a box of 300mg*120 tablets costing around nearly 10,000 yuan. However, after being included in medical insurance, the price dropped significantly. According to public data, the current price after medical insurance is about 7000 to 8000 yuan per box. According to the medical insurance reimbursement ratio in different regions, the actual out-of-pocket cost of patients ranges from 1500 yuan to 2500 yuan, which has a certain degree of economic accessibility.

The therapeutic effect of darotamide has been confirmed by multiple clinical trials. In addition to the approved indications for nmCRPC, at the beginning of 2025, Bayer has applied for indications in China for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), which is expected to further expand its clinical use. Data show that combined treatment with ADTmHSPC can extend progression-free survival and improve quality of life.

In general, darotamide, as a targeted drug with clear clinical effects and included in medical insurance, provides a new treatment option for prostate cancer patients. With the expansion of indications and further adjustment of prices, its scope of use may continue to expand in the future, and more patients will benefit from it.

Reference materials:https://www.fda.gov/drugs/