Zhengda Tianqing Gains Ground in $220 Million Linezolid Glucose Injection Market, Threatening Pfizer's Dominant Share

On February 18, the official website of the National Medical Products Administration showed that Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'s supplemental application for Linezolid Glucose Injection had been approved. Prior to this, the company already had one specification approved. Data from Menet shows that in 2020, the sales revenue of Linezolid Glucose Injection in China's public medical institutions exceeded 1.5 billion yuan, with a slight year-on-year increase of 2.66% in the first half of 2021. Among them, Pfizer has the largest market share. Currently, six companies have received approval for this product. The consistency evaluation supplemental application of Xinchang Pharmaceutical, a subsidiary of Zhejiang Medicine Co., Ltd., is under review. Sichuan Kelun Pharmaceutical and Chongqing Shenghuaxi Pharmaceutical, among other six companies, are undergoing review for production declaration as Category 4 generics. Once approved, they will be considered as having passed the evaluation.

Information on Pending Drug Approval Documents for February 18, 2022

Linezolid is a synthetic antibiotic of the oxazolidinone class, primarily used to treat infections caused by Gram-positive bacteria that are resistant to other antibiotics. The original research company is Pfizer.

Sales of Linezolid Glucose Injection in Chinese public medical institutions in recent years (Unit: billion yuan)

Source: MiNeiNet China Public Medical Institution Terminal Competitive Landscape

MiNe Network data shows that in 2020, the sales of Linezolid Glucose Injection at terminals of China's urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) exceeded 1.5 billion yuan, with a year-on-year increase of 2.66% in the first half of 2021. Among them, Pfizer has the largest market share, accounting for more than 50%; Jiangsu Hengrui Medicine, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ranked second and third respectively.

Source: MiNeiNet MED2.0 China Drug Evaluation Database

Currently, 12 companies hold the production approval for Linezolid Glucose Injection. Among them, 6 companies have passed the evaluation. Sichuan Meidakang Jiale Pharmaceutical, Hunan Kelun Pharmaceutical, Jiangsu Chia Tai Fenghai Pharmaceutical, and 3 other companies have passed the evaluation through supplementary applications. Shijiazhuang Fourth Pharmaceutical obtained approval for production as a Category 4 generic drug, which is considered equivalent to passing the evaluation.

In addition, the consistency evaluation supplementary application of Xinchang Pharmaceutical Factory, Zhejiang Medicine Co., Ltd. is under review and approval; Sichuan Kelun Pharmaceutical, Yangtze River Pharmaceutical Group Shanghai Haini Pharmaceutical, Guangzhou Green Cross Pharmaceutical, Chongqing Shenghuaxi Pharmaceutical and other six enterprises have submitted production applications as Category 4 generics which are under review and approval. Once approved, they will be considered as having passed the evaluation.

It is worth noting that Linezolid Glucose Injection is a fifth batch national procurement variety in China. Jiangsu Hengsen Pharmaceutical, Jiangsu Zhongda Fenghai Pharmaceutical, and Hunan Kelun Pharmaceutical have won the bids. In the future, the market pattern of this product will change.