NCPC(600812)

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华北制药:子公司获硫酸多黏菌素B上市批准
news flash· 2025-06-10 09:42
华北制药(600812)公告,公司控股子公司华北制药华胜有限公司近日收到国家药品监督管理局核准签 发的硫酸多黏菌素B《化学原料药上市申请批准通知书》。该药物用于治疗铜绿假单胞菌敏感菌株引起 的急性感染,是治疗由此类细菌引起的泌尿道、脑膜和血流感染的首选药物。截至目前,该药品的研发 累计投入为1099万元。此次批准将丰富公司的产品线,但不会对当期经营业绩产生重大影响。药物将在 通过GMP符合性检查后安排生产并上市销售。 ...
华北制药:华民公司获得注射用头孢他啶阿维巴坦钠药品注册证书
news flash· 2025-06-10 09:42
华北制药(600812)公告,全资子公司华北制药河北华民药业有限责任公司收到国家药品监督管理局核 准签发的注射用头孢他啶阿维巴坦钠(2.5g)的《药品注册证书》。该药品用于治疗革兰阴性菌感染,包 括复杂性腹腔内感染和医院获得性肺炎等。华民公司于2024年1月申报并取得药品注册受理号,2025年6 月获得注册证书。截至目前,累计研发投入为1434.53万元。国内已有15家仿制药获批上市,2020年至 2024年样本医院销售额分别为3.69亿元、4.83亿元、6.53亿元、11.77亿元、14.85亿元。 ...
华北制药维生素B6注射液新增规格获批
Zheng Quan Ri Bao· 2025-06-06 16:47
Core Viewpoint - North China Pharmaceutical has received approval for two products: Vitamin B6 injection and injectable Isavuconazole, indicating a strategic expansion in both essential vitamins and high-end anti-infection markets [1][2][3] Group 1: Product Approvals - The company has been granted a supplementary approval for Vitamin B6 injection (1ml: 100mg) and a drug registration certificate for injectable Isavuconazole (0.2g) by the National Medical Products Administration [1][2] - Vitamin B6 is widely used in clinical settings for various metabolic disorders, with its indications expanding due to ongoing research [1] - The sales data from 2020 to 2023 shows fluctuations in Vitamin B6 injection sales, with a peak of 62.02 million yuan in 2021 and a decline to 46.37 million yuan in 2023 [1] Group 2: Market Strategy - The company plans to leverage its production and sales resources to expand sales channels and increase market coverage following the approval of the new Vitamin B6 injection specification [2] - North China Pharmaceutical aims to participate actively in national and provincial alliance procurement initiatives [2] - The company is considering further product pipeline development in the B vitamin sector based on market trends and strategic goals [2] Group 3: Financial and Competitive Position - The cumulative R&D investment for injectable Isavuconazole is reported to be 15.27 million yuan, and the product is expected to enhance the company's product line in the anti-infection sector [3] - The approval of Isavuconazole signifies the company's entry into the high-end anti-infection market, potentially providing new revenue growth opportunities [3] - The presence of five companies in the domestic market holding registration for injectable Isavuconazole indicates a competitive landscape, with the product achieving sales of 100 million yuan in 2023 [2][3]
华北制药: 关于公司获得《药品注册证书》的公告
Zheng Quan Zhi Xing· 2025-06-05 10:31
Core Viewpoint - The company has received approval from the National Medical Products Administration for the injection of Isavuconazonium Sulfate (0.2g), which enhances its product line in the anti-infection sector [1][2]. Group 1: Drug Registration Details - The drug is named Isavuconazonium Sulfate for Injection, with a registration classification as a chemical drug of category 4 [1]. - The drug registration certificate was issued with a validity period of 18 months, and it is classified as a prescription drug [1]. - The company has invested a total of 15.27 million yuan in research and development for this drug [2]. Group 2: Market Situation - Isavuconazonium Sulfate has been approved for sale in over 40 countries globally, with five companies in China holding the registration certificate for the injection form [3]. - The sales revenue for Isavuconazonium Sulfate injection reached 100 million yuan in 2023, with 72.38 million yuan in sales during the first half of 2024 [3]. Group 3: Impact on the Company - The approval of Isavuconazonium Sulfate is expected to further supplement the company's product offerings in the anti-infection field [3].
