Core Viewpoint - Zhenghai Biological has recently obtained a medical device registration certificate from the National Medical Products Administration for its calcium silicate bioceramic oral bone repair material [1] Group 1 - The product is named calcium silicate bioceramic oral bone repair material [1] - The registration certificate was issued by the National Medical Products Administration [1]

Core Viewpoint - Zhenghai Biological has recently obtained a medical device registration certificate for its calcium silicate bioceramic oral bone repair material, which enhances its product line in the dental field and improves market competitiveness [2] Group 1: Product Details - The product is designed for the repair of alveolar bone defects and is manufactured using 3D printing technology, indicating potential for customized production [2] - The registration certificate number is 国械注准 20263170015, and it is valid until January 6, 2031 [2] Group 2: Market Impact - The acquisition of this registration certificate will enrich the company's product offerings in the oral sector [2] - The actual sales performance of the product post-launch will depend on market promotion effectiveness, making future performance impact difficult to predict [2]

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》。 ...

Core Viewpoint - Zhenghai Biological (300653.SZ) has received a medical device registration application acceptance notice from the National Medical Products Administration for its product, the intrauterine repair membrane [1] Group 1: Product Overview - The intrauterine repair membrane is made from bovine skin tissue processed to create a decellularized dermal matrix, primarily composed of collagen [1] - Its natural three-dimensional structure provides an excellent scaffold for cell infiltration and migration, effectively guiding tissue regeneration [1] Group 2: Product Functionality - When implanted in the uterine cavity, the repair membrane adheres tightly to the wall, creating a physical barrier that isolates the exposed wall until the endometrium has completed epithelialization [1] - This feature ensures a relatively independent repair space for the wall, contributing to a high level of safety [1]

Core Viewpoint - Zhenghai Biological has received a medical device registration acceptance notice from the National Medical Products Administration for its product, the intrauterine repair membrane [1] Group 1 - The company announced the receipt of the acceptance notice for the medical device registration [1]

Core Viewpoint - Zhenghai Biological (300653.SZ) has received a medical device registration application acceptance notice from the National Medical Products Administration for its product, the intrauterine repair membrane [1] Group 1: Product Overview - The intrauterine repair membrane is made from bovine skin tissue processed to create a decellularized dermal matrix, primarily composed of collagen [1] - Its natural three-dimensional structure provides an excellent scaffold for cell infiltration and migration, effectively guiding tissue regeneration [1] Group 2: Product Functionality - When implanted in the uterine cavity, the repair membrane adheres closely to the uterine wall, creating a physical barrier that isolates the exposed uterine wall until the endometrial epithelium is fully healed [1] - This product ensures a relatively independent repair space for the uterine wall, demonstrating a high level of safety [1]

Core Viewpoint - The company Zhenghai Biological (300653.SZ) has received a medical device registration application acceptance notice from the National Medical Products Administration for its product, the intrauterine repair membrane [1] Group 1 - The product name for the registered medical device is intrauterine repair membrane [1]

Core Viewpoint - Zhenghai Biological has received a medical device registration acceptance notice from the National Medical Products Administration for its product, a uterine cavity repair membrane, which is intended for preventing re-adhesion and repairing the endometrium after hysteroscopic adhesion separation surgery [1]. Group 1 - The product name is "Uterine Cavity Repair Membrane" [1] - The clinical use of the product is for preventing re-adhesion after hysteroscopic adhesion separation surgery and for endometrial repair [1]