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Durlobactam

Overview
Durlobactam is a novel broad-spectrum intravenous inhibitor of class A, C and D beta-lactamases. Durlobactam restores the in-vitro activity of multiple β-lactams against Gram-negative, multidrug-resistant pathogens. Entasis Therapeutics Holdings Inc. (Entasis) is initially developing Sulbactam-Durlobactam, a fixed-dose combination of Durlobactam and sulbactam, for the treatment of a variety of serious multidrug-resistant infections caused by A. baumannii. Sulbactam is a penicillin derivative and is used widely as an inhibitor of β-lactamases. It possesses intrinsic antimicrobial activity against A. baumannii. Increasing resistance of A. baumannii to sulbactam, however, has reduced its usefulness in treating infections caused by this bacterium. In preclinical studies, Durlobactam restored sulbactam antibacterial activity against A. baumannii. Durlobactam has completed single/multi-ascending dose Phase I trials, and a Phase II study as well. The FDA has granted Qualified Infectious Disease Product (QIDP) designation and Fast Track designation to Sulbactam-Durlobactam for the treatment of hospital-acquired and ventilator-acquired bacterial pneumonia and bloodstream infections due to A. baumannii. In 2018, we obtained an exclusive license for Durlobactam from Entasis in mainland China, Hong Kong (China), Macau (China), Taiwan region, Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia and Indonesia. And in the Philippines, Singapore, Australia, New Zealand and Japan, we entered into a global strategic development collaboration with Entasis. We are currently working closely with Entasis to prepare the Phase III study and to bring this novel drug into China as soon as possible.

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