Chia Tai Tianqing's Gadoxetic Acid Disodium Injection Passes Generic Drug Consistency Evaluation as Second Domestic Entrant

Recently, the NMPA official website showed that CHIATAI TIANQING's Gadoxetic Acid Disodium Injection passed the generic drug consistency evaluation, becoming the second product of this type to pass the evaluation. Gadoxetic Acid Disodium is a magnetic resonance contrast agent, with sales in Chinese public medical institutions exceeding 200 million yuan in 2020, representing a year-on-year increase of 36.83%. Currently, CHIATAI TIANQING Pharmaceutical Group Co., Ltd. has already had 49 varieties pass the evaluation.

Gadoxetic acid disodium, developed by Bayer, is a liver-specific magnetic resonance contrast agent that can help display the structure and patency of the intrahepatic and extrahepatic biliary systems, assess hepatocyte function, and characterize different types of liver injuries. This product aids in the detection of liver lesions, particularly enhancing the detection rate of small liver tumors, and facilitates the early diagnosis and treatment of liver diseases.

Data from MiNe Network shows that in 2020, the sales of gadoteric acid disodium at terminals of urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) in China exceeded 200 million yuan, with a year-on-year increase of 36.83%. In the first half of 2021, its sales exceeded 100 million yuan, with a year-on-year increase of 52.26%, and Chia Tai Tianqing Pharmaceutical Group Co., Ltd. has captured 20% of the market share.

Sales of Gadolinium Ethoxybenzyl Diethylenetriamine Pentaacetic Acid in Chinese Public Medical Institutions (Unit: 10,000 Yuan)

Source: Terminal Competition Pattern of Public Medical Institutions in China, MiNei Network

In June 2019, CHIATAI TIANQING's Gadoxetic Acid Disodium Injection, filed under Category 6 of generics, was approved for marketing in China, becoming the first domestically produced generic. In September 2020, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. submitted a supplemental application for consistency evaluation of Gadoxetic Acid Disodium Injection. In September 2021, Kelun Pharmaceutical's Gadoxetic Acid Disodium Injection, filed under Category 4 of generics, was approved for production and considered to have passed the consistency evaluation, making it the first company to pass the evaluation for this product. With the approval of the supplemental application for consistency evaluation of this product, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. became the second company to pass the evaluation for this product.

So far, CHIATAI TIANQING has had 49 varieties (69 specifications) pass/be deemed to pass the consistency evaluation, of which 20 varieties are the first in China to pass the evaluation. In the field of contrast agents, CHIATAI TIANQING has had two varieties pass the evaluation, including Iodixanol Injection and Gadolinium Ethoxybenzyl Diethylenetriamine Pentaacetic Acid Injection.

Data source: MiNeiNet database, NMPA