Raltitrexed

In the clinical treatment of advanced colorectal cancer, fluorouracil-based drugs have long been the cornerstone of first-line chemotherapy. However, due to their limitations of requiring continuous intravenous infusion and having many adverse reactions, the clinical community has been exploring better alternative solutions. Raltitrexed, as a specific thymidylate synthase inhibitor, belongs to the antimetabolite class of anti-tumor drugs. It can directly inhibit the activity of thymidylate synthase, block the production of thymine nucleotides required for DNA synthesis, and thereby inhibit the proliferation of tumor cells. At present, its indications cover patients with advanced colorectal cancer who are not suitable for 5-fluorouracil/calcium folinate combination chemotherapy, and it can also be used for the combination chemotherapy of malignant tumors such as gastric cancer, pancreatic cancer, and non-small cell lung cancer, providing a new treatment option for patients intolerant to fluorouracil-based drugs.

The global market size of raltitrexed has maintained steady growth in recent years. In 2023, the overall market size has exceeded 1.2 billion US dollars, with a compound annual growth rate maintained at around 8%. In terms of the domestic market, with the annual increase in the incidence of colorectal cancer and the inclusion of this drug in the National Medical Insurance Catalogue, the terminal sales in public medical institutions exceeded 1.8 billion yuan in 2023. In terms of the competitive landscape, the original research product accounts for about 35% of the market share, while domestic generic drugs have gradually seized the primary market with higher cost performance. At present, more than 7 domestic enterprises have obtained approvals for generic drugs, and the overall market competition is sufficient.

The original research enterprise of raltitrexed is AstraZeneca in the United Kingdom, and the original brand name is "Tomudex". Its core compound patent expired globally in 2010. The main dosage form approved for the original research product is powder for injection, with a specification of 2 mg per vial, which has been included in the FDA Reference Listed Drug Catalogue and the Chinese Catalogue of Reference Preparations for Chemical Drugs. In terms of domestic API registration, at present, 6 enterprises including Nanjing Chia Tai Tianqing and Qilu Pharmaceutical have obtained CDE registration numbers for raltitrexed API, all with the status of "A" (approved for use in marketed preparations); domestic raltitrexed for injection preparations have been approved for marketing, and multiple generic drugs 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 impurity reference standards for raltitrexed API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference standard support for API research and development, quality research and consistency evaluation work.