Qilu Pharmaceutical's Polymyxin B Sulfate for Injection (Taizhining®) Approved for Market Launch, Offering New Option for Drug-Resistant Infection Treatment

Recently, Qilu Pharmaceutical's Polymyxin B Sulfate for Injection (Tazhin®) has been approved by the National Medical Products Administration for marketing in China. This polymyxin-class antibiotic will provide a new option for the treatment of drug-resistant bacterial infections, addressing an important clinical need.

Polymyxin B sulfate is a polypeptide antibiotic that increases the permeability of bacterial outer membrane structures by disrupting them, causing cell swelling, leakage of contents, and ultimately leading to bacterial death, achieving the purpose of bacteriostasis. It is clinically used to treat acute and chronic infections caused by multidrug-resistant Gram-negative bacilli, especially urinary tract infections, pulmonary infections, meningitis, and bacteremia caused by susceptible strains of Pseudomonas aeruginosa; it is also suitable for severe infections caused by Enterobacterales or non-fermenting bacteria when treatment with less potentially toxic drugs is ineffective or contraindicated, particularly infections caused by carbapenem-resistant Gram-negative bacteria (CRO)¹.

Data from the 2025 CHINET China Bacterial Resistance Surveillance Network² shows that polymyxin B has the lowest resistance rate against carbapenem-resistant Pseudomonas aeruginosa, at only 0.7%. Unlike colistin, polymyxin B can be directly administered as an active antibiotic. It is primarily metabolized in the body through non-renal pathways, with only 4% excreted via the kidneys, and its metabolism is less affected by renal function³. Polymyxin B acts rapidly, reaching peak plasma concentration shortly after intravenous infusion (1-2 hours), making it more suitable for treating bloodstream infections. Due to its superior pharmacokinetic properties and lower risk of nephrotoxicity in humans, polymyxin B can be preferentially selected for systemic use in invasive infections⁴.

In recent years, the increase in multidrug-resistant Gram-negative bacterial infections, particularly CRO infections, has led to a growing clinical demand for polymyxins. Polymyxin B has become a crucial option for salvage therapy and plays a key role in the frontline treatment of severe infections⁵,⁶. In various domestic and international consensus guidelines, such as the "International Consensus Guidelines for the Rational Use of Polymyxins" and the "Multidisciplinary Expert Consensus on the Rational Clinical Use of Polymyxin Antibiotics in China," polymyxins are recommended as an essential therapeutic option, with their clinical value being widely acknowledged.

In response to significant clinical needs, Qilu Pharmaceutical initiated the development of this product in 2023. Researchers adhered to the "quality by design" development philosophy and conducted a comprehensive pharmaceutical comparison between the self-made product and the reference preparation. The results showed that the quality of the self-made product was equivalent to that of the reference preparation, ensuring the safety and efficacy of the product for clinical use. Taizhining® has now been approved for marketing and is considered to have passed the consistency evaluation. To date, Qilu Pharmaceutical has had 230 products pass the consistency evaluation, 71 of which are the first in China.

The approval and market launch of Qilu Pharmaceutical's Polymyxin B Sulfate for Injection is expected to effectively alleviate the current clinical drug shortage, providing more treatment options for clinicians and patients while further expanding the company’s product portfolio in the anti-infective field. In the future, Qilu Pharmaceutical will continue to research, develop, and produce more high-quality medicines, consistently contributing to the advancement of Healthy China with Qilu’s strength.

References

1、China MedicineInfectious Diseases Professional Committee of the Education Association, Respiratory Disease Branch of the Chinese Medical Association, Critical Care Medicine Branch of the Chinese Medical Association, et al. Multidisciplinary expert consensus on the rational clinical application of polymyxin antibiotics in China [J]. Chinese Journal of Tuberculosis and Respiratory Diseases, 2021, 44(4): 292-310.

2. CHINET China Bacterial Resistance Surveillance Network, First Half of 2025.

3. Neurocritical Care Expert Committee of Neurosurgery Branch of Chinese Medical Doctor Association, Chinese Expert Consensus on the Local Application of Polymyxin for Central Nervous System Infections in Neurocritically Ill Patients (2024 Edition). Chinese Journal of Neurology, 2024, 23(2):109-118.

4. Chen Yijian. International Consensus Guidelines for the Rational Use of Polymyxins[J]. Chinese Journal of Infection and Chemotherapy, 2019, 19(4): 460-463.

5. Asian Society for Critical Care and Emergency Medicine, China Abdominal Critical Care Collaborative Group. Expert Consensus on the Diagnosis and Treatment of Carbapenem-Resistant Bacteria in Complicated Intra-abdominal Infections (2025 Edition). Chinese Journal of Digestive Surgery, 2025, 24(11):1397-1412.

6. Zhaosi Rui, et al., Research Progress on Polymyxin B-Related Nephrotoxicity. Journal of Clinical Medication, 2025, 23(12):1-3.