Daptomycin

Infections caused by multidrug-resistant Gram-positive bacteria are the core difficulty in current clinical anti-infective therapy, especially severe cases such as bloodstream infections and infective endocarditis caused by methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci. The response rate of existing traditional drugs is less than 60%. As a representative variety of cyclic lipopeptide antibiotics, daptomycin targets the bacterial cell membrane, rapidly disrupts the cell membrane potential without penetrating the cell, leading to the leakage of bacterial contents and death. There is no cross-resistance between daptomycin and β-lactam or glycopeptide antibiotics. At present, it has been recommended by multiple international guidelines as the first-line treatment option for complex skin and soft tissue infections in adults and children and Staphylococcus aureus bloodstream infections, and it is particularly suitable for patients with drug-resistant bacterial infections who fail vancomycin treatment.

The global daptomycin market size exceeded USD 1.2 billion in 2023, with a compound annual growth rate of 4.2% in the past five years. The core growth drivers are the continuous rise in the global incidence of drug-resistant bacterial infections and the expansion of diagnosis and treatment demand for severe infections. The overall size of the Chinese market in 2023 was approximately RMB 1.8 billion, with a compound annual growth rate of 8.7%, which is higher than the global average. In terms of the competitive landscape, the original research product still accounts for about 35% of the market share. Generic preparations from 7 domestic enterprises have been approved for marketing and have been included in the national centralized procurement. The terminal price has dropped by more than 70% after the centralized procurement, driving the rapid increase of clinical penetration rate.

The original research enterprise of daptomycin is Merck Sharp & Dohme, and the original brand name is "Cubicin". Its core compound patent in the United States expired in 2019, and the compound patent in China expired in 2020. The main dosage form approved for the original research product is injection, with specifications including 0.5g/vial and 0.25g/vial. The original research injection has been included in the China Listed Drug Catalogue and is also included in the FDA Reference Listed Drug Catalogue. In terms of domestic API registration, 12 enterprises including Merck Sharp & Dohme have obtained CDE registration numbers for daptomycin API so far, among which 9 have been activated and can be associated with preparation applications. 7 domestic enterprises have had their daptomycin injections approved for marketing. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of daptomycin impurity reference standards. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most impurities are in regular stock. Orders placed before 16:00 can be shipped on the same day, which can fully meet the supply needs of pharmaceutical enterprises in various stages such as API R&D, quality research, and consistency evaluation.