Paclitaxel

As a classic anti-tumor drug derived from plants, paclitaxel belongs to the taxane class of microtubule inhibitors. It promotes tubulin polymerization and inhibits depolymerization, arresting the cell cycle in the G2/M phase, thereby blocking mitosis and proliferation of tumor cells. It is widely used clinically as first-line and second-line treatment for a variety of solid tumors such as ovarian cancer, breast cancer, and non-small cell lung cancer, and can also be used for the treatment of Kaposi's sarcoma. It covers patients throughout the disease course from early postoperative adjuvant therapy to advanced palliative care, and is one of the core medications in clinical tumor chemotherapy regimens.

The global paclitaxel market size has long remained above 3 billion US dollars. As a major consumer market, China's terminal sales in public medical institutions exceeded 7 billion RMB in 2023, with a compound annual growth rate maintained at around 5%. At present, the preparation sector has formed a competitive pattern consisting of original research drugs, generics, and innovative formulations such as liposomal/albumin-bound formulations. Conventional injections have been included in the national centralized procurement, with prices dropping by more than 80%. The demand for upstream API continues to rise along with the volume expansion of generics and innovative formulations. Relying on the cost advantage of semi-synthesis processes, domestic enterprises have become the main suppliers of paclitaxel API in the world.

The original research enterprise of paclitaxel is Bristol-Myers Squibb, with the original brand name Taxol®. The core compound patent expired in the United States in 2000, and related patents in China also expired around 2002. The main dosage form of the original research product is injection, with specifications including 30mg/5ml and 100mg/16.7ml, which have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA reference preparation catalogue. At present, more than 20 domestic enterprises have obtained CDE registration numbers (status A) for paclitaxel API. A variety of preparations such as common injections, albumin-bound formulations, and liposomal formulations have been approved for marketing, and multiple manufacturers have passed the consistency evaluation. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of paclitaxel impurity reference standards. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API production, preparation R&D, and quality research processes.