Dalbavancin

Infection caused by multidrug-resistant Gram-positive bacteria is one of the core challenges in current clinical anti-infective therapy. As a second-generation semi-synthetic lipoglycopeptide antibiotic, dalbavancin exerts a rapid bactericidal effect by targeting and binding to the D-alanyl-D-alanine terminus of peptidoglycan precursors in the bacterial cell wall, inhibiting cell wall synthesis and disrupting the integrity of the cell membrane. Its ultra-long half-life supports a once-weekly dosing regimen, which greatly improves patients' medication adherence. It is clinically mainly used for the treatment of acute bacterial skin and skin structure infection (ABSSSI) in adults, and is particularly suitable for sequential treatment of infections caused by drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-sensitive enterococci, as well as outpatient anti-infective scenarios.

The global dalbavancin market size was approximately USD 320 million in 2023, with a compound annual growth rate of 8.7% from 2019 to 2023. The core growth drivers are the increasing detection rate of drug-resistant bacteria in inpatient infection scenarios and the popularization of outpatient anti-infective treatment models. At present, the market is still dominated by the originator product, and no generic drug has been approved for marketing in China. Only 3 enterprises have submitted marketing applications for generic drugs, so the market competition pattern is still in the early stage. Following the expiration of patents and the launch of generic drugs, the clinical accessibility is expected to be further improved.

The originator enterprise of dalbavancin is Pfizer, with the original brand name Dalvance. Its core compound patent expires in 2027 in the United States and in 2026 in China. The main dosage form approved for the originator product is powder for injection, with the specification of 500 mg/vial. It has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the Catalog of Reference Preparations for Listed Chemical Drugs in China. According to the domestic API registration platform, there is currently no approved domestic dalbavancin API registration number, and only the originator imported dalbavancin for injection was approved for marketing by the National Medical Products Administration in 2022. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for dalbavancin API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs in the process of API R&D, quality research and consistency evaluation.