Great news! Shijiazhuang No.4 Pharmaceutical has obtained the drug production registration approval from the National Medical Products Administration for its new product, Linezolid Glucose Injection (100ml).


Time:2021-07-03

The linezolid glucose injection (100 ml), developed and submitted by Shijiazhuang No.4 Pharmaceutical Co., Ltd., has obtained the drug production registration approval from the National Medical Products Administration and is deemed to have passed the consistency evaluation.
On July 1, Shiyao Group (02005.HK) issued an announcement stating that its wholly-owned subsidiary, Shijiazhuang Siyao Co., Ltd., has obtained the drug production registration approval from the National Medical Products Administration for Linezolid Glucose Injection (100 ml), which is deemed to have passed the consistency evaluation. This follows the company’s receipt of approval for supplementary drug applications for Azithromycin Injection (0.5 g and 0.25 g) within just one week, marking another new product approval for market launch.
In April 2020, Shijiazhuang Fourth Pharmaceutical’s application for the marketing approval of Linezolid Glucose Injection, submitted under Generic Category 4, was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. After a period of 15 months, the product received its manufacturing registration approval and was deemed to have passed the consistency evaluation.
It is understood that linezolid is a synthetic oxazolidone antibiotic primarily used to treat infections caused by Gram-positive bacteria that have developed resistance to other antibiotics. The linezolid products currently available on the Chinese market include linezolid tablets, linezolid dry suspension, and linezolid glucose injection. According to data from Menet, in recent years, sales of linezolid at the terminals of China’s public medical institutions—namely, urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics—have been increasing year by year. In 2018, sales revenue reached 1.932 billion yuan, representing a year-on-year increase of 25.64%. Among these, linezolid glucose injection accounted for 78.41% of the market share.

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