年销超10亿元肾病创新药遇首仿！云顶新耀发文声讨

Core Viewpoint - The pharmaceutical company YunTing XinYao is actively defending its patent rights for its core product Budesonide Enteric Capsules (NaiFuKang) against the approval of a generic version by Hainan HeRui Pharmaceutical, asserting that its patent is valid until May 7, 2029 [2][9]. Company Summary - YunTing XinYao's stock price is currently at HKD 44.62, with a market capitalization of HKD 15.775 billion [2]. - The company has announced its intention to take legal action against any infringement of its patent rights regarding NaiFuKang [2][10]. Industry Summary - The approval of Hainan HeRui's Budesonide Enteric Capsules on December 16, 2023, may significantly impact the market for IgA nephropathy treatments, as NaiFuKang is the only approved drug targeting this condition in China [6][9]. - The sales forecast for NaiFuKang is projected to reach between CNY 12 billion to CNY 14 billion in 2025, and CNY 24 billion to CNY 26 billion in 2026 [6]. - The mechanism of action for NaiFuKang involves a unique dual-release formulation that targets the ileum, which is expected to provide renal function protection for IgA nephropathy patients [8]. Patent and Legal Dispute Summary - Hainan HeRui submitted a "Category 3 Declaration" when applying for the generic drug, indicating an acknowledgment of YunTing XinYao's patent and a commitment not to market the generic until the patent expires [9][10]. - The legal discourse centers around the implications of the "Category 3 Declaration" versus a "Category 4 Declaration," which challenges the validity of the patent [10][11]. - Other companies, such as Qilu Pharmaceutical and Shijiazhuang Yiling Pharmaceutical, have submitted applications with "Category 4 Declarations," indicating a more aggressive stance against YunTing XinYao's patent [11]. Market Impact Summary - Following the news of the generic approval, YunTing XinYao's stock experienced a decline of 8.98% over three trading days [12]. - The increasing number of approved generic drugs in the IgA nephropathy market is expected to intensify competition [12].