Huiyu Pharmaceutical(688553)

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汇宇制药(688553) - 自愿披露注射用硫酸多黏菌素B获得药品注册证书的公告
2025-06-04 09:30
证券代码:688553 证券简称:汇宇制药 公告编号:2025-045 二、药品的其他相关情况 硫酸多黏菌素 B 几乎对除奇异变形杆菌外所有革兰阴性菌有杀菌作用。多 黏菌素通过改变细菌细胞膜通透性导致细菌死亡。革兰阳性菌、真菌、革兰阴性 球菌对多黏菌素耐药。注射用硫酸多黏菌素 B 用于治疗碳青霉烯类耐药革兰氏 阴性杆菌引起的严重感染的成年患者,包括铜绿假单胞菌敏感菌株引起的脑膜炎 和菌血症。 四川汇宇制药股份有限公司 自愿披露注射用硫酸多黏菌素 B 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。 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 硫酸多黏菌素 B 的《药品注册证书》,现将相关情况公告如下: | 药品名称 | 注射用硫酸多黏菌素 B | | --- | --- | | 剂型 注射剂 | | | 规格 | 50万单位 | | 注册分类 | 化学药品3类 | | 药品有效期 24个月 | | | 上市许 ...
汇宇制药:注射用硫酸多黏菌素B获药品注册证书
news flash· 2025-06-04 09:07
Core Viewpoint - The company has received approval for the injectable colistin sulfate from the National Medical Products Administration, indicating a significant development in its product portfolio [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd., has been granted a drug registration certificate for injectable colistin sulfate [1] - Injectable colistin sulfate is classified as a Class 3 chemical drug with a specification of 500,000 units and a shelf life of 24 months [1] Group 2: Market Potential - The drug is intended for treating severe infections in adult patients caused by carbapenem-resistant Gram-negative bacteria, including meningitis and bacteremia caused by sensitive strains of Pseudomonas aeruginosa [1] - The projected sales revenue for injectable colistin sulfate in urban public hospitals in China for 2024 is estimated to be 529 million yuan [1] Group 3: Future Outlook - The company has initiated preparatory work for the product's market launch, but there is uncertainty regarding its potential to generate significant revenue in the future [1]
5月30日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-30 10:21
Group 1 - Huapei Power received a project intention letter from a domestic new energy vehicle company for a thermal management system PTC water heater, with an estimated sales amount of approximately 9 million yuan over a 5-year lifecycle starting from 2026 [1] - Antu Biotech obtained medical device registration certificates for products including "Cytomegalovirus IgM Antibody Test Kit" [1][2] - Yihong Technology adjusted the upper limit of its share repurchase price to 65.04 yuan per share, with a total repurchase amount of 6.9583 million yuan for 198,000 shares [2] Group 2 - Aihui Long received a medical device registration certificate for the Hepatitis B virus core antibody detection kit, valid until May 28, 2030 [2][3] - Quanxin Co. plans to engage in commodity futures hedging to mitigate raw material price fluctuations, with a maximum guarantee amount of 8 million yuan [3] - Jiahua Intelligent plans to lease idle assets in Dongguan for a total rental amount of approximately 6.3193 million yuan over 6 years [3] Group 3 - Qianjiang Biochemical announced the resignation of its chairman and a director, with a new chairman to be elected [4][5] - Aerospace Morning Light was suspended from participating in military procurement activities due to violations, with internal investigations underway [6] - Guang'an Aizhong intends to establish a fund with a total scale of 70.7 million yuan, focusing on distributed wind and solar power generation [7] Group 4 - Zhejiang Medicine plans to use up to 1 billion yuan of idle funds for entrusted wealth management, with a maximum investment period of 12 months [10] - Hengrui Medicine's subsidiary received approval for clinical trials of HRS9531 injection, aimed at treating type 2 diabetes patients [11] - Taiji Co. announced the purchase of 10 million yuan in wealth management products, with a minimum holding period of 6 months [12] Group 5 - Hong