Recently, the Center for Drug Evaluation (CDE) announced that the application for generic marketing of probucol tablets by Zhejiang Jiangbei Pharmaceutical Co., Ltd. has been officially accepted. This is one of the few new applications for this product since 2021.
Probucol is a lipid-lowering drug with antioxidant properties, originally developed by Merck & Co. in the United States and approved by the FDA in 1977. Its most significant characteristic lies not in its lipid-lowering power, but in its unique multiple mechanisms of action: it can both lower cholesterol and slow the progression of atherosclerosis through antioxidant pathways, giving it an irreplaceable clinical role in niche indications such as familial hypercholesterolemia and xanthomas.
According to data from Yaozhi, the domestic market size of probucol tablets has never been less than 400 million yuan since 2022, and reached 480 million yuan in 2025, representing a year-on-year increase of 5%.
The competitive landscape of the domestic market has remained relatively stable for a long time. Currently, only Qilu Pharmaceutical and Jingfukang Pharmaceutical hold the necessary licenses for this product, and this duopoly has persisted for many years. Data from 2025 shows that Jingfukang Pharmaceutical dominates the market with over 64% market share, while Qilu Pharmaceutical accounts for approximately 36%.
After entering 2026, three companies—Beijing Fuyuan, Ningxia Kangya, and Zhejiang Puli—submitted their generic drug applications for approval. Ningxia Kangya had already passed the consistency evaluation for several products and was an active player in the generic drug field; Beijing Fuyuan, on the other hand, had repeatedly been the first to market for generic versions of drugs such as roxadustat and ilaprazole. Both companies entered the market with clear strategies.

In the next 12-24 months, the probucol film market may shift from a duopoly to a six-way competition, and a reshuffling of prices and market share is almost inevitable.

https://news.yaozh.com/archive/48861.html