注射用阿糖胞苷
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浙江华海药业股份有限公司 关于获得药品补充申请批准通知书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-02-03 22:38
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个别及连带责任。 浙江华海药业股份有限公司(以下简称"公司")于近日收到国家药品监督管理局(以下简称"国家药监 局")核准签发的注射用阿糖胞苷的《药品补充申请批准通知书》。该产品是在公司已获批的注射用阿 糖胞苷(规格:0.5g)基础上,申请新增规格0.1g。现将相关情况公告如下: 一、药品的基本情况 药品名称:注射用阿糖胞苷 截至目前,公司在注射用阿糖胞苷研发项目上已投入研发费用约人民币817万元。 规格:0.1g 申请事项:境内生产药品补充申请 注册分类:化学药品 申请人:浙江华海药业股份有限公司 药品批准文号:国药准字H20269025 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品此次申请事项符合药品注册 的有关要求,批准本品增加0.1g规格,核发药品批准文号。 二、药品其他相关情况 公司已于2025年3月获得注射用阿糖胞苷(0.5g)的《药品注册证书》,具体内容详见公司于2025年3月 11日刊登在中国证券报、上海证券报、证券时报、证券日报及上海证券交易所网站(w ...
浙江华海药业股份有限公司关于获得药品补充申请批准通知书的公告
Shang Hai Zheng Quan Bao· 2026-02-03 18:23
股票简称:华海药业 股票代码:600521 公告编号:临2026-008号 债券简称:华海转债 债券代码:110076 浙江华海药业股份有限公司 关于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个别及连带责任。 浙江华海药业股份有限公司(以下简称"公司")于近日收到国家药品监督管理局(以下简称"国家药监 局")核准签发的注射用阿糖胞苷的《药品补充申请批准通知书》。该产品是在公司已获批的注射用阿 糖胞苷(规格:0.5g)基础上,申请新增规格0.1g。现将相关情况公告如下: 药品名称:注射用阿糖胞苷 剂型:注射剂 规格:0.1g 申请事项:境内生产药品补充申请 注册分类:化学药品 申请人:浙江华海药业股份有限公司 药品批准文号:国药准字H20269025 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品此次申请事项符合药品注册 的有关要求,批准本品增加0.1g规格,核发药品批准文号。 二、药品其他相关情况 公司已于2025年3月获得注射用阿糖胞苷(0.5g)的《药品注册证书》,具体内容详 ...
华海药业(600521.SH):注射用阿糖胞苷获得药品补充申请批准通知书
Ge Long Hui A P P· 2026-02-03 09:53
格隆汇2月3日丨华海药业(600521.SH)公布,公司于近日收到国家药品监督管理局核准签发的注射用阿 糖胞苷的《药品补充申请批准通知书》。该产品是在公司已获批的注射用阿糖胞苷(规格:0.5g)基础 上,申请新增规格0.1g。注射用阿糖胞苷用于成人和儿童急性非淋巴细胞性白血病的诱导缓解和维持治 疗,它对其他类型的白血病也有治疗作用,如:急性淋巴细胞性白血病和慢性髓细胞性白血病(急变 期)。本品可单独或与其他抗肿瘤药联合应用,联合用药疗效更好。 ...
华海药业:注射用阿糖胞苷获得药品补充申请批准通知书
Ge Long Hui· 2026-02-03 09:51
格隆汇2月3日丨华海药业(600521.SH)公布,公司于近日收到国家药品监督管理局核准签发的注射用阿 糖胞苷的《药品补充申请批准通知书》。该产品是在公司已获批的注射用阿糖胞苷(规格:0.5g)基础 上,申请新增规格0.1g。注射用阿糖胞苷用于成人和儿童急性非淋巴细胞性白血病的诱导缓解和维持治 疗,它对其他类型的白血病也有治疗作用,如:急性淋巴细胞性白血病和慢性髓细胞性白血病(急变 期)。本品可单独或与其他抗肿瘤药联合应用,联合用药疗效更好。 ...
板块持续跑赢大盘,关注后续创新药催化(附CD73靶点研究)
Tai Ping Yang Zheng Quan· 2025-06-11 12:58
Investment Rating - The report recommends a "Buy" rating for multiple companies in the pharmaceutical sector, including Junshi Biosciences, Hualing Pharmaceutical-B, and others [3]. Core Insights - The pharmaceutical sector has outperformed the market, with a focus on the potential of innovative drugs and the CD73 target in cancer immunotherapy [4][5]. - The report highlights the promising clinical progress of CD73 inhibitors, with several products in various stages of clinical trials [21][25]. Summary by Sections Industry Investment Rating - The report provides a list of recommended companies with "Buy" and "Hold" ratings, indicating strong investment potential in the pharmaceutical sector [3]. Industry Performance - The pharmaceutical sector rose by 1.13%, outperforming the CSI 300 index by 0.25 percentage points, with innovative drugs and vaccines leading the performance [5][32]. Company Dynamics - Companies such as Lepu Medical and Sunshine Nuohua have made significant announcements regarding new product approvals and clinical trial progress, indicating a robust pipeline and growth potential [33][34]. Industry Trends - The report discusses the increasing focus on innovative drugs and the impact of regulatory changes on the pharmaceutical landscape, suggesting a shift towards high-efficiency business models in the industry [31][40].