Kong-listed company Huichuang Pharmaceutical received approval for the clinical trial of a spray for treating primary premature ejaculation [26][27] - Haichuang Pharmaceutical's new drug application for a prostate cancer treatment was approved by the National Medical Products Administration [28] - Zhuhai Guanyu was selected as a designated supplier for low-voltage lithium batteries by SAIC Volkswagen [29] Group 6 - Huayi Technology opened a tax refund service for overseas travelers, enhancing its retail offerings [32] - Baobian Electric plans to transfer 90% of its subsidiary's shares for 137 million yuan [33] - Yiwei Communication intends to invest 100 million yuan to establish a wholly-owned subsidiary to enhance its strategic layout [34]
创新药ETF天弘(517380)涨0.8%,年内涨近20%,机构:创新药建议关注创新+业绩共振机会
2 1 Shi Ji Jing Ji Bao Dao· 2025-05-30 02:18
Group 1 - The core viewpoint of the news highlights the significant performance of the innovative drug sector, with the Tianhong Innovative Drug ETF (517380) showing a nearly 20% increase year-to-date as of May 29, 2023 [1] - The Tianhong Innovative Drug ETF, launched in 2021, tracks the "Hang Seng Shanghai-Shenzhen Hong Kong Innovative Drug Selected 50" index, providing comprehensive coverage of the innovative drug industry across A-shares and Hong Kong stocks [1] - On May 29, the National Medical Products Administration approved 11 new drugs, with five being from innovative companies listed on the Sci-Tech Innovation Board, covering various therapeutic areas including oncology and autoimmune diseases [1] Group 2 - The upcoming 2025 ASCO Annual Meeting in Chicago is expected to showcase significant data from domestic innovative drug companies, with 71 original research results from Chinese pharmaceutical companies selected for presentation [2] - The innovative drug sector is anticipated to gain increased attention and positive market sentiment, with institutional holdings currently at low levels and the sector's valuation significantly below historical averages [2] - The total amount of outbound transactions for innovative drugs has reached $45.5 billion since the beginning of 2025, indicating a strong trend towards internationalization and potential for future growth [3] Group 3 - The Chinese innovative drug industry has transitioned from imitation to rapid following and now to original innovation, marking a significant evolution in its development [3] - Most domestic innovative drugs currently in the U.S. are in clinical stages, with future milestones expected to validate the growth and internationalization of Chinese innovative drugs [3]
汇宇制药(688553) - 自愿披露公司产品获得境外上市许可的公告
2025-05-29 10:31
证券代码:688553 证券简称:汇宇制药 公告编号:2025-044 二、药品的其他相关情况 注射用环磷酰胺是一种肿瘤药,主要用于治疗慢性淋巴细胞白血病(CLL); 急性淋巴细胞白血病(ALL);作为骨髓移植的条件,联合全身照射或白消安治 疗急性淋巴细胞白血病、慢性淋巴细胞白血病和急性髓系白血病;霍奇金淋巴瘤、 非霍奇金淋巴瘤和多发性骨髓瘤;转移性卵巢癌和乳腺癌;乳腺癌的辅助治疗; 尤文氏肉瘤;小细胞肺癌;晚期或转移性神经母细胞瘤;危及生命的自身免疫性 疾病:严重进行性狼疮肾炎和韦格纳肉芽肿病。 公司注射用环磷酰胺研发成功后已进行了多国注册申报,分别已在中国、英 国、爱尔兰、葡萄牙、法国、荷兰、意大利、西班牙获得上市许可。截至目前, 公司已在德国提交注册申请。 三、对公司的影响及风险提示 公司研发的注射用环磷酰胺获得英国的上市许可,有利于公司在国际市场产 品管线的丰富,提升市场的品牌形象,持续拓展国际业务的广度和深度,为国际 序 号 产品名称 剂型 规格 上市许可号 发证国家 1 注射用环磷酰胺 注射剂 500mg; 1000mg; 2000mg; PL 41013/0079 PL 41013/0080 P ...
汇宇制药(688553) - 监事会决议公告
2025-05-29 10:30
证券代码:688553 证券简称:汇宇制药 公告编号:2025-041 四川汇宇制药股份有限公司 监事会决议公告 本公司监事会及全体监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。 一、 监事会会议召开情况 四川汇宇制药股份有限公司(以下简称"公司"或"汇宇制药")第二届监 事会第十五次会议于 2025 年 5 月 24 日以电子邮件方式发出通知,并于 2025 年 5 月 29 日以通讯表决方式召开。本次会议由公司监事会主席邓玲女士召集并主 持,应出席监事 3 人,实际出席监事 3 人。全体监事认可本次会议的通知时间、 议案内容等事项,本次监事会的召集和召开程序符合《中华人民共和国公司法》 《中华人民共和国证券法》等法律法规及《公司章程》的相关规定,会议决议合 法有效。 二、监事会会议审议情况 1、审议通过《关于部分募投项目节余募集资金永久补充流动资金的议案》 监事会认为:本次部分募投项目节余募集资金永久补充流动资金符合《上 市公司监管指引第 2 号——上市公司募集资金管理和使用的监管要求》《上海证 券交易所科创板股票上市规则》《上海证券交 ...
