▎WuXi AppTec Content Team Report

Yaxirui Lai is a compound preparation of imipenem, cilastatin, and relebactam. Among them,Imipenem is an approved β-lactam antibiotic, cilastatin prevents imipenem from being degraded by the kidneys, and relebactam is a diazabicyclooctane β-lactamase inhibitor with broad-spectrum anti-β-lactamase activity.Although β-lactamase inhibitors themselves do not have antibiotic activity, they can enhance the activity of β-lactam antibiotics.

In July 2019, Yasirui came to the United States for the first time.Approved for Marketing, marketed under the brand name Recarbrio, for the treatment ofComplicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by specific susceptible Gram-negative bacteriaIn June 2020, Yasirui was approved by the U.S. FDA.Extended Indications, treating HABP/VABP patients aged 18 years and above.The product has previously received the FDA's Qualified Infectious Disease Product (QIDP) designation, Fast Track status, and Priority Review status.

In China, according to the Drug Clinical Trial Registration and Information Disclosure Platform, MSD has completed aInternational Multicenter (including China)Phase 3, randomized, double-blind clinical trial,Comparison of Yaxirui Lai and in HABP/VABP SubjectsPiperacillin + Tazobactam (PIP/TAZ)Safety, Tolerability, and Efficacy。

RecarbrioThe approval in the U.S. for the treatment of HABP/VABP was based on the results of a pivotal Phase 3 RESTORE-IMI 2 trial. In this trial, 264 patients received Recarbrio, and 267 patients were treated with piperacillin/tazobactam (PIP/TAZ). The study met its primary and key secondary endpoints. Within 28 days of treatment, 15.9% of patients treated with Recarbrio died, compared to a mortality rate of 21.3% in patients receiving piperacillin/tazobactam.

HABP/VABP is a type of pneumonia that often occurs in hospitalized patients and can cause symptoms such as fever, chills, cough, chest pain, and increased oxygen demand. Due to the overuse of antibiotics, many bacteria causing HABP and VABP have developed resistance to existing antibiotics. Therefore, patients need new antibiotics to control bacterial infections.

We look forward to the approval of Asiria in China, which will enable patients with severe bacterial infections in China to access safe and effective new therapies as soon as possible.

[1] Drug Approval Certificate Delivery Information on December 2, 2024. From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241202104249182.html

[2] FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP). Retrieved Jun 5, 2024, from https://www.businesswire.com/news/home/20200605005187/en/

[3] Drug Clinical Trial Registration and Information Disclosure Platform. From http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml