NUTRINEAL

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华润双鹤药业股份有限公司 关于全资子公司上海长征富民金山制药有限公司 氨基酸(15)腹膜透析液获得药品补充申请批准通知书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-08-01 23:13
Core Viewpoint - The company has received approval for its amino acid (15) peritoneal dialysis solution, which will enhance its product line and market competitiveness [1][4]. Group 1: Drug Approval and Details - The company’s wholly-owned subsidiary, Shanghai Changfu, received the Drug Supplement Application Approval Notice from the National Medical Products Administration for the amino acid (15) peritoneal dialysis solution [1]. - This drug is designed for chronic renal failure patients, particularly those with serum albumin levels below 35g/L, and does not contain glucose [1]. Group 2: Market Situation of Similar Drugs - The amino acid (15) peritoneal dialysis solution is developed by Baxter and is marketed as "NUTRINEAL" in several countries, with a global sales figure of $21.3 million in 2024 [3]. - In China, three companies, including Shanghai Changfu, have approved the amino acid (15) peritoneal dialysis solution, with a total sales figure of 22.54 million yuan in 2024 [3]. - The market shares of the top three companies in the domestic market are as follows: Chengdu Qingshan Likang Pharmaceutical at 77.88%, Shandong Weigao Pharmaceutical at 14.04%, and Tianjin Tianyao at 8.08% [3]. Group 3: R&D Investment - The company has invested a total of 9.5 million yuan in the research and development of this drug, including technology transfer [2].