Gemcitabine

As one of the core varieties of nucleoside antitumor drugs, gemcitabine inhibits the activity of ribonucleotide reductase, blocks the supply of nucleotide raw materials required for DNA synthesis, and can be incorporated into DNA strands to trigger replication termination, ultimately inducing apoptosis of tumor cells. In clinical practice, it is mainly used for the first-line treatment of locally advanced or metastatic non-small cell lung cancer and pancreatic cancer. It can also be used in combination therapy for bladder cancer, breast cancer and ovarian cancer, covering the core treatment needs of adult patients with solid tumors, and is a basic chemotherapy drug recommended by multiple guidelines.

In 2023, the global gemcitabine market size was approximately USD 1.28 billion, with China's market share exceeding 32%, and the compound annual growth rate in the past three years has remained at 4.7%. At present, the domestic preparation market has formed a competitive pattern of coexistence of originator drugs and generics. More than 20 enterprises have had their generic drugs pass the consistency evaluation, and this variety has been included in multiple rounds of national centralized procurement. The highest drop in the winning bid price compared with the originator drug exceeds 90%, and the clinical accessibility has been greatly improved. Meanwhile, about 60% of the global production capacity of its API is concentrated in China, making it one of the advantageous varieties for the export of domestic characteristic APIs.

The originator enterprise of gemcitabine is Eli Lilly and Company, and the originator brand name is Gemzar®. Its core compound patents expired in 2010 and 2011 in the United States and Europe respectively, and the compound patent in China expired in 2010. The main dosage forms approved for the originator drug include injections, with specifications of 0.2g and 1.0g, which have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA Reference Preparation Catalogue. Up to now, there are more than 30 gemcitabine API registration numbers on the API Registration Platform of China CDE, among which more than 20 are in status A and can be supplied for domestic preparation production; more than 20 domestic enterprises have obtained approval for the marketing of gemcitabine injections. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of gemcitabine impurity reference standards. Most products are available from stock, and stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs in the stages of API R&D, quality research and registration declaration.