Qilu Pharmaceutical's 'Ertapeneem Sodium for Injection' was approved for marketing and the first to pass the consistency evaluation

According to Qilu Pharmaceutical's official Weiwei news on the 6th, its anti-infective drug ertapeneem sodium for injection was approved for marketing by the National Medical Products Administration, marking the first domestic product to pass the consistency evaluation and achieve a good start in drug research and development. Up to now, a total of 116 products of Qilu Pharmaceutical have passed or are deemed to have passed the consistency evaluation, of which 46 are the first in China.

Ertapenem is a novel carbapenem antibiotic that plays an antibacterial role by binding to penicillin-binding proteins and interfering with the synthesis of bacterial cell walls. As a broad-spectrum antibacterial drug, ertapenem has good antibacterial activity against gram-positive, negative, aerobic and anaerobic bacteria, and is mainly used clinically for the treatment of secondary abdominal infection, community-acquired pneumonia, complicated urinary tract infection, acute pelvic infection and bacteremia caused by sensitive bacteria, and can also be used for the prevention of surgical site infection after elective colorectal surgery in adult patients.

Injectable ertapenem sodium has the characteristics of stable renal dehydropeptidase, not easy to resist, good clinical efficacy, strong tolerability and long half-life, and is the first-line treatment choice for community infections and can be used in children ≥ 3 months.

In the development process of Qilu Pharmaceutical's ertapeneem sodium for injection, the researchers adhered to the research and development concept of "quality comes from design", successfully solved a number of technical problems, and finally established a stable production process, and carried out systematic pharmaceutical research and quality comparison between self-made products and reference preparations, which fully ensured quality equivalence and safe equivalence for clinical use.

The field of anti-infection is the key layout area of Qilu Pharmaceutical, and there are rich types of anti-infection products. The approval of ertapenem sodium for injection and the first domestic evaluation further improved the product's ability to serve patients at a high level and improved the company's anti-infection product pipeline. Qilu Pharmaceutical will continue to provide more high-quality and good drugs for clinical practice, provide a strong backing for the health protection of the people, and contribute to the construction of a healthy China.