Another Generic Budesonide Enteric-Coated Capsule Approved, Challenging Originator's Market Dominance

May 21,CSPC Announces that Its Developed Budesonide Enteric-Coated Capsules (4mg) Have Officially Received the Registration Approval from the National Medical Products Administration。

This drug for the treatment of primary Immunoglobulin A Nephropathy (IgAN) may appear to be just another generic drug approval, but it could potentially break through the three-year patent protection barrier of Everest Medicines' original drug "NefIgArd" and also completely change the market landscape for IgA nephropathy drugs in China.

As the world's first causative treatment drug for IgA nephropathy, Nefukang demonstrated outstanding market performance after its launch in China in 2024, with annual sales reaching 3.53 billion yuan. Following its inclusion in the medical insurance system, the market size further expanded, and sales climbed to 14.4 billion yuan in 2025, becoming a core revenue pillar for the company.

The exclusive market rights of this drug are supported by the core formulation patent numbered ZL200980127272.5, which is valid until May 2029. According to the conventional timeline, the original research could have exclusively enjoyed market dividends during this period.

Nowadays, the industry pattern is gradually being broken by the trend of generic drug applications, and different types of declarations under the patent linkage system have also become key nodes for all parties' competition.

In December 2025, Hainan Herui Pharmaceutical Co., Ltd.'s generic version of budesonide enteric-coated capsules was approved. However, when Hainan Herui submitted the generic application for budesonide enteric-coated capsules, it made a "Category 3 declaration" regarding Everest Medicines' patent ZL200980127272.5, meaning the product can only be marketed after the patent expires.

Qilu Pharmaceutical Co., Ltd. submitted its listing application in November 2025, and Shiyao Group Zhongnuo Pharmaceutical (Taizhou) Co., Ltd. submitted its listing application in March 2025. Moreover, the declaration types of CSPC Zhongnuo and Qilu Pharmaceutical are both..."4.2 Category", which means that the generic drug applicant declares that the drug applied for does not fall within the scope of patent protection related to the original drug as recorded in the China's Listed Drug Patent Information Registration Platform.

The approval of Budesonide Enteric-Coated Capsules,This may affect the business expectations of the original research companies.

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