Merck's Imipenem/Cilastatin/Relebactam Approved in China, Offering a Novel Therapeutic Option Against CRE Infections

       Shanghai, China, December 3, 2024 — MSD (the corporate name of Merck & Co., Inc., Kenilworth, NJ, USA) announced that its new carbapenem/enzyme inhibitor combination formulation, Imipenem/Cilastatin for injection, has been approved by the National Medical Products Administration of China. It is indicated for the treatment of the following infections caused by susceptible Gram-negative bacteria in patients aged 18 years and older: hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP); complicated urinary tract infections (cUTI), including pyelonephritis, with limited or no alternative treatment options; and complicated intra-abdominal infections (cIAI) with limited or no alternative treatment options.

       Bacterial resistance is a major challenge in the field of global public health, among which the threat posed by carbapenem-resistant Enterobacteriaceae (CRE) is particularly severe. CRE refers to Enterobacteriaceae that are resistant to any one of the carbapenem antibiotics such as imipenem, meropenem, ertapenem, or doripenem, or those confirmed to produce carbapenemase.^[1]Data from the China Bacterial Resistance Surveillance Network (CHINET) shows that the incidence of CRE infections in China was 12.5% in 2014, 22.9% in 2016, and rose to 26.8% in 2019. Compared with 2015, the incidence of CRE in China increased by more than 58% in 2023.^[2]。

       CRE infections mostly occur in patients with severe underlying diseases, immunodeficiency, and/or prolonged repeated use of broad-spectrum antibiotics. The condition tends to be relatively severe after infection, with limited treatment options.^[1]Posing a significant threat to clinical diagnosis and treatment as well as patient prognosis — the overall in-hospital mortality rate for patients with CRE infections is 46.2%.^[3]。Due to the certain limitations in the efficacy of existing antibacterial drugs when used as monotherapy^[1], how to more effectively respond to CRE infections is currently the most challenging issue in the field of anti-infectives.

       Professor Xiao Yonghong, President of the Infectious Disease Physicians Branch of the Chinese Medical Doctor Association and member of the National Health Commission's Expert Committee on Rational Drug Use, stated: "The battle between humanity and drug-resistant bacteria is destined to be a protracted one. The approval of the new carbapenem/enzyme inhibitor combination formulation—Imipenem/Cilastatin/Relebactam (Imipenem/Cilastatin/Relebactam for Injection)—will effectively aid clinicians in addressing the challenges of treating CRE infections. It is expected to become a crucial drug for CRE treatment, providing a strong line of defense for patients with multidrug-resistant bacterial infections."

       Dr. Li Zhengqing, Senior Vice President of MSD Global and President of MSD China Research and Development Center, stated: "At a time when antibiotic resistance is becoming increasingly severe, as a leader in the anti-infective field, MSD has always been at the forefront of fighting infections, committed to promoting the research and development of safe and effective new antibacterial drugs. The approval of Imacep Injection reflects MSD's deep accumulation in the field of antibiotics and its continuous investment in the innovative drug R&D pipeline, providing a new option for the clinical treatment of drug-resistant infections. MSD will continue to support the development of China's healthcare industry, accelerate the introduction of more cutting-edge innovative drugs to Chinese patients, save lives, and protect health."

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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 the people of China with high-quality innovative medicines, vaccines, and services for the benefit of Chinese society. For more information, please visit the MSD China official website or follow MSD China's official social media account on WeChat.

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[1]Expert Consensus on Diagnosis, Treatment, and Prevention of Carbapenem-Resistant Enterobacteriaceae Infections in China[J]. Chinese Medical Journal, 2021, 101(36): 2850-2860.

[2]Qian Shuyu, Li Tiejun. Research progress on the resistance mechanisms of carbapenem-resistant Enterobacteriaceae[J]. 2024.

[3] Zhou C, Jin L, Wang Q, et al. Infect Drug Resist. 2021;14731-742