HAINAN HAIYAO(000566)
Search documents
海南海药(000566) - 关于子公司获得利奈唑胺片药品注册批件的公告
2025-07-09 10:30
证券代码:000566 证券简称:海南海药 公告编号:2025-047 海南海药股份有限公司 关于子公司获得利奈唑胺片药品注册批件的公告 受理号:CYHS2302666 适应症:本品用于治疗由特定微生物敏感株引起的下列感染:院内获得性肺 炎,社区获得性肺炎,复杂性皮肤和皮肤软组织感染,非复杂性皮肤和皮肤软组 织感染,万古霉素耐药的屎肠球菌感染,包括伴发的菌血症等。 药品上市许可持有人:海口市制药厂有限公司 本公司董事会及全体董事保证公告内容的真实、准确和完整,没有虚假记载、 误导性陈述或者重大遗漏。 海南海药股份有限公司(以下简称"公司")全资子公司海口市制药厂有限 公司近日获得国家药品监督管理局核准签发的化学药品"利奈唑胺片"的《药品 注册证书》。现将相关情况公告如下: 一、药品基本情况 (一)药品名称:利奈唑胺片 剂型:片剂 规格:600mg 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 符合药品注册的有关要求,批准注册,发给药品注册证书。 (二)药品的其他相关情况 利奈唑胺是细菌蛋白质合成抑制剂,可以抑制核糖体 50S 亚基的 mRNA 基因 核苷酸与核糖体的结合,组织细菌形成 7 ...
海南海药:子公司获利奈唑胺片药品注册批件
news flash· 2025-07-09 10:17
Core Viewpoint - Hainan Haiyao's subsidiary has received approval for the antibiotic "Linezolid Tablets," which will enhance the company's product line and market competitiveness in the high-end antibiotic sector [1] Company Summary - Hainan Haiyao's wholly-owned subsidiary, Haikou Pharmaceutical Factory, has obtained the drug registration certificate for Linezolid Tablets from the National Medical Products Administration [1] - The approval of Linezolid, a bacterial protein synthesis inhibitor, will allow the company to enter the high-end antibiotic market and strengthen its brand influence in the antibiotic field [1] Industry Summary - Linezolid is indicated for the treatment of hospital-acquired pneumonia and community-acquired pneumonia caused by specific sensitive strains of microorganisms [1] - The unique mechanism of Linezolid, which inhibits the binding of mRNA to the ribosome, allows for the formation of the 70S ribosomal complex, providing a competitive edge in antibiotic treatment [1]
海南海药:子公司注射用头孢唑肟钠通过一致性评价
news flash· 2025-07-09 10:17
Core Viewpoint - Hainan Haiyao's subsidiary has received approval for the injectable drug Cefoperazone Sodium, which is expected to enhance market competitiveness and positively impact the company's performance [1] Company Summary - Hainan Haiyao's wholly-owned subsidiary, Haikou Pharmaceutical Factory, has been granted a drug supplement approval notice by the National Medical Products Administration for the injectable drug Cefoperazone Sodium [1] - The drug has passed the consistency evaluation of quality and efficacy for generic drugs, which is beneficial for the company's market position [1] Industry Summary - Cefoperazone Sodium is a third-generation broad-spectrum semi-synthetic cephalosporin antibiotic, effective against various infections including lower respiratory tract infections, urinary tract infections, and sepsis [1] - The approval of this drug aligns with the industry's trend towards enhancing the quality and efficacy of generic medications, which is crucial for maintaining competitiveness in the pharmaceutical market [1]
新华医疗子公司胸腹腔内窥镜获批;海南海药拟接受关联方财务资助 | 医药早参
Mei Ri Jing Ji Xin Wen· 2025-07-07 23:17
Group 1 - Xinhua Medical's subsidiary has received a Class II medical device registration certificate for its thoracic and abdominal endoscope, enhancing its product offerings in minimally invasive surgery [1] - The successful registration of the thoracic and abdominal endoscope enriches Xinhua Medical's portfolio and creates new market growth opportunities [1] Group 2 - Sino-Pharmaceutical has signed a joint research and licensing agreement with Gero PTE to develop new therapies for age-related diseases, involving potential payments of up to $250 million [2] - The collaboration reflects significant market interest and investment potential in the field of age-related disease treatments, combining Gero's AI-driven technology with Sino-Pharmaceutical's resources [2] Group 3 - Yiling Pharmaceutical's G201-Na capsule, a new chemical drug for controlling ovulation in assisted reproductive technology, has received approval for clinical trials [3] - The approval marks a significant breakthrough in Yiling Pharmaceutical's drug development, targeting a market with substantial potential [3] Group 4 - Hainan Haiyao plans to accept financial support from its controlling shareholder, with a maximum amount of RMB 500 million, to stabilize operations and enhance market confidence [4] - The financial assistance, with an annual interest rate of 5%, will be used for the company's main business and to supplement working capital [4]
海南海药: 独立董事提名人声明与承诺(邵蓉)
Zheng Quan Zhi Xing· 2025-07-07 16:24
