证券代码：600062 证券简称：华润双鹤 公告编号：临 2026－005 华润双鹤药业股份有限公司 关于小儿复方氨基酸注射液(19AA-I-SF)获得 药品补充申请批准通知书的公告 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"华润双鹤"或"公司") 收到了国家药品监督管理局(以下简称"国家药监局")颁发的小儿复方 氨基酸注射液(19AA-I-SF)(以下简称"该药品")《药品补充申请批准通 知书》。现将相关情况公告如下： 一、通知书主要内容 | | 药品通用名称：小儿复方氨基酸注射液(19AA-I-SF) | | | | | --- | --- | --- | --- | --- | | 药品名称 | 英 文 拉 名 ： Pediatric Compound Amino Acid | 名 | / | 丁 | | | Injection (19AA-I-SF) | | | | | 剂型 | 注射剂 | | | | | 注册分类 | 化学药品 | | | | | 规格 | 500m ...

华润双鹤公告称，近日收到国家药监局颁发的小儿复方氨基酸注射液(19AA-I-SF)《药品补充申请批准 通知书》，同意增加500ml:50g规格，视同通过一致性评价。该药品适用于婴幼儿及小儿营养支持，公 司于2021年启动补充研究，2024年提交申请。截至公告日，累计研发投入1034.16万元。2024年，原研 药"TrophAmine®"销售额925.96万美元，国内相关产品销售总额2.75亿元，公司产品收入1.3亿元，市场 份额75.67%。获批将利于发挥产品潜力，但销售有不确定性。 ...

Core Viewpoint - China Resources Double Crane (华润双鹤) has taken immediate action regarding the quality issues related to its sodium bicarbonate injection products, emphasizing its commitment to product safety and quality assurance [1] Group 1: Company Response - The company has established a special team to conduct an in-depth review of the quality issues [1] - The products in question were found during inventory checks and had not been sold to the public, indicating no harm to consumers [1] - The non-compliance was attributed to individual products experiencing leakage in the outer packaging during transportation [1] Group 2: Quality Assurance Measures - The company has conducted self-inspections and third-party testing on all inventory and production batches from the involved subsidiary, confirming that other batches are unaffected [1] - The company views product quality as a lifeline and plans to develop and implement corrective measures to enhance product quality checks and safety production supervision [1]

Group 1 - The company, China Resources Double Crane (华润双鹤), announced that its wholly-owned subsidiary, Beijing Double Crane Run Chuang Technology Co., Ltd., has received an implied approval from the FDA for the clinical trial application of the drug DC6001, marking the drug's advancement to the clinical trial phase [1] - The drug is indicated for Stargardt disease, with an IND number of 178781, and the total R&D investment amounts to 17.36 million yuan (approximately 2.5 million USD) [1] - The IND application was submitted to the FDA on November 26, 2025, and the confirmation letter was received on December 9, 2025, indicating that the implied approval period has expired, and the company will proceed with subsequent clinical trial work as required by the FDA [1] Group 2 - Additionally, the subsidiary applied for orphan drug designation for a rare pediatric disease on September 23, 2025, which was approved on November 24, 2025; however, there is uncertainty regarding policy support, and final market approval cannot be guaranteed [1]

Core Viewpoint - The company announced that its wholly-owned subsidiary, Beijing Shuanghe Run Chuang Technology Co., Ltd., has received implied permission from the FDA for clinical trials of the drug DC6001, marking a significant step in its development process [1][2]. Group 1: Drug Information - Drug Name: DC6001 - Dosage Form: Tablet - IND Number: 178781 - Applicant: Beijing Shuanghe Run Chuang Technology Co., Ltd. - Indication: Stargardt disease [6]. Group 2: Regulatory Milestones - The IND application for DC6001 was submitted to the FDA on November 26, 2025, and the confirmation letter was received on December 9, 2025. The implied permission period has now expired, allowing the company to proceed with clinical trials [2]. - The drug received Rare Pediatric Disease Designation (RPDD) from the FDA on November 24, 2025, which may provide certain policy support in the future, although this is subject to regulatory changes [2]. Group 3: Financial Investment - As of the announcement date, the total R&D investment for the drug DC6001 amounts to approximately RMB 17.36 million (unaudited) [3].

