Core Viewpoint - The innovative pharmaceutical company, YunTing XinYao, is actively defending its patent for Budesonide enteric-coated capsules (NaiFuKang) against a newly approved generic version by Hainan HeRui Pharmaceutical, asserting that its patent is valid until May 7, 2029 [1][5]. Group 1: Patent and Legal Dispute - YunTing XinYao has announced its intention to take legal action against any infringement of its patent rights related to NaiFuKang, which is currently under effective patent protection in China [1]. - Hainan HeRui's Budesonide enteric-coated capsules received approval on December 16, 2023, raising concerns about potential patent infringement [1][4]. - The legal discourse includes a distinction between "Category 3" and "Category 4" declarations made by generic drug applicants, with Hainan HeRui opting for a "Category 3" declaration, indicating an acknowledgment of the existing patent [5][6]. Group 2: Market Impact and Sales Projections - NaiFuKang is projected to achieve sales between 12 billion to 14 billion yuan in 2025, with expectations to reach 24 billion to 26 billion yuan in 2026, following its inclusion in the medical insurance negotiations [2]. - The drug is specifically designed for treating primary IgA nephropathy, a serious condition affecting a significant number of young adults in China, with approximately 30,000 new cases annually [2][3]. Group 3: Drug Mechanism and Innovation - The unique formulation of NaiFuKang utilizes a dual-release technology that targets the drug delivery to the ileum, significantly delaying kidney function decline and providing renal protection [4]. - Unlike traditional treatments that only alleviate symptoms, NaiFuKang represents a fundamental shift in the treatment of IgA nephropathy by addressing the underlying disease mechanism [3][4]. Group 4: Clinical and Regulatory Considerations - YunTing XinYao has raised concerns regarding the adequacy of conventional bioequivalence tests for generic versions of NaiFuKang, suggesting that clinical efficacy and safety need to be confirmed through large-scale studies [7]. - The approval of Hainan HeRui's generic version may intensify competition in the IgA nephropathy treatment market, potentially impacting YunTing XinYao's market position [7].
涉事企业董事长回应每经：是否侵权仍待判断