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敷尔佳:公司2025年有一款Ⅲ类医疗器械已经进入临床阶段
Zheng Quan Ri Bao Wang· 2026-01-08 13:43
证券日报网1月8日讯,敷尔佳(301371)在接受调研者提问时表示,从研发项目进展上看,目前还是以 公司披露的2025年半年报信息为准。械品方面,公司2025年有一款Ⅲ类医疗器械"重组Ⅲ型人源化胶原 蛋白贴敷料"已经进入临床阶段;注射类产品,重组Ⅲ型人源化胶原蛋白冻干纤维项目临床试验已经做 完了,处于临床试验总结报告筹备阶段;重组Ⅲ型人源化胶原蛋白凝胶项目公司还处于研发阶段,争取 今年启动临床。其他品类项目的研发进展,请关注公司将于4月份披露的年度报告。 ...
敷尔佳(301371) - 2026年1月8日投资者关系活动记录表
2026-01-08 07:42
证券代码:301371 证券简称:敷尔佳 哈尔滨敷尔佳科技股份有限公司 投资者关系活动记录表 编号:2026-001 投资者关系活 动类别 ☑ 特定对象调研 □分析师会议 □媒体采访 □业绩说明会 □新闻发布会 □路演活动 ☑ 现场参观 □其他 (请文字说明其他活动内容) 参与单位名称 及人员姓名 广发证券股份有限公司 嵇文欣、张望 易方达基金管理有限公司 黄逸群、冯业倩 时间 2026 年 1 月 8 日 10:00-11:00 地点 公司一楼花果山会议室 上市公司接待 人员姓名 张立国先生 董事长 邓百娇女士 董事、董事会秘书 吴 弘先生 证券事务代表 投资者关系活 动主要内容介 绍 Q1、请介绍一下公司双十一和双十二的上新情况,以及 明年的推新计划。 A:从 2025 年 11-12 月的上新数据看,两个月合计上新品 18 款(含旧品升级),械品和妆品各占 9 款,具体产品情况 可到公司在各大电商平台开设的官方旗舰店查询;从 2026 年 的上新计划看,械品和妆品都有,具体以实际上新情况为准。 Q2、公司在胶原蛋白化妆品和医美方面的进展有哪些? A:从研发项目进展上看,目前还是以公司披露的 2025 年 ...
“科兴”分家30年:疫苗王者陨落美股,干扰素老兵转战医美
Guan Cha Zhe Wang· 2025-12-25 08:34
当美股上市的科兴生物深陷退市危机与股东内斗泥潭之际,另一家同源异流的"科兴"正在A股悄然布局 一条全新赛道。 近日,科兴制药(688136.SH)旗下全资子公司科兴医疗自主研发的重组Ⅲ型人源化胶原蛋白冻干纤维 已完成首例受试者入组,这款第三类医疗器械产品的临床试验正式启动;与此同时,二类医疗器械产品 重组胶原蛋白敷贴也已提交注册申请。 这一动作标志着科兴制药正式切入千亿级重组胶原蛋白赛道。弗若斯特沙利文数据显示,中国重组胶原 蛋白市场规模预计2027年将达1083亿元,年复合增长率高达44.93%,被业界视为医美领域继玻尿酸之 后的下一个超级风口。对于营收在12亿元规模徘徊多年的科兴制药而言,这场押注既是战略转型的主动 求变,也是"吃老本"难以为继后的被动突围。 三十年前,两家"科兴"同出一源,皆以"科教兴国"的理想主义命名;三十年后,一家在美股停牌六年、 面临退市,另一家在科创板寄望于医美转型。资本与市场的裹挟之下,这对"同名不同命"的企业走向了 截然不同的命运。 千亿赛道押注:医美转型的逻辑与挑战 主业增长见顶之际,科兴制药将目光投向了重组胶原蛋白这条高速增长的赛道。 从行业趋势看,重组胶原蛋白正在成为医 ...
双证落地、竞争升级,胶原蛋白赛道谁能抢占下一程?
Bei Jing Shang Bao· 2025-12-18 09:00
胶原蛋白赛道再生变局。近日,崇山生物和艾佰瑞的两款胶原蛋白新品获得国家药品监督管理局批准,持证产品阵营由此扩充。前者凭借45mg/ml的高浓度 主打性价比,后者则从适应症细分切入,试图在日益拥挤的动物胶原赛道中建立差异化优势。与此同时,在赛道另一端的重组胶原领域,企业正以安全性与 规模化生产加速市场扩张,预计2023—2027年,其复合年增长率将赶超动物源胶原蛋白。 随着两款新产品获批,国内已获第三类医疗器械证书的胶原蛋白产品增至14款。然而,拿到"入场券"只是开始,真正的考验在于:在这条日益拥挤的赛道 上,谁能从性价比、品牌认知、产品安全性与有效性等方面构建差异化优势,实现最终突围。 动物源胶原赛道形成"八强"竞争 新入局者意图明确,不再满足于市场跟随,而是瞄准关键技术指标寻求差异化立足。崇山生物的新品是全球首款浓度达45mg/ml的牛跟腱来源I型胶原蛋白植 入剂。相比此前最高浓度为35mg/ml的同类产品,该公司试图以"高浓度"树立产品形象。 | 注册证编号 | 国械注准20253132516 | | --- | --- | | 注册人名称 | 浙江崇山生物制品有限公司 | | 注册人住所 | 浙江省杭州 ...
