Core Insights - Hangzhou Kang En Bei Pharmaceutical's application for the generic version of Finerenone has been accepted, with 30 companies currently competing for the first generic approval [1][7][10] - Finerenone, originally developed by Bayer, is used for treating type 2 diabetes-related chronic kidney disease (CKD) and heart failure, showing strong market performance with sales exceeding 410 million yuan in the first half of 2025, a 135.98% year-on-year increase [4][10] - The original patent for Finerenone is set to expire in February 2028, with 23 companies currently filing for a type 3 patent declaration, indicating they cannot market the product until the patent expires [10][13] Company Developments - Kang En Bei Pharmaceutical has successfully obtained approvals for over 50 products, with several being the first to pass consistency evaluations, including Sulfamethoxazole and Amisulpride solutions [16] - The competition for Finerenone has intensified, with 37 companies having completed bioequivalence (BE) trials and over 20 more currently conducting BE trials [13][16] Market Dynamics - The strong sales performance of Finerenone has attracted numerous domestic pharmaceutical companies to enter the market, leading to a competitive landscape [4][7] - The ongoing patent challenges and the competitive nature of the generic drug market suggest a dynamic environment for both original and generic manufacturers [10][13]

Core Insights - Shijiazhuang Four Pharmaceutical Co., Ltd. and Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd. have submitted applications for the marketing of the generic drug Finerenone tablets, which have been accepted by the CDE [1][2] Group 1: Product Overview - Finerenone is a "first-in-class" non-steroidal, selective mineralocorticoid receptor antagonist (MRA) developed by Bayer, approved by the FDA in July 2021 and in China for chronic kidney disease (CKD) associated with type 2 diabetes in June 2022 [3] - The cumulative sales of Finerenone in China have exceeded 400 million yuan, with a significant increase in sales after being included in the medical insurance list in January 2023, showing a year-on-year growth of 234.68% in 2024, reaching 322 million yuan [4][17] Group 2: Market Potential - Chronic kidney disease (CKD) is a major global chronic disease, with approximately 116 million type 2 diabetes patients in China as of 2021. About 40% of these patients may progress to diabetes-related CKD, indicating a large patient base for Finerenone [9][10] - The drug has been recommended in the "Clinical Practice Guidelines for Diabetic Kidney Disease in China" for reducing urinary albumin and managing cardiovascular complications in diabetic kidney disease patients [6] Group 3: Competitive Landscape - Finerenone's compound patent is set to expire on February 19, 2028, while its crystal form patent will expire on July 29, 2035, allowing for potential generic competition in the future [12][13] - Currently, Bayer holds the production license for Finerenone, with 14 other companies, including Shijiazhuang Four Pharmaceutical and Fosun Pharma, in the review stage for production [14] Group 4: Pricing and Accessibility - The price of Finerenone was significantly reduced from 445.2 yuan to 98.42 yuan after being included in the national medical insurance directory, a decrease of 78%, making the daily treatment cost as low as 7.03 yuan [17] - Following a successful renewal in 2025, the price is expected to drop further, enhancing the drug's accessibility [17] Group 5: Future Outlook - With the reduction in medical costs and the increasing number of domestic pharmaceutical companies entering the market, Finerenone is expected to benefit more patients with type 2 diabetes-related CKD [19] - The first generic application from Hunan Mingrui Pharmaceutical is anticipated to be submitted in September 2024, with potential approval in 2025 [19]