一周安徽上市公司要闻回顾(6.02-6.08)
Xin Lang Cai Jing· 2025-06-09 04:57
Group 1 - Honglu Steel Structure's wholly-owned subsidiary signed a significant procurement contract worth 458 million yuan for steel structures, estimated at 91,425 tons, which is about 2.13% of the company's audited revenue for 2024 [1] - The contract is expected to positively impact the company's revenue and profit in 2025 [1] Group 2 - Tai'er Co.'s actual controller, Tai Zhengbiao, had his detention lifted and changed to a directive for further investigation [2] - This change follows a previous announcement regarding his detention and investigation [2] Group 3 - Yifan Pharmaceutical's wholly-owned subsidiary received drug registration certificates for two injectable drugs, which will enhance the company's product offerings in the oncology sector [3] - The approval is anticipated to positively influence the company's performance, although market conditions may introduce uncertainties [3] Group 4 - Jiefeng Power announced the release of 6.44 million shares from pledge by its shareholder, which represents 13% of the company's total equity [4] - The release was completed on June 3, 2025, with the necessary registration procedures finalized [4] Group 5 - Lifan Pharmaceutical disclosed plans for share reductions by several board members and shareholders, with specific share amounts and percentages outlined [5] - The reduction period is set for three months following the announcement, and it is stated that this will not affect the company's governance or ongoing operations [5] Group 6 - Huaihe Energy's virtual power plant project has completed hardware installation and debugging, aiming to participate in the electricity market during the peak summer period [6] - The project aggregates various resources, including adjustable loads and distributed energy [6] Group 7 - Sanjia Technology plans to acquire 51% of Anhui Zhonghe Semiconductor Technology Co., Ltd. for 121.38 million yuan [7] - The acquisition involves multiple stakeholders and is aimed at enhancing the company's position in the semiconductor industry [7] Group 8 - The valuation of Anhui Zhonghe Semiconductor's total equity was assessed at 238 million yuan, showing an increase of 153.38 million yuan, with a growth rate of 181.27% compared to its book value [8] Group 9 - Three Squirrels established a new company, Anhui Super Fresh Code Food Co., Ltd., which will engage in the sale of food additives and agricultural products [9] - The new company is fully owned by Three Squirrels [9]
6月5日早间重要公告一览
Xi Niu Cai Jing· 2025-06-05 05:14
Group 1 - Weijie Chuangxin plans to reduce its shareholding by up to 3%, amounting to no more than 12.91 million shares, due to personal funding needs [1] - Lier Chemical's major shareholder intends to reduce its stake by up to 3%, equivalent to no more than 24.01 million shares, for investment returns [1] - Helin Micro-Nano's controlling shareholder plans to reduce its shareholding by up to 1.5%, which is no more than 1.75 million shares, due to personal funding needs [2] Group 2 - Yifan Pharmaceutical received drug registration certificates for two products, indicating a focus on oncology and leukemia treatments [3] - *ST Jinbi is planning a change in control, leading to a temporary suspension of its stock trading [4] - Kexing Pharmaceutical's shareholder plans to reduce its stake by up to 3%, amounting to no more than 5.90 million shares, to optimize the equity structure [7] Group 3 - Li New Energy plans to invest approximately 1.25 billion yuan in three independent energy storage projects [7] - Kingsoft Office intends to acquire the remaining 31.98% stake in its subsidiary for 254 million yuan, aiming for full ownership [8] - Northeast Pharmaceutical received a CEP certificate from the European Medicines Agency for an antibiotic raw material, enhancing its product credibility [9] Group 4 - Tai'er Co. announced the lifting of a detention order on its controlling shareholder, changing it to a notice of supervision [10] - Runjian Co. won a bid for a solar power project worth approximately 83.92 million yuan, highlighting its role in the energy sector [11] - Jiuan Medical plans to register and issue medium-term notes and short-term financing bonds, with a total scale of up to 35 billion yuan and 5 billion yuan respectively [12] Group 5 - Wanma Co.'s chairman resigned due to work adjustments, but will remain as a board member [13] - Changhua Chemical plans to transfer 1% of its shares through an inquiry transfer method due to personal funding needs [14] - Jinkai Biotechnology's two shareholders plan to reduce their combined stake by up to 4%, totaling 481.6 thousand shares [15] Group 6 - Aeston plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy [16] - Maiwei Biotechnology's chairman proposed a share buyback plan with a total amount between 25 million and 50 million yuan [17] - Montai High-tech's specific shareholders and executives plan to reduce their stake by up to 3.03%, citing personal funding needs [18] Group 7 - *ST Dongjing's stock will resume trading after a change in control, with a new actual controller [20] - Tongdahai's major shareholders plan to reduce their combined stake by up to 3.57%, totaling 345.24 thousand shares [23]
亿帆医药:全资子公司合肥亿帆生物制药收到注射用盐酸表柔比星、注射用阿糖胞苷药品注册证书
news flash· 2025-06-04 11:50
Core Viewpoint - Yifan Pharmaceutical (002019) announced that its wholly-owned subsidiary Hefei Yifan Biopharmaceutical received approval from the National Medical Products Administration for the registration certificates of injectable hydrochloride of gemcitabine and injectable cytarabine [1] Group 1: Product Approvals - The injectable hydrochloride of gemcitabine is indicated for the treatment of malignant lymphoma, breast cancer, and lung cancer, with an estimated domestic sales of approximately 456 million yuan in the first half of 2024 [1] - The injectable cytarabine is suitable for the induction and maintenance treatment of acute non-lymphocytic leukemia in adults and children, with an estimated domestic sales of approximately 188 million yuan in the first half of 2024 [1] Group 2: R&D Investment - The company invested approximately 11.96 million yuan in the research and development of injectable hydrochloride of gemcitabine [1] - The company invested approximately 16.93 million yuan in the research and development of injectable cytarabine [1]