Finasteride

As a core drug for the treatment of androgenetic alopecia and benign prostatic hyperplasia (BPH), finasteride is a specific 5α-reductase inhibitor. It competitively inhibits the activity of type Ⅱ 5α-reductase in vivo and blocks the conversion of testosterone to dihydrotestosterone (DHT), a potent androgen, thereby reducing the DHT concentration in serum and target tissues. For patients with BPH, this drug can reduce the prostate volume and relieve lower urinary tract obstruction symptoms, and is suitable for long-term maintenance treatment of moderate to severe BPH. For the male population with androgenetic alopecia, low-dose finasteride can inhibit the atrophy effect of DHT on hair follicles, delay the progression of alopecia and promote hair growth, and is currently a clinically recognized first-line oral drug for male androgenetic alopecia.

The global finasteride market size has maintained steady growth for a long time. In 2023, the overall market size was approximately USD 1.48 billion, of which generic drugs accounted for more than 85%. In the Chinese market, the total sales of public medical institutions and retail terminals in 2023 were approximately RMB 1.87 billion. With the younger age of alopecia population and the rising prevalence of prostate diseases, the compound annual growth rate in the next 3 years is expected to remain at around 5.2%. In terms of competitive landscape, there are more than 60 domestic preparation approvals, and the supply of API is mainly dominated by local enterprises. After the implementation of centralized procurement, the price of winning preparations has dropped by more than 90% compared with the original research drugs, and the cost control and quality compliance of upstream API have become the core competitive elements for downstream preparation enterprises.

The original research enterprise of finasteride is Merck Sharp & Dohme. The high-dose product for the treatment of prostatic hyperplasia is under the trade name "Proscar" with a specification of 5mg; the low-dose product for the treatment of male alopecia is under the trade name "Propecia" with a specification of 1mg. Its core compound patent expired in 2004, and all core preparation patents in the Chinese market also expired in 2014. Both original research products have been included in the China Listed Drugs Catalogue, and are officially recognized reference listed drugs. As of October 2024, the CDE API Registration Platform has publicly announced more than 30 valid registration numbers for finasteride, of which more than 20 are in A status, and multiple domestic manufacturers have obtained marketing approval for finasteride preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of finasteride impurity reference standards. Most products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable compliance support for API and preparation enterprises in links such as quality research, stability study, and registration declaration.