Announcement of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. on withdrawal of application for production of faropenem sodium tablets by holding subsidiary
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Last Update: 2020-04-03
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Source: Internet
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Author: User
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Securities code: 600196 stock abbreviation: Fosun Pharmaceutical No.: Lin 2015-101 bond Code: 122136 bond abbreviation: 11 Fosun bond Shanghai Fosun Pharmaceutical (Group) Co., Ltd announcement on withdrawal of faropenem sodium tablet production application by holding subsidiary the board of directors and all directors of the company guarantee that there are no false records, misleading statements or The major omissions of 25.62 + 0.01 0.04% of the stock trend of related companies are Fosun Pharmaceutical, and it shall be jointly and severally liable for the authenticity, accuracy and completeness of its contents Recently, Suzhou Erye Pharmaceutical Co., Ltd (hereinafter referred to as "Suzhou Erye"), a holding subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (hereinafter referred to as "the company"), submitted a production application for withdrawal of faropenem sodium tablets (hereinafter referred to as "the new drug") to the drug registry of Jiangsu food and Drug Administration (hereinafter referred to as "Jiangsu food and Drug Administration") Please The new drug was developed before 2005 According to the drug registration regulations and technical standards at that time, no systematic comparative study was conducted with the original product of the product Now, according to the new drug registration management and technical standards issued by the State Food and Drug Administration (hereinafter referred to as "the State Food and Drug Administration"), Suzhou Erye voluntarily withdraws the registration application of the new drug for production 1、 Basic information of the new drug name of the drug: faropenem sodium tablet dosage form: tablet specification: 0.15g application item: new drug application: chemical drug class 3.1 application stage: Production applicant: Suzhou Erye, Beijing bolda Biotechnology Development Co., Ltd acceptance No.: cxhs1200354, Su 2, research of the new drug On March 31, 2005, the State Food and Drug Administration (now the State Food and Drug Administration) approved faropenem sodium tablets for clinical trials On December 18, 2012, Suzhou Erye and Beijing Borda Biotechnology Development Co., Ltd submitted production application for faropenem sodium tablets to Jiangsu food and drug administration Main indications of faropenem sodium tablets: infectious diseases caused by sensitive bacteria such as Staphylococcus (except methicillin resistant), Streptococcus, pneumococcus, Enterococcus, catamoraxella, Enterobacteriaceae (E.coli, Citrobacter, Klebsiella, E.coli, Proteus mirabilis), Haemophilus, Acinetobacter, etc., including respiration Systemic infection, urinary system infection, etc According to IMS midatm data (provided by IMS Health, IMS Health is the world's leading provider of professional information and strategic consulting services for the pharmaceutical health industry), the sales volume of faropenem in China (excluding Hong Kong, Macao and Taiwan) in 2014 was about 22 million yuan As of the date of this announcement, Suzhou Erye has invested about 5.3 million yuan in R & D at this stage 3、 The impact and risk on the listed company indicate that the withdrawal of faropenem sodium tablet production application by Suzhou Erye will not have a significant impact on the current and future operation and production of the company and its holding subsidiaries / units (hereinafter referred to as "the group") The group attaches great importance to new drug research and development, and strictly controls the quality and safety of drug research and development, manufacturing and sales New drug research and development is a long-term work, there are many internal and external uncertainties, please pay attention to the investment risk of investors It is hereby announced Board of directors of Shanghai Fosun Pharmaceutical (Group) Co., Ltd November 24, 2015
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