• 25 Nov 2024
• Admin
• News Article

Zai Lab, Pfizer Enter Collaboration on Novel Antibacterial Drug Xacduro in Mainland China

Overview

Zai Lab (Zai Lab) and Pfizer announced a strategic collaboration for the novel antibacterial drug Xacduro (sulbactam-durlobactam) in mainland China. Pfizer’s affiliated companies will be exclusively authorized to undertake and perform certain commercialization activities for Xacduro in mainland China. Through this collaboration, Zai Lab will leverage the industry-leading commercialization infrastructure of Pfizer’s affiliated companies in the anti-infective therapeutic area to help accelerate access to this important therapy for patients in need in mainland China. The period of collaboration is for the imported product through November 2028, subject to early termination or extension.

Xacduro fro CRAB

• Xacduro is the only antimicrobial agent specifically developed for the treatment of carbapenem-resistant Acinetobacter baumannii (CRAB). 
• It has been approved in the United States and in mainland China for the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. 
• The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat. 
• Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019, and CRAB is included in the highest priority category, the Critical Group category, in the list of bacterial priority pathogens published by the World Health Organization (WHO) in 20244. 
• In China, Acinetobacter baumannii was the leading cause of death attributable to antimicrobial resistance according to the global burden of disease study 2019. 
• Approximately 300,000 Acinetobacter baumannii isolates were reported in mainland China in 2022.
• Treatment options for HABP/VABP caused by CRAB infections are limited, and prior to approval of Xacduro, there remains a lack of gold-standard therapy for CRAB infections.

Words from the COO: Zai Lab

• “Drug resistance is becoming increasingly serious, with high clinical mortality rate and poor prognosis in critically ill patients, resulting in a serious disease burden. According to recent surveillance data from China, resistance of Acinetobacter baumannii to the carbapenem class of antibiotics has reached approximately 74%,” said Josh Smiley, president and chief operating officer of Zai Lab. 
• “Zai Lab was instrumental in the development of Xacduro, leading to its approval in China earlier this year. By joining forces with Pfizer, we seek to bring this innovative treatment to Chinese patients more quickly, saving the lives of those most at risk.”

Statement from the Pfizer China

• “Pfizer has been deeply engaged in the anti-infective therapeutic area for many years. We have always been committed to addressing the challenges of multiple microbial infections, including bacterial, fungal as well as viral infections, and to reduce the burden of disease on patients,” said Jean-Christophe Pointeau, president of Pfizer China. 
• “The collaboration with Zai Lab will help enable us to work together as we strive to address the growing problem of drug resistance in the treatment of Acinetobacter baumannii, and reflects the new quality productive forces in pharmaceutical companies, helping to achieve the goal of ‘Healthy China’ initiative.”

About Xacduro

• Xacduro (sulbactam-durlobactam) is an intravenous drug developed by Entasis Therapeutics Inc., an affiliate of Innoviva Specialty Therapeutics, which is a combination of sulbactam, a ß-lactam antibiotic, and durlobactam, a ß-lactamase inhibitor, or BLI. 
• Xacduro was approved by the US Food and Drug Administration (FDA) in 2023 and China’s National Medical Products Administration (NMPA) in 2024 for the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

Behind the Approval

• The NMPA approval is based on positive results from the ATTACK trial (NCT03894046), a global, phase 3 registrational trial evaluating the safety and efficacy of Xacduro versus colistin in patients with infections caused by A. baumannii. 
• In the pivotal study, Xacduro demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a statistically significant improvement in clinical cure rates. 
• Xacduro was well tolerated and exhibited a favourable safety profile across the clinical program. 
• Zai Lab participated in the global ATTACK study by enrolling patients in China. 
• The Chinese patient cohort data confirm the findings of the global study regarding mortality and clinical response improvement.

Zai Lab- Exclusive License

Zai Lab has an exclusive license to develop and commercialize Xacduro in Greater China (mainland China, Hong Kong, Taiwan and Macau, collectively), Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, the Philippines, Singapore, Australia, New Zealand and Japan from Entasis Therapeutic Inc.

About the Company: Zai Lab

• Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. 
• The company is focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease.