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汇宇制药(688553) - 自愿披露注射用HY05350获得药物临床试验申请受理通知书的公告
2025-04-18 12:22
证券代码:688553 证券简称:汇宇制药 公告编号:2025-024 四川汇宇制药股份有限公司 自愿披露注射用 HY05350 获得药物临床试验申请 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、准确性和完整性依法承担法律责任。 近日,四川汇宇制药股份有限公司(以下简称"公司")全资子公司四川汇 宇海玥医药科技有限公司(以下简称"汇宇海玥")收到国家药品监督管理局核 准签发的《受理通知书》,注射用 HY05350(项目研发代号为"HY-0005")用 于治疗晚期实体瘤的临床试验申请获得受理。由于药品的研发周期长、审批环节 多,容易受到一些不确定性因素的影响,敬请广大投资者谨慎决策,注意防范投 资风险。现将相关情况公告如下: 一、药品基本情况 药品名称:注射用 HY05350 申请事项:境内生产药品注册临床试验 受理号:CXSL2500316 适应症:用于治疗晚期实体瘤。 申请人:四川汇宇海玥医药科技有限公司 审批结论:根据《中华人民共和国行政许可法》第三十二条的规定,经审查, 决定予以受理。 二、药品的其他相关情况 受理通知书的公告 四川汇宇制药股份有 ...
汇宇制药(688553) - 自愿披露注射用HY0001a 获得药物临床试验申请受理通知书的公告
2025-04-11 09:15
证券代码:688553 证券简称:汇宇制药 公告编号:2025-022 四川汇宇制药股份有限公司 自愿披露注射用 HY0001a 获得药物临床试验申请 申请事项:境内生产药品注册临床试验 受理号:CXSL2500294 适应症:用于治疗晚期实体瘤。 申请人:四川汇宇海玥医药科技有限公司 审批结论:根据《中华人民共和国行政许可法》第三十二条的规定,经审查, 决定予以受理。 二、药品的其他相关情况 受理通知书的公告 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、准确性和完整性依法承担法律责任。 近日,四川汇宇制药股份有限公司(以下简称"公司")全资子公司四川汇 宇海玥医药科技有限公司(以下简称"汇宇海玥")收到国家药品监督管理局核 准签发的《受理通知书》,注射用 HY0001a(项目研发代号为"HY-0001")用 于治疗晚期实体瘤的临床试验申请获得受理。由于药品的研发周期长、审批环节 多,容易受到一些不确定性因素的影响,敬请广大投资者谨慎决策,注意防范投 资风险。现将相关情况公告如下: 一、药品基本情况 药品名称:注射用 HY0001a 注射用 HY000 ...
汇宇制药:注射用HY0001a获受理
news flash· 2025-04-11 08:43
Core Viewpoint - The announcement indicates that Huiyu Pharmaceutical's wholly-owned subsidiary, Huiyu Haiyue, has received the acceptance notice from the National Medical Products Administration for the clinical trial application of injectable HY0001a for the treatment of advanced solid tumors, marking a significant milestone as it is the first drug targeting this specific site to enter clinical trials globally, with no similar products approved in the domestic or international markets [1] Group 1 - Huiyu Haiyue has received the acceptance notice for the clinical trial application of injectable HY0001a [1] - Injectable HY0001a is the first drug globally to disclose targeting this specific site for clinical trials [1] - There are currently no approved products targeting the same site in both domestic and international markets [1]
破发股汇宇制药第二大股东拟减持 上市即巅峰募24.7亿
Zhong Guo Jing Ji Wang· 2025-04-01 06:18
Group 1 - The major shareholder Huang Qianyi plans to reduce his stake in Huili Pharmaceutical by up to 12,708,000 shares, representing no more than 3% of the total shares, due to personal funding needs [1] - As of the announcement date, Huang Qianyi holds 27,219,439 shares, accounting for 6.426% of the company's total share capital [1] - Huili Pharmaceutical was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on October 26, 2021, with an initial public offering of 63.6 million shares at a price of 38.87 yuan per share [1] Group 2 - The total amount raised by Huili Pharmaceutical was 2.472 billion yuan, with a net amount of 2.361 billion yuan after deducting issuance costs, exceeding the original plan by 453 million yuan [2] - The funds raised are intended for the construction of the Huili EU standard injection industry base (Phase II), the Huili Innovative Drug Research Institute, and to supplement working capital [2] Group 3 - The total issuance costs amounted to 111 million yuan, with underwriting fees to CITIC Securities and Guodu Securities totaling 98.8748 million yuan [3]
汇宇制药: 持股5%以上股东减持股份计划公告
Zheng Quan Zhi Xing· 2025-03-31 12:37
Core Viewpoint - The major shareholder Huang Qianyi of Sichuan Huiyu Pharmaceutical Co., Ltd. plans to reduce his shareholding by up to 12,708,000 shares, representing no more than 3% of the company's total shares, due to personal funding needs [1][2]. Shareholder Reduction Plan - The reduction period is set from April 28, 2025, to July 26, 2025, starting 15 trading days after the announcement [1]. - The reduction will be executed through centralized bidding or block trading, with a maximum of 4,236,000 shares through centralized bidding and 8,472,000 shares through block trading [1][2]. - Huang Qianyi currently holds 27,219,439 shares, accounting for 6.426% of the total shares [1][2]. Compliance and Commitments - Huang Qianyi has committed to comply with relevant laws and regulations regarding the reduction, ensuring that the plan aligns with previous commitments made [3][4]. - The company will disclose any changes in the reduction plan based on market conditions and stock price fluctuations [3][4].
