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正海生物:公司口腔修复膜产品在公立市场的销售格局相对稳定
Zheng Quan Ri Bao Zhi Sheng· 2025-09-09 11:09
Core Viewpoint - The company is facing intensified competition and demand fluctuations in the private market for its oral repair membrane products, while maintaining a stable sales structure in the public market [1] Group 1: Market Challenges - The company reports that the competitive landscape in the private market is becoming increasingly aggressive, leading to a price war [1] - Demand fluctuations in the private market are posing additional pressures and challenges for the company [1] Group 2: Strategic Responses - The company aims to solidify its competitive position in the implant sector by executing a precise marketing strategy [1] - There is a focus on strengthening collaboration with leading end-users to stabilize market share coverage [1] - The company plans to accelerate the launch and promotion of new products, leveraging the combined capabilities of its membrane powder product line to enhance market competitiveness [1]
正海生物:公司脑膜系列产品在已经开展集采的省份全部中标
Zheng Quan Ri Bao Zhi Sheng· 2025-09-09 11:09
Group 1 - The company announced that it will actively respond to the upcoming centralized procurement project for medical consumables related to hard brain (spinal) membrane patches, as per the notice issued by Tianjin City in June 2024 [1] - The company's series of membrane products have successfully won bids in all provinces where centralized procurement has been implemented, indicating a stable market share despite price reductions [1] - Overall, the centralized procurement has led to a decrease in the selling price of the company's membrane products, which has correspondingly increased sales volume [1]
正海生物(300653) - 关于取得医疗器械注册变更文件的公告
2025-09-09 08:54
关于取得医疗器械注册变更文件的公告 证券代码:300653 证券简称:正海生物 公告编号:2025-039 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、 误导性陈述或重大遗漏。 烟台正海生物科技股份有限公司(以下简称"公司")于近日取得由国家药 品监督管理局颁发的 1 项《医疗器械变更注册(备案)文件》,公司完成产品"硬 脑(脊)膜补片"的产品技术要求及规格型号相关内容的变更,现将相关情况公 告如下: 一、该医疗器械的基本信息 | 产品名称 | 注册证编号 | | | | | 注册证有效期 注册分类 适用范围 | | --- | --- | --- | --- | --- | --- | --- | | 硬脑(脊) | 国械注准 | 年 12 23 | | 月 | 日至 | 第三类医疗 用于硬脑(脊)膜缺损的修 2022 | | 膜补片 | 20223131789 | 12 月 22 | 年 | | 日 | 2027 器械 复。 | 变更内容: 1、增加产品的规格型号。 2、对产品技术要求相关内容进行变更。 上述变更文件与"国械注准 20223131789"注册证共同使用。 烟台正 ...
正海生物(300653) - 2025年9月8日投资者关系活动记录表
2025-09-09 01:02
Group 1: Market Performance and Competition - The company has successfully won bids for its meninges series products in all provinces where centralized procurement has been implemented, leading to a decrease in prices but an increase in sales volume, maintaining market share stability [3]. - The oral repair membrane products face intensified competition in the private market, with a price war becoming increasingly fierce; the company aims to solidify its market position through targeted strategies and collaboration with key terminals [4]. Group 2: Product Development and Innovations - The calcium silicate bioceramic bone repair material, expected to be registered by the end of 2025, features a porous structure similar to autologous bone, promoting bone regeneration and differentiation [4]. - The active biological bone product's promotion and hospital admission are progressing as planned, with no current impact from centralized procurement policies; the company is monitoring potential future policy changes [4]. Group 3: Future Plans and Strategic Initiatives - The company is exploring international market opportunities for some of its products and is in the planning stages for overseas expansion [4]. - A stock incentive plan is being developed in accordance with relevant regulations and the company's operational status, with updates to be disclosed in future announcements [4].
