Core Viewpoint - Zhenghai Biological has announced the initiation of clinical trials for its "oral absorbable biological membrane" after successfully enrolling the first subject in a randomized trial [1] Group 1: Product Development - The oral absorbable biological membrane is classified as a Class III medical device [1] - This product is designed to be used in conjunction with bone filling materials, providing a physical barrier during dental implant procedures to prevent the movement of filling materials [1] - It is applicable for use in various dental situations, including post-extraction filling, alveolar ridge restoration, and repair of alveolar bone defects caused by periodontal diseases [1]

Core Viewpoint - Zhenghai Biological (300653.SZ) has announced the completion of the first random enrollment of subjects for its research project "Oral Absorbable Biological Membrane," officially entering clinical trials [1] Group 1: Product Development - The "Oral Absorbable Biological Membrane" is designed to be used in conjunction with bone filling materials [1] - The product serves a physical barrier role during dental implant repairs for missing teeth, preventing the movement of filling materials [1] - It is also applicable for filling extraction sockets after tooth extractions and for the recovery of alveolar ridges [1] Group 2: Clinical Application - The membrane is intended for the repair of alveolar bone defects caused by periodontal diseases [1]

Core Viewpoint - The company Zhenghai Biological has announced that its research project "Oral Resorbable Biological Membrane" has officially entered clinical trials, aiming to evaluate its effectiveness and safety for guiding bone regeneration [1] Group 1: Clinical Trial Details - The clinical trial is a multi-center, randomized controlled, single-blind, non-inferiority trial [1] - The trial aims to assess the effectiveness and safety of the oral resorbable biological membrane in guiding bone regeneration [1] - The project has successfully completed the random enrollment of the first subject [1] Group 2: Product Characteristics - The oral resorbable biological membrane is made from decellularized dermal matrix material [1] - It provides a favorable scaffold for cell infiltration and migration, facilitating bone tissue growth and deposition [1] - The product aims to achieve regenerative repair in areas of bone defects [1]

现金管理进展公告 证券代码：300653 证券简称：正海生物 公告编号：2025-042 烟台正海生物科技股份有限公司 关于使用闲置自有资金进行现金管理的进展公告 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。 2025 年 4 月 12 日，公司召开第四届董事会第六次会议及第四届监事会第五 次会议审议通过了《关于使用闲置自有资金进行现金管理的议案》，同意公司使 用总额度不超过人民币 70,000 万元闲置自有资金进行现金管理。使用期限自公 司股东会审议通过之日起 12 个月内。公司在 2025 年 5 月 6 日召开的 2024 年年 度股东大会审议通过了上述议案。本次购买现金管理产品的额度和期限均在审批 范围内，无需另行提交董事会、股东会审议。 现将公司近期使用闲置自有资金进行现金管理的相关事宜公告如下： 一、本次使用闲置自有资金进行现金管理的进展情况 1、理财产品情况 | 受托方 | 产品名称 | 产品 | 金额 | 起始日 | 到期日 | 预计年化 | | --- | --- | --- | --- | --- | --- | --- | | | | ...

烟台正海生物科技股份有限公司 关于完成工商变更登记的公告 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。 2025 年 8 月 27 日，烟台正海生物科技股份有限公司（以下简称"公司"）召开 2025 年第一次临时股东会，审议通过了《关于变更公司经营范围暨修订公司章程的议案》， 以上具体内容详见公司在中国证监会指定的信息披露网站上披露的公告。 近日，公司就上述经营范围变更等事项完成了工商变更登记手续，取得了烟台市市 场监督管理局换发的《营业执照》，具体登记信息如下： 关于完成工商变更登记的公告 证券代码：300653 证券简称：正海生物 公告编号：2025-041 注册资本：人民币元 壹亿捌仟万元整 成立日期：2003 年 10 月 22 日 住所：烟台经济技术开发区南京大街 7 号 特此公告。 1 统一社会信用代码：913706007554199342 名称：烟台正海生物科技股份有限公司 类型：股份有限公司（中外合资、上市） 法定代表人：郭焕祥 经营范围：许可项目：第二类医疗器械生产；第三类医疗器械生产；第三类医疗器 械经营；药品生产；药品零售；药品批发。（ ...