科兴医疗重组Ⅲ型胶原蛋白医疗器械临床试验首例受试者入组 开启抗衰领域新征程
GB14采用先进的生物技术制备,其氨基酸序列与人体天然Ⅲ型胶原蛋白同源,具备优异的生物相容性 和生物活性,可有效避免传统动物源胶原可能存在的免疫排斥风险。 在临床应用场景中,重组Ⅲ型人源化胶原蛋白通过面部真皮组织填充注射,能够精准填补额部动力性皱 纹形成的皮肤凹陷,同时激活皮肤成纤维细胞活性,促进自体胶原再生,从根源上改善皮肤松弛、干 纹、皱纹产生等衰老问题,为爱美人士提供更安全、更长效的抗衰解决方案。 Ⅲ型胶原蛋白是年轻皮肤的核心组成部分,随着年龄增长逐渐流失,这也是额部动力性皱纹等衰老迹象 出现的重要原因。作为皮肤的"核心支撑",胶原蛋白在护肤品领域的应用早已得到市场广泛认可,而重 组Ⅲ型人源化胶原蛋白以安全性、高纯度、高活性等特性,成为近年来医美填充注射方面研发的焦点。 其柔性网状结构,"促再生、修屏障"的优势,尤其适合改善眉间纹、额头纹、鱼尾纹等浅层动力性皱 纹,同时在医美术后修复场景中,可加速创面愈合、减少瘢痕形成等,临床应用前景广阔。 近日,科兴制药(688136.SH)全资子公司深圳科兴医疗器械有限公司(以下简称"科兴医疗")自主研 发的GB14项目重组Ⅲ型胶原蛋白,第三类医疗器械产品——"重组 ...
丰富产品矩阵和渠道 锦波生物构建新的“护城河”
从国际技术首创到国内、国际标准引领,从生物材料到生命材料,锦波生物凭借先发优势、原始创新能 力等构筑起业内"牌照壁垒"。面对行业竞争愈发激烈的情况,公司将完善产品矩阵和渠道,致力于建设 国际一流的科技创新型生物材料企业。 核心产品不断突破 在公司展厅内,锦波生物副总经理陆晨阳举起红蓝相间的模型,展示了重组Ⅲ型人源化胶原蛋白的原子 三螺旋结构。公司2018年通过生物合成的方式,在国际上首次发现、解析了Ⅲ型胶原蛋白核心功能区原 子结构,即呈现164.88°柔性弯曲的三螺旋结构。 "正是依托'164.88°根技术',锦波生物不断进行技术升级,推出新产品。"陆晨阳介绍,公司的"全人源 化胶原蛋白新材料"是我国首个有自主知识产权的原创型新型生物材料。公司还首次实现了广谱抗HPV 生物蛋白、广谱抗新冠病毒多肽药物的产业化及终端产品开发。 锦波生物被称为A股"重组人源化胶原蛋白第一股"。自2021年公司第一张重组人源化胶原蛋白三类医疗 器械注册证获批至今,锦波生物独揽三张重组人源化胶原蛋白三类医疗器械注册证,实现了冻干纤维、 溶液、凝胶全剂型覆盖。 今年9月,锦波生物"重组Ⅲ型人源化胶原蛋白冻干纤维"正式获得国家药监局药品 ...
锦波生物胶原蛋白产品获境外医疗器械注册证
Bei Jing Shang Bao· 2025-11-24 09:52
北京商报讯(记者王寅浩宋雨盈)11月24日,锦波生物发布公告称,公司重组Ⅲ型人源化胶原蛋白冻干 纤维获得菲律宾主管当局颁发的D类医疗器械注册证,根据公告,该产品适用于面部真皮组织填充以纠 正额部动力性皱纹(包括眉间纹、额头纹和鱼尾纹)。 (文章来源:北京商报) ...
