阿泰特韦

During the COVID-19 pandemic, 3CL protease inhibitors have become one of the core directions of antiviral drug R&D due to their characteristics of conserved target and low drug resistance risk. Enseltrelvir is exactly a domestically developed innovative oral small-molecule anti-COVID-19 drug in this category. It specifically binds to the active site of the 3CL protease of SARS-CoV-2 and blocks the cleavage process of viral polyproteins, thereby inhibiting viral replication in host cells. At present, this drug is mainly used for the treatment of adult patients with mild to moderate novel coronavirus infection who have high risk factors for progression to severe disease. It can significantly reduce the incidence of severe disease and the risk of inpatient death, and is one of the recommended drug options in the domestic COVID-19 diagnosis and treatment protocols.

At present, the domestic small-molecule anti-COVID-19 drug market is still in a dynamic adjustment stage. As the first 3CL protease inhibitor with independent intellectual property rights, Enseltrelvir has the medication advantage of no need to be used in combination with ritonavir, which gives it differentiated competitiveness among patients with abnormal liver and kidney functions and people who need to take multiple drugs due to comorbid underlying diseases. There is no publicly verifiable full-market size statistical data at present. Domestic market participants are mainly original research enterprises and a small number of pharmaceutical companies that have laid out generic drugs. As the demand for COVID-19 antiviral drugs in primary diagnosis and treatment is gradually released in the future, there is room for improvement in its market penetration rate.

The original research enterprise of Enseltrelvir is Guangdong Zhongsheng Ruisheng Biotech Co., Ltd., and the original brand name is Leruiling®. The expiration date of its core compound patent in China is September 2042. The main dosage form currently approved for marketing is tablet, with a specification of 0.125g per tablet. The original research preparation has been included in the *Catalogue of Chemical Drugs* of the National Medical Products Administration and listed as a reference listed drug. As of June 2025, no other Enseltrelvir API registration information other than the original research-associated declaration has been found on the CDE API registration platform, and only the preparation of the original research company has been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for Enseltrelvir. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide reliable reference material support for enterprises in links such as API quality research and preparation stability investigation.