海南海药股份股份有限公司 独立董事提名人声明与承诺 提名人海南海药股份有限公司董事会现就提名邵蓉 为海南海药股份有限公司第十一届董事会独立董事候选 人发表公开声明。被提名人已书面同意作为海南海药股 份有限公司第十一届董事会独立董事候选人(参见该独 立董事候选人声明)。本次提名是在充分了解被提名人 职业、学历、职称、详细的工作经历、全部兼职、有无 重大失信等不良记录等情况后作出的,本提名人认为被 提名人符合相关法律、行政法规、部门规章、规范性文 件和深圳证券交易所业务规则对独立董事候选人任职资 格及独立性的要求,具体声明并承诺如下事项: 一、被提名人已经通过海南海药股份有限公司第十 一届董事会提名委员会或者独立董事专门会议资格审查, 提名人与被提名人不存在利害关系或者其他可能影响独 立履职情形的密切关系。 ? 是 □ 否 二、被提名人不存在《中华人民共和国公司法》第 一百七十八条等规定不得担任公司董事的情形。 ? 是 □ 否 如否,请详细说明: 三、被提名人符合中国证监会《上市公司独立董事 管理办法》和深圳证券交易所业务规则规定的独立董事 任职资格和条件。 ? 是 □ 否 如否,请详细说明: 四、被提名人符合公 ...
海南海药: 关于接受关联方财务资助的公告
Zheng Quan Zhi Xing· 2025-07-07 16:24
Overview - Hainan Haiyao Co., Ltd. has approved a financial assistance agreement with its controlling shareholder, Xinxing Jihua Pharmaceutical Holdings Co., Ltd., for a maximum amount of RMB 500 million, with a borrowing period of three years [1][2]. Financial Assistance Details - The financial assistance will primarily be used for Hainan Haiyao's main business and to supplement working capital [1]. - The annual interest rate for the financial assistance is set at 5% [4]. Related Party Transaction - The transaction constitutes a related party transaction and does not qualify as a major asset restructuring under relevant regulations [2]. - The independent directors have reviewed and approved the transaction, confirming it does not harm the interests of the company or its shareholders, particularly minority shareholders [5]. Company and Shareholder Information - Xinxing Jihua Pharmaceutical Holdings Co., Ltd. was established on March 13, 2018, with a registered capital of RMB 1.5 billion and total assets of RMB 7.655 billion as of April 30, 2025 [2][3]. - The company has already engaged in various related party transactions amounting to RMB 1.35 billion since the beginning of the year [5]. Impact on Company - The financial assistance is expected to optimize the company's debt structure and enhance liquidity, contributing to stable business operations without significant adverse effects on financial status or operational results [4][5].
海南海药亮相中医药学会脾胃病年度盛会,知名单品获上市后再评价疗效确证
Quan Jing Wang· 2025-07-07 11:50
Core Viewpoint - The 37th Academic Exchange Conference on Spleen and Stomach Diseases organized by the Chinese Association of Traditional Chinese Medicine was successfully held, showcasing the latest clinical research and developments in the treatment of gastrointestinal diseases, particularly highlighting the unique product "Fengliao Stomach and Intestine Kang Granules" from Hainan Haiyao Co., Ltd [1][2]. Group 1: Company Developments - Hainan Haiyao presented its unique traditional Chinese medicine product, Fengliao Stomach and Intestine Kang Granules, at the conference, which has shown promising results in clinical evaluations [1][2]. - The clinical study of Fengliao Stomach and Intestine Kang Granules demonstrated its effectiveness in treating adult acute diarrhea, showing a trend of better efficacy compared to the control group [2]. - The product has received multiple registrations and certifications, including five registration approvals and two invention patents, and has been recognized in twelve treatment guidelines [2]. Group 2: Market Trends - The sales of digestive system medications in China's urban retail pharmacies have shown steady growth, with a rebound in the first quarter of 2025 reaching nearly 15 billion yuan, a year-on-year increase of 2.29% [3]. - The market for traditional Chinese medicine in digestive diseases has remained stable, with significant growth in specific categories, such as stomach medications, which accounted for 24.09% of the market share [3]. - The increasing willingness of consumers to use natural and low-side-effect traditional Chinese medicine products is expected to enhance the market prospects for Hainan Haiyao's flagship products [3]. Group 3: Research and Development - Hainan Haiyao has established a robust R&D system, focusing on innovative drugs, formulations, and traditional Chinese medicine, with significant investments in major disease areas [5][6]. - The company has invested 397 million yuan in R&D over the past three years, with 124 million yuan allocated in 2024, representing 12.48% of its revenue [5]. - Two key innovative drugs, Fluorofenone and Painegabin, are currently in Phase II clinical trials, indicating the company's commitment to advancing its drug development pipeline [6].
