Workflow
CR Double-Crane(600062)
icon
Search documents
华润双鹤:盐酸吡格列酮分散片获得药品补充申请批准通知书
Zhi Tong Cai Jing· 2025-12-01 09:27
Core Viewpoint - China Resources Double Crane Pharmaceutical (600062.SH) announced that its subsidiary, Double Crane Tianan Pharmaceutical (Guizhou) Co., Ltd., received approval from the National Medical Products Administration for the supplementary application of Pioglitazone Hydrochloride Dispersible Tablets, which is considered to have passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The approved drug, Pioglitazone Hydrochloride Dispersible Tablets, is used for the treatment of type 2 diabetes [1] - The successful consistency evaluation is expected to enhance future market sales and competitiveness for the company [1] - This achievement will also provide valuable experience for the company in conducting future evaluations of generic drug consistency [1]
华润双鹤(600062.SH):盐酸吡格列酮分散片获得药品补充申请批准通知书
智通财经网· 2025-12-01 09:25
Core Viewpoint - China Resources Double Crane Pharmaceutical (600062.SH) announced that its subsidiary, Double Crane Tianan Pharmaceutical (Guizhou) Co., Ltd., received the approval notice for the supplementary application of Pioglitazone Hydrochloride Dispersible Tablets from the National Medical Products Administration, indicating that the drug has passed the consistency evaluation for generic drug quality and efficacy [1] Group 1 - The approved drug, Pioglitazone Hydrochloride Dispersible Tablets, is used for the treatment of type 2 diabetes [1] - The successful consistency evaluation is expected to enhance future market sales and competitiveness for the company [1] - This achievement will also provide valuable experience for the company in conducting future evaluations of generic drug consistency [1]
华润双鹤:盐酸吡格列酮分散片获得药品补充申请批准
Ge Long Hui A P P· 2025-12-01 09:17
Core Viewpoint - China Resources Double Crane announced that its subsidiary, Double Crane Tianan Pharmaceutical Co., Ltd., received the approval notice for the supplementary application of Pioglitazone Hydrochloride Dispersible Tablets from the National Medical Products Administration [1] Summary by Categories - **Regulatory Approval** - The company has received a supplementary application approval for Pioglitazone Hydrochloride Dispersible Tablets from the National Medical Products Administration [1] - **Research and Development Investment** - As of the date of the announcement, the total R&D investment for this drug's consistency evaluation amounts to RMB 8.8227 million (unaudited) [1]
华润双鹤(600062) - 华润双鹤关于控股子公司双鹤天安药业(贵州)股份有限公司盐酸吡格列酮分散片获得药品补充申请批准通知书的公告
2025-12-01 09:15
证券代码:600062 证券简称:华润双鹤 公告编号:临 2025-100 华润双鹤药业股份有限公司 关于控股子公司双鹤天安药业(贵州)股份有限公司 盐酸吡格列酮分散片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"公司")控股子公 司双鹤天安药业(贵州)股份有限公司(以下简称"双鹤天安")收到了 国家药品监督管理局(以下简称"国家药监局")颁发的盐酸吡格列酮 分散片(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: | 申请内容 | 仿制药质量和疗效一致性评价 | | --- | --- | | 审批结论 | 根据《中华人民共和国药品管理法》、《国务院 号) | | | 关于改革药品医疗器械审评审批制度的意见》(国 | | | 发〔2015〕44 号)和《关于仿制药质量和疗效一致 | | | 性评价工作有关事项的公告》(2017 年第 100 | | | 规定,经审查,本品视同通过仿制药质量和疗效 | | | 一致性评价。 ...
华润双鹤药业股份有限公司关于全资子公司华润赛科药业有限责任公司 比索洛尔氨氯地平片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")全资子公司华润赛科药业有限责任公司(以下简 称"华润赛科")收到了国家药品监督管理局(以下简称"国家药监局")颁发的比索洛尔氨氯地平片(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 ■ 三、同类药品的市场状况 比索洛尔氨氯地平片由默克(Merck Kft)公司研制开发,于2017年11月在欧盟获批上市,商品名 为"Concor AMLO?",于2021年5月在中国获批上市。根据全球71国家药品销售数据库显示,2024年比索 洛尔氨氯地平片全球销售额为7,404.93万美元,其中"Concor AMLO?"的销售额为4,429.46万美元。 国内市场,根据国家药监局网站信息显示,中国大陆境内已批准上市的比索洛尔氨氯地平片生产企业有 14家(含华润赛科),其中视同通过一致性评价的生产企业13家(含华润赛科)。根据米内网数据显示, 2024年国内医疗市场和零售市场比索洛尔氨氯地平片销售总额(终 ...