华北制药(600812) - 关于公司获得《药品注册证书》的公告
2025-06-05 09:45
证券代码:600812 股票简称:华北制药 编号:临 2025-035 | | | | | | | 期 | | --- | --- | --- | --- | --- | --- | --- | | | | 年 | | | | | | | | | 05 | | | | | | | | | 月 | | | | | | | | | 26 日 | | | 至 | 2030 | | | | | 药品批准文号有效 | 二、药物研究的其他相关情况 硫酸艾沙康唑最初由 Basilea 制药公司开发,后 Basilea 与多家制药公 司签署许可协议,2010 年 2 月,安斯泰来(Astellas)制药获得全球共同开 发和推广权;2017 年 7 月和 12 月,辉瑞(Pfizer)获得了在欧洲(包括奥 地利、法国、德国、意大利、英国、俄罗斯、以色列和土耳其)和 16 个亚 太国家(包括澳大利亚、印度、韩国、新加坡、中国台湾、中国(包括香 港和澳门)等)独家开发和商业化权利。2015 年 3 月 6 日,Astellas 首先 在美国推出本品注射用粉针剂(372mg,相当于艾沙康唑 200mg)。同年 10 月 15 日,B ...
华北制药(600812) - 关于公司获得《药品补充申请批准通知书》的公告
2025-06-05 09:45
证券代码:600812 股票简称:华北制药 编号:临 2025-034 华北制药股份有限公司 关于公司获得《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。 维生素 B6是一种水溶性维生素,是人体内某些辅酶的组成成分,参与 多种代谢反应,同时还参与核酸、DNA 和某些神经介质的合成,是目前应 用最广泛的维生素 B 类药物之一。近年随着临床应用研究的深入,生物化 学机制和药理作用的研究进展,临床适应证不断扩大,在许多临床领域取 得新的进展除说明书适应症外,临床还用于治疗或辅助治疗:预防代谢综 合征、婴儿痉挛症、同型半胱氨酸血症、回乳、原发性痛经、抗震颤麻痹、 急性乳腺炎、婴儿肠痉挛、寻常性痤疮、肼类中毒、复发性阿弗他口炎、 抑郁症、老年性皮肤瘙痒症、脑血管疾病、帕金森综合征、降低透析病人 血脂、妊娠糖尿病、动脉粥样硬化、白细胞较少症、破伤风治疗、腕管综 合征、铁中毒及铁幼粒细胞性贫血的防治和大脑保护剂等。 公司的维生素 B6注射液于 2004 年经国家药品监督管理局批准上市,剂 型为注射剂,规格为 ...
华北制药(600812) - 2024年年度股东大会会议资料
2025-06-03 08:45
华北制药股份有限公司 二〇二四年年度股东大会会议资料 2025 年 6 月 11 日 华北制药股份有限公司 2024 年年度股东大会会议资料 华北制药股份有限公司 二〇二四年年度股东大会会议议程 会议召开方式:现场会议和网络投票相结合 现场会议时间:2025 年 6 月 11 日上午 10:00 现场会议地点:石家庄经济技术开发区海南路 98 号九楼会议室 会议召集人:公司董事会 主持人:王立鑫先生 出席人员:公司股东、公司董事、监事及高级管理人员、公司聘 请的见证律师及公司相关人员。 网络投票时间:2025 年 6 月 11 日 采用上海证券交易所网络投票系统,通过交易系统投票平台的投 票 时 间 为 股 东 大 会 召 开 当 日 的 交 易 时 间 段 , 即 9:15-9:25 , 9:30-11:30,13:00-15:00;通过互联网投票平台的投票时间为股东 大会召开当日的 9:15-15:00。 现场会议开始前由工作人员统计现场与会股东及股东代表人数 和所持股份数,主持人宣布会议开始。同时报告出席现场会议的股东 及股东代表人数和所持有股份数及比例;选举现场会议监票人、记票 人。 一、会议逐项审议 ...
