Relebactam

In response to the clinical treatment gap for multidrug-resistant Gram-negative bacterial infections, the compound combinations of β-lactamase inhibitors with cephalosporins and carbapenems have become an important R&D direction. Relebactam is a novel diazabicyclooctane class β-lactamase inhibitor, which has almost no antibacterial activity itself. It can irreversibly bind to class A, class C and some class D β-lactamases, thereby restoring the bactericidal activity of antibacterial agents such as ceftazidime and imipenem against enzyme-producing resistant strains. Currently, its approved indications are mainly in combination with ceftazidime for the treatment of complicated urinary tract infections, complicated intra-abdominal infections, hospital-acquired pneumonia and ventilator-associated pneumonia. The applicable population is patients aged 18 and above with sensitive bacterial infections, and it can also be used for the treatment of specific resistant bacterial infections in children when there is sufficient evidence.

In recent years, the global market for the treatment of multidrug-resistant bacterial infections has continued to expand. The global sales of relebactam-related compound preparations exceeded US$1.9 billion in 2023, with a compound annual growth rate of more than 42% in the past three years, making it one of the fastest-growing varieties in the anti-infective field at present. The domestic market is in the rapid introduction period, and the terminal sales in public medical institutions were nearly RMB 1.2 billion in 2023, a year-on-year increase of 117%. In terms of the competitive landscape, the original research product occupies nearly 90% of the market share. Three domestic enterprises have been approved for ceftazidime-avibactam generics, and the generic applications of another seven enterprises are in the review stage. In the future, with the implementation of the centralized procurement policy, the market size is expected to further increase.

The original research enterprise of relebactam is GlaxoSmithKline, and the original research trade name is "Zavicefta", which is a compound preparation of ceftazidime and relebactam in the ratio of 2:1. Its core compound patent will expire in China in 2031. At present, the domestically approved original research dosage form is injection, with the specification of 2g ceftazidime/1g relebactam per vial, which has been included in the *Catalogue of Chemical Reference Preparations* of China. In terms of domestic API registration, 4 enterprises have completed the registration of relebactam API in CDE (status A) so far, and the registration applications of another 8 enterprises are under review; in terms of preparations, in addition to the original research, 3 domestic enterprises have been approved for the marketing of ceftazidime and relebactam for injection. (Data as of July 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of relebactam impurity reference standards. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs in the process of API R&D, quality research and production.