销售过十亿元的肾病药被仿制，这家药企股价大跌

Core Viewpoint - The successful imitation of the kidney disease drug Nefukang (Budesonide enteric-coated capsules) has led to a significant decline in the stock price of CloudTop New Medicine (01952.HK), which has dropped over 20% in the past week due to concerns over competition from generic drug manufacturers [2]. Group 1: Company Overview - Nefukang, introduced by CloudTop New Medicine 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 [4]. - The product achieved sales exceeding 1 billion yuan in the first three quarters of 2025 [4]. Group 2: Patent and Competition - CloudTop New Medicine asserts that the patent for Nefukang is valid until May 7, 2029, and the company reserves the right to take legal action against any infringement [2]. - The first generic version of Budesonide enteric-coated capsules was approved for Hainan Huirui Pharmaceutical Co., Ltd. on December 16, 2025, with a commitment to not market the generic until the patent expires [5]. - Other companies, including Shijiazhuang Yiling Pharmaceutical Co., Ltd. and Qilu Pharmaceutical Co., Ltd., are also in the process of developing generic versions, potentially allowing them to enter the market before the patent expiration [6]. Group 3: Legal and Regulatory Framework - The early resolution mechanism for drug patent disputes aims to balance the interests of original drug manufacturers and generic drug developers, promoting high-level development of generic drugs while protecting innovation [7]. - CloudTop New Medicine can challenge the patent declarations of Shijiazhuang Yiling and Qilu within 45 days of the public announcement of their drug applications [8]. - The case is seen as a test of China's drug patent linkage system, with implications for how administrative and judicial bodies balance the interests of original and generic drug manufacturers [9].