MSD's Ceftolozane/Tazobactam (Zavicefta®) Approved in China, Offering a New Option for Resistant Bacterial Infections

       Shanghai, China, February 13, 2025 — MSD (the corporate name of Merck & Co., Inc., Kenilworth, NJ, USA) announced its new enzyme inhibitor combination formulation — Ceflogozil Tazobactam Sodium for Injection (registered trademark: Zoryda).^®) has been approved by the National Medical Products Administration of China for use in combination with metronidazole to treat infections caused by susceptible Gram-negative and Gram-positive microorganisms in adult and pediatric patients (from birth to under 18 years of age).Complicated Intra-abdominal Infections (cIAI); For the treatment of adult and pediatric patients (from birth to under 18 years of age) with infections caused by susceptible Gram-negative microorganismsComplicated Urinary Tract Infection (cUTI) (including pyelonephritis); For the treatment of adult patients (18 years and above) caused by susceptible Gram-negative microorganismsHospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP)。

       Pseudomonas aeruginosa (PA) and Enterobacterales are common Gram-negative bacteria causing hospital-acquired infections in China, accounting for 47.1% of pathogens isolated from HAP.^[1]PA is characterized by easy colonization, high variability, and multidrug resistance. ^[2]Studies show that the proportion of drug-resistant PA is high among patients with various types of infections in China, of which 57.3% are multidrug-resistant Pseudomonas aeruginosa (MDRPA). ^[3]The issue of drug resistance directly increases the burden of clinical treatment —— the mortality rate of lower respiratory tract infections caused by MDRPA is high, and treatment is difficult.^[2]Studies have shown that patients with MDRPA respiratory tract infections have increased mortality rates, longer hospital stays, and higher 30-day readmission rates. ^[4]。

       Moreover, the challenges posed by extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) are becoming increasingly severe. Studies show that the detection rate of ESBL-producing Escherichia coli in patients with urinary tract infections is as high as 62%. ^[5], whose early appropriate treatment and improvement of prognosis have become an important issue that urgently needs to be addressed in clinical practice. ^[6]。

In this regard, Professor Yu YunSong, Honorary Chairman of the Infectious Diseases Professional Committee of the Chinese Medicine Education Association, Vice President of Zhejiang Provincial People's Hospital, and Head of the Infectious Diseases DepartmentIt was pointed out: "Against the increasingly severe backdrop of antimicrobial resistance, infections caused by multidrug-resistant organisms have become a significant challenge in clinical anti-infective treatment. Cefoperazone Sulbactam Sodium for Injection (Zhuo Li Da)^®) The approval within China provides a new option for clinical challenges in drug-resistant bacterial infections. Especially at a time when the issue of antimicrobial resistance is becoming increasingly prominent, Zolida^®"Provides new options for the treatment of MDRPA and ESBL infections. We look forward to this new enzyme inhibitor combination drug aiding clinicians in addressing increasingly complex drug-resistant infections in clinical practice, offering patients a new therapeutic choice."

Dr. Zhengqing Li, Senior Vice President of MSD Global and President of MSD China R&D CenterSaid: "This time, MSD^®The approval will bring an innovative option for clinical challenges in PA and ESBL-E infections. As a leader in the anti-infective field, MSD has long been committed to addressing clinical needs in bacterial treatment, especially in drug-resistant bacteria treatment. The company continuously strengthens its investment in the R&D of new antibacterial drug pipelines, aiming to solve key issues in resistance management and provide Chinese patients with more effective and safe treatment options. Building on its profound expertise in the antibiotic field, MSD will continue to focus on clinical needs, driven by innovation, to bring cutting-edge drugs to more patients in China.

About MSD

      At MSD (the corporate name of Merck & Co., Inc. in the United States, located in Rahway, New Jersey), we work together to pursue a shared goal: harnessing the power of cutting-edge science to save lives and improve health worldwide. For over 130 years, we have brought hope to humanity by developing vital medicines and vaccines. We are committed to being a leading research-intensive biopharmaceutical company—today, we stand at the forefront of innovation, delivering transformative solutions to advance the prevention and treatment of diseases in humans and animals. We have built a diverse and inclusive global workforce, operating responsibly every day to ensure a safe, sustainable, and healthy future for all people and communities. For more information, visit www.msd.com and follow us on X (formerly Twitter), LinkedIn, and YouTube. 

About MSD China

      China is a crucial part of MSD's global growth strategy. MSD’s China headquarters is located in Shanghai, with a research and development center in Beijing and manufacturing plants in Hangzhou, Ningbo, and Tianjin, integrating R&D, manufacturing, and commercial operations. We are fully committed to providing high-quality innovative medicines, vaccines, and services to the people of China, benefiting Chinese society. For more information, please visit MSD China's official website or follow MSD China's official social media accounts on WeChat.

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[1] Yin Y et al. Eur J Clin Microbiol Infect Dis 2021;40:683-90

[2]Infectious Diseases Group of the Respiratory Branch of the Chinese Medical Association. Expert Consensus on Diagnosis and Treatment of Pseudomonas aeruginosa Lower Respiratory Tract Infections in China (2022 Edition) J. Chinese Journal of Tuberculosis and Respiratory Diseases, 2022; 45(8): 739-752.

[3] Yu W, et al. Int J AntimicrobAgents. 2023 Apr;61(4):106741.

[4] Tabak YP, et al. J Hosp Infect.2019;103(2):134-141.

[5]Han Mingming, Yuan Yue, Analysis of Extended-Spectrum Beta-Lactamase Producing Escherichia coli in Urinary Tract Infections. International Journal of Urology and Nephrology, 2024, 44(02): 260-264.

[6]Zhou Hua, Li Guanghui, Chen Baiyi, et al. Expert Consensus on Response Strategies for China-Produced Extended-Spectrum β-Lactamase-Producing Enterobacteriaceae Infections. National Medical Journal of China, 2014, 94(24):1847-1856.