汇宇制药(688553) - 董事会决议公告
2025-05-29 10:30
四川汇宇制药股份有限公司 董事会决议公告 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:2025-040 公司将部分募投项目节余募集资金永久补充流动资金,有利于提高募集资金 使用效率,促进公司发展,符合公司和公司全体股东的利益,不存在损害公司股 东特别是中小股东利益的情形,符合《上市公司监管指引第 2 号——上市公司募 集资金管理和使用的监管要求》《上海证券交易所科创板上市公司自律监管指引 第 1 号——规范运作》、公司《募集资金管理制度》等法律法规、规范性文件及 公司管理制度的有关规定。 表决结果:8 票赞成;0 票弃权;0 票反对。 该议案无需提交公司股东大会审议,具体内容详见公司同日在上海证券交易 所网站(www.sse.com.cn)披露的《汇宇制药关于部分募投项目节余募集资金永 久补充流动资金的公告》(公告编号:2025-042)。 特此公告。 四川汇宇制药股份有限公司 董事会 2025 年 5 月 30 日 一、董事会会议召开情况 四川汇宇制药股份有限公司 ...
汇宇制药(688553) - 中信建投证券股份有限公司关于四川汇宇制药股份有限公司部分募投项目节余募集资金永久补充流动资金的核查意见
2025-05-29 10:17
关于四川汇宇制药股份有限公司 部分募投项目节余募集资金永久补充流动资金的核查意见 中信建投证券股份有限公司 中信建投证券股份有限公司(以下简称"中信建投证券""保荐机构")作 为四川汇宇制药股份有限公司(以下简称"汇宇制药"或"公司")首次公开发行 股票并在科创板上市的保荐机构,根据《证券发行上市保荐业务管理办法》《上 市公司监管指引第2 号——上市公司募集资金管理和使用的监管要求》《上海证 券交易所科创板股票上市规则》及《上海证券交易所科创板上市公司自律监管指 引第1 号——规范运作》等相关法律、法规和规范性文件的规定,对公司部分募 投项目节余募集资金永久补充流动资金进行了审慎核查,核查情况如下: 一、募集资金基本情况 经上海证券交易所科创板上市委员会2021年5月26日审核同意,并经中国证 券监督管理委员会于2021年8月3日《关于同意四川汇宇制药股份有限公司首次公 开发行股票注册的批复》(证监许可〔2021〕2596号)同意注册,汇宇制药向社 会公开发行人民币普通股(A 股)股票63,600,000 股,发行价格38.87元/股,本 次发行的募集资金总额为 247,213.20万元,扣除相关发行费用人民 ...
汇宇制药(688553) - 关于部分募投项目节余募集资金永久补充流动资金的公告
2025-05-29 10:16
证券代码:688553 证券简称:汇宇制药 公告编号:2025-042 四川汇宇制药股份有限公司 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。 重要内容提示: 四川汇宇制药股份有限公司(以下简称"公司")拟使用 6,172.43 万元 节余募集资金补充流动资金,用于公司的日常生产经营活动。 公司保荐机构中信建投证券股份有限公司(以下简称"保荐机构")对 本事项出具了同意的核查意见。 本事项已通过第二届董事会十五次会议、第二届监事会第十五次会议审 议通过。 一、募集资金基本情况 经上海证券交易所科创板上市委员会 2021 年 5 月 26 日审核同意,并经中国 证券监督管理委员会于 2021 年 8 月 3 日《关于同意四川汇宇制药股份有限公司 首次公开发行股票注册的批复》(证监许可〔2021〕2596 号)同意注册,汇宇 制药向社会公开发行人民币普通股(A 股)股票 63,600,000 股,发行价格 38.87 元/股,本次发行的募集资金总额为 247,213.20 万元,扣除相关发行费用人民币 11,145.72 万 ...
汇宇制药:注射用环磷酰胺获英国上市许可
news flash· 2025-05-29 10:03
Core Insights - The company, Huayu Pharmaceutical, announced that its subsidiary, SEACROSS PHARMACEUTICALS LIMITED, has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency for its injectable cyclophosphamide product [1] - This drug is primarily used for the treatment of chronic lymphocytic leukemia (CLL) and various other diseases [1] - The injectable cyclophosphamide has already obtained marketing approvals in China, the UK, Ireland, Portugal, France, the Netherlands, Italy, and Spain, and a registration application has been submitted in Germany [1] - The approval in the UK is expected to enhance the company's product pipeline in international markets and improve its brand image [1]