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全链条智能化升维 华润双鹤构筑“第二增长曲线”
Zheng Quan Shi Bao· 2025-12-01 18:09
Core Viewpoint - The company is advancing its smart manufacturing capabilities, enhancing production efficiency and competitiveness through automation and digitalization, while also focusing on innovation and international expansion in the pharmaceutical sector [2][3][4]. Group 1: Smart Manufacturing and Automation - The new facility emphasizes automation, digitalization, and intelligent design, incorporating advanced equipment such as AI inspection machines and integrated filling machines, achieving industry-leading smart manufacturing levels [3]. - Production efficiency has increased by 15% to 20%, with daily output rising by 15%, significantly enhancing competitiveness [3]. - Since relocating in 2021, overall production capacity has surged by 346% without increasing labor costs, resulting in a 310% rise in per capita labor productivity [3]. Group 2: Digital Transformation - The company has accelerated its digital transformation, achieving an 85% digital coverage rate in key business areas and receiving recognition as an "Excellence Level Smart Factory" [4]. - The digital transformation supports operational excellence and innovation, aligning with the company's strategic goals [4]. Group 3: Product and Market Expansion - The company is committed to low-cost, large-scale, multi-product, innovative, and high-quality strategies, focusing on developing products that better serve clinical needs [6]. - The acquisition of global commercialization rights for a new diabetes treatment marks a significant advancement in addressing unmet medical needs in the diabetes foot ulcer market [6]. Group 4: Innovation and R&D Strategy - The company aims to balance generic and innovative drug development, utilizing a "License-out" strategy to manage R&D costs and enhance quality while expanding international presence [7]. - Mergers and acquisitions are pivotal for expanding the product portfolio and driving innovation, with a focus on leading companies in niche markets and biomanufacturing [8]. Group 5: Synthetic Biology and Future Growth - The company has established a "raw material and formulation integration" strategy, acquiring biopharmaceutical firms to enhance profitability through synthetic biology technologies [9]. - The synthetic biology research institute has been set up to drive innovation, with several products already in the pilot testing phase, focusing on raw materials and specialty formulations [10]. Group 6: Strategic Goals and Internationalization - The company aims to become the leading brand in prescription drugs in China, with plans to enhance brand influence and expand its product pipeline through strategic acquisitions [11]. - Internationalization is viewed as a key pathway for achieving strategic goals, transitioning from raw material exports to finished product exports to enhance competitiveness in the global market [11].
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
盐酸吡格列酮分散片用于2型糖尿病的治疗。本次盐酸吡格列酮分散片通过一致性评价将有利于未来的 市场销售和市场竞争,并为后续开展仿制药一致性评价积累了宝贵的经验。 华润双鹤(600062)(600062.SH)发布公告,近日,公司控股子公司双鹤天安药业(贵州)股份有限公司 (简称"双鹤天安")收到了国家药品监督管理局颁发的盐酸吡格列酮分散片《药品补充申请批准通知 书》。经审查,该药品视同通过仿制药质量和疗效一致性评价。 ...
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
智通财经APP讯,华润双鹤(600062.SH)发布公告,近日,公司控股子公司双鹤天安药业(贵州)股份有限 公司(简称"双鹤天安")收到了国家药品监督管理局颁发的盐酸吡格列酮分散片《药品补充申请批准通知 书》。经审查,该药品视同通过仿制药质量和疗效一致性评价。 盐酸吡格列酮分散片用于2型糖尿病的治疗。本次盐酸吡格列酮分散片通过一致性评价将有利于未来的 市场销售和市场竞争,并为后续开展仿制药一致性评价积累了宝贵的经验。 ...
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
格隆汇12月1日|华润双鹤公告,公司控股子公司双鹤天安药业股份有限公司收到了国家药品监督管理 局颁发的盐酸吡格列酮分散片《药品补充申请批准通知书》。截至本公告日,公司针对该药品开展一致 性评价累计研发投入为人民币882.27万元(未经审计)。 ...
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
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: 证券代码:600062 证券简称:华润双鹤 公告编号:临2025-099 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。 一、药品注册证书主要内容 ■ 二、药品相关情况 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。 华润赛科于2022年11月启动该药品的仿制药研发工作,于2024年6月14日向国家药监局提交上市许可申 请,于2024年6月19日获得受理通知书,并于2025年11月18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 ...
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。 ...