Core Viewpoint - The successful generic challenge to the kidney disease drug Nefukang (Budesonide Enteric Capsules) by competitors has led to a significant decline in the stock price of CloudTop New Drug (01952.HK), which has dropped over 20% in the past week [1] Group 1: Company Overview - Nefukang, introduced by CloudTop New Drug in June 2019 and approved for market in November 2023, is aimed at treating adult patients with primary IgA nephropathy at risk of progression, filling a treatment gap in China [3] - The drug achieved sales exceeding 1 billion yuan in the first three quarters of 2025 and was included in China's medical insurance reimbursement list [3] Group 2: Patent and Generic Drug Challenges - The patent for Nefukang is valid until May 7, 2029, and CloudTop New Drug retains the right to take legal action against any infringement [1] - Competitors, including Hainan Huirui Pharmaceutical, Shijiazhuang Yiling Pharmaceutical, and Qilu Pharmaceutical, are also in the process of developing generic versions of Budesonide Enteric Capsules, with Hainan Huirui already receiving approval [4][5] - Hainan Huirui's patent declaration type is "Category 3," promising not to market the generic until the relevant patent expires, while Shijiazhuang and Qilu's declarations are "Category 4.2," indicating their generics may not infringe on existing patents [4][6] Group 3: Regulatory and Legal Framework - The early resolution mechanism for drug patent disputes aims to balance interests between original drug manufacturers and generic drug developers, promoting high-level development of generics while protecting innovation [6][8] - CloudTop New Drug 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 potential 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 [8]
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