Zhitong Finance App News, Fosun Pharmaceutical (02196) announced that the company's holding subsidiary Fuhong Kanghe Pharmaceutical Jiangsu Co., Ltd. and Japan's Meiji Seika Pharma Co., Ltd. (“Meiji Pharmaceutical”) jointly developed OP0595 (generic name: Nacubactam; hereinafter referred to as “this new drug”) with cefepime or aztreonam in China for adults with limited treatment plans. (not included (Hong Kong, Macao and Taiwan regions, same below) recently initiated two phase III clinical trials, including (1) a phase III clinical trial evaluating the efficacy and safety of cefepime/the new drug or aztreonam/this new drug compared to imipename/cilastatin in treating complex adult urinary tract infections or acute simple pyelonephritis; and (2) a phase III clinical trial evaluating the efficacy and safety of cefepime/the new drug in treating complex acute urinary tract infections caused by carbapenem resistant enterobacteria in adults compared to existing best treatments Simple pyelonephritis, hospital-acquired bacterial pneumonia, and respirator correlation Phase III clinical trial of efficacy and safety of bacterial pneumonia and complicated abdominal infections.
The new drug is being developed to intravenously intravenously inject a novel beta-lactamase inhibitor. It is intended for use in adults with limited treatment options for aerobic gram-negative bacterial infections, including infections caused by carbapene-resistant Enterobacter bacteria.
As of the date of this announcement, the new drug was co-administered with cefepime or aztreonam and is in phase I clinical trials for adult aerobic gram-negative bacterial infections with limited treatment options in China. The two phase III clinical trials initiated this time are all part of an international multi-center clinical trial of the new drug carried out by Meiji Pharmaceutical.
As of February 2024, the Group (i.e. the company and its holding subsidiaries/units) has invested approximately RMB 26.63 million in R&D of this new drug at this stage (unaudited).
As of the date of this announcement, drugs approved for marketing globally to treat drug-resistant gram-negative bacterial infections include imipename/cilastadine/relaibactan, ceftazidime, avibactan, etc. According to the latest data from IQVIAMIDAS, in 2022, the total global sales volume of the aforementioned drugs approved for marketing to treat drug-resistant gram-negative bacterial infections was approximately USD 5,047 million.