On July 8, 2025, Evopoint
announced the official acceptance of New Drug Application (NDA) by National Medical Products Administration
(NMPA)for its investigational category 1 new drug Imipenem/Cilastatin/Funobactam
for Injection (acceptance No. CXHS2500074), a first-in-class
β-lactam/β-lactamase inhibitor (BL/BLI) combination therapy. This therapy is
the first BL/BLI combination therapy
globally that is specially designed to target all the three major
carbapenem-resistant organisms (CROs)
with broad-spectrum antibacterial activity. It is indicated in patients with
hospital-acquired bacterial pneumonia and ventilator-associated bacterial
pneumonia (HABP/VABP).
The NDA acceptance for Imipenem/Cilastatin/Funobactam for Injection marks a significant milestone for Evopoint. As an innovative , independently-developed BL/BLI combinational treatment by Evopoint, this therapy has the potential to
enrolled in this this randomized, double-blind, active-controlled study and the results demonstrated:
Superior Efficacy: The investigational combination therapy met the predefined primary endpoint ( Day 14 all-cause mortality rate).
Prominent advantages: The combination therapy (Imipenem/Cilastatin/Funobactam for Injection) outperformed the comparator (Imipenem/Cilastatin Sodium/Relebactam for Injection) in terms of clinical success rate and microbial clearance rate in the carbapenem-resistant population.
Favorable Safety Profile: The combinational therapy was well tolerated, with a safety profile consistent with expectations.
* The study results are planned to be presented at upcoming academic conferences or published in peer-reviewed journals.
02 Addressing the Global Challenge of Antibiotic Resistance
Imipenem/Cilastatin/Funobactam for Injection is effective to treat infections caused by all the three major drug-resistant pathogens identified by the World Health Organization (WHO) as high-priority threats:
- Carbapenem-resistant Acinetobacter baumannii (CRAB)
- Carbapenem-resistant Enterobacteriaceae (CRE)
- Carbapenem-resistant Pseudomonas aeruginosa (CRPA)
Drug resistance remains a critical global public health challenge. Data from the China Antimicrobial Resistance Surveillance System (CARSS) highlight the persistently high prevalence of CROs and the limited availability of effective treatment options. In response, Evopoint is committed to delivering innovative solutions to this challenge since its establishment. Funobactam (XNW4107) demonstrated broader and more potent enzyme inhibiting activities compared to other β-lactamase inhibitors such as Avibactam and Relebactam, effectively decreased the enzyme activities of commonly expressed Class A, C and D β-lactamases in Gram-negative bacteria, especially the OXA-23 enzyme activity in CRAB as well as the KPC and OXA-48 enzyme activities in CRE.
03 Broad Market Prospects
Jason Le, CEO of Evopoint, remarked:
“The acceptance of the NDA for Imipenem/Cilastatin/Funobactam for Injection marks a significant breakthrough in Evopoint’s pursuit of excellence in the anti-infectives field. Evopoint is always committed to improving global health through scientific innovation. We will work closely with regulatory authorities to accelerate the approval and commercialization of this novel therapy to provide a high-quality treatment option to the clinic and to improve public health.”
The NDA acceptance for Imipenem/Cilastatin/Funobactam for Injection marks a significant milestone for Evopoint. As an innovative , independently-developed BL/BLI combinational treatment by Evopoint, this therapy has the potential to become the only broad-spectrum, highly potent antibacterial therapy to treat HAVB/VABP caused by major drug-resistant pathogens in the market, providing a brand new treatment option for HABP/VABP patients in China. The combination therapy may significantly improve the clinical outcome.
For more detailed information and updates, please follow Evopoint’s official news.
Forward-looking Statement
This press release contains forward-looking statements based on the company’s current expectations and beliefs. Actual results may differ materially due to a variety of factors.
*Note: This press release is for informational purposes only and does not constitute any investment advice. Evopoint does not endorse the use of any unapproved drug or indication. For more information about diseases, drugs, diagnosis, or treatment, please consult a qualified healthcare professional.
