Sofosbuvir

Chronic hepatitis C was once a heavy burden in the global public health field. The traditional treatment regimen of interferon combined with ribavirin has obvious limitations such as low response rate and many adverse reactions. The advent of sofosbuvir has completely rewritten the treatment path of this disease. As the first NS5B polymerase nucleoside analog inhibitor, it can directly act on the core target of hepatitis C virus replication, achieve potent antiviral effect by terminating the synthesis of viral RNA chains, and is suitable for almost all genotypes of hepatitis C patients. In clinical practice, it is often combined with other antiviral drugs to form an all-oral interferon-free regimen, which can increase the sustained virological response rate to more than 90%. The applicable population covers hepatitis C patients without cirrhosis, with compensated cirrhosis and some with decompensated cirrhosis, greatly reducing the risk of hepatitis C progressing to liver failure and liver cancer.

The global market size related to sofosbuvir once exceeded USD 12 billion at its peak. With the popularization of pan-genotypic regimens and the launch of generic drugs, the overall market structure has gradually tilted towards cost-effective generic drugs. The base of hepatitis C patients in China is approximately 10 million. Since sofosbuvir-related preparations were included in the National Medical Insurance Catalogue in 2019, the annual treatment cost has dropped from tens of thousands of yuan to less than 10,000 yuan, and the market penetration rate has increased rapidly. At present, domestic generic drug enterprises have occupied the majority of the market share, and the API supply side presents a pattern of joint supply by the original research manufacturer and domestic compliant manufacturers. The annual growth rate of API demand corresponding to generic drugs remains above 15%.

The original research enterprise of sofosbuvir is Gilead Sciences, and the original research trade name is "Sovaldi". Its core compound patent will expire in the United States in 2028, and the Chinese compound patent was declared partially invalid in 2019 due to patent challenge. The main dosage form approved by the original research is tablet with a specification of 400mg, which has been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA reference preparation catalogue. As of the retrieval time point, there are more than 30 sofosbuvir API registration information on the China CDE API Registration Platform, most of which are in A status and can be used in association with the domestically approved sofosbuvir preparation products. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demand for qualitative and quantitative research on impurities in the process of generic drug research and development and quality control of sofosbuvir, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All impurities meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support drug declaration and routine quality inspection work.