Penciclovir

In the clinical treatment system for herpes virus infections, penciclovir is an important member of the nucleoside anti-herpes virus drugs. Its mechanism of action is that it is phosphorylated in virus-infected cells to generate active penciclovir triphosphate, which competitively inhibits herpes virus DNA polymerase and blocks the viral DNA replication process. Compared with similar drugs, it has higher selectivity for viruses and lower cytotoxicity. Clinically, it is mainly used for the treatment of herpes simplex virus type 1, type 2 and varicella-zoster virus infections, and can effectively relieve the skin lesions and pain symptoms of patients with orolabial herpes, genital herpes and herpes zoster. The applicable population covers immunocompetent patients and infected patients with mild immunodeficiency.

At present, the global penciclovir market size is stable at around USD 1.8 billion, with a compound annual growth rate of approximately 3.2%. The growth mainly comes from the expansion of demand from the middle-aged and elderly groups with high incidence of herpes zoster and the increase in the penetration rate of orolabial herpes medication in developing countries. In terms of the domestic market, the annual sales of penciclovir preparations at public medical institution terminals are approximately RMB 470 million. The competitive landscape is dominated by generic drugs, with local enterprises accounting for more than 85% of the market share. External preparations have been included in the local centralized procurement of multiple provinces, and the price reduction of selected products is approximately 62%, which further drives the release of medication demand at the primary level.

The original research enterprise of penciclovir is GlaxoSmithKline, and the original trade name is "Vectavir". The core compound patents of the original product expired in 2005 and 2007 in Europe and the United States respectively, and the compound patent in China expired in 2004. The main dosage form of the original product is 1% external cream, which has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. Up to now, there are more than 15 registration entries of penciclovir API on China's CDE API Registration Platform, of which more than 10 are in status A. The domestically approved penciclovir preparations on the market include multiple dosage forms such as cream, injection and eye drops. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of penciclovir impurity reference standards. Relevant products all meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most of the products are in regular stock. Spot orders placed before 16:00 can be shipped on the same day, which can fully meet the reference substance use requirements in the process of API R&D, quality research and production.