华润双鹤药业股份有限公司关于全资子公司华润赛科药业有限责任公司比索洛尔氨氯地平片获得药品注册证书的公告
Core Viewpoint - The announcement highlights that China Resources Double Crane Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, China Resources Saike Pharmaceutical Co., Ltd., has received a drug registration certificate for Bisoprolol Amlodipine Tablets, which is a significant development for the company's product line and market competitiveness [1][4]. Group 1: Drug Registration and Development - The drug registration certificate for Bisoprolol Amlodipine Tablets was issued by the National Medical Products Administration (NMPA) [1]. - The research and development of this drug began in November 2022, with the application for market approval submitted in June 2024 and the approval granted in November 2025 [1][2]. Group 2: Market Situation - Bisoprolol Amlodipine Tablets, developed by Merck Kft, were approved for sale in the EU in November 2017 and in China in May 2021 [3]. - The global sales of Bisoprolol Amlodipine Tablets are projected to reach approximately $74.05 million in 2024, with Merck's product "Concor AMLO?" accounting for about $44.29 million of that total [3]. - In the Chinese market, the total sales of Bisoprolol Amlodipine Tablets are estimated to be around 4.29 million RMB in 2024, with Merck holding a dominant market share of 99.90% [3]. Group 3: Impact on the Company - The approval of the drug registration certificate is expected to enhance the company's product line and market competitiveness, while also providing valuable experience for future product development [4].
华润双鹤:关于全资子公司华润赛科药业有限责任公司比索洛尔氨氯地平片获得药品注册证书的公告
Zheng Quan Ri Bao· 2025-11-25 13:40
证券日报网讯 11月25日晚间,华润双鹤发布公告称,近日,公司全资子公司华润赛科药业有限责任公 司收到了国家药品监督管理局颁发的比索洛尔氨氯地平片《药品注册证书》。 (文章来源:证券日报) ...
11月25日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-25 10:16
分组1 - Weili Medical plans to distribute a cash dividend of 2 yuan per 10 shares to all shareholders, based on an undistributed profit of 704 million yuan as of September 30, 2025 [1] - Tongding Interconnect's shareholder plans to reduce their stake by up to 0.49%, equating to a maximum of 605,800 shares [1] - Caitong Securities has received approval from the China Securities Regulatory Commission to issue short-term corporate bonds with a total face value of up to 5 billion yuan [1] 分组2 - Youfu Food intends to use 70 million yuan of its own funds to invest in wealth management products with expected annual returns of up to 4.2% [3] - Keres received an administrative regulatory decision from the Guangdong Securities Regulatory Bureau for violations related to accounts receivable aging calculations and related party transactions [5] - Ouma Software's controlling shareholder has completed the transfer of state-owned equity, changing the controlling shareholder to Shandong Guotou [7] 分组3 - ST Huapeng's wholly-owned subsidiary has completed a major overhaul project and is now in production [8] - Beiqi Blue Valley has received approval from the China Securities Regulatory Commission for a stock issuance to specific investors [8] - Weijie Chuangxin received a government subsidy of 5 million yuan, accounting for 21.07% of its projected net profit for 2024 [9] 分组4 - China Resources Double Crane's subsidiary has received a drug registration certificate for a hypertension treatment drug [11] - Huafeng shares are continuing to suspend trading due to a planned change in control [13] - Kaifa Electric's shareholder plans to transfer 36.6869 million shares, representing 11.63% of the total share capital [14] 分组5 - Heng Rui Medicine has received approval for two clinical trials for innovative anti-tumor