海南海药(000566) - 独立董事候选人声明与承诺(邵蓉)
2025-07-07 11:30
独立董事候选人声明与承诺 声明人邵蓉作为海南海药股份股份有限公司第十一 届董事会独立董事候选人,已充分了解并同意由提名人 海南海药股份有限公司董事会提名为海南海药股份有限 公司(以下简称该公司)第十一届董事会独立董事候选 人。现公开声明和保证,本人与该公司之间不存在任何 影响本人独立性的关系,且符合相关法律、行政法规、 部门规章、规范性文件和深圳证券交易所业务规则对独 立董事候选人任职资格及独立性的要求,具体声明并承 诺如下事项: 一、本人已经通过海南海药股份股份有限公司第十 一届董事会提名委员会或者独立董事专门会议资格审查, 提名人与本人不存在利害关系或者其他可能影响独立履 职情形的密切关系。 ☑ 是 □ 否 如否,请详细说明: 二、本人不存在《中华人民共和国公司法》第一百 七十八条等规定不得担任公司董事的情形。 ☑ 是 □ 否 如否,请详细说明: 海南海药股份有限公司 如否,请详细说明: 四、本人符合该公司章程规定的独立董事任职条件。 ☑ 是 □ 否 如否,请详细说明: 五、本人已经参加培训并取得证券交易所认可的相 关培训证明材料(如有)。 ☑ 是 □ 否 如否,请详细说明: 六、本人担任独立董事不会违反 ...
海南海药(000566) - 关于接受关联方财务资助的公告
2025-07-07 11:30
证券代码:000566 证券简称:海南海药 公告编号:2025-045 海南海药股份有限公司 关于接受关联方财务资助的公告 本公司董事会及全体董事保证公告内容的真实、准确和完整,没有虚假记载、 误导性陈述或者重大遗漏。 一、概述 根据海南海药股份有限公司(以下简称"公司"或"海南海药")资金需求 和未来发展战略需要,公司于 2025 年 7 月 7 日召开第十一届董事会第二十六次 会议,以 5 票同意,0 票反对,0 票弃权审议通过了《关于接受关联方财务资助 的议案》。公司拟接受控股股东海南华同实业有限公司之控股股东新兴际华医药 控股有限公司(以下简称"医药控股")提供的财务资助,本次财务资助最高不 超过人民币 5 亿元,借款期限为三年,在上述借款额度内,资金可以滚动使用。 本次借款的资金主要用于海南海药主营业务及补充流动资金。 依据《深圳证券交易所股票上市规则》《公司章程》等相关规定,本次接受 财务资助事项构成关联交易,不构成《上市公司重大资产重组管理办法》规定的 重大资产重组。王建平先生、封多佳先生、田勇先生为审议本次议案的关联董事, 已回避本议案的表决。公司已召开第十一届董事会独立董事专门会议 2025 ...
海南海药(000566) - 独立董事提名人声明与承诺(邵蓉)
2025-07-07 11:30
海南海药股份股份有限公司 二、被提名人不存在《中华人民共和国公司法》第 一百七十八条等规定不得担任公司董事的情形。 ☑ 是 □ 否 如否,请详细说明: 三、被提名人符合中国证监会《上市公司独立董事 管理办法》和深圳证券交易所业务规则规定的独立董事 任职资格和条件。 ☑ 是 □ 否 如否,请详细说明: 独立董事提名人声明与承诺 提名人海南海药股份有限公司董事会现就提名邵蓉 为海南海药股份有限公司第十一届董事会独立董事候选 人发表公开声明。被提名人已书面同意作为海南海药股 份有限公司第十一届董事会独立董事候选人(参见该独 立董事候选人声明)。本次提名是在充分了解被提名人 职业、学历、职称、详细的工作经历、全部兼职、有无 重大失信等不良记录等情况后作出的,本提名人认为被 提名人符合相关法律、行政法规、部门规章、规范性文 件和深圳证券交易所业务规则对独立董事候选人任职资 格及独立性的要求,具体声明并承诺如下事项: 一、被提名人已经通过海南海药股份有限公司第十 一届董事会提名委员会或者独立董事专门会议资格审查, 提名人与被提名人不存在利害关系或者其他可能影响独 立履职情形的密切关系。 ☑ 是 □ 否 如否,请详细说明: ...