本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 奥精医疗科技股份有限公司（以下简称"公司"）于2024年8月向国家药监局递交了公司可吸收复合骨修 复材料医疗器械产品的注册申报资料。公司于近日收到国家药监局通知，公司可吸收复合骨修复材料医 疗器械产品获得批准。现将相关情况公告如下： 一、注册证内容 证件有效期：2025.09.25-2030.09.24 产品分类：三类 二、医疗器械基本情况 本次获得可吸收复合骨修复材料医疗器械产品是在现有产品技术（人工骨修复材料，注册证号： 20193131531）的基础上，引入可吸收聚酯材料，在具有前代产品优良的生物相容性及促进骨愈合能力 的前提下，进一步增加了材料强度，并增强了材料降解可控性，能够更好的满足临床中不同条件下的骨 缺损修复。奥精医疗拥有可吸收复合骨修复材料医疗器械产品的完全自主知识产权，产品关键技术是骨 修复材料领域的重大进展，是生物材料领域的原始创新，开辟了一条自主制备生物材料的新途径，达到 国际领先水平。 三、对公司的影响及风险提示 本次公司产品获得注册证，进一步完善了 ...

证券代码：688613 证券简称：奥精医疗 公告编号：2025-054 奥精医疗科技股份有限公司 三、对公司的影响及风险提示 自愿披露关于公司产品获得注册证的公告 注册证编号：国械注准20253131942 产品名称：可吸收复合骨修复材料 证件有效期：2025.09.25-2030.09.24 产品分类：三类 二、医疗器械基本情况 本次获得可吸收复合骨修复材料医疗器械产品是在现有产品技术（人工骨修复材料，注册证号： 20193131531）的基础上，引入可吸收聚酯材料，在具有前代产品优良的生物相容性及促进骨愈合能力 的前提下，进一步增加了材料强度，并增强了材料降解可控性，能够更好的满足临床中不同条件下的骨 缺损修复。奥精医疗拥有可吸收复合骨修复材料医疗器械产品的完全自主知识产权，产品关键技术是骨 修复材料领域的重大进展，是生物材料领域的原始创新，开辟了一条自主制备生物材料的新途径，达到 国际领先水平。 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 奥精医疗科技股份有限公司（以下简称"公司"）于2024年8月向国家药监局递 ...

证券日报网讯正海生物（300653）9月17日发布公告，在公司回答调研者提问时表示，活性生物骨是国 内首个含与胶原特异结合的rhBMP-2的骨填充产品，具有很高的创新性。目前，骨形态发生蛋白(BMP) 类产品在骨修复材料领域的市场份额相对较小，仍具备较大的增长潜力。在骨形态发生蛋白类产品的细 分赛道内，公司活性生物骨将凭借该产品特性等优势，不断提升产品市占率，逐步实现产品销售收入的 增长。今年以来，活性生物骨的推广入院工作有序开展，整体入院节奏符合预期，公司将不断强化销售 团队的专业推广能力，加速市场开拓。 ...

Core Viewpoint - Zhenghai Biological (300653) announced on August 6 that its calcium silicate bioceramic bone repair material is currently in the registration supplement phase, with an expected approval for the registration certificate by the end of 2025 [1] Group 1: Product Details - The calcium silicate bioceramic bone repair material is a calcium silicate-based product that promotes osteogenic differentiation and vascularization through silicon ions, effectively guiding the repair and regeneration of alveolar bone [1] - The product utilizes 3D printing technology to achieve a porous structure similar to autologous bone, providing an excellent osteogenic environment for tissue [1] - This product has the potential for customized production to meet patient-specific needs [1]

