According to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, Yangtze River Pharmaceutical Group's application for a Class 4 generic drug, iodofol injection, has been accepted. This is not Yangtze River's first foray into this product. As early as November 2025, Yangtze River independently submitted a marketing application for this product and it was accepted by the CDE. Behind these two applications lies the pharmaceutical giant's deep ambition for the CT contrast agent market.

Ioflufenicol injection was originally developed by Mallinckrodt in the United States. It is a non-ionic, low-permeability, water-soluble, monomeric X-ray contrast agent. In 1988, ioflufenicol received FDA approval for marketing in the United States under the brand name Optiray. This product entered the Chinese market in 1999 and was included in the Class A medical insurance program in 2009. According to data from Yaozhi, the domestic CT contrast agent market has exceeded 15 billion yuan. Although the contrast agent market was significantly affected by the centralized procurement policy in 2022, it rebounded in 2023 and exceeded 160 yuan in 2024, representing a year-on-year increase of 18%.

In the contrast agent market, iohexol, iodixanol, and ioflufenicol constitute the "three pillars." Currently, five companies in China hold marketing authorization for ioflufenicol, including Jiangsu Hengrui, Chengdu Better, and Chongqing Shenghuaxi; Hengrui became the first domestic company to pass the consistency evaluation for this product in August 2021. Meanwhile, in addition to the approved companies, nine other companies have generic versions pending review, including Chongqing Yaoyou, Hainan Beikang, and Fu'an Pharmaceutical.

Yangtze River Pharmaceutical Group already possesses a pipeline of contrast agents, with iohexol injection and iodixanol both receiving market approval in the past two years. This application for iodofol injection indicates that Yangtze River is further enriching its contrast agent product line, particularly its focus on high-value products. If approved, Yangtze River will become a significant competitor in the domestic iodofol market.