每经AI快讯，有投资者在投资者互动平台提问：贵公司原本预计钙硅生物陶瓷骨修复材料预计于2025 年内取得注册证，年内能达成吗？活性生物骨目前市场推广和营收贡献情况怎么样？ 正海生物（300653.SZ）12月24日在投资者互动平台表示，公司钙硅生物陶瓷骨修复材料产品注册工作 已接近尾声，公司将持续跟进产品注册进展并及时履行信披义务。此外，活性生物骨全年推广入院量稳 步攀升且符合预期，未来公司将继续大力推进产品入院放量，力求不断提升产品市场覆盖率及产品营收 贡献水平。 （记者 胡玲） ...

Core Viewpoint - The company, Zhenghai Biological, announced on November 17 that its active biological bone product has received positive feedback in clinical applications due to its excellent performance, combining efficacy and safety [1] Product Performance - The active biological bone product utilizes the active factor rhBMP-2, which specifically binds with bone filling products, creating an effective bone regeneration system that operates with low overall dosage and high local efficacy [1] - This technology enhances treatment outcomes while significantly reducing safety risks, addressing some concerns that doctors have regarding BMP products [1] Future Development Strategy - The company plans to continue advancing product development and hospital admissions to increase market coverage [1] - There will be a focus on increasing usage penetration in benchmark hospitals and enhancing the development proportion in leading hospitals to support sustained product growth [1]

Group 1: R&D and Market Strategy - The company plans to enhance its R&D capabilities by focusing on three main technology platforms: scaffold materials, factors, and cells, aiming to strengthen its position in the high-barrier III class implantable medical device sector [4] - The company aims to deepen its market presence by consolidating existing channels and core brands, driving product revenue growth, and expanding its product matrix to enhance synergy [4] Group 2: Product Advantages and Market Promotion - The active biological bone product has shown excellent performance in clinical applications, combining effectiveness and safety, which helps alleviate concerns regarding BMP products among doctors [5] - The company has successfully participated in bulk procurement for its membrane products across 24 provinces, maintaining a complete record of winning bids [5] Group 3: Future Product Development and International Expansion - The calcium silicate bioceramic bone repair material is designed to promote bone regeneration and has the potential for customized production, with differentiated marketing strategies planned to maximize profitability [6] - The company is exploring opportunities for international market expansion, with plans to increase overseas revenue [6] Group 4: R&D Investment Planning - The company’s R&D investment strategy is aligned with strategic needs, ensuring that investments support overall growth and product development [6]

Core Viewpoint - The company, Zhenghai Biological, announced on October 27 that its active biological bone, which contains bone morphogenetic protein (BMP) as a scaffold material, is a crucial component of bone repair materials, demonstrating both efficacy and safety in clinical applications [1] Group 1: Product Efficacy and Safety - Active biological bone effectively combines with the active factor rhBMP-2 and bone filling products, creating a low-dose, high-efficiency bone regeneration system that enhances clinical outcomes while significantly reducing safety risks [1] - The promotion and hospital admission of active biological bone have been progressing smoothly in the first three quarters of this year, with the overall admission pace meeting expectations and positive feedback on product application [1] Group 2: Company Confidence - The company maintains confidence in the continued growth and market penetration of its active biological bone products [1]

Core Viewpoint - Zhenghai Biological (300653) emphasizes that active biological bone remains a crucial component driving the company's revenue growth [1] Group 1 - The company will continue to vigorously promote product development and hospital admissions to enhance market coverage [1] - The company aims to increase the usage penetration rate in benchmark hospitals and improve the development proportion of leading hospitals [1] - The company plans to implement flexible sales policies and establish long-term trust relationships with distributors to collaboratively advance product market promotion and hospital admissions [1]

