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On February 7, Sinopharm Modern announced that its holding subsidiary Sinopharm Zhijun received the "Approval Notice for Supplementary Drug Application" approved and issued by the State Drug Administration, approving cefixime capsules (0.
1g) and cefaclor.
The dry suspension (0.
125g) passed the quality and efficacy consistency evaluation of generic drugs
.
Cefixime is the first third-generation oral cephalosporin, which is clinically suitable for bacterial infections caused by cefixime-sensitive Streptococcus (except Enterococcus), pneumococcus, and Neisseria gonorrhoeae
.
According to data from the PDB Drug Comprehensive Database, the global sales of cefixime preparations in 2020 will be US$881 million; the sales of domestic sample hospitals will be RMB288 million
.
In 2020, the sales revenue of Sinopharm Zhijun Cefixime Capsules (0.
The CDE website shows that in addition to Sinopharm Zhijun, cefixime capsules (0.
1g), Chengdu Bite Pharmaceutical Co.
, Ltd.
and CSPC Ouyi Pharmaceutical Co.
, Ltd.
have passed or are deemed to have passed the consistency evaluation
.
Up to now, Sinopharm Zhijun has invested approximately RMB 27 million in R&D (unaudited) for the consistency evaluation of cefixime capsules (0.
Cefaclor is an important oral second-generation cephalosporin, which has the characteristics of high efficiency, good oral absorption, wide tissue distribution, and few and mild adverse reactions
.
It is suitable for otitis media, lower respiratory tract infections (including pneumonia), pharyngitis and tonsillitis, urinary tract infections (including pyelonephritis and cystitis), skin and skin and soft tissue infections caused by sensitive strains
According to data from the PDB Drug Comprehensive Database, the global sales of cefaclor preparations in 2020 will be US$265 million; the sales of domestic sample hospitals will be RMB184 million
.
In 2020, the sales revenue of Sinopharm Zhijun Cefaclor Dry Suspension (0.
According to the CDE website, in addition to Sinopharm Zhijun, Cefaclor Dry Suspension (0.
125g) has been approved by Hainan Xiansheng Pharmaceutical Co.
, Ltd.
, Jinhong Pharmaceutical Co.
, Ltd.
, Kunming Jida Pharmaceutical Co.
, Ltd.
, etc.
Or deemed to pass the consistency evaluation
.
Up to now, Sinopharm Zhijun has invested approximately RMB 22 million (unaudited) in research and development for the consistency evaluation of cefaclor dry suspension (0.
