Everest Medicines, a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today XERAVA® (eravacycline) has been successfully launched in China with its first prescription issued at Huashan Hospital affiliated to Fudan University. The commercialization of XERAVA® in China marks Everest's transformation into a commercial-stage innovative biopharmaceutical company.

XERAVA® (eravacycline) is the world's first fluorocycline antibiotic for the treatment of infections caused by susceptible gram positive, gram negative and anaerobic pathogens including multidrug resistant ("MDR") isolates. It was approved by the National Medical Products Administration ("NMPA") of China for the treatment of complicated intra-abdominal infections ("cIAI") in adult patients in March 2023, and has been recommended by multiple treatment guidelines in China and globally, based on its broad bacterial spectrum coverage and high potency against multidrug-resistant bacterial infections.

"The commercialization of XERAVA® in China is a significant milestone for Everest as a company, as this marks the beginning of Everest as a commercial-stage biopharma company. I want to thank everyone involved in bringing XERAVA® to a successful launch," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "After the commercial launch, we will accelerate patient access to XERAVA® with a lean commercial team, following a highly efficient commercial strategy. The company will continue to advance the approval and commercialization of other first-in-class or best-in-class drug candidates such as Nefecon to further address urgent unmet needs in China and the rest of Asia."

"Eravacycline has broad antibacterial spectrum and high potency against common clinical multi-drug resistant bacteria such as ESBL-producing bacteria, CRE, CRAB, MRSA and VRE," said Dr. Zhu Duming, leader and chief physician of the Critical Care Department at Zhongshan Hospital Affiliated with Fudan University. "It has been recommended by authoritative guidelines at home and abroad for the treatment of MDR Gram-negative bacterial infections. The launch of eravacycline in China will help doctors tackle the challenges of clinical drug resistance."

"Patients with malignant hematological diseases have a high incidence of neutropenia and fever caused by radiotherapy, chemotherapy, and hematopoietic stem cell transplantation. Antibacterial treatment is very important for patients with neutropenia and fever as MDR/Carbapenem-resistant Organism ("CRO") infections have high mortality rates," said Sun Aining, chief physician at the First Affiliated Hospital of Soochow University. "As the world's first fluorocycline antibiotic, eravacycline has completed phase II/III clinical trials and multiple real-world studies around the world to demonstrate that it has good clinical efficacy and safety profiles. It is an innovative choice for the treatment of MDR/CRO infections."

In addition to XERAVA®, Everest anticipates the launch of three additional innovative drugs in China over the next two years, including Nefecon, the first-in-disease treatment for adults with primary immunoglobulin A nephropathy (IgAN) and expected to be approved in China in the second half of this year. In the infectious disease space, Everest is actively developing other important drug candidates to meet the urgent demand for innovative antibacterial treatment. The company plans to file New Drug Application for cefepime-taniborbactam in China this year for complicated urinary tract infection. In immunology, etrasimod is a next-generation, oral selective sphingosine 1-phosphate (S1P) receptor modulator with a differentiated efficacy and safety profiles. The company aims to submit NDA in Everest territories as soon as possible.

 

Source: prnewswire.com

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