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正海生物口腔可吸收生物膜进入临床试验
Bei Jing Shang Bao· 2025-10-09 09:07
北京商报讯(记者 王寅浩 实习记者 宋雨盈)10月9日,正海生物发布公告称,公司研发项目"口腔可吸 收生物膜"于近日完成首例受试者随机入组,正式进入临床试验。 公告显示,口腔可吸收生物膜分类为第三类医疗器械,该产品与骨填充材料联合使用,适用于口腔牙缺 失需种植修复时起物理阻隔作用,防止充填材料移动,以及拔牙后、残根拔除术后拔牙窝填充;牙槽嵴 恢复;牙周疾病引起的牙槽骨缺损修复。 ...
正海生物(300653.SZ):医疗器械进入临床试验
Ge Long Hui A P P· 2025-10-09 08:18
格隆汇10月9日丨正海生物(300653.SZ)公布,研发项目"口腔可吸收生物膜"于近日完成首例受试者随机 入组,正式进入临床试验,该产品与骨填充材料联合使用,适用于口腔牙缺失需种植修复时起物理阻隔 作用,防止充填材料移动,以及拔牙后、残根拔除术后拔牙窝填充;牙槽嵴恢复;牙周疾病引起的牙槽 骨缺损修复。 ...
正海生物:口腔可吸收生物膜完成首例受试者入组
Xin Lang Cai Jing· 2025-10-09 08:03
正海生物公告,公司研发项目"口腔可吸收生物膜"已正式进入临床试验。该临床试验为多中心、随机对 照、单盲、非劣效性试验,旨在评价口腔可吸收生物膜用于引导骨再生的有效性和安全性。目前,项目 已顺利完成第一例受试者随机入组。口腔可吸收生物膜作为脱细胞真皮基质材料,能够为细胞的长入和 迁移提供良好的支架,从而引导骨组织生长与沉积,实现骨缺损区域的修复性再生。 ...
收购价缩水近4亿元,业绩承诺砍半!海利生物口腔赛道转型“踩急刹”
Hua Xia Shi Bao· 2025-09-18 06:19
Core Viewpoint - Haili Biological has adjusted the acquisition price of 55% equity in Ruisheng Biological from 935 million yuan to 536 million yuan due to industry policy changes and intensified market competition, aiming to mitigate goodwill impairment risks [2][5][6]. Company Summary - Haili Biological completed the acquisition of Ruisheng Biological in October 2024, marking a significant business transformation into the oral repair materials sector [2]. - The acquisition price was initially set at 935 million yuan, but was later reduced to 536 million yuan, with a difference of approximately 399 million yuan to be refunded by Meilun Management [5][6]. - The adjustment reflects a decrease in Ruisheng Biological's valuation from 1.711 billion yuan to 974 million yuan, resulting in a significant reduction in goodwill [5][6]. - Haili Biological still holds 55% of Ruisheng Biological after the price adjustment, which is expected to positively impact cash flow [2][6]. Industry Summary - Ruisheng Biological specializes in human tissue repair and regenerative medical products, including oral bone graft materials and absorbable membranes [3]. - The market has seen an influx of new competitors, leading to price wars that have negatively impacted Ruisheng Biological's product pricing, with a nearly 30% decrease in prices compared to Q1 2024 and a further 40% drop in Q2 2025 [4][9]. - The tightening of tax incentives has also adversely affected Ruisheng Biological's revenue and profit margins, as the company shifted from a simplified tax rate of 3% to a general tax rate of 13% [5]. - Despite the challenges, Haili Biological anticipates long-term growth in the oral repair materials market driven by aging populations and increasing demand for dental implants [9][10].
康拓医疗:PEEK骨板美国本土化生产线已正式投产,开展"4D 生物活性板"在当地准入工作
Cai Jing Wang· 2025-09-17 08:44
还有投资者就公司毛利率已连续呈现小幅下滑趋势提出疑问,管理层回应,公司一方面通过实施积极的 营销政策,提高PEEK材料产品的收入规模,另一方面通过拓宽产品品类,提升非集采区域高值产品的 收入规模,以及通过持续优化生产流程,降低生产成本,以维持公司毛利率的稳定。 谈及口腔、心胸外科、颌面修复等新业务,管理层提到,针对口腔业务,公司一方面持续围绕"优贝 雅"品牌种植系统开展市场拓展,另一方面通过收购蝾螈生物股权,引进与公司现有的口腔种植体具有 高度协同的"口腔可吸收生物膜"及"口腔用骨修复材料"等产品,共同构建起覆盖口腔种植全流程的一体 化解决方案,以提升公司在口腔种植市场的竞争力。 9月17日,康拓医疗举办2025年半年度业绩说明会。会上管理层介绍,公司位于美国的控股子公司 BIOPLATE作为公司实施全球化战略的窗口,其承担海外研发、生产、销售多项职能,导致其运营成本 较高,BIOPLATE已通过丰富产线、转移生产、提升机构运营效率等多方面措施来提高其盈利能力, BIOPLATE 2025年上半年已较上年同期大幅减亏。 针对海外业务,公司已完成近40个国家或地区的产品市场准入,未来将通过持续扩充团队、加大资源 ...
