Core Viewpoint - The approval of a generic version of the nephrology drug Neficon (Budesonide Enteric Capsules) has led to a significant decline in the stock price of Cloudy New Horizon (01952.HK), which has dropped over 20% in the past week due to concerns over competition from generic manufacturers [2]. Group 1: Company Overview - Neficon, introduced by Cloudy New Horizon 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]. - The original patent for Neficon is valid until May 7, 2029, and the company retains the right to take legal action against any infringement [2][5]. Group 2: Generic Competition - Hainan Huirui Pharmaceutical Co., Ltd. has successfully obtained approval for its generic Budesonide Enteric Capsules, with a patent declaration type of "Category 3," promising not to market the generic until the relevant 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, with their patent declarations classified as "Category 4.2," indicating they may not infringe on the original patent [5][6]. - If these companies succeed in obtaining approval, they could potentially launch their products before the original patent expiration date [5]. Group 3: Legal and Regulatory Framework - The early resolution mechanism for drug patent disputes, established by the National Medical Products Administration and the National Intellectual Property Administration, aims to balance interests between original and generic drug manufacturers [6][8]. - Cloudy New Horizon can challenge the patent declarations of Shijiazhuang and Qilu within 45 days of the public announcement of their drug applications [7]. - The case is seen as a test of the new patent linkage system in China, which seeks to protect innovation while promoting the development of high-quality generics [8][9].
云顶新耀销售过十亿元的肾病药被仿制 原研与仿制药厂的专利纷争待解