Summary of Zhenghai Biological Conference Call Company Overview - **Company**: Zhenghai Biological - **Industry**: Biopharmaceuticals, specifically focusing on medical materials and products Key Financial Performance - **Net Profit**: Decreased by 46.77% YoY in H1 2025, with a net profit of 46.49 million yuan [2][3] - **Earnings Per Share**: Dropped by 45.83% YoY, standing at 0.26 yuan [2][3] - **Revenue**: Total revenue for H1 2025 was 187 million yuan, a decline of 5.14% YoY [3] - **Impact of VAT Adjustment**: The increase in VAT from 3% to 13% significantly affected revenue and profit, leading to an effective price drop of approximately 9% [2][18][19] Product Performance - **Main Revenue Sources**: - Meningeal series products generated sales of 80.27 million yuan - Oral repair membranes contributed 77.12 million yuan [2][3] - **Active Biological Bone**: - Sales team consists of about 20 members, with a network of 1,175 distributors [3][12] - Target to achieve sales of approximately 40 million yuan for the year, doubling last year's figures [3][24] - **Calcium Silicate Bioceramic Repair Materials**: - Currently in the registration phase, expected to be approved by the end of the year [5][6] Market Challenges and Strategies - **Oral Sector Pressure**: The oral segment faces challenges due to weak demand for implants and price reductions, making it difficult to meet annual targets [2][7] - **Sales Strategy**: The company is focusing on precise marketing strategies and collaboration with leading terminals to stabilize market share [4][7] - **Clinical Application**: Active biological bone products have shown good effectiveness and safety in clinical applications, gaining recognition from clinicians [4][12] Future Outlook - **Annual Growth Target**: The company aims for a 20% revenue growth despite the challenges faced in H1 2025 [3][14] - **Stem Cell Project**: Currently in the process validation stage, with no clinical trials yet; the timeline for future progress remains uncertain [8][9] - **Market Expansion**: Plans to explore Southeast Asian markets, with recruitment for overseas sales personnel underway [27] Additional Insights - **Accounts Receivable**: Increased to 56.71 million yuan, primarily from hospitals, but cash flow remains stable [3][28] - **Stock Levels**: Inventory levels are normal, with no significant issues reported [38] - **Long-term Goals**: The company aims to increase market penetration for BMP-containing products, currently at less than 10% market share [31] Conclusion Zhenghai Biological is navigating significant challenges due to regulatory changes and market dynamics. The company is actively pursuing growth through strategic marketing, product development, and market expansion while managing financial pressures from increased taxation and competitive pricing.

Company Summary - Aojing Medical (688613) reported a significant increase in sales volume of its core product "Gaojin," with a year-on-year growth of 93.54% in 2024, selling 1.4714 million cm3 compared to 760,300 cm3 in 2023 [1] - In Q1 2025, the sales volume of "Gaojin" further accelerated, achieving a remarkable growth of 174% [1] - The price of artificial bone products, including "Gaojin," decreased significantly due to centralized procurement, with prices dropping from 1,000-1,500 RMB/cm3 to 320-340 RMB/cm3, allowing more patients to access these materials [1] Industry Overview - The domestic bone repair market is in a phase of continuous expansion, with significant growth potential for artificial bone, particularly biomimetic mineralized collagen materials [3] - The market size of bone repair materials in China was approximately 2.58 billion RMB in 2023, with a projected compound annual growth rate (CAGR) of 14.5% from 2022 to 2028 [3] - Artificial bone materials are becoming the primary clinical application consumables in the bone repair field, overcoming the limitations of autologous and natural bone [3]

Core Viewpoint - The article highlights the innovative development of magnesium-based biodegradable polymer bone repair materials by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd., which addresses significant challenges in orthopedic surgery and has shown promising clinical results [1][19]. Group 1: Product Development and Features - The magnesium-based biodegradable polymer bone repair material is composed of PLGA, β-TCP, and magnesium, utilizing low-temperature additive manufacturing technology [1][4]. - This material is designed to fill and repair bone defects without compromising bone structural stability, making it suitable for various orthopedic applications [1][4]. - The product has received special approval from NMPA and is recognized as an international innovation [3][19]. Group 2: Clinical Applications and Efficacy - The material has been tested in clinical trials across eight major hospitals in China, with a bone fusion rate exceeding 98% among 176 patients, demonstrating excellent biocompatibility [13][14]. - Micro-CT analysis indicated significant improvements in new bone trabecular thickness and bone mineral density compared to control groups [14]. - The material is particularly effective for non-weight-bearing bone defects and can be shaped during surgery to fit complex defect geometries [14] . Group 3: Market Dynamics - The global bone repair materials market is projected to reach approximately $15 billion by 2025, with a CAGR of about 6.5%, driven by aging populations and increasing orthopedic diseases [19]. - The Chinese market for bone repair materials is expected to exceed 5 billion RMB by 2024, with a CAGR of over 18%, indicating substantial growth potential [19]. - The domestic market is primarily dominated by imported products, with a local market share of about 30%, but increasing support for domestic innovation is expected to enhance local market presence [19]. Group 4: Competitive Landscape - Key competitors in the bone repair materials market include Stryker's Vitoss, Geistlich's Bio-Oss and Bio-Gide, Zimmer Biomet's RegenerOss, and Medtronic's INFUSE, each offering unique materials and technologies for bone repair [20][22][23][24]. Group 5: Company Overview - Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd. was established in 2013 and focuses on the R&D, production, and sales of high-tech medical devices in orthopedics, neurosurgery, and dentistry [25]. - The company is recognized as a national high-tech enterprise and has a core technology team from the Shenzhen Institute of Advanced Technology and the Chinese University of Hong Kong [25].