Kelun Pharma Enters the $2.2 Billion Contrast Media Market, Competing with Yangtze River Pharma and Hengrui for First Generic Gadobutrol Injection

Recently, the official website of the CDE indicated that Hunan Kelun Pharmaceutical Co.,Ltd.'s Gadobutrol Injection has been accepted for a Class 4 generic drug marketing application. Data from Menet shows that in 2020, sales of contrast agents at public medical institution terminals in China exceeded RMB 15 billion, with Bayer being the sole manufacturer of Gadobutrol Injection. Prior to this, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Beijing Beilu Pharmaceutical Co., Ltd., YANGTZE RIVER PHARMACEUTICAL GROUP GUANGZHOU HAIRUI PHARMACEUTICAL CO.,LTD, and YANGTZE River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co., Ltd. had already submitted Class 4 generic marketing applications for the product, which are currently under review and approval.

According to the information, gadobutrol injection is indicated for diagnostic use and is for intravenous administration only. It is used for contrast enhancement in magnetic resonance imaging (MRI) of the brain and spinal cord, and for contrast-enhanced magnetic resonance angiography (CE-MRA).

Terminal Sales of Contrast Agents in China's Public Healthcare Institutions in Recent Years (Unit: RMB 100 Million)

Source: MENET Competitive Landscape of China's Public Medical Institution Terminal

Data from Menet shows that in recent years, the sales growth rate of contrast agents at the terminal level of urban public hospitals, county-level public hospitals, urban community centers, and township health centers in China (collectively referred to as Chinese public medical institutions) has consistently exceeded 10%. Despite a slight decline in 2020 due to the pandemic, the sales scale still surpassed RMB 15 billion. Gadobutrol Injection ranked 18th among the top 20 products, with Bayer as the sole manufacturer.

Source: MENET MED2.0 China Drug Evaluation Database

Prior to this, marketing authorization applications for Gadobutrol Injection had already been submitted under the Class 4 generic category by Jiangsu Hengrui Pharmaceuticals Co., Ltd., Beijing Beilu Pharmaceutical Co., Ltd., and Yangtze River Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd. | Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co., Ltd., and are currently under regulatory review and approval.

In June this year, Kelun Pharmaceutical's Iopamidol Injection was approved, marking the company's first approved drug to enter the diagnostic contrast media field. Currently, Gadobenate Dimeglumine Injection and Gadoteritol Injection are both under regulatory review as Class 4 generic applications. Together with the recent CDE acceptance of the marketing application for Gadobutrol Injection, these will establish a competitive product portfolio for the company in the diagnostic imaging sector.

Source: CDE Official Website, MENET Database