Qilu Pharmaceutical's Cefprozil Granules (Yidai) Becomes First in China to Pass Consistency Evaluation

Recently, Qilu Pharmaceutical received the supplementary drug application approval issued by the National Medical Products Administration for Cefprozil Granules (brand name: Yidai), marking the product as the first in China to pass the consistency evaluation. To date, Qilu Pharmaceutical has a total of 33 products that have passed the consistency evaluation, among which 20 are the first in China.

Data indicates that cefprozil is a second-generation oral cephalosporin that exerts its bactericidal effect by inhibiting bacterial cell wall synthesis. Cefprozil granules were the first cephalosporin approved by the U.S. FDA for the treatment of otitis media and sinusitis in children, offering a convenient dosage form suitable for pediatric use. Qilu Pharmaceutical initiated consistency evaluation studies for cefprozil granules in 2017, submitted a supplemental application for consistency evaluation in March 2019, and ultimately received approval.

Sales of Cefprozil at Public Medical Institution Terminals in China in Recent Years (Unit: 10,000 Yuan)

Data from Menet shows that in 2019, the sales of cefprozil at the terminal level of Chinese public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—reached RMB 1.683 billion, representing a year-on-year increase of 6.68%.

Brand Landscape of Cefprozil Granules at Public Medical Institution Terminals in China, 2019

In terms of dosage forms, cefprozil is available as tablets, oral solutions, capsules, and granules. Among these, granules account for nearly 5% of the market share. The main manufacturers include Guangzhou Baiyunshan Pharmaceutical General Factory, Harbin Kaicheng Pharmaceutical, Qilu Pharmaceutical, and Hainan Simcere Pharmaceutical.

Compiled by Bai Yu, Menet

Source: Menet Database, Qilu Pharmaceutical WeChat

[Approved] Disrupting the RMB 1.6 billion antibacterial drug market, Qilu Pharmaceutical becomes the first to pass consistency evaluation