Ensifentrine

Bacterial infection has always been a core problem in prevention and control in the field of animal husbandry. As a new type of pleuromutilin antibiotic exclusively for animals, valnemulin inhibits protein synthesis by targeted binding to the 50S subunit of bacterial ribosomes, and has strong antibacterial activity against Gram-positive bacteria, mycoplasma and some Gram-negative bacteria. It is mainly used to prevent and treat common infections in breeding such as mycoplasma pneumonia in pigs and poultry, porcine actinobacillus pleuropneumonia, and staphylococcosis in chickens. It can significantly reduce the mortality and elimination rate of breeding and improve the production performance of livestock and poultry, and is one of the core drugs for the prevention and control of respiratory tract infections in livestock and poultry at present.

In the global animal health antibiotic market, the annual market size of pleuromutilin drugs is about 3.2 billion yuan, with a compound annual growth rate of 8.7% in the past 3 years. Among them, valnemulin, with lower risk of drug resistance and higher target tissue enrichment, has seen its market share increase year by year to 12% of the total pleuromutilin category. At present, the domestic market is still in the introduction period, only 2 enterprises have been approved to produce API, and the number of applications from generic enterprises is less than 5, so the market competition pattern is relatively loose. As the scale rate of livestock and poultry breeding exceeds 65%, the domestic valnemulin market is expected to grow at a rate of more than 15% in the next 3 years.

The original research enterprise of valnemulin is Novartis in Switzerland, with the original research trade name "Taiyong". The core compound patent will expire in China in 2023. The main marketed dosage forms are two specifications: 10% soluble powder and 80% premix, and its reference listed drug has been included in the *Catalogue of Reference Listed Drugs for Chemical Drugs (39th Batch)* of China. Up to now, the API registration platform of China's CDE has publicly announced 4 pieces of valnemulin API registration information, of which 2 have been activated to status A, and 11 product specifications of the corresponding preparations have been approved for marketing, covering two commonly used dosage forms of premix and soluble powder. (Data as of October 2024, please refer to the official CDE website for the latest information.)

CATO provides a full set of impurity reference standards for valnemulin API, and most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day, which can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable reference standard support for enterprises' API R&D, quality research and declaration and registration.