Zhejiang medicine linezolid glucose injection has been approved for listing, and the market pattern of Zhengda Tianqing, Haosen and Zhengda Fenghai will change

Yesterday evening, Zhejiang Pharmaceutical announced that its company's original chemical, class 6 linezolid glucose injection, had recently received the approval for drug registration issued by the State Drug Administration 1、 Basic information of drug 1 Drug name: linezolid glucose injection dosage form: injection specification: 100ml: linezolid 0.2g and glucose 5g application items: domestic drug registration classification: original chemical category 6 acceptance No.: cyhs1301387 Zhejiang approval No.: 2019s00022 drug approval No.: gjzz h20193017 Drug manufacturer: Xinchang pharmaceutical factory of Zhejiang Pharmaceutical Co., Ltd approval conclusion: 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, approval of registration and issuance of drug approval number 2 Drug name: linezolid glucose injection dosage form: injection specification: 300ml: linezolid 0.6g and glucose 15g application items: domestic drug registration classification: original chemical category 6 acceptance No.: cyhs1301388 zhe approval No.: 2019s00023 drug approval No.: gyzz h20193018 drug manufacturer: Xinchang pharmaceutical factory of Zhejiang Pharmaceutical Co., Ltd Examination and 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, approves the registration and issues the drug approval number 2、 Other product information Linezolid, an oxazolidinone antibiotic, is mainly used to treat infections caused by gram-positive Staphylococcus aureus, including suspected or confirmed hospital acquired pneumonia (HAP), community acquired pneumonia (CAP), complex skin or soft tissue infection (SSTI) and vancomycin resistant Enterococcus (VRE) caused by methicillin-resistant Staphylococcus aureus (MRSA) Linezolid injection is a class B drug in the catalogue of national basic medical insurance, industrial injury insurance and maternity insurance (2017 Edition) According to the data on the website of the State Drug Administration, as of the date of disclosure of this announcement, Jiangsu Haosen Pharmaceutical Group Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltd., Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd and Xinchang pharmaceutical factory of Zhejiang Pharmaceutical Co., Ltd have obtained the approval documents for domestic linezolid injection, and pfizeras1 has obtained linezolid injection Approval of imported drugs for injection According to the IMS database, the global sales volume of linezolid injection in 2017 was US $345827000, including US $85.2145 million in China; the global sales volume from January to June 2018 was US $186049500, including US $58.1968 million in China On December 11, 2013, Zhejiang Pharmaceutical submitted an application for drug registration to Zhejiang food and Drug Administration and was accepted As of the disclosure date of this announcement, the R & D cost of the product project has been about 5.07 million yuan Zhejiang Pharmaceutical has passed the GMP certification of the injection drug production line, the next step will immediately organize the production and marketing of the product.