Pharma 3.1 chemical new drug biapenem enters the three in one review

According to the website of the State Food and Drug Administration (CFDA) on April 14, the production site inspection of biapenem for APIs and preparations for injection, a new class 3.1 chemical drug, has been completed, which has entered the three in one review and is close to approval According to the new drug review process, after the completion of the three in one review, only the drug review center of the State Food and drug administration forms a report and submits it to the State Food and Drug Administration for signature According to the R & D process of other new drugs, UL is expected to get production approval documents in about two months Biapenem for injection is a new type of synthetic carbapenem antibiotic for injection developed by Meiji, Japan Its trade name is omegacin It was approved for marketing in Japan as early as March 2003 At present, omegacin, the original research drug, has not yet entered China, but four domestic enterprises have imitated and produced the product, namely, Ouyi pharmaceutical, Zhengda Tianqing pharmaceutical, Chenxin pharmaceutical and Nanjing Xiansheng Dongyuan pharmaceutical The federal pharmaceutical, which is mainly engaged in antibiotics, APIs and intermediates, is expected to become the fifth Biapenem for injection is used to treat septicemia, pneumonia, pulmonary abscess caused by sensitive bacteria, secondary infection caused by chronic respiratory diseases, refractory cystitis, pyelonephritis, peritonitis, gynaecological adnexitis, etc The data showed that it was 2-4 times stronger than imipenem in inhibiting the activity of Pseudomonas aeruginosa and anaerobic bacteria, and 4-8 times stronger than meropenem in inhibiting the activity of resistant Pseudomonas aeruginosa According to CFDA, at present, there are only four domestic enterprises producing biapenem for injection, but more than 10 enterprises have applied for the product, and some enterprises have entered the clinical trial stage.