KPC(SH:600422) Zheng Quan Zhi Xing·2025-07-21 10:34Core Viewpoint - Kunming Pharmaceutical Group Co., Ltd. has received the drug registration certificate for Carbonate Sevelamer Dry Suspension, enhancing its product pipeline in the chronic kidney disease (CKD) management sector [1][2]. Drug Basic Information - The drug is named Carbonate Sevelamer Dry Suspension with a specification of 0.8g and is classified as a prescription chemical drug (Category 3) [1]. - The drug registration number is 国药准字 H20254872, and it is produced by Kunming Beikenuoton Pharmaceutical Co., Ltd. [1]. Drug Indications - The drug is indicated for controlling hyperphosphatemia in adult patients with chronic kidney disease undergoing dialysis and those with serum phosphorus levels ≥1.78 mmol/L who are not on dialysis [2]. Market Context - Carbonate Sevelamer tablets were developed by Genzyme and approved in the U.S. in 2007, with the dry suspension form approved in the U.S. and EU in 2009 [2]. - In China, there are 10 approved manufacturers for Carbonate Sevelamer tablets, while only 3 for the dry suspension form, including the company [2]. - The domestic sales of Carbonate Sevelamer tablets are projected to be approximately 1.39 billion RMB in 2024 [2]. R&D Investment - The company has invested approximately 13.18 million RMB in the research and development of Carbonate Sevelamer Dry Suspension to date [3]. Strategic Impact - The approval of the drug registration certificate is expected to enhance the company's competitiveness in the chronic disease management market and contribute to its strategic focus on the aging health industry [3].