Shanghai's Zai Lab (NSDQ: ZLAB) received word that China's Center for Drug Evaluation will review its NDA for omadacycline, a novel tetracycline designed to overcome resistance, under priority rules. In February 2020, China's NMPA accepted the omadacycline NDA to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Zai in-licensed greater China rights to the antibiotic in 2017 from Boston-based Paratek (NSDQ: PRTK), which was approved for a US launch of omadacycline in 2019. CABP is a common secondary infection associated with respiratory viruses like COVID-19.

According to Zai, Omadacycline (NUZYRA®) is a novel tetracycline, specifically designed to overcome tetracycline resistance and improve activity across a broad spectrum of bacterial infections such as those caused by Gram-positive, Gram-negative, atypical and other problem pathogens. It was approved in the US as a once-daily oral and IV antibiotic for the treatment of adults with CABP and ABSSSI.

“The NMPA’s decision to grant priority review to our NDA for omadacycline underscores the importance of addressing a growing unmet need of bacterial resistance in China with an innovative medicine,” said Dr. Samantha Du, Founder, Chairperson and CEO of Zai Lab. “We believe omadacycline is particularly well positioned for the China market due to its broad activity covering a wide spectrum of pathogens, including multi-drug resistant bacteria, associated with CABP and ABSSSI. We look forward to working closely with the agency to move our first anti-infective therapeutic toward approval.”

“CABP is a common secondary infection associated with respiratory viruses like influenza and coronavirus, and recent influenza outbreaks and coronavirus epidemics are a reminder of the need for antibiotics like omadacycline. We believe few intravenous/oral antibiotics exist which are as potent as omadacycline in this indication,” added Dr. Harald Reinhart, Chief Medical Officer for Autoimmune and Infectious Diseases of Zai Lab.

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