Jinan Zhuocheng Bio-Tech Co., Ltd.

Approval Strengthens Domestic Supply Chain for Last-Resort Antibiotics Against Multidrug-Resistant Infections

July 8, 2026 — According to information released by China's National Medical Products Administration (NMPA), Fukang Pharmaceutical has officially received marketing approval for its Polymyxin B Sulfate Active Pharmaceutical Ingredient (API). The Drug Master File (DMF) registration status has been updated to "A" (Active), indicating that the API has successfully passed regulatory review and is now authorized for commercial manufacturing and supply to pharmaceutical formulation manufacturers.

The approval represents another important milestone in strengthening China's domestic supply of critical anti-infective APIs, particularly for the treatment of multidrug-resistant (MDR) Gram-negative bacterial infections.

A "Last-Resort" Antibiotic Regains Strategic Importance

Polymyxin B Sulfate is a cyclic polypeptide antibiotic produced through the fermentation of Paenibacillus polymyxa. Although considered a long-established antibiotic, its clinical importance has grown significantly with the global rise of carbapenem-resistant bacterial infections.

According to data released by the China Antimicrobial Resistance Surveillance System (CHINET) 2025, resistance rates of carbapenem-resistant Pseudomonas aeruginosa to polymyxin B remain as low as 0.7%. The antibiotic also maintains strong activity against other critical multidrug-resistant pathogens, including Acinetobacter baumannii and Klebsiella pneumoniae, making it one of the internationally recognized last-line treatment options for severe Gram-negative bacterial infections.

Mechanistically, polymyxin B binds to lipopolysaccharides (LPS) on the bacterial outer membrane through electrostatic interactions, displacing calcium and magnesium ions, disrupting membrane integrity, and rapidly killing bacteria. This unique mechanism also enables synergistic activity when combined with carbapenems, tigecycline, and other antimicrobial agents, providing valuable options for salvage therapy in critically ill patients.

API Approval Enhances Domestic Supply Chain

Industry observers note that China's supply of compliant polypeptide antibiotic APIs has historically been limited, with formulation manufacturers relying heavily on imported materials or a small number of domestic suppliers. This has created challenges in supply stability, procurement costs, and product development.

The approval of Fukang Pharmaceutical's Polymyxin B Sulfate API is expected to expand the domestic supply base for high-end anti-infective raw materials and support the development and registration of injectable and topical formulations.

A stable supply of regulatory-compliant APIs can significantly shorten the review timeline for formulation products under China's associated review and approval system while reducing the risk of supply interruptions during commercialization.

For healthcare providers, broader availability of domestically manufactured polymyxin B formulations could improve access to life-saving treatments in intensive care units (ICUs), transplant centers, respiratory medicine departments, and other settings managing severe multidrug-resistant infections.

Demonstrating Strength in Fermentation-Based API Development

According to company information, the approval followed comprehensive optimization of fermentation processes, extensive quality research, and completion of the full regulatory registration procedure, highlighting Fukang Pharmaceutical's technical capabilities in microbial fermentation-derived pharmaceuticals.

The successful approval also marks another step forward in the company's strategic expansion into the critical care anti-infective market and demonstrates its growing expertise in the research, development, and manufacturing of therapies targeting antimicrobial resistance.

As global concern over antimicrobial resistance continues to increase, the commercialization of high-quality domestic APIs such as Polymyxin B Sulfate is expected to play an increasingly important role in strengthening pharmaceutical supply chain resilience and improving access to essential anti-infective medicines.