Everest Medicines Announces Official Publication of the Specifications for Antimicrobial Susceptibility Testing of Eravacycline (2025)

SHANGHAI, June 23, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the Specifications for Antimicrobial Susceptibility Testing of Eravacycline (2025) (hereinafter referred to as the "Specifications") have been officially published in the Chinese Journal of Laboratory Medicine. The Specifications aim to offer standardized protocols for microbiology laboratory professionals and clinicians to conduct and interpret in vitro antimicrobial susceptibility testing (AST) of eravacycline. It supports rational clinical use of eravacycline based on standardized evidence and enhances the accuracy and consistency of susceptibility testing results across clinical microbiology laboratories, thereby better addressing the challenges of treating multidrug-resistant (MDR) and complicated infections.

The Specifications were jointly developed by the Expert Committee of the National Health Commission on Antimicrobial Susceptibility Testing and Standard Research (hereinafter referred to as the "ChinaCAST"), the Clinical Microbiology Laboratory Specialized Committee of Chinese Hospital Association, and the Chinese Committee on Antimicrobial Susceptibility Testing, affiliated to the European Committee on Antimicrobial Susceptibility Testing (EUCAST).

As a novel fluorocycline antimicrobial, eravacycline possesses broad-spectrum antibacterial coverage, potent activity, and favorable safety and efficacy in comparison to a carbapenem in the registrational trials. It is widely applied in the treatment of multidrug-resistant (MDR) pathogens and complicated intra-abdominal infections. The Specifications comprehensively outline three key areas: the antimicrobial mechanism and features of eravacycline, the AST methods, and clinical breakpoints for result interpretation. It emphasizes the standardization of procedures and accuracy of interpretation, and covers leading AST methodologies including broth microdilution, gradient diffusion (MTS/Etest), and disk diffusion methods, along with defined quality control parameters and interpretive criteria.

This publication complements the China clinical breakpoints for eravacycline released by ChinaCAST in 2024, creating a unified technical framework that integrates breakpoint definitions with standardized testing protocols. These breakpoints were established based on thorough evaluation of international standards, including those from EUCAST and the FDA, and were further informed by the latest in vitro and clinical research data from China and other global regions. The clinical breakpoints include minimum inhibitory concentration (MIC) and zone diameter criteria for common pathogens such as Staphylococcus aureus, Enterococcus faecalis, Enterococcus faecium, Streptococcusanginosus group, Bacteroides fragilis, Acinetobacter baumannii, Klebsiella pneumoniae, and Escherichia coli. Eravacycline is the first and currently the only antimicrobial agent to have been granted China-specific clinical breakpoints following formal expert evaluation by ChinaCAST. This publication and the granting of China's clinical breakpoints for eravacycline mark a milestone in establishing China's national antimicrobial susceptibility standards.

"The publication of Specifications for Antimicrobial Susceptibility Testing of Eravacycline (2025) in the Chinese Journal of Laboratory Medicine marks a pivotal transition for China's antimicrobial susceptibility testing standards from adopting international references to independent formulation, " said Professor Yingchun Xu, The inaugural chairman of the Chinese Committee of the EUCAST (European Committee on Antimicrobial Susceptibility Testing) and Chair of the Department of Clinical Laboratory Diagnostics, Peking Union Medical College. "The establishment of clinical breakpoints for eravacycline, a novel drug approved by China's NMPA, will ensure procedural standardization and result accuracy of Antimicrobial Susceptibility Testing of eravacycline in clinical laboratories, achieving 'standardization and uniformity.' This advancement will guide rational clinical use of new antimicrobial agents, expand treatment options, and improve patient prognoses, while significantly contributing to Combating Bacterial Resistance. According to the final report of the "Comprehensive Evaluation Project on the Clinical Application of Eravacycline.", released by the National Health Commission of China, the efficacy of eravacycline in treating drug-resistant bacterial infections, especially in ICU and hematology applications, has brought significant clinical benefits to patients."

"Currently, antimicrobial resistance has been listed by the World Health Organization as one of the top ten public health threats globally, bringing a heavy disease burden to human health. The official publication of the Specifications for Antimicrobial Susceptibility Testing of Eravacycline (2025) marks a critical step toward the standardized clinical application of XERAVA^® (eravacycline)." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "The Specifications provides clinical microbiology laboratories with a standardized procedural pathways and evidence-based practice guideline, helping to enhance the consistency of susceptibility testing procedures and the accuracy of result reporting. This will enable more patients threatened by drug-resistant infections to benefit from eravacycline-based therapies. Furthermore, it establishes a robust foundation for ensuring the rational clinical use of XERAVA^® in the treatment of complicated infections thereby facilitating its inclusion in clinical pathways and treatment guidelines to maximize its value in combating resistant bacterial infections. As the first and only flourocycline antibiotic, eravacycline has been recommended by multiple domestic and international treatment guidelines. It is also included in the WHO's updated 2024 list of antimicrobials of high medical importance."

The Comprehensive Evaluation Project, led by the National Health Commission's Expert Committee on Clinical Use of Antimicrobials and Evaluation of Antimicrobial Resistance,  began in September 2023, and the data analysis was completed in November 2024. A total of 3,369 cases from 839 physicians across 231 hospitals nationwide were collected. Six final reports were released, including one overall project data analysis report and five specialty reports. The final report showed a 91.1% overall efficacy rate after 3 days of eravacycline treatment, and the 90.1% at the end of treatment.

In March 2024, the World Health Organization (WHO) updated its list of "Medically Important Antimicrobials" (MIA). Based on the novel modification of the tetracycline side chain, which significantly changes its resistance mechanisms, the WHO categorized fluorocycline as a new class of antimicrobial drugs, with eravacycline as the only drug in this class.

XERAVA^® was approved by the National Medical Products Administration (NMPA) of China in March 2023 and commercially launched in July. Its antibacterial spectrum covers a wide range of clinically relevant bacteria, including Gram-negative, Gram-positive, anaerobic bacteria. Eravacycline has been included in several clinical guidelines and expert consensuses, such as the 2023 edition of China's "Diagnosis, Treatment, and Prevention Guidelines for Carbapenem-Resistant Gram-Negative Organisms (CRO) Infections".

About XERAVA^® (eravacycline)

XERAVA^® (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative, Gram-positive and anaerobic pathogens, including those pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. XERAVA^® is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK, Singapore, mainland China, Hong Kong, and Taiwan. XERAVA^® was licensed to Everest by Tetraphase Pharmaceuticals, Inc., an affiliate of Innoviva Specialty Therapeutics, Inc.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

Forward-Looking Statements:

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

source: Everest Medicines