On November 12, Xinnova reported that China’s National Medical Products Administration had approved its in-house Class 1 drug imipenem–cilastatin–funobactam for injection for hospital-acquired and ventilator-associated bacterial pneumonia. It is the company’s first marketing approval since its September 16 STAR Market listing. The product combines imipenem and cilastatin sodium with the novel beta-lactamase inhibitor funobactam.
Results from the multinational Phase III trial appeared in The Lancet Infectious Diseases on November 4. Imipenem–cilastatin–funobactam was noninferior to imipenem–cilastatin–relebactam for day-14 all-cause mortality. Funobactam inhibits several beta-lactamases, including class D enzymes commonly found in Acinetobacter baumannii. The filing cited carbapenem resistance of approximately 60% to 70% in A. baumannii from relevant cases in large Chinese general hospitals.
China accepted the marketing application in July 2025. In the US, the product has received Fast Track and Qualified Infectious Disease Product designations. The company has built a sterile powder facility with annual capacity of three million vials and plans to reach Chinese tertiary hospitals through its own promotion team and distribution partners.

Source: http://finance.eastmoney.com/a/202611133930524841.html