华北制药与关联财务公司签约,预计2025年发生金融业务20亿元
Xin Lang Cai Jing· 2025-05-23 13:16
Core Viewpoint - Huabei Pharmaceutical (600812.SH) has recently announced a series of agreements with its affiliated company regarding financial services, which has attracted investor attention [1]. Financial Services Agreement - Huabei Pharmaceutical plans to sign a financial services agreement with Jizhong Energy Group Financial Co., Ltd. to enhance capital efficiency, secure better deposit and loan rates, and reduce financing costs. The agreement will be valid for three years [2]. - The company expects to engage in various financial transactions totaling 2 billion yuan in 2025, including deposit and loan services [2][3]. Financial Company Overview - Jizhong Energy Group Financial Co., Ltd. has total assets of 20.63 billion yuan and liabilities of 14.64 billion yuan as of March 31, 2025. The company reported a net profit of 64.27 million yuan for the first quarter of 2025 [4][6]. - The financial company is controlled by the Hebei Provincial State-owned Assets Supervision and Administration Commission and provides services such as accepting deposits and granting loans [3][4]. Risk Management Measures - To ensure the safety of funds deposited with the financial company, Huabei Pharmaceutical has established a risk management plan, including a leadership group responsible for monitoring and managing risks [7]. - The company has also conducted a risk assessment report detailing the shareholding structure of the financial company, with Huabei Pharmaceutical holding a 20% stake [7]. Financial Performance - In the first quarter of 2025, Huabei Pharmaceutical achieved a revenue of 2.57 billion yuan, a year-on-year increase of 0.65%, and a net profit of 57.49 million yuan, up 216.72% compared to the previous year [10][11]. - The company's total assets increased by 2.43% year-on-year, reaching approximately 21.99 billion yuan [11]. Upcoming Shareholder Meeting - Huabei Pharmaceutical will hold its 2024 annual shareholder meeting on June 11, 2025, to discuss various proposals, including the 2024 Board of Directors' work report [10].
华北制药: 关于召开2024年度暨2025年第一季度业绩说明会的公告
Zheng Quan Zhi Xing· 2025-05-21 11:27
证券代码:600812 证券简称:华北制药 编号:临 2025-032 华北制药股份有限公司 关于召开 2024 年度暨 2025 年第一季度业绩说明会的公告 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。 重要内容提示: ? 会议召开时间:2025年5月29日(星期四)16:00-17:00 ? 会议召开地点:上海证券交易所上证路演中心(https://roadshow.sseinfo.com/) ? 会议召开方式:上证路演中心网络互动 ? 投资者可于2025年5月22日(星期四)至5月28日(星期三)16:00前登录上证路演 中心网站首页点击"提问预征集"栏目或通过公司邮箱:ncpcdshbgs@163.com进行提问, 公司将在说明会上对投资者普遍关注的问题进行回答。 (二)会议召开地点:上证路演中心(https://roadshow.sseinfo.com/) (三)会议召开方式:上证路演中心网络互动 三、参加人员 董事长、总经理:王立鑫先生 华北制药股份有限公司(以下简称"公司" )已于2025年3月28日、2025 ...
华北制药: 华北制药股份有限公司在冀中能源集团财务有限责任公司存款风险处置预案
Zheng Quan Zhi Xing· 2025-05-21 11:27
Core Viewpoint - The company has established a risk management plan to effectively prevent, control, and resolve deposit risks associated with its deposits in the financial company controlled by Jizhong Energy Group [1][2]. Group 1: Risk Management Structure - A risk prevention and disposal leadership group has been formed, led by the company's chairman, with responsibilities for monitoring and managing daily risk indicators [2][3]. - The leadership group is responsible for organizing risk prevention and disposal efforts, and an office is set up within the finance department for daily supervision [3][6]. Group 2: Risk Prevention Principles - The risk disposal process follows principles of unified leadership, early warning, timely disposal, and coordinated cooperation among relevant departments [3][4]. - Emphasis is placed on monitoring risks, ensuring timely information flow, and maintaining effective risk prevention measures [3][4]. Group 3: Risk Reporting and Disclosure - The company has established a risk reporting system to regularly or temporarily report to the board of directors [4][5]. - Prior to depositing funds, the company must review the financial company's audited annual report to assess operational and financial risks [4][5]. Group 4: Emergency Response Procedures - The leadership group must initiate emergency procedures if specific risk indicators are triggered, such as violations of financial regulations or significant financial distress [6][7]. - The company may require the financial company to halt new loans and recover funds if necessary [6][7]. Group 5: Post-Incident Measures - After a risk event is resolved, the leadership group will enhance supervision of the financial company and reassess deposit risks [8]. - If risk factors persist, the company may take action to withdraw all deposits [8].