Group 1: Company Performance Overview - In the first three quarters of 2025, the company achieved operating revenue of 276 million yuan, a decrease of 5.36% compared to the same period last year [4] - The net profit attributable to shareholders was 67.4 million yuan, down 46.10% year-on-year [4] - The net profit after deducting non-recurring gains and losses reached 59.2 million yuan, a decrease of 45.34% compared to the previous year [4] Group 2: Product Development and Market Strategy - The active biological bone product is a key driver for revenue growth, with ongoing efforts to enhance market coverage and penetration in leading hospitals [5] - The company is actively developing new products, including calcium silicate bio-ceramic bone repair materials, which are in the registration phase [4] - The oral implant market is currently facing weak demand, particularly in the private sector, but the company maintains a stable market position for its oral repair membrane products [5] Group 3: Sales and Marketing Initiatives - The company has established an independent sales team focused on the active biological bone product to enhance market promotion capabilities [7] - Flexible sales policies and long-term relationships with distributors are being pursued to boost product market promotion and hospital admissions [5] - Plans for overseas market expansion are underway, with certain products identified as having export potential [7] Group 4: Research and Development Progress - The company is collaborating with Jiangsu Jicui Future Food Technology Research Institute on the development of recombinant bioactive protein products, with steady progress reported [7] - The research and development of the uterine repair membrane and breast patch products are ongoing, with clinical trials completed for the former [6] Group 5: Investor Relations and Future Outlook - The company has consistently maintained performance dividends since its listing and plans to continue investor return strategies based on overall performance [6] - Employee incentive plans are being developed in accordance with relevant regulations to enhance motivation and performance [6]

Summary of Zhenghai Biological Conference Call Company Overview - **Company**: Zhenghai Biological - **Industry**: Biopharmaceuticals, specifically focusing on bone repair materials and dental products Key Points and Arguments Financial Performance - **Net Profit Decline**: Net profit decreased by 45.34% year-on-year, primarily due to tax policy adjustments (VAT increased from 3% to 13%) and intensified market competition, particularly in the meninges product segment and oral implant sector [2][4][5] - **Revenue Trends**: For the first three quarters of 2025, total revenue was 276 million yuan, a decrease of 5.36% year-on-year. In Q3 alone, revenue was 87.87 million yuan, down approximately 5% year-on-year [3][4] - **Gross Margin**: The overall gross margin was around 85%, showing a recovery compared to the first half of the year due to changes in product mix [3] Product Performance - **Active Biological Bone Products**: Currently in 196 hospitals, with expectations for significant revenue growth due to the inclusion of BMP-2, which enhances bone induction. The company aims to increase market share by expanding hospital admissions and improving penetration in benchmark hospitals [2][6][11] - **Stem Cell Project**: In the process of technology validation, this project is crucial for addressing clinical tissue repair and regeneration issues, indicating strategic importance [7] - **Oral Membrane Products**: The second-generation oral repair membrane is in the early promotion stage, contributing minimally to revenue. The company is focusing on applications in soft tissue defects and avoiding price wars [2][8][10] Market Dynamics - **Market Competition**: The oral implant market is facing challenges due to price governance and a sluggish consumer market, leading to a decline in private institution implant volumes. Some patients are opting for repair treatments instead of implants, impacting the growth of bone powder and membranes [2][13] - **Price Pressure**: The company is experiencing price declines across its products, although it maintains a stable gross margin. Sales and management expenses have increased, putting pressure on net profits [5][16] Regulatory and Development Updates - **Regulatory Approvals**: The company is tracking the procurement policies for artificial bone repair materials and is preparing for the registration of new products like the calcium silicate bone powder, expected to receive certification by the end of this year or early next year [4][20] - **Future Product Launches**: The company anticipates launching the intrauterine repair membrane in 2026 and the breast patch in 2027, with detailed market strategies to be developed closer to launch dates [17] Strategic Outlook - **Acquisition Plans**: The company is open to acquisitions to expand its business pipeline and explore new growth opportunities [29] - **International Expansion**: Zhenghai Biological is exploring overseas business opportunities and has begun preparations for international certifications [28] - **Employee Incentives**: The company has completed share buybacks for employee incentives and plans to implement stock incentive schemes based on future performance [30] Future Market Perspective - **Confidence in Growth**: The company remains optimistic about future development, focusing on core business growth, new product launches, and cost control to achieve good performance returns [31]

