证券代码：600062 证券简称：华润双鹤 公告编号：临 2025-118 华润双鹤药业股份有限公司 关于羟钴胺注射液获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记 载、误导性陈述或者重大遗漏，并对其内容的真实性、准确性和完 整性承担法律责任。 近日，华润双鹤药业股份有限公司(以下简称"公司")收到国家 药品监督管理局(以下简称"国家药监局")签发的羟钴胺注射液(以下 简称"该药品")《药物临床试验批准通知书》。现将相关情况公告 如下： 一、通知书主要内容 | 药品名称 | | 药品通用名称：羟钴胺注射液 | | --- | --- | --- | | | | 英文名/拉丁名：Hydroxocobalamin Injection | | 注册分类 | | 化学药品 2 类 | | 受 理 | 号 | CXHL2501157、CXHL2501158、CXHL2501159 | | 通知书编号 | | 2025LP03567、2025LP03568、2025LP03569 | | 审批结论 | | 根据《中华人民共和国药品管理法》及有关规定， 经审查，2025 年 月 日受 ...

证券代码：600062 证券简称：华润双鹤 公告编号：临 2025－117 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 低钙腹膜透析液(碳酸氢盐)、腹膜透析液(碳酸氢盐) 系列药品获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、 误导性陈述或者重大遗漏，并对其内容的真实性、准确性和完整性承 担法律责任。 近日，华润双鹤药业股份有限公司全资子公司上海长征富民金山 制药有限公司(以下简称"上海长富")收到了国家药品监督管理局(以 下简称"国家药监局")颁发的低钙腹膜透析液(碳酸氢盐-G1.5%)、低 钙腹膜透析液(碳酸氢盐-G2.5%)[以下简称"低钙腹膜透析液(碳酸氢 盐)系列药品"]，腹膜透析液(碳酸氢盐-G1.5%)、腹膜透析液(碳酸氢 盐-G2.5%)[以下简称"腹膜透析液(碳酸氢盐)系列药品"]《药品注册 证书》。现将相关情况公告如下： 上海长富于2023年2月启动低钙腹膜透析液(碳酸氢盐)、腹膜透析 液(碳酸氢盐)系列药品的仿制药研发工作，于2024年8月22日向国家药 监局提交上市许可申请，于2024年8月31日获得受理通知书，并于2025 ...

人民财讯12月29日电，华润双鹤（600062）12月29日公告，近日，全资子公司上海长征富民金山制药有 限公司收到了国家药品监督管理局颁发的低钙腹膜透析液(碳酸氢盐-G1.5%)、低钙腹膜透析液(碳酸氢 盐-G2.5%)(简称"低钙腹膜透析液(碳酸氢盐)系列药品")，腹膜透析液(碳酸氢盐-G1.5%)、腹膜透析液(碳 酸氢盐-G2.5%)(简称"腹膜透析液(碳酸氢盐)系列药品")《药品注册证书》。低钙腹膜透析液(碳酸氢盐) 适用于慢性肾功能衰竭患者的腹膜透析(在高镁血症改善不充分，且因使用钙制剂和活性维生素D制剂 而可能引起高钙血症的情况时使用)；腹膜透析液(碳酸氢盐)适用于慢性肾功能衰竭患者的腹膜透析(在 高镁血症没有得到充分改善时使用)。 ...

Core Viewpoint - China Resources Double Crane (华润双鹤) has received approval from the National Medical Products Administration for clinical trials of Hydroxocobalamin Injection, aimed at treating metabolic disorders in children with methylmalonic acidemia, with or without homocystinuria [1] Group 1 - The company announced the receipt of the clinical trial approval notice on December 29 [1] - Hydroxocobalamin Injection is specifically indicated for pediatric patients suffering from metabolic disorders related to methylmalonic acidemia [1] - This development may enhance the company's product portfolio in the pediatric therapeutic area [1]

Core Viewpoint - The company has received the clinical trial approval notice for Hydroxocobalamin Injection from the National Medical Products Administration, indicating progress in its drug development efforts [2] Group 1: Drug Development - Hydroxocobalamin Injection is intended for the treatment of metabolic disorders in children with methylmalonic acidemia, with or without homocystinuria [2] - The total research and development investment for this drug has reached RMB 13.0581 million (unaudited) as of the date of the announcement [2]

Core Viewpoint - China Resources Double Crane Pharmaceutical Co., Ltd. has received drug registration certificates for low-calcium peritoneal dialysis solutions, which will enhance the company's product line and market competitiveness [1] Group 1: Product Development - The company’s wholly-owned subsidiary, Shanghai Changzheng Fumin Jinshan Pharmaceutical Co., Ltd., has obtained registration for low-calcium peritoneal dialysis solutions (bicarbonate-G1.5% and bicarbonate-G2.5%) [1] - The registration of these products will enrich the company's product offerings and contribute to its competitive edge in the market [1] - The experience gained from the development of these products will be valuable for future product research and development [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of Hydroxocobalamin injection, indicating progress in its drug development pipeline [1] Group 1: Regulatory Approval - The company announced on December 29 that it received the clinical trial approval notice for Hydroxocobalamin injection from the National Medical Products Administration [1] - The acceptance notice for the drug was received on October 22, 2025, and the clinical trial approval was granted on December 25, 2025 [1] Group 2: Financial Investment - As of the date of the announcement, the company has invested a total of RMB 13.0581 million (approximately 1.3 million) in the research and development of this drug [1] Group 3: Indication - Hydroxocobalamin injection is indicated for the treatment of metabolic disorders in children with methylmalonic acidemia, with or without homocystinuria [1]

Core Viewpoint - China Resources Double Crane (600062.SH) has received the clinical trial approval notice from the National Medical Products Administration for Hydroxocobalamin Injection, indicating a significant step in the development of this treatment for metabolic disorders in children [1] Group 1 - The approved drug, Hydroxocobalamin Injection, is intended for the treatment of methylmalonic acidemia with or without homocystinuria in pediatric patients [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of Hydroxocobalamin injection, indicating progress in its drug development pipeline [1] Group 1: Regulatory Approval - The company received the clinical trial approval notice for Hydroxocobalamin injection on December 25, 2025, after the acceptance notice on October 22, 2025 [1] - The approval is significant for the treatment of metabolic disorders in children with methylmalonic acidemia, with or without homocystinuria [1] Group 2: Research and Development Investment - The total R&D investment for Hydroxocobalamin injection has reached RMB 13.0581 million (unaudited) as of the date of the announcement [1]

格隆汇12月29日丨华润双鹤(600062.SH)公布，近日，华润双鹤药业股份有限公司全资子公司上海长征 富民金山制药有限公司(以下简称"上海长富")收到了国家药品监督管理局颁发的低钙腹膜透析液(碳酸氢 盐-G1.5%)、低钙腹膜透析液(碳酸氢盐-G2.5%)[以下简称"低钙腹膜透析液(碳酸氢盐)系列药品"]，腹膜 透析液(碳酸氢盐-G1.5%)、腹膜透析液(碳酸氢盐-G2.5%)[以下简称"腹膜透析液(碳酸氢盐)系列药品"] 《药品注册证书》。 低钙腹膜透析液(碳酸氢盐)、腹膜透析液(碳酸氢盐)系列药品获得《药品注册证书》，将进一步丰富公 司产品线，有助于提升公司产品的市场竞争力，并为后续其他产品研发积累了宝贵的经验。 ...