Tildipirosin

Against the continuously rising clinical treatment demand for drug-resistant bacterial infections, the R&D and application of novel antibacterial agents have always been the focus of attention in the field of infectious diseases. Tifropirocin belongs to the pleuromutilin class of antibacterial agents. It exerts a bactericidal effect by targeting and binding to the 50S subunit of bacterial ribosomes to inhibit bacterial protein synthesis, and has strong antibacterial activity against multi-drug resistant Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE). It is mainly used clinically to treat skin and soft tissue infections caused by susceptible bacteria, and can also be used in adult patients with complicated skin infections, providing a new option for local and systemic treatment of drug-resistant bacterial infections.

At present, the global market size of pleuromutilin antibacterial agents maintains steady growth. In 2023, the overall market size exceeded 1.8 billion US dollars, with a compound annual growth rate maintained at around 7%. As one of the representative varieties of this class of drugs, the market demand for tifropirocin continues to expand with the increase in the infection rate of drug-resistant bacteria. Currently, the tifropirocin preparations marketed globally are dominated by the originator product, with a small number of generic drug declaration enterprises and a relatively relaxed market competition pattern. The potential demand for this variety in the domestic skin antibacterial drug market is approximately 230 million yuan, presenting good market development space.

The originator enterprise of tifropirocin is Bristol-Myers Squibb (USA), with the original trade name Altabax. Its core compound patent in the US market expired in 2021. The main dosage form approved for the originator product is topical ointment, with a specification of 15g per tube (containing 1% tifropirocin), and this product has been included in the FDA Reference Listed Drug Catalog. As of now, there are no approved tifropirocin preparation products marketed in China, and no Drug Master File (DMF) for the active pharmaceutical ingredient submitted by enterprises is in valid status. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for tifropirocin API, with most products in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the various needs of pharmaceutical enterprises for impurity reference standards in the stages of drug R&D, quality research and declaration, providing reliable technical support for the compliant marketing of products.