Qilu Pharmaceutical's Cefazolin Sodium for Injection Gains Consistency Evaluation Approval as Third Domestic Manufacturer

Recently, the official website of the National Medical Products Administration (NMPA) indicated that Qilu Pharmaceutical's Cefazolin Sodium for Injection has been approved to pass the consistency evaluation via a supplementary application, making it the third product manufactured in China to pass the evaluation. According to data from Menet, sales revenue of Cefazolin Sodium for Injection at the public medical institution terminal in China exceeded 1.5 billion RMB in 2020. While there are over 60 manufacturers of Cefazolin Sodium for Injection, currently only three companies—Chengdu Beite Pharmaceutical, Guangdong Jincheng Jinsu Pharmaceutical, and Qilu Pharmaceutical—have been approved to pass the consistency evaluation through supplementary applications. Notably, this is the eighth injectable product from Qilu Pharmaceutical to pass the evaluation in May. To date, Qilu Pharmaceutical has a total of 76 products that have passed or are deemed to have passed the consistency evaluation, among which 35 are the first in China.

Notice on the Release of Information Regarding Drug Approval Documents Pending Collection (May 31, 2021)

Cefazolin Sodium for Injection belongs to the first-generation cephalosporin antibiotics and is clinically indicated for the treatment of respiratory tract infections, urinary tract infections, bone and joint infections, sepsis, and genital tract infections caused by susceptible bacteria.

Recent Sales Trends of Cefazolin Sodium for Injection at China's Public Medical Institution Terminal

Source: Competitive Landscape of the Terminal Market in China's Public Healthcare Institutions

According to data from Menet, in recent years, the terminal sales of Cefazolin Sodium for Injection across China's urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (collectively referred to as China's public medical institutions) have consistently maintained a growth rate exceeding 10%, surpassing RMB 1.5 billion in 2020. Among them, China Resources Jiuxin Pharmaceutical, Shenzhen Lijian Pharmaceutical, and Chengdu Better Pharmaceutical rank top three in market share.

Source: MENET MED2.0 China Drug Evaluation Database

There are over 60 manufacturers of Cefazolin Sodium for Injection. Currently, only three companies—Chengdu Bright Pharmaceutical, Guangdong Jincheng Jinsu Pharmaceutical, and Qilu Pharmaceutical—have been approved for passing the consistency evaluation via supplementary applications. Additionally, the supplementary applications for consistency evaluation from five companies, including CSPC Zhongnuo Pharmaceutical and Harbin Pharmaceutical Group General Pharmaceutical Factory, are under review and approval. The marketing authorization applications for Class 3 generics submitted by Shenzhen China Resources Jiuxin Pharmaceutical | Zhejiang China Resources Sanjiu Zhongyi Pharmaceutical are also under review; upon approval, they will be deemed as having passed the consistency evaluation.

Source: Official Website of the National Medical Products Administration, Menet Database