drugs [15] - Kosen Technology plans to invest 30 million USD to establish a new production base in Malaysia [17] - Sanxing Medical's subsidiary is expected to win a procurement project from the State Grid worth approximately 107 million yuan [18] 分组6 - Sitai Li's subsidiary has received a drug registration certificate for a contrast agent used in MRI [21] - Daren Tang's subsidiary has received a drug registration certificate for a pain relief gel [22] - Saike Xide has received approval for three medical device products, expanding its product range in the in vitro diagnostic field [23] 分组7 - Hasa Lian has elected a new chairman and vice chairman for its board of directors [24] - Two-sided Needle's subsidiary plans to invest 68.8522 million yuan in a production base expansion project [25] - Sunshine Nuohe plans to transfer 70% of its controlling subsidiary's equity for 2 million yuan [26] 分组8 - Hengbang shares received an administrative regulatory decision from the Shandong Securities Regulatory Bureau for failing to complete the election of independent directors [27] - Huali shares plan to sign a related transaction contract worth approximately 59.2847 million yuan [28] - Shangwei shares plan to invest 520.4 million yuan to gain a controlling stake in Sichuan Zhongfu Taihua [30] 分组9 - Zejing Pharmaceutical's ZG006 has been included in the list of breakthrough therapeutic varieties for treating advanced neuroendocrine cancer [32] - Yaopi Glass's shareholder plans to reduce their stake by up to 2.26%, equating to a maximum of 21.1469 million shares [34] - Huate Gas has initiated a major lawsuit involving a claim of 180 million yuan [36] 分组10 - Zhongchumei's controlling shareholder plans to increase their stake by between 42 million and 80 million yuan [37] - Huitong shares' shareholder plans to reduce their stake by up to 1% [38] - Miaowei Exhibition plans to apply for an initial public offering of H shares on the Hong Kong Stock Exchange [40] 分组11 - Tianqi Lithium's subsidiary has appealed to the Chilean Supreme Court regarding a partnership agreement with SQM and Codelco [42] - Naxin Micro plans to repurchase shares worth between 200 million and 400 million yuan [44] - Pingao shares have reported significant uncertainty regarding future business development and profitability [46] 分组12 - Shunyu shares have been pre-selected for a project worth 1.023 billion yuan [48] - Zhongyuan Neipei plans to acquire a 2.5% share in an aerospace industry fund for 50 million yuan [50] - Huifa Food's shareholder plans to reduce their stake by up to 3%, equating to a maximum of 727.14 million shares [53] 分组13 - Junshi Biosciences' subcutaneous PD-1 new formulation has reached its primary endpoint in a Phase III clinical trial [54] - Industrial Fulian clarified that it has not lowered its fourth-quarter profit target amid market rumors [55] - Longpan Technology's subsidiary has signed a major supply agreement for lithium iron phosphate materials, significantly increasing the supply volume [56]
华润双鹤子公司比索洛尔氨氯地平片获得药品注册证书
Zhi Tong Cai Jing· 2025-11-25 09:31
华润双鹤(600062)(600062.SH)发布公告,近日,公司全资子公司华润赛科药业有限责任公司(简称"华 润赛科")收到了国家药品监督管理局颁发的比索洛尔氨氯地平片《药品注册证书》。 比索洛尔氨氯地平片作为高血压治疗的替代疗法,用于目前同时服用与复方制剂剂量相同的单药且血压 控制良好的患者。 ...
华润双鹤:产品“比索洛尔氨氯地平片”取得注册证
Mei Ri Jing Ji Xin Wen· 2025-11-25 09:25
每经头条(nbdtoutiao)——688496,被证监会立案!刚上市业绩就变脸,亏损超1亿元;核心产品受重 创:第一大客户"自产自用",减少采购 每经AI快讯,华润双鹤(SH 600062,收盘价:18.68元)11月25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华润赛科药业有限责任公司收到了国家药品监督管理局颁发的比索洛尔氨氯 地平片《药品注册证书》。产品名称为"比索洛尔氨氯地平片"。 (记者 贾运可) 2025年1至6月份,华润双鹤的营业收入构成为:非输液占比75.13%,输液占比25.98%,分部间抵销占 比-1.11%。 截至发稿,华润双鹤市值为194亿元。 ...