Sarecycline

Multidrug-resistant bacterial infections have become a severe challenge in the global public health field, and the spread of tetracycline-resistant bacteria has greatly reduced the efficacy of traditional anti-infective regimens. As a novel aminomethylcycline antibiotic, eravacycline modifies the core structure of tetracycline, which can effectively avoid the two common tetracycline resistance mechanisms of bacterial ribosome protection and efflux pump, and maintains strong in vitro activity against multidrug-resistant pathogens such as methicillin-resistant *Staphylococcus aureus*, vancomycin-resistant enterococci, and carbapenem-resistant Gram-negative bacteria. It is mainly used clinically to treat adult patients with complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia, providing a new treatment option for populations at high risk of drug-resistant bacterial infections.

According to public data, the global market size of eravacycline in 2023 was approximately USD 480 million, with a compound annual growth rate of more than 22% in the past three years. The main growth drivers are the rising global infection rate of drug-resistant bacteria and the continuous release of clinical demand for new broad-spectrum anti-infective drugs. At present, the global market is still dominated by the original research product, with few enterprises laying out generic drugs. In China, only a small number of pharmaceutical companies have initiated the R&D and application for generic drugs, and no generic drug has been approved for marketing yet, so the market is in a development stage with an obvious supply-demand gap.

The original research enterprise of eravacycline is Tetraphase Pharmaceuticals, with the original brand name Xerava. Its core compound patent in the United States expires in 2033, and the Chinese compound patent will expire in 2032. The dosage form approved for the original product is injection, with a specification of 50 mg per vial. The original injection has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *List of Chemical Drugs* of China. Currently, no eravacycline preparation has been approved for marketing in China, and no enterprise in the API field has obtained the API registration number of Status A registered with CDE. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of eravacycline impurity reference standards, which can fully meet the reference substance requirements in the whole process of API R&D, quality research, and registration application. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, which can effectively shorten the R&D cycle and reduce compliance risks.