资本腾挪后业绩倍增 海利生物遭问询
Core Insights - The company, Haili Biological (603718.SH), reported a significant net profit increase of 172.28% in 2024, with non-recurring gains accounting for 93.82% of net profit, despite a revenue decline in Q1 2025 [2][5][8] - Haili Biological has transitioned from animal health products to human health products, leading to a substantial restructuring of its business model [2][9] Financial Performance - In 2024, Haili Biological's net profit reached approximately 1.71 billion yuan, with a notable increase attributed to asset disposals and acquisitions [4][5] - The company achieved an investment return exceeding 1 billion yuan from the sale of a 30% stake in WuXi Vaccines, which had previously generated low returns [5][6] - The sale of Yangling Jinhai at a nominal price of 1 yuan was a strategic move to eliminate ongoing losses, with the company recovering all debts owed by Yangling Jinhai [6][8] Asset Management - Haili Biological completed the acquisition of a 55% stake in Shaanxi Ruisheng Biotechnology, which is focused on oral tissue repair and regeneration materials, resulting in a goodwill of approximately 782 million yuan [9][10] - The company has prioritized finding quality projects in the oral and IVD sectors following the restructuring, although it acknowledges the challenges in identifying such opportunities [3][9] Market Dynamics - The oral vaccine market, particularly for foot-and-mouth disease, is facing increased competition and declining profitability, prompting Haili Biological to divest from Yangling Jinhai [7][8] - The revenue from Ruisheng Biotechnology in 2024 was approximately 265 million yuan, slightly below expectations, but the net profit exceeded targets [11]
跨界并购驶入口腔“黄金赛道” 海利生物开启发展新征程
Core Viewpoint - In 2024, Haili Biological (603718) underwent a significant strategic transformation by divesting long-term loss-making assets and acquiring the dental restoration materials company Ruisheng Biological, successfully shifting its focus to the human health sector. This transformation is reflected in a 172% year-on-year increase in net profit for 2024 and a turnaround to profitability in Q1 2025 with a net profit of 10.9 million yuan, a 393.11% increase year-on-year [1][2]. Group 1: Business Transformation - Haili Biological, originally established as a veterinary biological pharmaceutical factory, expanded into the human health sector in 2018 by acquiring IVD company Jiemen Biological, creating two main business segments: veterinary and IVD [2]. - The veterinary business faced continuous development pressure, leading to stagnant revenue since its IPO in 2015, which did not exceed 350 million yuan [2]. - In 2024, the company strategically adjusted its business layout by divesting loss-making veterinary assets and acquiring a 55% stake in Ruisheng Biological, focusing on high-tech dental restoration materials [2]. Group 2: Market Opportunity - Ruisheng Biological operates in a rapidly expanding market for dental implant restoration materials, benefiting from explosive demand and structural opportunities in China's dental healthcare market [3]. - Following the implementation of centralized procurement for dental implants in April 2023, the cost of a single dental implant dropped from tens of thousands to 4,000-6,000 yuan, stimulating demand [3]. - The dental implant market in China grew from approximately 27 billion yuan in 2022 to 38 billion yuan in 2023, with a projected growth to over 50 billion yuan in 2024 and 80 billion yuan by 2026 [3][4]. Group 3: Competitive Position - Ruisheng Biological has established a strong position in the domestic dental restoration materials market, with a market share that continues to rise and is accelerating the replacement of imported brands [5]. - The company’s bone repair products, made from bovine bone, and its collagen membranes have shown effective results in clinical applications, with a significant increase in sales volume [6]. - In 2023, Ruisheng Biological's bone powder sales grew by 138%, and in 2024, it is expected to continue growing by 61%, leading the market among domestic brands [6]. Group 4: Future Growth Potential - Ruisheng Biological is set to double its production capacity for bone powder from 800,000 bottles per year to 2 million bottles per year by 2025, with a 15% reduction in unit costs [6][7]. - The company is also expanding its collagen membrane production capacity and has achieved competitive pricing, winning bids in 95% of provinces under centralized procurement [7]. - Ruisheng Biological has committed to achieving a cumulative net profit of no less than 414 million yuan from 2024 to 2026, with 138 million yuan expected in 2024, indicating a feasible path to meet its performance commitments [7].