Baiyunshan class 1 chemical new drug cefaziamidine sodium clinical approval

Source: Sina medical news 2018-01-02 On January 2, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd (hereinafter referred to as "Baiyunshan") announced that Baiyunshan branch Baiyunshan Pharmaceutical Group Co., Ltd Baiyunshan Pharmaceutical General Factory (Baiyunshan Pharmaceutical General Factory) and Baiyunshan chemical pharmaceutical factory (chemical pharmaceutical factory) of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd received the State Food and drug Administration recently Approval documents for clinical trials of drugs (approval No.: 2017l05167, 2017l05168, 2017l05169, 2017l05170; acceptance No.: cxhl1600324, cxhl1600337, cxhl1600338, cxhl1600339) and notice of approval opinions (approval No.: 2017l05171; acceptance No.: cxhl1600340) issued by the General Administration of supervision and administration The specific information of the drug is as follows: 1 English name / Latin name of ceftriamidine sodium for injection: ceftriamidine sodium for injection dosage form: injection specification: 0.25g (calculated by c21h29n706s3), 0.5g (calculated by c21h29n706s3), 1.0g (calculated by c21h29n706s3), 2.0g (calculated by c21h29n706s3) application matters: Domestic drug registration classification: chemical drug No.1 Class B applicant: Baiyunshan Pharmaceutical General Factory of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd and Guangdong South China new drug creation center approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, this product meets the relevant requirements of drug registration, and is approved for clinical trial 2 Ceftriamidine sodium English name / Latin name: ceftriamidine sodium dosage form: API application matters: domestic drug registration classification: chemical applicant: Baiyunshan chemical pharmaceutical factory of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd and Guangdong South China new drug creation center approval opinions: According to the drug administration law of the people's Republic of China and relevant regulations, after examination, the product meets the relevant requirements of drug registration, and the preparation of the product is approved for clinical trial The acceptance time of clinical trial application submitted by Baiyunshan Pharmaceutical General Factory for cefazimidine sodium for injection was December 2016 (acceptance No.: Yuexin 160077, Yuexin 160078, Yuexin 160079, Yuexin 160080); the acceptance time of clinical trial application submitted by chemical pharmaceutical factory for cefazimidine sodium was December 2016 (acceptance No.: cxhl1600340) As of the date of this announcement, the total investment in R & D is about RMB 35.8418 million Cefathiamidine sodium belongs to the first class of new chemical drugs, which is a new compound based on the structural transformation of cefathiamidine The indication was community acquired pneumonia Compared with cefathiamidine, cefathiamidine sodium maintained strong antibacterial activity against Gram-positive bacteria, especially against Streptococcus (including penicillin insensitive Streptococcus pneumoniae), and against Haemophilus and catamoraxella and other gram-negative bacteria The antimicrobial spectrum includes: Staphylococcus aureus (methicillin sensitive), coagulase negative staphylococcus, Hemolytic Streptococcus A, hemolytic streptococcus B, Streptococcus pneumoniae (PSSP, PISP, PRSP) and other Gram-positive bacteria; Haemophilus influenzae, catamora, proteus Kii, Salmonella typhi and other gram-negative bacteria; Streptococcus Alimentarius, Propionibacterium acne And other gram positive anaerobes It is understood that cephalosporins have the advantages of broad antibacterial spectrum, strong antibacterial effect, penicillinase resistance, less allergic reactions than penicillins, and are widely used in clinical practice, and play an important role in the global antibiotic market According to the PDB drug comprehensive database of China Pharmaceutical Industry Information Center, cephalosporins accounted for the first place in the sales of anti infective drugs from 2005 to 2016 In 2016, the sales reached 13.01 billion yuan, accounting for 38.97% At present, more than 50 varieties of cephalosporins have been listed in the world, which are divided into five generations according to the time of invention and different antibacterial properties Among them, the first and second generation cephalosporins are the first-line clinical drugs because of their definite curative effect and low price, and they are also the cephalosporins with the largest market sales and quantity scale There is no information about the listing or registration of the drug with the same structure as cefazimidine sodium at home and abroad, nor the sales amount at home and abroad The same kind of cefathiamidine sodium is cefathiamidine, which is the representative of the first generation of cephalosporins In recent five years, cefathiamidine ranks first in the sales volume of the first generation of cephalosporins In 2016, the sales volume of cefathiamidine sodium in hospitals in key cities in China reached 610 million yuan, which was confirmed by clinical experts as a safe and effective first-line drug of choice against gram-positive coccal infection According to the announcement, cefazimidine sodium is the only cephalosporin antibiotic independently developed by China after cefathiamidine, and the only clinical approval document of cephalosporin class a new drug successfully approved in recent 20 years in China