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：2025-024 烟台正海生物科技股份有限公司 关于取得医疗器械注册变更文件的公告 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 品监督管理局颁发的 1 项《医疗器械变更注册（备案）文件》，公司完成产品"活 性生物骨"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： 变更内容： 1、增加产品的规格型号。 1 2、对产品技术要求相关内容进行变更。 烟台正海生物科技股份有限公司 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 活性生物骨 国械注准 20223131334 2022 年 10 月 8 日至 2027 年 10 月 7 日 以医疗器械 为主的药械 组合产品 用于填充由于创伤或手术造 成的、不影响骨结构稳定性 的骨缺损 上述变更文件与"国械注准 20223131334"注册证共同使用。 二、对公司的影响及风险提示 上述医疗器械注册证的变更符合公司发展 ...

Group 1 - The core viewpoint of the articles highlights the performance and valuation of Zhenghai Biological, which has a current PE ratio of 31.02, significantly lower than the industry average of 50.64 [1][2] - Zhenghai Biological's market capitalization stands at 3.749 billion yuan, ranking 68th in the medical device industry based on PE ratio [1][2] - The company has been recognized as one of the top 50 new material leading enterprises in Shandong Province for 2023, indicating its strong position in the industry [1] Group 2 - As of the first quarter of 2025, eight institutions hold shares in Zhenghai Biological, with a total holding of 19.6518 million shares valued at 442 million yuan [1] - The latest financial report shows that Zhenghai Biological achieved a revenue of 97.4158 million yuan, representing a year-on-year increase of 8.68%, while net profit decreased by 34.06% to 26.6267 million yuan [1] - The company's gross profit margin is reported at 80.96%, indicating a strong profitability despite the decline in net profit [1]

暗盘资金一眼洞悉庄家意图>> 牙科医疗板块盘初拉升，皓宸医疗（002622）封板涨停，爱迪特（301580）涨超5%，康惠制药 （603139）、悦心健康（002162）、正海生物（300653）、国瓷材料（300285）等均涨超2%。 ...

Group 1 - The core viewpoint of the articles highlights the performance and market position of Zhenghai Biological, noting its stock price increase and market capitalization [1] - As of May 29, Zhenghai Biological's closing price was 19.95 yuan, with a rolling PE ratio of 29.71 times and a total market value of 3.591 billion yuan [1] - The company ranks 67th in the medical device industry, which has an average PE ratio of 49.64 times and a median of 36.36 times [1] Group 2 - Zhenghai Biological's main business involves the research, production, and sales of bio-regenerative materials, including oral repair membranes and absorbable dura mater patches [1] - The company was recognized as one of the top 50 new material leading enterprises in Shandong Province for 2023 [1] - In the first quarter of 2025, the company reported revenue of 97.42 million yuan, a year-on-year increase of 8.68%, while net profit was 26.63 million yuan, a year-on-year decrease of 34.06%, with a gross profit margin of 80.96% [1]

Industry Overview - The dental medical equipment industry is experiencing rapid growth in China, driven by an aging population and increasing disposable income, leading to heightened awareness of oral health [1][8] - The market size for dental medical equipment in China is projected to grow from 22.3 billion yuan in 2020 to 41.2 billion yuan in 2024, with a compound annual growth rate (CAGR) of 16.59% [1][8] - The global dental medical equipment market is also expanding, expected to increase from 14.6 billion USD in 2020 to 20.7 billion USD in 2024, with a CAGR of 9.12% [6] Market Dynamics - The demand for dental medical services is rising, leading to a robust growth phase for the dental equipment market in China [1][8] - The domestic market for dental medical equipment is forecasted to reach 47.9 billion yuan by 2025 [1][8] - The domestic CBCT (Cone Beam Computed Tomography) market is becoming a focal point, with the localization rate expected to rise from 16.3% in 2020 to 56.44% in 2024 [10][18] Competitive Landscape - Major players in the Chinese dental medical equipment market include Xinhua Medical, Meiya Optoelectronics, Times Angel, and Kangzhong Medical [2][12] - The industry is currently reliant on imports for 90% of its dental equipment, particularly in the mid-to-high-end segments, but there is a significant opportunity for domestic companies to replace imports [12][18] - Key products from leading companies include CBCT systems, dental sterilization equipment, and implant devices [14][16] Development Trends - There is a notable acceleration in domestic replacement and technological breakthroughs, particularly in CBCT, with expectations for further advancements in high-end sectors [18] - The integration of digital and intelligent technologies is transforming the dental medical equipment industry, enhancing diagnostic efficiency and patient experience [19] - The market is witnessing a segmentation in demand, with older populations driving the need for dental implants and younger consumers pushing for aesthetic treatments like invisible orthodontics [20]

2024 年年度权益分派实施公告 证券代码：300653 证券简称：正海生物 公告编号：2025-023 烟台正海生物科技股份有限公司 2024 年年度权益分派实施公告 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。 特别提示： 1、烟台正海生物科技股份有限公司（以下简称"本公司"或"公司"）回购 专用证券账户中的 2,360,050 股公司股份不参与本次权益分派。本次权益分派以 公司现有总股本 180,000,000 股剔除已回购股份 2,360,050 股后的 177,639,950 股 为基数，向全体股东每 10 股派发现金 4.60 元（含税），合计派发现金红利人民 币 81,714,377.00 元（含税）。 2、本次权益分派实施后除权除息价格计算时，按公司总股本折算每 10 股现 金红利=实际现金分红总额/总股本*10=81,714,377 元/180,000,000*10=4.539687 元（保留六位小数，最后一位直接截取，不四舍五入，并据此计算调整相关参数）。 本次权益分派实施后的除权除息价格=股权登记日收盘价-0.4539687 元/股。 ...