汇宇制药(688553) - 持股5%以上股东减持股份计划公告
2025-03-31 11:49
四川汇宇制药股份有限公司 证券代码:688553 证券简称:汇宇制药 公告编号:2025-021 持股 5%以上股东减持股份计划公告 本公司董事会、全体董事及相关股东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、准确性和完整性依法承担法律 责任。 重要内容提示: 大股东持股的基本情况 截至本公告披露之日,四川汇宇制药股份有限公司(以下简称"公司") 股东黄乾益持有公司股份数量为 27,219,439 股,占公司总股本的 6.426%;上述股份来源于公司首次公开发行前取得的股份,且已于 2022 年 10 月 26 日起解除限售并上市流通。 减持计划的主要内容 因自身资金需求,股东黄乾益拟通过集中竞价或大宗交易的方式减持 公司股份不超过 12,708,000 股,合计减持股份比例不超过公司股份总 数的 3%。 减持期间为自本公告披露之日起 15 个交易日后的 3 个月内。 若减持计划实施期间公司有派息、送股、资本公积金转增股本、配股 等除权除息事项,减持股份数将进行相应调整。 | 股东名称 | 黄乾益 | | | | --- | --- | --- | --- | | 股东身份 ...
3月26日晚间重要公告一览
Xi Niu Cai Jing· 2025-03-26 10:20
Group 1 - China Aluminum reported a net profit of 12.4 billion yuan for 2024, an increase of 85.38% year-on-year, with a proposed cash dividend of 0.135 yuan per share [1] - Lihua Technology's net profit for 2024 decreased by 25.41% to 245 million yuan, with a proposed cash dividend of 0.7 yuan per 10 shares [1][2] - Zhongjing Food achieved a net profit of 175 million yuan in 2024, up 1.81% year-on-year, proposing a cash dividend of 8 yuan per 10 shares [3][4] - Sanwei Chemical's net profit fell by 6.92% to 263 million yuan, with a proposed cash dividend of 3 yuan per 10 shares [5] - Meino Biological's project for corn protein processing has received construction approval, with an investment of approximately 391 million yuan [6][7] Group 2 - Guangdian Electric's net profit surged by 411.28% to 74.73 million yuan, proposing a cash dividend of 0.7 yuan per 10 shares [13][14] - Xin'ao Co. reported a net profit of 4.493 billion yuan for 2024, down 36.64%, with a proposed cash dividend of 10.3 yuan per 10 shares [15] - Huaren Pharmaceutical's subsidiary received approval for a raw material drug, enhancing its product line [16] - Huanxin Technology received a project confirmation from BAIC Group for two display screen products, expected to enter mass supply [17] - Haitong Development plans to purchase four bulk carriers for a total of 59.25 million USD to expand its fleet [18] Group 3 - Guochuang High-tech won a bid for an asphalt procurement project worth 128 million yuan [22][23] - Huayi Pharmaceutical's subsidiary received overseas marketing approvals for several products [24] - Haisco's innovative drug HSK41959 has received clinical trial approval [25] - Hetai Machinery's subsidiary obtained a patent for a dust-proof chain technology [28] - Le Xin Medical's fetal heart rate monitor registration renewal application has been accepted [29] Group 4 - Feilong Co. became a designated supplier for an international client's electronic oil pump project, with expected sales of approximately 160 million yuan [29] - Yunnan Copper reported a net profit of 1.265 billion yuan for 2024, down 19.9%, with a proposed cash dividend of 2.4 yuan per 10 shares [42] - China Merchants Bank's net profit increased by 1.22% to 148.39 billion yuan, proposing a cash dividend of 20 yuan per 10 shares [43] - Shuanghui Development's net profit decreased by 1.26% to 4.989 billion yuan, with a proposed cash dividend of 7.5 yuan per 10 shares [44]