Core Viewpoint - China Resources Double Crane (600062.SH) announced that its wholly-owned subsidiary, Beijing Double Crane Run Chuang Technology Co., Ltd. (referred to as "Double Crane Run Chuang"), has received effective approval from the FDA for the new drug clinical trial application (IND) for DC6001 tablets, marking the drug's entry into the clinical trial phase [1] Group 1 - The drug DC6001 is currently in the early stages of clinical development, pending confirmation of safety, efficacy, and quality control through clinical trials [1] - The drug is subject to objective failure rates and other associated risks during the clinical trial process [1] - According to U.S. drug registration laws and regulations, a series of clinical studies must be conducted in the U.S. and approved by the FDA before the drug can be marketed [1]

证券代码：600062 证券简称：华润双鹤 公告编号：临 2026－004 华润双鹤药业股份有限公司 关于全资子公司北京双鹤润创科技有限公司 DC6001片获得FDA药物临床试验默示许可的公告 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。 华润双鹤药业股份有限公司(以下简称"公司")全资子公司北京 双鹤润创科技有限公司(以下简称"双鹤润创")就DC6001片(以下简 称"该药品")向FDA(即"美国食品药品监督管理局")提交的新药临 床试验申请(以下简称"IND")生效，该药品已进入可推进临床试验 的阶段。现将相关情况公告如下： 一、药品基本信息 5、适应症：Stargardt病 二、药品相关情况 该药品已经获得国家药品监督管理局颁发的《药物临床试验批准 通知书》，具体详见公司于2025年12月24日披露的《关于全资子公司 双鹤润创于2025年11月26日向FDA提交该药品IND申请，于2025 年12月9日收到FDA出具的IND确认函。根据FDA相关法规，公司在 FDA收到IND申请的30天(默示许可期)内，未收到FDA ...

Core Viewpoint - China Resources Double Crane (华润双鹤) announced that its wholly-owned subsidiary, Beijing Double Crane Run Chuang Technology Co., Ltd. (双鹤润创), has received effective status for its new drug clinical trial application (IND) for the drug DC6001 from the FDA, marking the drug's advancement into the clinical trial phase [1] Group 1 - The IND application for DC6001 was submitted to the FDA on November 26, 2025, and the FDA confirmed receipt of the application on December 9, 2025 [1] - According to FDA regulations, the company can commence human clinical trials as the 30-day implied approval period has elapsed without receiving a Clinical Hold notice from the FDA [1] - The company will proceed with subsequent clinical trial work in an orderly manner in accordance with FDA requirements [1]

Core Viewpoint - China Resources Double Crane announced that its wholly-owned subsidiary, Double Crane Run Chuang, has received effective approval for the clinical trial application of the new drug DC6001 from the FDA, entering the clinical trial phase for Stargardt disease [1] Group 1 - The drug DC6001 has previously received clinical trial approval from the National Medical Products Administration [1] - The IND application for the drug was submitted on November 26, 2025, and the confirmation letter was received on December 9, 2025 [1] - The drug has been designated as a rare pediatric disease drug by the FDA [1] Group 2 - The total R&D investment for the drug has reached 17.36 million yuan [1] - The drug is still in the early clinical stage, and there is uncertainty regarding its market launch [1]

Group 1 - The first phase of the 500 million yuan Hohhot Biomedical Industry High-Quality Development Fund, co-established by local state-owned enterprises and China Resources Group, has been officially registered, marking its entry into the substantive investment phase [1][5] - The fund focuses on three main directions: underlying technology innovation, terminal product industrialization, and industrial ecosystem support, with an emphasis on synthetic biology, innovative drugs, and biotechnology [1][5] - Currently, the fund has reserved 36 biomedical projects, indicating a strong pipeline for future investments [1] Group 2 - Hohhot is located at the fermentation golden latitude of 42°N, providing favorable climatic conditions for strain fermentation and continuous production, making it highly suitable for the development of synthetic biological manufacturing [2][8] - Two key areas of focus in the synthetic biology sector are the biovaccine field and the established supply chain from corn to pharmaceuticals, which has a fermentation capacity of 94,000 cubic meters [2][8] Group 3 - The city issued the "Implementation Opinions on Supporting the High-Quality Development of the Synthetic Biology Industry" in February last year, aiming for an industry output value of 50 billion yuan by 2027 and to become a national benchmark city for synthetic biology by 2030 [4][10] - China Resources Group's subsidiary, China Resources Double Crane, has been actively investing in synthetic biology, including a 500 million yuan acquisition of a major coenzyme Q10 supplier and the establishment of a synthetic biology research institute [5][10] Group 4 - The research institute has developed seven technology platforms focusing on industrial enzymes and microorganisms, covering large and small molecule drugs, concentrated medicines, and key compounds, while also promoting the construction of pilot fermentation workshops [7][12] - China Resources Pharmaceutical has partnered with the Shenzhen Institute of Advanced Technology to establish joint laboratories for synthetic biological materials and in vitro diagnostic technologies [7][12]