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SHANGHAI, Oct. 7, 2022 /PRNewswire/ -- Everest Medicines Limited (HKEX 1952.HK, "Everest Medicines", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asia, announced today that the Department of Health of the Hong Kong Special Administrative Region, China, has approved a New Drug Application (NDA) for XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in Hong Kong.
"The regulatory approval in Hong Kong marks another important milestone for Everest Medicines and reinforces our commitment to help patients with limited choices of effective treatment options," said Sunny Zhu, Chief Medical Officer for Infectious Diseases at Everest Medicines. "cIAI remains as a major bacterial infectious disease in clinics and the increasing multi-drug resistance bacterial related infection presents a significant and growing public health concern. We are pleased that this approval will make available a new and innovative option for patients and physicians in Hong Kong in the management of serious infectious diseases and we look forward to bringing this important therapy to other parts of Asia including mainland China."
Everest Medicines has exclusive rights to develop and commercialize XERAVA in Greater China, South Korea, and the key markets of South East Asia, under a licensing agreement with Tetraphase Pharmaceuticals, Inc. (a wholly owned subsidiary of La Jolla Pharmaceutical Company). XERAVA was approved for the treatment of cIAI in adults in Singapore in April 2020 and is currently under regulatory review for cIAI in mainland China and the Taiwan region.
Since 2020, XERAVA has been recommended in multiple global treatment guidance issued by Infectious Disease Society of America's (IDSA) and European Society of Clinical Microbiology and Infectious Diseases (ESCMID) as a treatment choice for multi drug resistant gram-negative bacterial infections including Carbapenem resistant organisms. Meanwhile, it was included in an expert consensus on the multidisciplinary management of intra-abdominal infections by the Chinese Society of Surgery of Chinese Medical Association, Infectious Diseases Society for Evidence-based and Chinese Research Hospital Association and the Editorial Board of Chinese Journal of Surgery.
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 and Gram-positive 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 and Singapore and the medicine is currently under review for cIAI in Greater China. Everest Medicines is also developing XERAVA for the treatment of community-acquired bacterial pneumonia (CABP). XERAVA is licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of La Jolla Pharmaceutical Company. For more information, please visit https://www.xerava.com/.
About Complicated Intra-Abdominal Infections
Complicated intra-abdominal infections (cIAI) are a type of major hospital- or community-acquired infection which extend beyond the source organ into the peritoneal space and can result from perforation of or damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. cIAI is caused by different bacterial pathogens, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria. In 2018, there were 2.9 million cIAI patients in China alone, with increasing rates of infections caused by drug-resistant bacteria, which limits the effectiveness of currently available antibiotics.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products 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 of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eleven potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. 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.
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SOURCE Everest Medicines