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华润双鹤药业股份有限公司 关于全资子公司西安京西双鹤药业 有限公司平衡盐冲洗液获得药品注册证书的公告
■ 证券代码:600062 证券简称:华润双鹤 公告编号:临2026-012 华润双鹤药业股份有限公司 关于全资子公司西安京西双鹤药业 有限公司平衡盐冲洗液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(以下简称"公司")全资子公司西安京西双鹤药业有限公司(以下简 称"京西双鹤")收到了国家药品监督管理局(以下简称"国家药监局")颁发的平衡盐冲洗液(以下简称"该药 品")《药品注册证书》。现将相关情况公告如下: 一、药品注册证书主要内容 二、药品相关情况 平衡盐冲洗液为无菌电解质水溶液,适用于外科冲洗。 京西双鹤于2022年1月启动该药品的仿制药研发工作,于2024年4月26日向国家药监局提交上市许可申 请,于2024年5月21日获得受理通知书,并于2026年2月10日获得国家药监局批准上市。根据国家相关政 策规定,本次获得《药品注册证书》视同通过一致性评价。 截至本公告日,公司针对该药品累计研发投入为人民币365.31万元(未经审计)。 三、同类药品的市场状况 平衡盐冲 ...
华润双鹤:关于全资子公司西安京西双鹤药业有限公司平衡盐冲洗液获得药品注册证书的公告
Zheng Quan Ri Bao· 2026-02-26 11:16
(文章来源:证券日报) 证券日报网讯 2月26日,华润双鹤发布公告称,公司全资子公司西安京西双鹤药业有限公司收到了国家 药品监督管理局颁发的平衡盐冲洗液《药品注册证书》。 ...
华润双鹤:平衡盐冲洗液取得注册证
Mei Ri Jing Ji Xin Wen· 2026-02-26 09:30
每经AI快讯,华润双鹤2月26日晚间发布公告称,近日,华润双鹤药业股份有限公司全资子公司西安京 西双鹤药业有限公司收到了国家药品监督管理局颁发的平衡盐冲洗液《药品注册证书》。产品名称 为"平衡盐冲洗液"。 (记者 曾健辉) 每经头条(nbdtoutiao)——超10万人挤爆服务器,围观8家房企抢"马场":9小时竞价243轮,236亿元 成交!广州楼面价新地王诞生:8.5万元/㎡ ...
华润双鹤(600062.SH):子公司平衡盐冲洗液获得药品注册证书
Ge Long Hui A P P· 2026-02-26 09:21
格隆汇2月26日丨华润双鹤(600062.SH)公布,公司全资子公司西安京西双鹤药业有限公司(称"京西双 鹤")收到了国家药品监督管理局颁发的平衡盐冲洗液(称"该药品")《药品注册证书》。平衡盐冲洗液为 无菌电解质水溶液,适用于外科冲洗。 ...
华润双鹤(600062) - 华润双鹤关于全资子公司西安京西双鹤药业有限公司平衡盐冲洗液获得药品注册证书的公告
2026-02-26 09:15
证券代码:600062 证券简称:华润双鹤 公告编号:临 2026-012 华润双鹤药业股份有限公司 关于全资子公司西安京西双鹤药业有限公司 平衡盐冲洗液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。 三、同类药品的市场状况 | 药品名称 | 药品通用名称:平衡盐冲洗液 英文名/拉丁名:Balanced Salt Irrigating Solution | | --- | --- | | 剂型 | 冲洗剂 | | 注册分类 | 化学药品 类 3 | | 规格 | 500ml、1000ml | | 编号 | 2026S00435、2026S00436 | | 药品批准文号 | 国药准字 H20263368、国药准字 H20263369 | | 申请事项 | 药品注册(境内生产) | | 根据《中华人民共和国药品管理法》及有关规定,经 | | --- | | 审查,本品符合药品注册的有关要求,批准注册,发 | | 审批结论 给药品注册证书。质量标准、说明书、标签及生产工 | | 艺照所附执行。药品生产企业 ...
华润双鹤(600062) - 华润双鹤关于通过GMP符合性检查的公告
2026-02-26 09:15
华润双鹤药业股份有限公司 关于通过GMP符合性检查的公告 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")收到北京 市药品监督管理局颁发的《药品 GMP 符合性检查告知书》(编号:京 药监药 GMP〔2025〕020134),现将相关情况公告如下: 一、GMP 检查相关信息 被检查单位名称:华润双鹤药业股份有限公司 证券代码:600062 证券简称:华润双鹤 公告编号:临 2026-011 结论:根据本次检查情况,经审查,该企业此次检查范围符合《药 品生产质量管理规范(2010 年修订)》和附录要求。 本次检查为改造冻干车间半固体制剂生产线药品 GMP 符合性检 查合并开展非诺贝特酸胆碱缓释胶囊、帕立骨化醇注射液、利丙双卡 因乳膏上市前药品 GMP 符合性检查,前述改造车间生产线、新增设 备的投入为人民币 152.62 万元(未经审计)。 三、同类产品的市场状况 检查地址:北京市朝阳区双桥东路 2 号 检查范围及相关车间、生产线: ①硬胶囊剂:固体制剂车间硬胶囊剂生产线 ②小 ...
华润双鹤:子公司平衡盐冲洗液获得药品注册证书
Ge Long Hui· 2026-02-26 09:14
格隆汇2月26日丨华润双鹤(600062.SH)公布,公司全资子公司西安京西双鹤药业有限公司(称"京西双 鹤")收到了国家药品监督管理局颁发的平衡盐冲洗液(称"该药品")《药品注册证书》。平衡盐冲洗液为 无菌电解质水溶液,适用于外科冲洗。 ...
