Gamithromycin

针对牛呼吸系统疾病的临床防控需求，半合成大环内酯类抗生素加米霉素凭借独特的药代动力学优势成为兽用抗菌领域的重要选择。其作用机制为通过与细菌核糖体50S亚基结合，抑制肽链延伸与蛋白质合成，从而快速杀灭溶血性曼氏杆菌、多杀性巴氏杆菌等常见致病菌。加米霉素单剂注射后可在肺组织维持7天以上有效抑菌浓度，大幅减少养殖场景的给药频次，主要用于防治牛、猪等畜禽的细菌性呼吸道感染，是规模化养殖疫病防控的核心用药之一。In response to the clinical prevention and control needs of bovine respiratory diseases, gamithromycin, a semi-synthetic macrolide antibiotic, has become an important choice in the field of veterinary antibacterial applications with its unique pharmacokinetic advantages. Its mechanism of action is to bind to the 50S subunit of bacterial ribosomes, inhibit peptide chain elongation and protein synthesis, thereby rapidly killing common pathogenic bacteria such as *Mannheimia haemolytica* and *Pasteurella multocida*. After a single injection, gamithromycin can maintain an effective antibacterial concentration in lung tissue for more than 7 days, which greatly reduces the frequency of administration in breeding scenarios. It is mainly used for the prevention and treatment of bacterial respiratory infections in livestock and poultry such as cattle and pigs, and is one of the core drugs for epidemic prevention and control in large-scale breeding.

全球兽用加米霉素市场规模2023年约为2.3亿美元，预计2028年复合年增长率将保持7.2%，增长动力主要来自全球肉牛、生猪规模化养殖率提升以及抗菌药减用政策下长效制剂需求扩张。当前市场供应格局中，原研产品仍占据近60%的市场份额，中国、印度企业的仿制原料药正凭借成本优势逐步渗透，截至2024年国内已有3家企业获批加米霉素原料药生产资质，集采落地后国内制剂终端价格较原研下降42%，进一步推动产品普及率提升。The global market size of veterinary gamithromycin was approximately USD 230 million in 2023, and the compound annual growth rate is expected to remain at 7.2% by 2028. The growth momentum mainly comes from the increase in the large-scale breeding rate of beef cattle and live pigs worldwide and the expansion of demand for long-acting preparations under the policy of reducing the use of antibacterial drugs. In the current market supply pattern, the original research product still accounts for nearly 60% of the market share, and generic API from Chinese and Indian enterprises are gradually penetrating with cost advantages. As of 2024, 3 domestic enterprises have obtained the production qualification of gamithromycin API. After the implementation of centralized procurement, the terminal price of domestic preparations has dropped by 42% compared with the original research product, further promoting the increase of product penetration.

加米霉素原研企业为法国梅里亚（现勃林格殷格翰动物保健旗下），原研商品名为“Zactran（瑞可新）”，其核心化合物专利 in the EU expired in 2022, and the core compound patent in China expired in 2021. The main marketed dosage form of the original research product is injection, with a specification of 150 mg gamithromycin per milliliter. It has been included in the FDA Reference Listed Drug Catalog for Animal Drugs, and also included in the *Catalog of Reference Preparations for Veterinary Chemical Drugs* of China. In terms of domestic API registration, as of now, there are 5 valid registration numbers for gamithromycin API, and 11 enterprises have obtained marketing approval for gamithromycin injection. (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 gamithromycin, most of which are in stock. Orders for in-stock products 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 provide reliable reference standard support for API and preparation enterprises in the links of quality research, stability study, registration and declaration, etc.