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

 

The novel antibacterial drug Zydus® is currently the only antibacterial drug specifically developed for the treatment of carbapenem-resistant Acinetobacter baumannii (CRAB).¹. The 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 World Health Organization's list of priority bacterial pathogens identified CRAB as one of the antibiotic-resistant bacterial pathogens posing the most severe threat to public health, placing it in 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 Surveillance Network, approximately 300,000 strains of Acinetobacter baumannii were detected in mainland China.⁶Before the approval of Dingyoule®, treatment options for HABP/VABP caused by CRAB infections were very limited, and there was a lack of gold-standard therapies for treating CRAB infections.⁷。

 

Zai Lab President and Chief Operating Officer Josh Smiley stated: "The increasing drug resistance of Acinetobacter baumannii is becoming more severe, with high clinical mortality rates in critically ill patients and poor prognosis, leading to 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 played an important role in the development of Ding Youle, which led to its approval 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 and Chairman of the RDPAC Executive Committee, stated, "Pfizer has been deeply committed to the anti-infective field for many years. We are always dedicated to 'bringing breakthrough innovations that change patients' lives' to address the challenges posed by various microbial infections such as bacteria, fungi, and viruses, thereby reducing the disease burden on patients. Through this collaboration with Zai Lab, we will work together to combat the growing issue of drug resistance in Acinetobacter baumannii treatment, quickly meet the unmet clinical treatment needs of patients, demonstrate the new productive forces of pharmaceutical enterprises, and contribute 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 Zavicefta® (Sulbactam Sodium-Durlobactam Sodium)
Intravenous Combination Drug Dynablast® (Sulbactam Sodium-Durlobactam Sodium) Developed by Entasis Therapeutics Inc. (a subsidiary of Innoviva Specialty Therapeutics), 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 China National Medical Products Administration in 2024 for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older caused by susceptible isolates of the Acinetobacter baumannii-calcoaceticus complex.
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 the study, Sulbactam-Durlobactam demonstrated non-inferiority compared to Colistin E in the primary endpoint, the 28-day all-cause mortality rate in patients with carbapenem-resistant Acinetobacter infections, and showed a significant improvement in clinical cure rates. Sulbactam-Durlobactam was well-tolerated and exhibited a favorable safety profile throughout the clinical research 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, commercially focused biopharmaceutical company with a research-based approach, headquartered in China and the United States. We are committed to addressing significant unmet medical needs in the fields of oncology, autoimmune diseases, infectious diseases, and central nervous system disorders through the discovery, development, and commercialization of innovative products. Our goal is to leverage our capabilities and resources to promote the health and well-being of people in China and around the world. For more information about Zai Lab, please visit www.zailaboratory.com or follow the company’s official WeChat account: Zai Lab.

Zai Lab Forward-Looking Statements
This press release contains forward-looking statements regarding Zai Lab’s future expectations, plans and prospects, including, but not limited to, our commercialization plans for Zydus, the potential benefits of Zydus, and the potential therapy for certain infections caused by Acinetobacter baumannii (including carbapenem-resistant Acinetobacter strains) in mainland China. These forward-looking statements may include words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would," and other similar expressions. These statements constitute "forward-looking statements" as defined under the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact, nor are they guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those anticipated in the forward-looking statements. Actual results may differ materially from those indicated in the forward-looking statements due to various important factors, including those outlined in our most recent annual and quarterly reports filed with the U.S. Securities and Exchange Commission (SEC) and other reports. These reports can be accessed on the company’s website at www.zailaboratory.com or on the SEC’s website at www.sec.gov. Except as required by law, we have no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

About Pfizer: Bringing Life-Changing Breakthrough Innovations to Patients
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Throughout the process of discovery, development, and manufacture of healthcare products, Pfizer is committed to upholding stringent standards of quality, safety, and value. Our global portfolio includes innovative medicines and vaccines. Every day, Pfizer employees in developed and emerging markets advance human health and push the prevention, treatment, and cure of diseases to confront the persistent illnesses of our time. Pfizer also collaborates with healthcare providers, governments, and communities to support and expand access to more reliable and affordable healthcare services worldwide. This aligns with Pfizer's responsibility as a leading global innovative biopharmaceutical company. For 175 years, Pfizer has been dedicated to making a difference for all who depend on us. For more information, please visit www.pfizer.com.cn.

Pfizer Disclaimer
The information contained in this press release is current only as of November 21, 2024. Pfizer assumes no obligation to update any forward-looking statements contained in this press release, whether as a result of new information, future events, or developments.
This release contains forward-looking information about the strategic collaboration between Pfizer and Zai Lab regarding the novel antibiotic Zaviceftat® (Ding Youle®) in mainland China, as well as Pfizer’s efforts to address the challenges of various microbial infections, including their potential benefits. This information involves significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in these statements. Risks and uncertainties include, but are not limited to: risks related to the ability to achieve the anticipated benefits of the strategic collaboration, including the possibility that the anticipated benefits may not be realized or may not be realized within the expected timeframe; whether Zaviceftat® (Ding Youle®) can be successfully commercialized; decisions by regulatory authorities regarding product labeling, manufacturing processes, safety, and/or other matters that may impact the availability or commercial potential of Zaviceftat® (Ding Youle®); uncertainties arising from the impact of COVID-19 on Pfizer’s business, operations, and financial results; and uncertainties due to developments in market competition.
More information about risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and updated in subsequent reports on Form 10-Q, including the sections titled "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results," as well as in its subsequent reports on Form 8-K, all of which have been filed with the U.S. Securities and Exchange Commission and are available at www.sec.gov and www.pfizer.com.