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]

Group 1: Market Outlook and Product Development - The active biological bone product is the first domestic bone filling product containing rhBMP-2, indicating high innovation potential. The market share for BMP products in bone repair materials is currently small but has significant growth potential [3]. - The company is enhancing its sales team's professional promotion capabilities to accelerate market expansion for the active biological bone product, with promotional activities progressing as expected this year [3]. Group 2: Oral Implant Industry and Competitive Landscape - Short-term demand for oral implants is relatively flat; however, long-term growth is expected due to factors like aging population and cost reductions from centralized procurement policies, which will increase implant penetration [3]. - The company aims to solidify its position in the oral repair membrane market by deepening cooperation with key terminals and stabilizing market share despite increasing competition and price wars [4]. Group 3: Procurement Projects and Market Share - As of now, 6 provincial and 2 inter-provincial alliances have initiated bulk procurement for the company's membrane products, covering a total of 24 provinces. The company has successfully bid in all provinces where procurement has occurred [4]. - Although bulk procurement has led to a decrease in membrane prices, it has also resulted in increased sales volume, maintaining stable market share [4]. Group 4: Stem Cell Project and Future Plans - The company is in the product process verification stage for its umbilical cord mesenchymal stem cell project, which will enhance its product offerings in the field of soft tissue repair and regenerative medicine [4]. - The company is actively planning to expand some products into overseas markets, aiming to achieve overseas revenue growth [5].

Core Viewpoint - Zhenghai Biological is at a crossroads of transformation as its marketing expenses surged by 39%, yet it failed to achieve revenue growth, with a significant decline in net profit and core product revenues [4][5] Financial Performance - The company reported a 5.14% year-on-year decline in revenue to 187 million yuan, while net profit dropped by 45.97% to 46.49 million yuan, and non-recurring net profit fell by 46.77% to 40.28 million yuan [4][6] - The main reasons for the profit decline include a nearly 20% drop in oral repair membrane revenue, increased cost pressures, and changes in the external environment [4][6] Product Performance - The sales revenue of the brain membrane series products increased by 5.88% to 80.27 million yuan, becoming a rare highlight in the report, attributed to successful bids in multiple provincial alliances [6] - Conversely, the oral repair membrane business saw a revenue decline of 19.38% to 77.12 million yuan, with a decrease in gross margin by 1.63 percentage points to 85.98% [6][7] - The decline in oral repair membrane revenue is attributed to weak market demand, intensified competition, and continuous price reductions [6][7] Tax and Regulatory Impact - Starting January 1, 2025, the VAT on key raw materials for Zhenghai Biological's main products will increase from a simplified rate of 3% to a general rate of 13%, significantly eroding profit margins [7] Structural Issues - The company's revenue structure is heavily reliant on two main products, which account for over 80% of total revenue, making it vulnerable to market fluctuations [6][7] Marketing and Sales Strategy - In response to declining performance, the company increased its sales expenses to 71.18 million yuan, a 38.87% increase, primarily for market promotion and commercial support [8] - The sales expense ratio rose from 25.88% to 37.90%, while net profit margin decreased from 43.45% to 24.75%, indicating a mismatch between marketing investment and revenue generation [8][9] New Product Development - The company is pinning hopes on new products like active biological bone, which has not yet generated significant sales despite being registered for nearly three years [9][10] - Other in-development products are progressing slowly, with potential revenue contributions expected in 2-3 years, which may not address immediate financial pressures [10] International Expansion - The company is exploring international markets, which present significant potential but require higher standards for product quality, certification, and marketing capabilities [10]