Ganciclovir

For immunocompromised populations, cytomegalovirus infection is a common complication with a high risk of death. Ganciclovir is the first approved nucleoside antiviral drug for the treatment of this disease. It exerts a highly effective antiviral effect through a dual mechanism of action: competitively inhibiting viral DNA polymerase and inserting into the viral DNA strand to block its extension. Clinically, it is mainly used for the prevention and treatment of cytomegalovirus retinitis, pneumonia and gastrointestinal infections in immunodeficient patients (including AIDS patients, tumor patients receiving chemotherapy, and organ transplant recipients), and can also be used for the intervention of congenital cytomegalovirus infection in newborns. It is a basic drug in this therapeutic field.

The current global market size of ganciclovir is approximately USD 1.28 billion. Driven by factors such as the popularization of immunotherapy and the increase in the number of organ transplantation surgeries, the compound annual growth rate is maintained at around 4.2%. The domestic market size is approximately RMB 1.87 billion, of which oral dosage forms account for 36% and injectable dosage forms account for 64%. On the production side, a pattern of full competition between the original research drug and generic drugs has been formed. More than 30 domestic enterprises have obtained approval for generic drugs of this variety, and this variety has been included in multiple batches of national centralized drug procurement. The price reduction of selected preparations exceeds 80%, and the cost control and quality compliance requirements for corresponding API have become the core competitiveness of the upstream supply chain.

The original research enterprise of this drug is Roche, and the original trade name is Cymevene®. The expiration dates of its core compound patent in the United States and Europe are 2002 and 2003 respectively, and the Chinese compound patent expired in 2001. At present, the main dosage forms of the original research drug marketed globally include 0.25g oral capsules, 500mg powder for injection, and 0.15% ophthalmic gel. All relevant dosage forms have been included in the FDA Reference Listed Drug Catalog. Meanwhile, ganciclovir for injection and ganciclovir capsules have also been included in the *Catalog of Reference Preparations for Chemical Drugs* of China. According to the domestic API registration platform, more than 20 enterprises have obtained A-status registration numbers for ganciclovir API, and the number of domestically approved preparations corresponding to oral and injectable dosage forms has exceeded 20 specifications. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of ganciclovir impurity reference standards. Most products are available from stock. Orders for in-stock products 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 provide stable and reliable reference standard support for API and preparation enterprises in links such as quality research, consistency evaluation, and registration declaration.