正海生物:董群女士因工作调整辞去公司董事会中相关职务
Zheng Quan Ri Bao· 2025-09-03 10:15
Core Viewpoint - Dong Qun has resigned from her position on the board of directors of Zhenghai Bio due to work adjustments, but this resignation will not impact the company's production and operations [2] Company Summary - Dong Qun's resignation is attributed to work adjustments, indicating potential internal restructuring within the company [2] - The company reassures investors that the resignation will not affect its operational capabilities [2]
正海生物(300653.SZ):活性生物骨产品具备出海潜力
Ge Long Hui· 2025-08-29 07:13
Group 1 - The core viewpoint of the article is that Zhenghai Biological (300653.SZ) has potential for its active biological bone products in international markets, and the company will fulfill its information disclosure obligations according to regulatory requirements [1]
正海生物(300653) - 山东川奇律师事务所关于烟台正海生物科技股份有限公司2025年第一次临时股东会的法律意见书
2025-08-27 12:32
山东川奇律师事务所 关于烟台正海生物科技股份有限公司 2025 年第一次临时股东会的 法律意见书 致:烟台正海生物科技股份有限公司 山东川奇律师事务所(以下简称"本所")接受烟台正海生物科 技股份有限公司(以下简称"公司")的委托,指派王建洲律师、徐 学广律师(以下合称"本所律师")列席并见证公司 2025 年第一次 临时股东会(下称"本次股东会")。 根据《中华人民共和国公司法》(以下简称"《公司法》")、《中华 人民共和国证券法》、《上市公司股东会规则》(以下简称"《股东会规 则》")等法律、行政法规及公司《章程》的有关规定,本所律师按照 中国律师行业公认的业务标准、道德规范和勤勉尽责精神,对本次股 东会的有关事项进行了核查和验证,出具法律意见书。 在本法律意见书中,本所律师根据《股东会规则》的要求,就本 次股东会的召集人资格、召集、召开程序是否合法及是否符合公司《章 程》、出席会议人员资格的合法有效性、会议表决程序、表决方式的 合法有效性发表意见。 本所在此同意贵公司将本法律意见书作为本次股东会的必备文 件予以公告,并依法对本所出具的法律意见书承担责任。 一、本次股东会的召集人资格及召集、召开程序 1、 ...
正海生物(300653) - 关于非独立董事辞职及选举职工代表董事的公告
2025-08-27 12:32
关于非独立董事辞职及选举职工代表董事的公告 证券代码:300653 证券简称:正海生物 公告编号:2025-038 烟台正海生物科技股份有限公司 关于非独立董事辞职及选举职工代表董事的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、 误导性陈述或重大遗漏。 一、关于非独立董事辞职的事项 烟台正海生物科技股份有限公司(以下简称"公司")董事会于近日收到公 司董事 Qun Dong 女士的书面辞职报告。Qun Dong 女士因工作调整申请辞去公 司第四届董事会副董事长、非独立董事职务,辞职后不再担任公司任何职务。 Qun Dong 女士的辞职自其辞职报告送达公司董事会即生效,根据《中华人民共 和国公司法》、《公司章程》等的有关规定,Qun Dong 女士的辞职不会导致公司 董事会成员人数低于法定最低人数,不会影响公司董事会的正常工作。 Qun Dong 女士原定任期至公司第四届董事会届满之日止。截至本公告披露 之 日 , Qun Dong 女 士 通 过 Longwood Biotechnologies Inc. 间 接 持 有 本 公司 13,811,874 股股份,占公司总股本的 ...
正海生物(300653) - 2025年第一次临时股东会决议公告
2025-08-27 12:32
股东会决议公告 证券代码:300653 证券简称:正海生物 公告编号:2025-037 烟台正海生物科技股份有限公司 2025 年第一次临时股东会决议公告 二、会议出席情况 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、 误导性陈述或重大遗漏。 特别提示: 1、本次股东会未出现否决议案的情形。 2、本次股东会未涉及变更以往股东会已通过的决议。 一、会议召开情况 烟台正海生物科技股份有限公司(以下简称"公司")2025 年第一次临时股 东会于 2025 年 8 月 27 日下午 14:30 在烟台经济技术开发区南京大街 7 号烟台正 海生物科技股份有限公司会议室召开,本次会议采取现场投票与网络投票结合的 表决方式。其中: (1)现场会议召开时间:2025 年 8 月 27 日(星期三)下午 14:30 (2)网络投票时间:通过深圳证券交易所交易系统进行网络投票的时间为 2025 年 8 月 27 日的交易时间,即 9:15—9:25,9:30—11:30 和 13:00—15:00;通 过深圳证券交易所互联网系统投票的具体时间为 2025 年 8 月 27 日 9:15—15:00。 ...
正海生物股价微跌0.98% 公司回应脑膜产品研发计划
Jin Rong Jie· 2025-08-26 20:04
Group 1 - The stock price of Zhenghai Biological as of August 26, 2025, closed at 22.23 yuan, down 0.22 yuan or 0.98% from the previous trading day [1] - The trading volume on that day was 33,418 hands, with a transaction amount of 0.75 billion yuan and a turnover rate of 1.86% [1] - Zhenghai Biological operates in the medical device sector, focusing on the research, production, and sales of biological regenerative materials, including oral repair membranes and biological membranes [1] Group 2 - The company announced that its calcium silicate bioceramic bone repair material is a non-animal-derived synthetic bone repair material, which will be subject to a 13% value-added tax upon market launch [1] - Zhenghai Biological clarified that there are currently no plans to develop non-animal-derived meningeal series products [1] - A temporary shareholders' meeting is scheduled for August 27 to review multiple proposals, including changes to the business scope and amendments to the company’s articles of association [1] Group 3 - On August 26, the net outflow of main funds was 2.4205 million yuan, with a cumulative net outflow of 21.9957 million yuan over the past five days [1]