烟台正海生物科技股份有限公司 关于公司取得医疗器械注册证的公告 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"）于近日取得由国家药 品监督管理局下发的《中华人民共和国医疗器械注册证》，现将相关情况公告如 下： 关于公司取得医疗器械注册证的公告 证券代码：300653 证券简称：正海生物 公告编号：2026-003 1 关于公司取得医疗器械注册证的公告 供强力支持。 三、风险提示 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 | | --- | --- | --- | --- | --- | --- | | 钙硅生物陶瓷 | 国械注准 | 年 月 2026 1 7 | | | 日至 | | 口腔骨修复材料 | 20263170015 | 2031 1 6 | 年 | 月 | 日 | | | | | | | 第三类 医疗器械 | | | | | | | 适用范围 产品需要与屏障膜联 合使用，适用于牙槽骨 缺损修复 | 二、对公司的影响 外伤、肿瘤、炎症及拔牙等多种因素 ...

Policy Developments - The National Medical Products Administration (NMPA) is optimizing the review and approval process for urgently needed overseas drugs that have already been marketed, aiming to meet the pressing clinical needs of patients [1] Drug and Device Approvals - Yifan Pharmaceutical's subsidiary received a registration acceptance notice for Yihuang Decoction Granules, which is indicated for kidney strengthening and dampness clearing [2] - Zhenghai Bio announced that it received a medical device registration acceptance notice for a uterine cavity repair membrane, currently in the acceptance stage [3] - Microchip Biotech's Xidabendan Tablets have been approved for sale in Macau, marking an expansion into overseas markets [4] - Heng Rui Medicine's innovative drug Ruirafulpu α injection has been approved for marketing, with no similar products currently approved domestically or internationally, and a cumulative R&D investment of approximately 711 million yuan [5] Capital Market Insights - Bibet reported that it is not yet profitable and has accumulated unremedied losses, with only one product approved and several others in various clinical trial stages, indicating a need for significant ongoing R&D investment [6] - Innovation Medical confirmed that its production and operational status is normal, with no undisclosed significant matters [7][8] Industry Events - Yiming Onco announced the termination of its collaboration agreement with Axion Bio, regaining global development and commercialization rights for two core anti-cancer drugs, with previously received payments unaffected [9] Public Opinion Alerts - The Director of the Jiangxi Provincial Health Commission is under disciplinary review and investigation for serious violations of discipline and law [10]

（文章来源：证券日报） 证券日报网讯 1月7日，正海生物发布公告称，公司于近日收到国家药品监督管理局下发的医疗器械注 册申请《受理通知书》。 ...

格隆汇1月7日丨正海生物(300653.SZ)公布，近日收到国家药品监督管理局下发的医疗器械注册申请 《受理通知书》。产品名称：宫腔修复膜。公司产品宫腔修复膜，是牛的皮肤组织经一系列处理后制备 的异种脱细胞真皮基质，主要成分为胶原蛋白，其天然的三维空间结构，可以为细胞的长入和迁移提供 良好的支架，有效地引导组织再生。宫腔修复膜植入宫腔后，能够严密的贴敷在壁上，从而在内膜尚未 完成上皮化前物理隔离暴露的壁，确保壁相对独立的修复空间，具有较高的安全性。 ...

智通财经APP讯，正海生物(300653.SZ)公告，公司近日收到国家药品监督管理局下发的医疗器械注册申 请《受理通知书》，相关产品名称为：宫腔修复膜。 ...

格隆汇1月7日丨正海生物(300653.SZ)公布，近日收到国家药品监督管理局下发的医疗器械注册申请 《受理通知书》。产品名称：宫腔修复膜。公司产品宫腔修复膜，是牛的皮肤组织经一系列处理后制备 的异种脱细胞真皮基质，主要成分为胶原蛋白，其天然的三维空间结构，可以为细胞的长入和迁移提供 良好的支架，有效地引导组织再生。宫腔修复膜植入宫腔后，能够严密的贴敷在子宫壁上，从而在子宫 内膜尚未完成上皮化前物理隔离暴露的子宫壁，确保子宫壁相对独立的修复空间，具有较高的安全性。 ...

正海生物（300653）(300653.SZ)公告，公司近日收到国家药品监督管理局下发的医疗器械注册申请 《受理通知书》，相关产品名称为：宫腔修复膜。 ...

人民财讯1月7日电，正海生物（300653）1月7日公告，公司于近日收到国家药品监督管理局下发的医疗 器械注册申请《受理通知书》。产品名称：宫腔修复膜，临床用途：适用于宫腔粘连分离术后的预防再 粘连及子宫内膜修复。 ...

关于公司获得医疗器械注册申请《受理通知书》的公告 证券代码：300653 证券简称：正海生物 公告编号：2026-002 烟台正海生物科技股份有限公司 关于公司获得医疗器械注册申请《受理通知书》的公告 该医疗器械目前注册申请已获得受理。 三、后续所需审批流程 后续所需的审批流程：审评审批、制证。 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"）于近日收到国家药品 监督管理局下发的医疗器械注册申请《受理通知书》。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：宫腔修复膜 临床用途：适用于宫腔粘连分离术后的预防再粘连及子宫内膜修复。 申请人：烟台正海生物科技股份有限公司 产品类别：第三类医疗器械 二、目前所处审批阶段 四、该项目其他相关情况 目前宫腔镜下粘连分离术为宫腔粘连的常用治疗方法，但术后残存的正常子 宫内膜较少，损伤后子宫内膜的修复过程复杂，探索新的材料应用于预防术后再 粘连，并重建和修复术后的子宫内膜、降低复发率成为妇产科临床工作中面临的 重点及难点。 公司产品宫腔修复膜，是牛的皮肤组织经一系列 ...

Group 1 - The core viewpoint of the news is that Zhenghai Biological has experienced a decline in both revenue and net profit, indicating potential challenges in its financial performance [2] - As of January 6, Zhenghai Biological's stock price decreased by 0.57%, with a trading volume of 72.16 million yuan, and a net financing buy of -2.11 million yuan [1] - The company has a total financing and securities balance of 132 million yuan, with the financing balance accounting for 3.48% of its market capitalization, which is below the 30% percentile level over the past year [1] Group 2 - For the period from January to September 2025, Zhenghai Biological reported an operating income of 276 million yuan, a year-on-year decrease of 5.36%, and a net profit attributable to shareholders of 67.4 million yuan, down 46.10% year-on-year [2] - The number of shareholders as of September 30 is 15,900, a decrease of 5.57% from the previous period, while the average circulating shares per person increased by 5.90% to 11,336 shares [2] - The company has distributed a total of 617 million yuan in dividends since its A-share listing, with 334 million yuan distributed over the past three years [2]