Zai Lab Ltd. (Nasdaq: ZLAB) announced Monday that the company has received approval for its new drug application (NDA) for omadacycline that treats bacterial pneumonia and skin infections, which sent it stock nearly 5% higher to 58.00 per American depositary share by midday.
With its NDA gaining acceptance by the China National Medical Products Administration, it marked the third time Zai Lab attempted to receive approval for omadacycline, the company said in a statement today. The product is also Zai Lab’s first anti-infective NDA and was accepted as a Category 1 drug that will be manufactured in China.
“Omadacycline is particularly well positioned for the China market due to its broad activity covering a wide spectrum of pathogens (including multi-drug resistance) associated with CABP and ABSSSI. As it is available in intravenous (IV) and oral (PO) formulations, omadacycline provides the option for IV-to-PO step down therapy thus allowing physicians to discharge patients earlier and reduce exposure to hospital pathogens,” Harald Reinhart the chief medical officer for Autoimmune and Infectious Diseases at Zai Lab, said in a statement today.
He added, “There are limited treatment options against drug-resistant bacteria in China, and omadacycline is an innovative drug that can address such unmet medical needs.”
According to its statement, omadacycline was first developed by Zai Lab’s partner Paratek Pharmaceuticals. Omadacycline received approval in October 2018 and the clinical trial program involved more than 2,000 patients.
Before announcing the pricing of its additional offering last month, the stock of Zai Lab was trading at $48.48 per ADS and has skyrocketed since then. Today, Zai Lab reached an historic high of $58.43 per ADS.
Based in Shanghai, Zai lab develops and commercializes therapeutics to meet unmet medical needs in areas including oncology, infectious and autoimmune diseases. With approximately 700 employees, Zai Lab operates in China and around the world.