Remdesivir

In response to the clinical treatment needs of SARS-CoV-2 infection, nucleoside antiviral drugs have always been one of the core directions of research and development. As a broad-spectrum RNA polymerase inhibitor, remdesivir can inhibit the replication of a variety of RNA viruses including SARS-CoV-2 and Ebola virus by inserting into the viral RNA synthesis chain and terminating its extension process. At present, the drug has been approved for the treatment of SARS-CoV-2 infection in many countries and regions around the world, and the applicable population covers adults and adolescent patients aged 12 years and above with a body weight of ≥40 kg. Especially for mild to moderate infected patients with high risk factors for severe disease, it can significantly reduce the risk of hospitalization and death.

As a once core drug for COVID-19 treatment, the global market size of remdesivir reached a peak of USD 5.6 billion in 2021. As the prevention and control of SARS-CoV-2 infection has entered a normalized stage, the market demand has gradually declined, and the global market size in 2023 was approximately USD 870 million. In terms of the competitive landscape, the original research product still occupies most of the market share in Europe and the United States, and generic drug enterprises in China, India and other countries have gradually entered the market. At present, more than 20 domestic enterprises have submitted marketing applications for generic remdesivir, and the price reduction related to centralized procurement has also greatly improved the accessibility of the drug.

The original research enterprise of remdesivir is Gilead Sciences, and the original trade name is Veklury. Its core compound patent will expire in China in July 2031, and the formulation patent will expire in 2036. The main dosage form of the original research product is injection with a specification of 100 mg per vial, which has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs (Third Batch)* of China. Up to now, the remdesivir active pharmaceutical ingredients (APIs) of more than 30 domestic enterprises have completed registration with the Center for Drug Evaluation (CDE), and the generic formulations of many enterprises have passed the consistency evaluation and been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information.)

As a core service provider in the field of global impurity reference standard supply, CATO can provide a full set of remdesivir impurity reference standards to support enterprises in completing the whole process of API research, consistency evaluation and other work. Most products are available from stock, and stock orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of pharmaceutical regulatory authorities of various countries such as the Chinese Pharmacopoeia and FDA, and can be provided with complete technical materials such as structure confirmation and purity testing.