Qilu Pharmaceutical's Ertapenem Sodium for Injection Gains NMPA Approval as First Domestic Product to Pass Consistency Evaluation

According to the official WeChat account of Qilu Pharmaceutical on the 6th,ItsThe injectable antiviral drug Ertapenem Sodium has been approved for marketing by the National Medical Products Administration, marking the first product in China to pass the consistency evaluation, achieving a successful start in drug development.As of now, Qilu Pharmaceutical Co., Ltd. has a total of 116 products that have passed or are considered to have passed the consistency evaluation, of which 46 are the first in China.

Ertapenem is a new type of carbapenem antibiotic that exerts its antibacterial effect by binding to penicillin-binding proteins, thereby interfering with the synthesis of bacterial cell walls.As a broad-spectrum antibacterial drug, ertapenem exhibits good antibacterial activity against Gram-positive, Gram-negative, aerobic, and anaerobic bacteria. Clinically, it is mainly used to treat secondary intra-abdominal infections, community-acquired pneumonia, complicated urinary tract infections, acute pelvic infections, and bacteremia caused by susceptible bacteria. It can also be used for the prevention of surgical site infections after elective colorectal surgery in adult patients.

Ertapenem Sodium for Injection is characterized by its stability against renal dehydropeptidase, low resistance development, good clinical efficacy, strong tolerability, and long half-life. It is a first-line treatment option for community-acquired infections and can be used in infants aged ≥3 months.

During the development of Qilu Pharmaceutical's Ertapenem Sodium for Injection, researchers adhered to the "Quality by Design" concept, successfully resolved multiple technical challenges, and ultimately established a robust production process. A systematic pharmaceutical study and quality comparison were conducted between the self-produced product and the reference preparation, fully ensuring equivalent quality and clinically safe efficacy.

The anti-infective field is a key focus area for Qilu Pharmaceutical, with a rich variety of anti-infective products. The recent approval and market launch of Ertapenem Sodium for Injection, as the first in China to pass the quality evaluation, further enhances the product's ability to serve patients at a high level and strengthens the company’s anti-infective product pipeline. Qilu Pharmaceutical will continue to provide more high-quality medicines to clinical practice, acting as a strong backup for public health security, contributing Qilu's strength to the construction of Healthy China.

Editor: Dadasiva

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