Core Viewpoint - The article discusses the impact of successful generic drug approvals on the stock price of Cloudtop New Yao (01952.HK), particularly focusing on the generic version of its drug, Neficon (Budesonide Enteric-Coated Capsules), which has led to a significant decline in the company's stock price by over 20% in the past week [3][6]. Group 1: Drug Approval and Market Impact - Neficon, introduced by Cloudtop New Yao in June 2019, received approval from the Chinese National Medical Products Administration in November 2023 for treating adult patients with primary IgA nephropathy at risk of progression, filling a treatment gap in China [6]. - The sales of Neficon exceeded 1 billion yuan in the first three quarters of 2025, indicating strong market performance [6]. - The approval of a generic version by Hainan Huirui Pharmaceutical on December 16, 2025, has raised concerns for Cloudtop New Yao, as it may lead to increased competition [6][7]. Group 2: Patent and Legal Considerations - Cloudtop New Yao maintains that its patent for Neficon is valid until May 7, 2029, and reserves the right to take legal action against any infringement [3][7]. - Hainan Huirui's patent declaration type is classified as "Category 3," indicating a commitment not to market the generic drug until the relevant patent expires [7]. - Other companies, such as Shijiazhuang Yiling Pharmaceutical and Qilu Pharmaceutical, are also in the process of developing generic versions, with their patent declarations classified as "Category 4.2," suggesting they may not infringe on the original patent [8]. Group 3: Response Strategies - Cloudtop New Yao is considering its options in response to potential challenges from generic competitors, emphasizing the need for clinical studies to confirm the efficacy and safety of any generic versions [10]. - The article highlights the importance of the early resolution mechanism for drug patent disputes established by the National Medical Products Administration and the National Intellectual Property Administration, which aims to balance interests between original and generic drug manufacturers [10][11]. - Legal experts suggest that Cloudtop New Yao has a 45-day window to challenge the patent declarations of generic applicants in court, which could influence the market dynamics [11][12].
销售过十亿元的肾病药被仿制，这家药企股价大跌