Letermovir

In response to the clinical pain points that the incidence of cytomegalovirus (CMV) infection in patients undergoing allogeneic hematopoietic stem cell transplantation is as high as 30%-70%, and traditional anti-CMV drugs have obvious adverse reactions such as myelosuppression and nephrotoxicity, the advent of letermovir has filled the gap in targeted anti-CMV therapy. As the world's first new non-nucleoside CMV inhibitor, it specifically targets the terminase complex of CMV to block the cleavage and packaging of viral DNA without interfering with host cell DNA polymerase, thus significantly improving safety. It is mainly used to prevent CMV infection and related diseases in recipients of allogeneic hematopoietic stem cell transplantation, and can also be used for the prevention and control of CMV infection in immunocompromised populations, and is a first-line recommended drug in the current field of CMV prophylaxis.

The global market size of letermovir exceeded US$1.6 billion in 2022, with a year-on-year growth of approximately 18% in 2023, and is expected to exceed US$3 billion in 2028. The domestic market is still in a period of rapid growth. In 2023, the sales volume in sample hospitals exceeded RMB 300 million, with a year-on-year growth rate of over 120%. At present, the original research product still occupies a dominant position. A number of domestic pharmaceutical companies have arranged for the research and development of generic drugs. Since 2023, 3 generic letermovir products have been approved for marketing. In the future, with the increase of the penetration rate of generic drugs and the expansion of indications, the market growth space will be further released.

The original research enterprise of letermovir is Merck Sharp & Dohme (MSD), with the trade name Prevymis. The core compound patent of letermovir expires in 2027 in the United States, and in 2026 in China. The main dosage forms approved for the original research product are tablets and injections. The specifications of the tablets are 240 mg and 480 mg, and the specification of the injection is 480 mg/12 ml. The original research product has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA, and is also a reference preparation recognized by the FDA. At present, 7 domestic letermovir active pharmaceutical ingredients (APIs) have obtained CDE registration numbers, among which 3 are in A status. In addition to the original research preparations, 3 domestic letermovir preparations have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of letermovir impurity reference standards, covering all categories such as process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. The structures of impurities have been confirmed by multiple technologies such as NMR, MS and HPLC, which can fully meet the experimental needs of various stages such as API R&D, quality research and registration declaration.