医疗器械进入临床试验公告 证券代码：300653 证券简称：正海生物 公告编号：2025-040 烟台正海生物科技股份有限公司 关于医疗器械进入临床试验的公告 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。 烟台正海生物科技股份有限公司（以下简称"公司"）的研发项目"口腔可 吸收生物膜"于近日完成首例受试者随机入组，正式进入临床试验，现将具体情 况公告如下： 一、该项目临床试验的基本情况 申办者：烟台正海生物科技股份有限公司 临床试验名称：评价口腔可吸收生物膜用于引导骨再生的有效性和安全性的 多中心、随机对照、单盲、非劣效性临床试验 试验目的：评价口腔可吸收生物膜用于引导骨再生的有效性和安全性。 试验用医疗器械名称：口腔可吸收生物膜 分类：第三类医疗器械 临床用途：该产品与骨填充材料联合使用，适用于口腔牙缺失需种植修复时 起物理阻隔作用，防止充填材料移动，以及拔牙后、残根拔除术后拔牙窝填充； 牙槽嵴恢复；牙周疾病引起的牙槽骨缺损修复。 进展阶段：现已完成第一例受试者随机入组。 特此公告。 烟台正海生物科技股份有限公司 董 事 会 2025 年 10 月 9 日 ...

Core Viewpoint - Zhenghai Biological (300653) has reported that it is actively participating in volume-based procurement for its meninges products across multiple provinces, indicating a strategic response to market changes and regulatory developments [1] Group 1: Company Developments - As of now, six provincial and two inter-provincial alliances have initiated volume-based procurement for meninges products, covering a total of 24 provinces (autonomous regions and corps) [1] - The company has successfully won bids for its meninges series in all provinces where centralized procurement has been implemented, leading to a stable market share despite price reductions [1] Group 2: Market Impact - The centralized procurement has resulted in a decrease in the selling price of the company's meninges products, which has correspondingly increased sales volume [1] - The company is preparing for upcoming volume-based procurement projects, particularly in response to a notification from Tianjin regarding the maintenance of medical consumables information for hard brain (spinal) membrane patches [1]

Core Viewpoint - Zhenghai Biological (300653) announced on September 17 that its human umbilical cord mesenchymal stem cell project is currently in the product process validation stage, which will enhance the company's product layout in the field of intrauterine soft tissue repair and enrich its reserves in regenerative medicine [1] Group 1 - The company is in the research and development phase of its human umbilical cord mesenchymal stem cell project [1] - The project aims to supplement the company's product offerings in the intrauterine soft tissue repair sector [1] - The company will strictly fulfill its information disclosure obligations as the project progresses and achieves relevant milestone advancements [1]

Core Viewpoint - Zhenghai Biological (300653) announced on September 17 that its active biological bone product is the first domestic bone filling product containing rhBMP-2, which has high innovation potential [1] Company Summary - The active biological bone product is characterized by its specific binding with collagen, indicating a significant innovation in the market [1] - The market share of bone morphogenetic protein (BMP) products in the bone repair materials sector is currently small, suggesting substantial growth potential [1] - The company aims to increase its market share and sales revenue through the unique characteristics of its active biological bone product [1] - Promotion and hospital entry efforts for the active biological bone have been progressing smoothly this year, aligning with expectations [1] - The company plans to enhance the professional promotion capabilities of its sales team to accelerate market expansion [1]

内容概要：人工硬脑膜是用生物材料制成人体脑膜的替代物，用于因颅脑、脊髓损伤、肿瘤及其他颅脑 疾病引起的硬脑膜或脊膜缺损的修补，防止脑脊液外漏、颅内感染、脑膨出、脑粘连和疤痕等严重并发 症，以恢复其完整性。人工硬脑膜属于植介入耗材，伴随着国民可支配收入增加、老龄化程度加深，脑 血管疾病发病率上升，神经外科介入类手术需求增加，推动人工硬脑膜的需求放量增长。但2021年以来 随着集采的稳步推进，国内人工硬脑膜产品价格下降较为明显。2024年，我国人工硬脑膜需求量从2017 年的44.63万片增长至94.61万片，产品价格从2017年的1775元/片下降至800元/片，人工硬脑膜市场规模 则从2020年的10.26亿元下降至2024年的7.57亿元。 关键词：人工硬脑膜行业政策、人工硬脑膜产业链、人工硬脑膜需求量、人工硬脑膜行业均价、人工硬 脑膜市场规模、人工硬脑膜市场竞争格局、人工硬脑膜行业发展趋势 一、人工硬脑膜行业基本概况 神经外科作为医学领域最为复杂的学科之一，是以手术为主要手段，医治中枢神经系统（脑、脊髓）、 周围神经系统和植物神经系统疾病的一门临床外科专科。作为高精尖的前沿学科之一，神经外科对应用 在手术 ...