Gemcitabine

As one of the core chemotherapeutic drugs for the treatment of advanced solid tumors, gemcitabine is a pyrimidine antimetabolite antitumor drug, which blocks nucleotide synthesis by embedding into DNA strands and induces apoptosis of tumor cells. The single-drug or combination regimens of this drug widely cover multiple cancer types such as non-small cell lung cancer, pancreatic cancer, bladder cancer, breast cancer and ovarian cancer. Especially for pancreatic cancer, a tumor type with high malignancy and limited optional treatment regimens, gemcitabine is still a first-line basic drug up to now, providing a large number of patients with intermediate and advanced solid tumors the possibility of prolonging survival and improving quality of life.

At present, the global market size of gemcitabine API has exceeded 320 million US dollars, and the compound annual growth rate is maintained at around 4.7%. Affected by the long-expired original research patents, the global market has formed a pattern dominated by generic drugs. China is the world's largest supplier of gemcitabine API, with a production capacity accounting for nearly 65%. In terms of the domestic market, this drug has been included in multiple rounds of national centralized procurement, and the winning bid price has dropped by more than 90% compared with the original research drug. The demand of downstream preparation manufacturers for APIs with high cost-effectiveness and stable compliance continues to rise, and suppliers with complete registration qualifications have more prominent competitive advantages.

CATO can provide a full set of impurity reference standards for gemcitabine API. All products of the full series meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. The stock reserve of core impurities is sufficient, which can quickly respond to the reference standard supply needs of pharmaceutical enterprises in the whole process of R&D, registration and production, helping customers reduce R&D costs and shorten the compliance declaration cycle.