华润双鹤:全资子公司平衡盐冲洗液获药品注册证书
Xin Lang Cai Jing· 2026-02-26 09:09
华润双鹤公告称,其全资子公司京西双鹤收到国家药监局颁发的平衡盐冲洗液《药品注册证书》,批准 上市。该药品为无菌电解质水溶液,适用于外科冲洗,视同通过一致性评价。京西双鹤于2022年1月启 动研发,2026年2月获批。截至公告日,累计研发投入365.31万元。2024年该药品全球销售额334.42万美 元,国内市场销售总额5585万元。该药品获批将丰富公司产品线,提升竞争力,但销售情况有不确定 性。 ...
第11届生物基大会暨展览丨40+名企已报名DT新叶奖!第二轮报名开启,截止3月13日
DT新材料· 2026-02-13 16:04
Core Viewpoint - The DT New Leaf Award is a global, professional, and comprehensive award focused on innovation in the bio-based sector, often referred to as the "Oscar of the bio-based industry" [2]. Group 1: Award Overview - The DT New Leaf Award features four main categories: Innovation Materials Award, Innovation Application Award, Most Commercially Valuable Award, and Innovative Industry Solutions Award [2]. - Free registration for the award is open until March 13 [2]. Group 2: Participating Companies and Products - Over 40 listed and representative companies have registered for the 2026 DT New Leaf Award, including notable firms such as Wanhua Chemical, Shuangqiang Technology, and Yutong Technology [3]. - Wanhua Chemical (600309) is a leading global chemical new materials company and has established a bio-based polyurethane industry chain [5]. - Shuangqiang Technology (001211) is recognized as China's first publicly listed chopstick company and has partnered with Ningbo Materials to develop bamboo-based composite logistics pallets, showcasing significant market potential [7]. - China Resources Double Crane (600062) has its 1,4-butanediamine included in the Ministry of Industry and Information Technology's list of landmark bio-manufacturing products, having completed pilot tests [9]. Group 3: Product Innovations - Wanhua Chemical's PCDL product utilizes dimethyl carbonate as a raw material, produced through carbon capture technology, and exhibits excellent mechanical properties [11]. - The bamboo-based composite pallets developed by Shuangqiang Technology demonstrate high rigidity and toughness, with costs only 60%-70% of traditional plastic pallets [12]. - Yutong Technology is advancing the development of non-wood fiber, bio-adhesives, and bio-waxes, filling domestic technological gaps with products like biodegradable cat litter [13]. Group 4: Future Prospects and Collaborations - Lifebio is a global leader in PEF & FDCA and has partnered with leading companies to develop a production line for FDCA, with an investment of 1 billion yuan expected to yield an annual output of 15,000 tons [16]. - Zhongke Guosheng is completing a 200 million yuan A+ round of financing and is set to achieve mass production of FDCA by 2026 [17]. - Fengyuan Bio is recognized as a "chain leader" in the bio-based materials industry, utilizing non-grain technology to convert straw into mixed sugars for lactic acid production [19]. Group 5: Technological Innovations - Guwei Yuan Chuang is the first global company to focus on non-grain bio-based succinic acid production, recently receiving ISCC PLUS certification for its innovative processes [21]. - The company has developed a high-efficiency cell factory for the synthesis of bio-based 1,4-butanediamine, achieving over 98% purity and a 60% reduction in carbon emissions [22]. - The innovative use of plant fiber materials in the production of biodegradable packaging solutions is gaining traction, with several companies showcasing advancements in this area [23][24].
DT新叶奖参选:万华/华润双鹤/利夫/道生/聚维元创/华澄/碳和新材, 第二轮报名截止03.13
Core Viewpoint - The DT New Leaf Award is a global, professional, and comprehensive award focused on innovation in the bio-based sector, often referred to as the "Oscar of the bio-based industry" [2]. Group 1: Award Overview - The DT New Leaf Award features four main categories: Innovation Materials Award, Innovation Application Award, Most Commercially Valuable Award, and Innovative Industry Solution Award [2]. - Free registration for the award is open until March 13 [2]. Group 2: Participating Companies - Over 40 listed and representative companies have registered for the 2026 DT New Leaf Award, including notable firms such as Wanhua Chemical, Shuangqiang Technology, and Yutong Technology [3]. - Wanhua Chemical is recognized as a leading global chemical new materials company and has established a bio-based polyurethane industry chain [5]. - Shuangqiang Technology, known as the first stock of chopsticks in China, has partnered with Ningbo Materials to develop bamboo-based composite logistics pallets, showcasing significant market potential [7]. Group 3: Selected Products and Innovations - Wanhua Chemical's PCDL product utilizes dimethyl carbonate as a raw material, produced through carbon capture technology, and exhibits excellent mechanical properties [11]. - Shuangqiang Technology's bamboo-based composite pallets are noted for their high rigidity and toughness, with costs only 60%-70% of traditional plastic pallets [12]. - Huazhong University of Science and Technology's team has developed a unique liquid gel foaming technology aimed at producing 100% biodegradable gel foam materials [78]. Group 4: Industry Trends and Developments - The bio-based materials sector is seeing significant innovations, such as the development of bio-based 1,4-butanediamine by Huazhong University, which has been recognized in the Ministry of Industry and Information Technology's list of landmark bio-manufacturing products [9][10]. - Companies like Lifebio and Zhongke Guosheng are advancing in the production of bio-based chemicals and materials, with Lifebio's FDCA production line expected to yield 15,000 tons annually after reaching full capacity [16][17]. Group 5: Award Process and Evaluation - The award process includes registration, online voting for preliminary selection, and expert reviews for final selection, culminating in an award ceremony on May 21 [110]. - Evaluation criteria for the awards include innovation, application, functionality, commercial value, and sustainability, with different weightings for each category [111].