Calcium folinate

For tumor patients receiving high-dose methotrexate chemotherapy, calcium folinate is the core supportive medication for reducing drug toxicity and avoiding severe adverse reactions, and it belongs to the folate analog class of anti-tumor adjuvant drugs. Its mechanism of action is as a formylated derivative of tetrahydrofolate, which can directly provide the activated form of folate in the body. It can competitively relieve the inhibitory effect of methotrexate on dihydrofolate reductase, reducing toxic and adverse reactions such as mucosal injury and myelosuppression. It can also be used in combination with 5-fluorouracil to enhance the anti-tumor activity of 5-fluorouracil by stabilizing the complex of fluorouracil deoxynucleotide and thymidylate synthase. In clinical practice, in addition to being used for methotrexate rescue and combined chemotherapy for gastrointestinal tumors such as colorectal cancer, it can also be used for the treatment of megaloblastic anemia caused by folate deficiency, and the applicable population covers tumor chemotherapy patients and patients with anemia related to abnormal folate metabolism.

The current global calcium folinate market size has exceeded 300 million US dollars, with a compound annual growth rate maintained at around 4.2%, among which the Chinese market accounts for approximately 28%, making it the fastest-growing regional market. The competitive landscape is dominated by generic drugs, with local enterprises accounting for more than 90% of the domestic API supply share, and leading enterprises accounting for 62% of the production capacity. The preparation segment has been included in the national centralized procurement, with the average price reduction of selected products exceeding 70%, and clinical accessibility has been significantly improved. With the increase in the incidence of solid tumors such as colorectal cancer and the popularization of chemotherapy regimens, the clinical dosage of calcium folinate will continue to maintain a steady growth trend.

The original developer of calcium folinate is Pfizer, with the original brand name Leucovorin Calcium. Its compound patent in the US market expired in 2001, and the core patent in China has also expired. The main dosage forms approved for the original drug include injections (specifications of 50mg, 100mg, 350mg) and tablets (specification of 15mg), among which the injection has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Listed Drugs for Chemical Drugs*. In terms of domestic API registration, currently 17 enterprises' calcium folinate APIs have passed the review of CDE and obtained A-status registration numbers, more than 50 domestic manufacturers have obtained approval for generic preparations, and the original preparation has also been approved for marketing in China. (Data as of December 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of calcium folinate impurity reference standards. Most products are available in stock, and in-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API research and development, quality research and compliance declaration.