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On the evening of February 9, Haichen Pharmaceutical announced that it had recently received the "Approval Notice for Supplementary Drug Application" for the company's product tigecycline for injection, which was approved and issued by the State Food and Drug Administration.
The product has passed the consistency of generic drugs.
evaluation
.
Tigecycline for injection was the first glycylcycline antibiotic, a semi-synthetic derivative of the tetracycline antibiotic
.
Tigecycline binds to the A site of the bacterial ribosomal 30s subunit, preventing bacterial transcription and thereby inhibiting protein synthesis.
By overcoming acquired ribosomal protection and active efflux, two resistance mechanisms of tetracyclines, reducing the Potential for bacterial resistance to tigecycline
Tigecycline was developed by Pfizer Wyeth and was first listed in the United States in June 2005; in November 2010, it was approved for import by NMPA and is currently a Category B variety in the National Medical Insurance Catalogue
.
Haichen Pharmaceuticals Tigecycline for Injection (trade name: Zekang) was approved for marketing in May 2013, and passed the consistency evaluation of quality and efficacy in February 2022
.
