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2024-12-03

Merck's Imidazolid injection approved in China provides an innovative option for clinical response to CRE infection challenges
China Business Network, December 3rd. Merck announced today that its new carbapenem/enzyme inhibitor combination formulation, imipenem for injection, has been approved by the National Medical Products Administration for the treatment of the following infections caused by sensitive Gram-negative bacteria in patients aged 18 years and above: hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP); complicated urinary tract infections (cUTI) (including pyelonephritis) with limited treatment options or no alternative treatments; and complicated intra-abdominal infections (cIAI) with limited treatment options or no alternative treatments.

Bacterial resistance is a major challenge to global public health, and the threat posed by carbapenem-resistant Enterobacteriaceae (CRE) is particularly severe. CRE refers to Enterobacteriaceae that are resistant to any of the carbapenem antibiotics, imipenem, meropenem, ertapenem, or doripenem, or that are confirmed to produce carbapenemases. Data from the China Antimicrobial Resistance Monitoring Network (CHINET) show that the incidence of CRE infections in my country was 12.5% in 2014, 22.9% in 2016, and 26.8% in 2019. Compared with 2015, the incidence of CRE in my country increased by more than 58% in 2023.

CRE infections often occur in patients with severe underlying medical conditions, immunodeficiency, and/or long-term, repeated use of broad-spectrum antibiotics. These infections are relatively severe, and treatment options are limited, posing a significant threat to clinical diagnosis and treatment, as well as patient outcomes. The overall in-hospital mortality rate for CRE-infected patients is 46.2%. Given the limitations of existing monotherapy antibiotics, finding a more effective solution to CRE infections remains one of the most challenging challenges in the current anti-infective field.

Professor Xiao Yonghong, President of the Infectious Diseases Physicians Branch of the Chinese Medical Doctor Association, member of the Expert Committee on Rational Drug Use of the National Health Commission, and Professor of the First Affiliated Hospital of Zhejiang University School of Medicine, said that the fight between humans and drug-resistant bacteria is destined to be a protracted war. The approval of the new carbapenem/enzyme inhibitor combination preparation - imipenem/cilastatin/relebactam (imipenem for injection) will effectively help the clinic cope with the dilemma of CRE treatment and is expected to become an important drug for the treatment of CRE, building a strong lifeline for patients infected with multidrug-resistant bacteria.

Dr. Zhengqing Li, Senior Vice President of Merck and President of the China R&D Center, said: "At a time when antibiotic resistance is becoming increasingly serious, Merck, as a leader in the anti-infective field, has always been at the forefront of the fight against infection and is committed to promoting the development of safe and effective new antibacterial drugs. The approval of imipenem for injection embodies Merck's deep accumulation in the field of antibiotics and its continued investment in the innovative drug R&D pipeline, which will provide new options for the clinical treatment of drug-resistant infections. Merck will continue to support the development of China's medical and healthcare industry, accelerate the introduction of more cutting-edge innovative drugs to Chinese patients, and save lives and protect health."

(Editor: Wang Qingyu)
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