Docetaxel

Taxane drugs are the cornerstone category for the treatment of advanced solid tumors. Docetaxel, as a semi-synthetic taxane anti-tumor drug, arrests the cell cycle in the G2/M phase by promoting tubulin polymerization and inhibiting microtubule depolymerization, and ultimately induces apoptosis of tumor cells. Compared with paclitaxel, it has higher anti-tumor activity and better water solubility. At present, it has become the first-line or second-line treatment regimen for a variety of malignant tumors such as breast cancer, non-small cell lung cancer, prostate cancer and gastric cancer, covering the whole disease course population from early neoadjuvant therapy to advanced palliative therapy, and is the core component in clinical anti-tumor combination therapy regimens.

The global market size of docetaxel has long remained above USD 1.5 billion, and the annual sales in the Chinese market are approximately RMB 3 billion. Despite having been on the market for many years, driven by factors such as the rising prevalence of tumors and the expansion of combination therapy regimens, it has still maintained a steady growth of 2%~3% in recent years. In terms of the competitive landscape, the market share of the original research product is less than 10%, and domestic generic preparations occupy a dominant position. Domestic API manufacturers are concentrated in Jiangsu, Zhejiang, Shandong and other regions. More than 20 enterprises have had their docetaxel preparations pass the consistency evaluation of generic drugs, and the winning bid price in multiple national centralized drug procurements has decreased by more than 90% at the highest compared with the original research product, which has greatly improved clinical accessibility.

The original research enterprise of docetaxel is Sanofi, and the original research trade name is Taxotere. Its core compound patents expired in Europe and the United States in 2010 and 2011 respectively, and the Chinese compound patent also expired in 2009. The specifications of the original reference preparation include 20mg/0.5ml and 80mg/2ml injections, which have been included in the China Listed Drug Catalogue and are also reference preparations listed by the FDA. Up to now, there are more than 30 docetaxel API registration records on the API registration platform of China CDE, among which more than 20 registration numbers are in status A (can be used in marketed preparations). Many domestic enterprises have been approved to produce docetaxel injection, docetaxel for injection and other preparations. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of docetaxel impurity reference standards, covering the full-chain research needs such as impurities from the synthesis process and degradation impurities. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day, which can meet the needs of different scenarios such as methodological verification, stability research and quality standard establishment. All products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and help pharmaceutical enterprises efficiently complete the R&D and declaration of APIs and preparations.