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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: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。 ...
华润双鹤(600062.SH)子公司比索洛尔氨氯地平片获得药品注册证书
智通财经网· 2025-11-25 09:00
智通财经APP讯,华润双鹤(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。 ...
湖南方盛制药股份有限公司关于2025年第三季度业绩说明会召开情况的公告
Core Viewpoint - The company held a Q3 2025 performance briefing on October 24, 2025, to discuss its operational performance and address investor concerns [1] Group 1: Company Performance and Strategy - The company's respiratory medication revenue has decreased by nearly 60% year-on-year due to industry factors, prompting a strategic focus on expanding market coverage and enhancing brand awareness for key products [2] - The company has successfully expanded its pediatric cough syrup's market presence, covering over 2,000 public medical institutions, with significant progress in adult indications research [2] - The management plans to accelerate the development of innovative traditional Chinese medicine (TCM) products, aiming to establish a product matrix with annual sales of 300-500 million yuan for multiple products [3][4] Group 2: Product Development and Market Position - The company has received approval for its blood-nourishing pain relief granules but has not yet launched them in hospitals; it plans to consider OTC status for easier access [5] - The company is focusing on chronic disease areas such as orthopedics and cardiovascular health, with several innovative TCM projects in the pipeline, including clinical trials for various products [5] - The company aims to leverage historical opportunities in TCM development to enhance market coverage and brand building, fostering new profit growth points [5]
花园生物(300401.SZ):花园药业收到硫辛酸片、比索洛尔氨氯地平片的药品注册证书
Ge Long Hui A P P· 2025-08-25 08:19
Core Viewpoint - Garden Biologics (300401.SZ) announced that its wholly-owned subsidiary, Zhejiang Garden Pharmaceutical Co., Ltd., has received the drug registration certificates for "Alpha-Lipoic Acid Tablets" and "Bisoprolol Amlodipine Tablets" from the National Medical Products Administration [1] Group 1 - The "Alpha-Lipoic Acid Tablets" are primarily used for the treatment of diabetic peripheral neuropathy [1] - The "Bisoprolol Amlodipine Tablets" are mainly used for the treatment of hypertension and can be used alone or in combination with other antihypertensive medications [1]
花园生物:子公司取得药品注册证书
Xin Lang Cai Jing· 2025-08-25 08:18
Core Viewpoint - The company has received drug registration certificates for "Alpha-Lipoic Acid Tablets" and "Bisoprolol Amlodipine Tablets" from the National Medical Products Administration, which will enhance its product line and positively impact its development [1] Group 1 - The full subsidiary Zhejiang Huayuan Pharmaceutical Co., Ltd. has been approved for the registration of "Alpha-Lipoic Acid Tablets," which are primarily used for treating diabetic peripheral neuropathy [1] - The "Bisoprolol Amlodipine Tablets" are mainly used for the treatment of hypertension [1] - Obtaining these drug registration certificates will further enrich the company's product line and promote the upgrade of product capabilities [1]
苑东生物20250819
2025-08-19 14:44
Summary of Yandong Biopharmaceuticals Conference Call Company Overview - **Company**: Yandong Biopharmaceuticals - **Date**: August 19, 2025 Key Points Industry and Company Performance - Yandong Biopharmaceuticals reported a revenue of **654 million** yuan in the first half of 2025, a decrease of **2.25%** year-on-year [3] - The net profit attributable to shareholders was **137 million** yuan, down **6.77%** year-on-year, with a non-recurring net profit of **104 million** yuan, a decrease of **8.68%** [3] - The company faced challenges from the **10th batch of national centralized procurement** and intensified industry competition, but maintained operational stability through innovation and efficiency improvements [3] Research and Development (R&D) Investment - R&D investment reached **133 million** yuan, an increase of **8.74%** year-on-year, accounting for **20.25%** of revenue [2][4] - Over **33%** of R&D investment was directed towards innovative drugs, including small molecule drugs and biopharmaceuticals [2][4] - The company is accelerating international business, particularly in the development and certification of nasal spray products [4] Product Pipeline and Sales Performance - In the **anesthesia and analgesia** sector, traditional products like **ibuprofen injection** showed stable growth, while new products like **butorphanol tartrate injection** are experiencing rapid growth [6] - The **cardiovascular** sector saw significant growth in products like **sodium hydrogen clopidogrel tablets** and **bisoprolol amlodipine tablets** [6] - The domestic formulation segment focuses on high-barrier complex formulations, with **21** production approvals granted this year [7] Innovation and Clinical Trials - The innovative drug segment includes several key projects: - **EP9,001A monoclonal antibody injection** completed Phase 1 clinical trials [8] - **YLSH003 ADC** has completed IND application [8] - **EP0,170T** is in Phase 3 clinical trials, targeting cardiovascular diseases [8] - The company is also advancing its **HP001** immune regulator, which shows potential advantages over existing treatments [17][19] Internationalization and Market Expansion - The international business achieved over **10 million** yuan in revenue in the first half of the year, with plans to expand into Southeast Asia and other markets [11] - The nasal spray production line passed FDA inspection, and the company signed a commercialization agreement with **Glenmark** for the naloxone nasal spray [11][14] Financial Outlook and Strategic Initiatives - The company anticipates a challenging year due to the impact of centralized procurement but aims for double-digit growth in revenue and a **20%** increase in profit through strategic initiatives [31] - Yandong plans to maintain R&D investment at over **20%** of revenue, focusing on innovative drugs and biopharmaceuticals [32] - The acquisition of **Chao Yang Pharmaceutical** is expected to positively impact financial results, with a manageable effect on Yandong's financial statements [33] Future Directions - Yandong will continue to focus on accelerating innovative drug development, optimizing resource allocation, and enhancing international market presence [36] - The company aims to leverage its current investments in innovation to drive future growth and maintain a competitive edge in the market [36] Additional Insights - The company is actively pursuing partnerships and collaborations to enhance its product pipeline and market reach [21][24] - Yandong's strategic focus on high-barrier products and innovative therapies positions it well for future growth despite current market challenges [32][34]