汇宇制药(688553) - 自愿披露公司产品获得境外上市许可的公告
2025-03-26 08:00
证券代码:688553 证券简称:汇宇制药 公告编号:2025-020 四川汇宇制药股份有限公司 自愿披露公司产品获得境外上市许可的公告 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、准确性和完整性依法承担法律责任。 四川汇宇制药股份有限公司(以下简称"公司")子公司 Seacross Pharma (Europe) Ltd. 及 Seacross Pharmaceuticals Ltd.分别于近期收到意大利卫生部、葡 萄牙国家药品和健康产品管理局、沙特阿拉伯食品药品管理局分别核准签发的公 司产品丙戊酸钠注射用浓溶液、唑来膦酸注射液、注射用替考拉宁、普乐沙福注 射液的上市许可。现将相关情况公告如下: 二、药品的其他相关情况 (一)丙戊酸钠注射用浓溶液 丙戊酸钠注射用浓溶液是一种抗癫痫药,在成人和儿童中,当暂时不能服用 口服剂型时,用于替代口服剂型,主要用于治疗全身性发作,表现为失神性发作、 肌肉抽搐性发作、强直-阵挛性发作,以及局灶性和继发性全身性发作。 公司丙戊酸钠注射用浓溶液研发成功后已进行了多国注册申报,分别已在中 国、英国、德国、荷兰、葡萄牙、爱 ...
四川汇宇制药股份有限公司自愿披露注射用盐酸美法仑获得药品注册证书的公告
Core Viewpoint - Sichuan Huiyu Pharmaceutical Co., Ltd. has received the drug registration certificate for injectable methotrexate hydrochloride, which is expected to enhance its competitive position in the market [1][4]. Drug Information - Injectable methotrexate hydrochloride is a cytotoxic alkylating agent effective against both resting and rapidly dividing tumor cells, particularly used for high-dose pre-treatment before hematopoietic stem cell transplantation in multiple myeloma patients [1][2]. - The drug is classified as a Category 4 chemical drug and has passed the consistency evaluation for generic drug quality and efficacy [4]. Market Context - The original manufacturer, Acrotech Biopharma Inc., has already launched injectable methotrexate hydrochloride in China, with Xian Libang holding the approval for the drug [2]. - According to data from Minet, the sales revenue of injectable methotrexate hydrochloride in urban public hospitals in China was approximately 86 million yuan in the first half of 2024 [3]. Company Impact - The approval of injectable methotrexate hydrochloride is expected to provide greater support in areas such as medical insurance payments and procurement by medical institutions due to its passing of the consistency evaluation [4]. - The company has initiated preparations for the product's market launch, although future revenue generation remains uncertain due to competition and market dynamics [4].
汇宇制药(688553) - 自愿披露注射用盐酸美法仑获得药品注册证书的公告
2025-03-17 08:00
自愿披露注射用盐酸美法仑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、准确性和完整性依法承担法律责任。 证券代码:688553 证券简称:汇宇制药 公告编号:2025-019 四川汇宇制药股份有限公司 原研 Acrotech Biopharma Inc.的注射用盐酸美法仑已在国内上市,目前国内 有西安力邦持有注射用盐酸美法仑的批件并通过或视同通过仿制药质量和疗效 一致性评价,公司为第二家视同通过仿制药质量和疗效一致性评价的企业。 根据米内网数据显示,2024 年上半年中国城市公立医院终端注射用盐酸美 法仑销售额约为 0.86 亿元。 四川汇宇制药股份有限公司(以下简称"公司")于近日收到国家药品监督 管理局核准签发的公司产品注射用盐酸美法仑的《药品注册证书》,现将相关情 况公告如下: | 药品名称 | 注射用盐酸美法仑 | | --- | --- | | 剂型 | 注射剂 | | 规格 | 50mg(按 C₁₃H₁₈Cl₂N₂O₂计) | | 注册分类 | 化学药品4类 | | 药品有效期 | 18个月 | | 上市许可持有人 | ...