2025-03-18

Global Development: Fobeni’s Novel β-Lactamase Inhibitor Demonstrates Positive Results in International Multi-Center Phase III Clinical Trial

March 18th, 2025— Fobeni Healthcom Pharmaceutical Jiangsu Company (hereinafter referred to as "Fobeni"), a joint venture established by Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (hereinafter "Fosun Pharma") and Marubeni Corporation (hereinafter "Marubeni"), announced the positive results from a double-blind controlled trial (OP0595-5 Trial) for the novel β-lactamase inhibitor (generic name:Nacubactam; hereinafter "the Investigational Drug") in patients with complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AUP). This trial was conducted in collaboration with Meiji Seika Pharma Co., Ltd. (hereinafter "Meiji Seika Pharma").


The OP0595-5 trial is an international, multi-center, Phase III study comparing the efficacy and safety of cefepime or aztreonam in combination with the Investigational Drug versus imipenem/cilastatin (a carbapenem antibiotic) in patients with complicated urinary tract infections or acute uncomplicated pyelonephritis. Non-inferiority and superiority of cefepime/the Investigational Drug versus imipenem/cilastatin were demonstrated for the primary endpoint of composite clinical and microbiological success at 7 days after the end of treatment. Additionally, non-inferiority of aztreonam/the Investigational Drug versus imipenem/cilastatin was confirmed. Regarding safety, the incidence of adverse events was comparable between either cefepime/the Investigational Drug or aztreonam/the Investigational Drug and imipenem/cilastatin, and no major clinical safety concerns were identified.

Further details and data will be presented at scientific conferences and in publications.

 The Investigational Drug is advancing into international multi-center Phase III clinical trials (OP0595-6 Trial), targeting patients with Carbapenem-resistant Enterobacterales (CRE) infections—a critical challenge in global healthcare. Fobeni aims to develop a new solution in the fight against Antimicrobial Resistance (AMR),which is recognized as a silent pandemic.


About Shanghai Fosun Pharmaceutical (Group) Co., Ltd.


Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196.SH, 02196.HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.


Fosun Pharma is patient-centered and unmet clinical needs-oriented. Through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and industrial investment, the company continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. Fosun Pharma's innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation. It also strengthens core technology platforms such as antibodies/ADC, cell therapy, and small molecules.


Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma adheres to the business philosophy of "Innovation for Good Health", continues to promote innovative transformation, actively deploys internationalization, strengthens business focus by product lines, promotes integrated operations and efficiency improvement, and is dedicated to being the global leading integrator of pharmaceutical and healthcare innovation.

About Meiji Seika Pharma Co., Ltd.


Established in 1916 and headquartered in Tokyo, Japan, Meiji Seika Pharma is a pharmaceutical company under Meiji Holdings Co., Ltd. As a market leader in the anti-infectives field, it offers a diverse portfolio including preventive vaccines and therapeutic antibiotics. Leveraging advanced science and R&D capabilities, the company delivers innovative and reliable medicines while improving accessibility and cost-efficiency through high-quality generic drugs.


AboutFobeni Healthcom Pharmaceutical Jiangsu


A joint venture betweenFosun PharmaandMarubeni, Fobeni was established in 2018 with headquarters inTaizhou, Jiangsu Province, and a branch in Shanghai. To date, the company has successfully collaborated with multiple Japanese pharmaceutical companies to develop and commercialize products in China. The clinical development of OP0595 in Mainland China, excluding the regions of Hong Kong, Macau, and Taiwan, is being diligently pursued by Fobeni. As a bridge forSino-Japanese cooperationand a pioneer in healthcare innovation, Fobeni is dedicated to delivering high-quality therapeutic products and services to patients in both countries.