Zai Lab and Pfizer Announce Strategic Collaboration on Novel Antibiotic Xacduro® (Sulbactam-Durlobactam) in Mainland China

Nov 21, 2024 20:30 CST Updated 20:30

Zai Lab

Innovative Global Biopharmaceutical Company

Pfizer

Pharmaceutical R&D Developer

Shanghai, China and Cambridge, Massachusetts, USA, November 21, 2024 — Zai Lab (referred to as “Zai Lab”, NASDAQ stock code: ZLAB; Hong Kong Stock Exchange stock code: 9688) and Pfizer (referred to as “Pfizer”, NYSE: PFE) today announced that the two parties have reached an agreement on the novel antibacterial drug Ding Youle.^®(Sulbactam Sodium-Durlobactam Sodium) has reached a strategic cooperation in mainland China, with the product's commercial operations exclusively managed by a Pfizer subsidiary in China. Through this collaboration, Zai Lab will leverage the leading commercialization capabilities of Pfizer’s subsidiary in the anti-infective field to help patients in need across China gain faster access to this important therapy. The cooperation period for this imported product extends until November 2028, subject to early termination or extension.

New Antibacterial Drug Ding You Le^®Is currently the only antimicrobial drug specifically developed for the treatment of carbapenem-resistant Acinetobacter baumannii (CRAB).¹The product was approved in the United States in 2023 and in mainland China in 2024 for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adult patients caused by susceptible isolates of the Acinetobacter baumannii-calcoaceticus complex. The U.S. Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant organisms as an urgent threat.²Globally, Acinetobacter baumannii was one of the six leading pathogens responsible for deaths due to drug resistance in 2019.³In 2024, the list of priority bacterial pathogens released by the World Health Organization included CRAB as one of the antibiotic-resistant bacterial pathogens posing the most severe threat to public health, categorized under the critical priority group.⁴In China, Acinetobacter baumannii is also one of the leading causes of death due to bacterial resistance.⁵According to the 2022 annual report of the National Bacterial Resistance Monitoring Network, approximately 300,000 strains of Acinetobacter baumannii were reported in mainland China.⁶. At Zai Lab^®Before approval, the treatment options for HABP/VABP caused by CRAB infection were very limited, and there was a lack of gold standard therapy for CRAB infection.⁷。

Zai Lab President and Chief Operating Officer Josh Smiley said:

The drug resistance of Acinetobacter baumannii is becoming increasingly severe, with high clinical mortality and poor prognosis in critically ill patients, causing a significant disease burden. The latest surveillance data shows that the resistance rate of Acinetobacter baumannii to carbapenem antibiotics in China has risen to approximately 74%.⁸Zai Lab at Ding Youle^®played an important role in the development process, enabling the drug to be approved in China earlier this year. Through our collaboration with Pfizer, we hope to bring this innovative therapy to Chinese patients more quickly, helping to save the lives of critically ill patients.

Jean-Christophe Pointeau, President of Pfizer China, stated:

Pfizer has been deeply engaged in the anti-infective field for many years. We are always committed to 'bringing breakthrough innovations that change patients' lives' to address the challenges of various microbial infections such as bacteria, fungi, and viruses, reducing the disease burden on patients. This collaboration with Zai Lab will see both parties working together to combat the growing issue of drug resistance in Acinetobacter baumannii treatment, quickly meeting the unmet clinical treatment needs of patients, demonstrating the new productive forces of pharmaceutical enterprises, and contributing to the realization of the 'Healthy China' goal.

References:

(1) El-Ghali A, Kunz Coyne AJ, Caniff K, Bleick C, Rybak MJ. Sulbactam-durlobactam: A novel β-lactam-β-lactamase inhibitor combination targeting carbapenem-resistant Acinetobacter baumannii infections. Pharmacotherapy. 2023; 43(6):502-513. doi:10.1002/phar.2802

(2) Centers for Disease Control and Prevention, “Carbapenem-resistant Acinetobacter baumannii (CRAB): An urgent public health threat in United States healthcare facilities,” August 2021: https://arpsp.cdc.gov/story/cra-urgent-public-health-threat

(3) Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399(10325):629-655. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext

(4) WHO Bacterial Priority Pathogens List, 2024

(5) Zhang C, Fu X, Liu Y, Zhao H, Wang G. Burden of infectious diseases and bacterial antimicrobial resistance in China: a systematic analysis for the global burden of disease study 2019. Lancet Reg Health West Pac. 2023; 43:100972. Published 2023 Nov 22. doi:10.1016/j.lanwpc.2023.100972

(6) 2022 Annual Report of China Antimicrobial Resistance Surveillance System (CARSS)

(7) Zhang S, Di L, Qi Y, Qian X, Wang S. Treatment of infections caused by carbapenem-resistant Acinetobacter baumannii. Front Cell Infect Microbiol. 2024; 14:1395260. Published 2024 Jul 18. doi:10.3389/fcimb.2024.1395260

(8) 2023 Annual Report of China Antimicrobial Surveillance Network (CHINET)

About Ding Youle^®(Sulbactam Sodium-Durlobactam Sodium)

Intravenous Infusion Combination Drug Ding Youle^®(Sulbactam Sodium-Durlobactam Sodium) was developed by Entasis Therapeutics Inc. (a subsidiary of Innoviva Specialty Therapeutics) and is a combination of Sulbactam Sodium (a β-lactam antibiotic) and Durlobactam Sodium (a β-lactamase inhibitor). Sulbactam Sodium-Durlobactam Sodium was approved by the U.S. Food and Drug Administration in 2023 and by the National Medical Products Administration of China in 2024 for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of the Acinetobacter baumannii-calcoaceticus complex in patients aged 18 years and older.

The approval of Sulbactam-Durlobactam in China was based on the positive results of the ATTACK study (NCT03894046), a global Phase 3 registrational study evaluating the safety and efficacy of Sulbactam-Durlobactam versus Colistin E for treating patients with Acinetobacter baumannii infections. In this study, Sulbactam-Durlobactam demonstrated non-inferiority in the primary endpoint — 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections — compared to Colistin E, with a significant improvement in clinical cure rates. Sulbactam-Durlobactam was well-tolerated and exhibited a favorable safety profile throughout the clinical program. Zai Lab participated in the global ATTACK study and recruited patients in China. Data from the Chinese patient cohort confirmed the global study’s findings regarding improvements in mortality and clinical response.

Zai Lab has been granted an exclusive license by Entasis Therapeutics Inc. to develop and commercialize Sulbactam Sodium-Durlobactam Sodium in Greater China (mainland China, Hong Kong, Taiwan, and Macao), South Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, the Philippines, Singapore, Australia, New Zealand, and Japan.

About Zai Lab

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovation-driven biopharmaceutical company with a focus on research and development, and is currently in the commercialization stage. Headquartered in China and the United States, the company is committed to addressing significant unmet medical needs in the fields of oncology, immunology, central nervous system disorders, and infectious diseases through the discovery, development, and commercialization of innovative products. The company’s goal is to leverage its capabilities and resources to promote the health and well-being of people in China and around the world.

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