Group 1 - The core viewpoint of the articles highlights the performance and valuation of Zhenghai Biological, which closed at 20.38 yuan, with a PE ratio of 30.35, marking a new low in 23 days, and a total market capitalization of 3.668 billion yuan [1] - Zhenghai Biological ranks 67th in the medical device industry, which has an average PE ratio of 49.51 and a median of 36.17 [1] - As of March 31, 2025, Zhenghai Biological had 16,966 shareholders, a decrease of 193 from the previous count, with an average holding value of 352,800 yuan and an average shareholding of 27,600 shares [1] Group 2 - The main business of Zhenghai Biological involves the research, production, and sales of bio-regenerative materials, including oral repair membranes, absorbable dura mater patches, bone repair materials, and surgical sponges [1] - The company was recognized as one of the top 50 new material leading enterprises in Shandong Province for 2023, as announced by the Shandong Provincial Department of Industry and Information Technology [1] - In the latest quarterly report for Q1 2025, Zhenghai Biological reported revenue of 97.42 million yuan, a year-on-year increase of 8.68%, and a net profit of 26.63 million yuan, a year-on-year decrease of 34.06%, with a gross profit margin of 80.96% [1]

Group 1: Financial Performance - The company's sales revenue in Q1 2025 showed positive growth driven by both existing and new products [4] - In Q1 2025, net profit continued to decline significantly, with sales expenses increasing compared to the same period last year [4] - The overall sales volume has been growing over the years, with a 9.21% growth expected in 2024 despite a severe slowdown in 2023 [5] Group 2: Market Challenges - The decline in revenue and profit in 2024 was influenced by multiple factors, including price optimization of oral products and market demand fluctuations [5] - The company faced challenges with the active biological bone product due to limited sales scale and market conditions [5] - The first quarter of 2025 recorded the lowest gross and net profit since the company went public, indicating a potential ongoing trend [5] Group 3: Product Development and Strategy - The company is focusing on enhancing market promotion for active biological bone products and implementing precise marketing strategies in the oral field [4] - There are plans to expand the indications for active biological bone and to conduct comparative experiments with autologous bone [6] - The company is actively working on the registration and market introduction of new products, including calcium-silicon biological ceramics [10] Group 4: Investor Relations and Future Outlook - The company is committed to improving sales volume and achieving sustainable development despite current challenges [5] - There is an ongoing effort to enhance brand recognition and market coverage for active biological bone products [8] - The company is planning to disclose its profit distribution plan and net profit targets for 2025 in future announcements [30]

Industry Overview - Regenerative medicine (RM) utilizes biological and engineering theories to promote self-repair and regeneration of the body, or to construct new tissues and organs for repairing, regenerating, and replacing damaged tissues and organs [1][4] - The global regenerative medicine market is expanding, with the market size projected to grow from $20.04 billion in 2021 to $35.82 billion in 2024 [1][12] Market Status - Regenerative medicine is considered the "third medical revolution" following drug and surgical treatments, becoming a core component of life science strategies globally [6][12] - The industry includes upstream raw materials and equipment supply, midstream product R&D and production, and downstream application through medical institutions and aesthetic organizations [4][12] Policy and Regulatory Environment - Various countries have implemented policies to promote the development of regenerative medicine, such as the U.S. "21st Century Cures Act" and the EU's regulations on biotechnology [7][9] - In China, policies have been established to support the clinical application of regenerative medicine technologies, including the management of stem cell therapies and the promotion of innovative medical technologies [9][23] Market Competition - The regenerative medicine sector has attracted numerous companies, with major players including Johnson & Johnson, Bard, Geistlich, and domestic firms like Zhenghai Biological, Guanhou Biological, and Maipu Medical [16][18] - The market is characterized by a diverse range of products and applications, with companies focusing on specific therapeutic areas such as cancer treatment, tissue repair, and organ transplantation [18][20] Development Trends - The industry is witnessing technological integration and innovation, with advancements in 3D bioprinting, gene editing, and artificial intelligence enhancing treatment efficacy [22][24] - The dual drive of policy support and capital investment is accelerating the commercialization of regenerative medicine, with increasing coverage of medical insurance for regenerative products [23][24]

Group 1: Market Competition and Strategy - The oral industry is experiencing intensified competition, particularly in the private market, following a brief surge in demand for dental implants, which is now slowing down [4] - The company aims to maintain its competitive edge in the dental sector by implementing precise marketing strategies and enhancing collaboration with leading end-users [4] - The company is actively pursuing product upgrades to adapt to market changes [4] Group 2: Product Development and Sales - The second oral repair membrane will focus on applications for superficial soft tissue defects and gingival mucosa repair [4] - The market demand for the company's meninges products remains stable, with 24 provinces participating in bulk procurement, leading to a decrease in prices but an increase in sales volume [5] - The company plans to continue tracking the progress of bulk procurement projects and respond proactively [5] Group 3: Growth Drivers and Financial Outlook - The company will implement a "precision marketing" strategy to strengthen existing channels and core brands, aiming for revenue growth from existing products [6] - New product approvals, including the second-generation oral repair membrane and calcium silicate bio-ceramic bone repair materials, are expected to enhance the product matrix in the oral field [6] - Sales expense ratio is projected to increase in the second half of 2024 due to intensified marketing efforts, but is expected to return to a reasonable level in 2025 as sales revenue grows [6]