04:08 AM EDT, 05/20/2024 (MT Newswires) -- Zai Lab ( ZLAB ) and Innoviva's ( INVA ) Specialty Therapeutics subsidiary said Monday China's National Medical Products Administration has approved Zai's new drug application for Xacduro, the two firms' treatment for two hospital infections in adult patients.

The approved indications for the drug, also called sulbactam-durlobactam, include hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, the companies said.

The approval is based on results from a phase 3 study that demonstrated the drug's statistical non-inferiority versus the drug colistin for its primary endpoint and a statistically significant improvement in cure rates.

Zai Lab ( ZLAB ) holds the license to develop and commercialize Xacduro in China, South Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, the Philippines, Singapore, Australia, New Zealand and Japan.

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