Pristinamycin

Multidrug-resistant bacterial infection has always been a core difficulty in clinical anti-infective treatment, especially for diseases such as hospital-acquired pneumonia and skin and soft tissue infections caused by Gram-positive bacteria. The drug resistance rate of existing treatment regimens is increasing year by year, and there is an urgent clinical need for new antibacterial drugs. Pristinamycin is a streptogramin antibiotic, which is composed of pristinamycin IA and pristinamycin IIA in a fixed ratio. The two components act synergistically, binding to different sites of the 50S subunit of the bacterial ribosome respectively, and dually block the synthesis of bacterial proteins. It has strong antibacterial activity against multidrug-resistant Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE), and is mainly used for the treatment of infections of the respiratory tract, skin and soft tissue and other parts caused by sensitive bacteria. It is an important option for the second-line treatment of multidrug-resistant bacterial infections.

At present, the global market size related to pristinamycin maintains a steady growth. The overall market size in 2023 is approximately USD 1.28 billion, with a compound annual growth rate of approximately 6.2% from 2019 to 2023. The main driving factors for the growth are the increase in the incidence of multidrug-resistant bacterial infections and the expansion of clinical demand for anti-infective treatment. In terms of the competitive landscape, the original research enterprises still occupy the main market share, and the generic drug market has a high concentration. Europe and India are the main suppliers of pristinamycin API in the world. At present, only a few domestic enterprises have the large-scale production capacity of this API, and the market supply is relatively concentrated.

The original research enterprise of pristinamycin is Sanofi, France, and the original research brand name is "Staphylex". The core compound patents expired in 2002 in Europe and 2004 in the United States respectively. The main dosage form approved for the original research product is oral tablet, with a specification of 250 mg per tablet, which has been included in the FDA Reference Listed Drug Catalog. As of June 2024, China NMPA has not yet approved the import of the original research pristinamycin preparation. In China, the pristinamycin APIs of 3 enterprises have completed registration at CDE and obtained Class A status, and the pristinamycin oral preparations declared by another 5 enterprises are in the clinical trial stage and have not yet 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 impurity reference standards for pristinamycin API. Most of the products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different stages such as API R&D, quality research, and registration declaration.