Zai Lab and Innoviva Specialty Therapeutics Gain NMPA Approval for New Drug XACDURO for Treating Serious Pneumonia in China
SHANGHAI & CAMBRIDGE, Mass. & WALTHAM, Mass. - Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Innoviva Specialty Therapeutics have announced that China’s National Medical Products Administration (NMPA) has granted approval for Zai Lab’s New Drug Application (NDA) for XACDURO (sulbactam-durlobactam) for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
Hospital-acquired and ventilator-associated pneumonia are serious and potentially life-threatening infections that affect patients who are already hospitalized or on mechanical ventilation. Acinetobacter baumannii-calcoaceticus complex is a common pathogen responsible for these types of pneumonia, and it is often resistant to commonly used antibiotics. This approval by the NMPA gives healthcare professionals in China a new treatment option to combat these infections effectively.
XACDURO, a combination of sulbactam and durlobactam, has demonstrated promising results in clinical trials, showing its effectiveness in combating Acinetobacter baumannii-calcoaceticus complex infections. The approval of this NDA signifies a significant milestone for both Zai Lab and Innoviva, as it represents an important addition to the companies’ portfolios and their commitment to improving patient outcomes in China.
The NMPA approval was based on positive data from the Phase 3 clinical trial program, which included two multicenter, randomized, double-blind studies evaluating the safety and efficacy of XACDURO compared to Meropenem, a commonly used antibiotic. The trials demonstrated that XACDURO achieved non-inferiority to Meropenem in terms of the primary endpoint, clinical response rate, and also showed favorable safety and tolerability profiles.
Dr. Samantha Lee, CEO of Zai Lab, expressed her excitement about the NMPA approval, stating, We are delighted to have received regulatory approval for XACDURO in China. This is an important milestone for Zai Lab and represents our commitment to bringing innovative treatment options to patients in need.
Zai Lab is a leading biopharmaceutical company focused on discovering, developing, and commercializing innovative medicines for the Chinese market. This approval further strengthens their position in the Chinese market and their dedication to addressing critical healthcare needs.
As part of the approval for XACDURO, Zai Lab will be responsible for the marketing and distribution of the drug in China. Furthermore, Zai Lab plans to initiate additional clinical trials to explore the potential of XACDURO for the treatment of other infections caused by multidrug-resistant bacteria.
Innoviva Specialty Therapeutics, a global biopharmaceutical company, specializes in the development and commercialization of innovative therapies targeting respiratory diseases. This collaboration with Zai Lab represents another step forward in their mission to deliver novel treatments for patients worldwide.
The approval of XACDURO by the NMPA brings hope and relief to both healthcare professionals and patients battling hospital-acquired and ventilator-associated pneumonia caused by Acinetobacter baumannii-calcoaceticus complex in China. The availability of this new treatment option offers a ray of hope amidst the rising concerns of antibiotic resistance and provides an opportunity to effectively combat these infections.
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