锦波生物(920982):2025Q1-Q3营收同比+31%,期待后续新品发力和养生堂多元赋能
Hua Yuan Zheng Quan· 2025-11-10 11:58
Investment Rating - The investment rating for the company is "Buy" (maintained) [4] Core Views - The company achieved a revenue growth of 31% year-on-year for Q1-Q3 2025, driven by new product launches and the multi-faceted empowerment from Yangshengtang [4][5] - The forecasted net profits for the company from 2025 to 2027 are expected to be 879 million, 1.217 billion, and 1.56 billion RMB respectively, with corresponding P/E ratios of 31, 22, and 17 times based on the closing price on November 7, 2025 [5] Financial Performance Summary - For Q1-Q3 2025, the company reported a revenue of 1.296 billion RMB (yoy +31%) and a net profit of 568 million RMB (yoy +9%) [7] - The revenue growth is primarily attributed to the increase in sales of medical devices and functional skincare products, with a notable rise in the sales of A-type recombinant human collagen products [7] - The company’s revenue for 2025 is projected to reach 1.904 billion RMB, with a year-on-year growth rate of 31.98% [6][8] - The gross profit margin is expected to remain high at around 90% for the coming years, indicating strong profitability [8] Product and Market Development - The company launched the new HiveCOL collagen product in July 2025, which is anticipated to drive growth in the medical aesthetics sector [7] - The company is actively expanding its market presence through online promotions and collaborations with both international and domestic brands, enhancing its sales channels [7] - The company has received regulatory approval for its recombinant type III human collagen freeze-dried fibers, which have broad application prospects in various medical fields [7]
锦波生物前三季度营收同比增长31.1% AI赋能生命材料 科研创新打开增长空间
Core Insights - The company reported a total revenue of 1.296 billion yuan for the first three quarters of 2025, representing a year-on-year growth of 31.10%, and a net profit attributable to shareholders of 568 million yuan, up 9.29% year-on-year, driven by continuous investment in research and innovation [2] Group 1: Financial Performance - The company achieved a total revenue of 1.296 billion yuan in the first three quarters of 2025, marking a 31.10% increase compared to the previous year [2] - The net profit attributable to shareholders reached 568 million yuan, reflecting a year-on-year growth of 9.29% [2] Group 2: Product Development and Innovation - The company received registration for "recombinant type III humanized collagen protein lyophilized fibers" as a pharmaceutical excipient, marking a significant milestone in its development history and indicating the entry of recombinant collagen materials into core pharmaceutical applications [3] - The new material has broad application prospects in various fields, including injectables, biological agents, and topical preparations, particularly as a drug carrier for targeted delivery and sustained release [3] - The successful registration of the pharmaceutical excipient demonstrates the company's core technological advantages and continuous innovation capabilities in the field of recombinant humanized collagen [3] Group 3: Research and Development - The company's R&D expenses reached 71.2616 million yuan, a year-on-year increase of 64.31%, driven by increased collaboration with universities and research institutions, as well as a rise in research projects [4] - The company has established a dual-driven model of "independent innovation + joint research," effectively integrating resources for basic research and industrialization [4] - The company led an international standard proposal on medical devices, marking a significant breakthrough in the international standardization of bioengineering medical devices in China [4] Group 4: Digital Transformation and AI Integration - The company developed the "AI Collagen Brain System," which includes six core technology platforms for high-throughput screening, structural research, and efficient biosynthesis [5] - The "AI Collagen Brain System" was recognized as a national-level case in the Ministry of Industry and Information Technology's 2025 digital transformation case collection, indicating its leading position in digital transformation [6] - The integration of AI in production processes has significantly improved efficiency, with reports indicating a tenfold increase in fermentation process optimization [6]
北交所消费服务产业跟踪第三十六期(20251026):锦波生物不断拓展重组胶原蛋白应用领域,建议关注后续进展
Hua Yuan Zheng Quan· 2025-10-27 14:29
Investment Rating - The report suggests to pay attention to Jinbo Biological's ongoing developments in the collagen protein application field, indicating a positive outlook for the company [1] Core Viewpoints - Jinbo Biological is actively responding to the demand in China's health industry by expanding its product matrix. The company has made significant moves recently, including the launch of new products and strategic partnerships [2][5] - The company has successfully registered its "recombinant type III humanized collagen freeze-dried fiber" as a pharmaceutical excipient, marking a major breakthrough in high-end biomedical materials [7] - Jinbo Biological's functional skincare brands have shown impressive sales growth during the recent "Double Eleven" shopping festival, with a notable increase in revenue from its proprietary brands [12] - The overall market for consumer services on the Beijing Stock Exchange has seen a median price increase of 2.14% in stock prices, indicating a positive trend in the sector [15][18] - The TTM median price-to-earnings ratio for the broader consumer industry has increased to 56.3X, reflecting a growing valuation in the sector [27][30] Summary by Sections Jinbo Biological's Expansion - Jinbo Biological is expanding its product applications in response to the health industry demand, with a focus on collagen products and strategic partnerships with companies like Yangshengtang [2][10] - The company has established a national-level intellectual property operation center for functional proteins, enhancing its competitive edge in the recombinant collagen market [5][6] Market Performance - The median stock price change for consumer service companies on the Beijing Stock Exchange was +2.14%, with 31 out of 39 companies experiencing stock price increases [15][18] - The total market capitalization for consumer service companies rose from 1140.72 billion to 1143.84 billion, indicating a healthy market environment [20][22] Industry Valuation - The TTM median price-to-earnings ratio for the consumer sector has increased from 55.1X to 56.3X, suggesting a positive valuation trend [27][30] - Specific sectors such as food and beverage, as well as professional technical services, have also seen increases in their TTM median price-to-earnings ratios, indicating overall growth in the consumer market [29][32] Announcements - The successful launch of a 150,000 tons/year n-butane maleic anhydride production facility by Ruihua Technology demonstrates advancements in production technology and reinforces its leading position in the industry [35][37]