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医美乱象频现!5万元美容针竟是“骨科材料”
Jing Ji Guan Cha Wang· 2025-11-20 02:31
公开信息显示,菲林普利是成都睿合医药旗下的医美品牌,产品由四川拜阿蒙生物材料公司研发生产。国家药监局官网信息明确其注册全称为"羟基磷灰石 生物陶瓷",适应范围为"各种原因所致的骨缺损修复或填充;各种原因所致的软组织修复或增强,如眼球摘除或眼内容物剜除后的义眼台植入"。 日前,杭州电视台官微发布一篇名为《杭州思达芮医疗数万元打的美容针 竟是"骨科材料"疑似违规用药》的报道,再度将羟基磷灰石(CaHA)这一医美新 材料的使用乱象推向公众视野。 报道披露,今年8月,市民骆女士在杭州思达芮医疗美容诊所花费50830元,注射了宣称可以刺激胶原蛋白再生、让皮肤变得更有弹性的"菲林普利",然而事 后发现该产品不具备面部医美注射的资质。 骆女士同时反映,该诊所仅告知产品功效,未详细说明注射部位及次数,且事后核对发现,诊所收取了鼻基底1针的费用,但她并未接受该部位注射。无独 有偶,另一位投诉人章女士也反映,其在该诊所注射"菲林普利"时,遭遇了与骆女士一样的"未注射却收费"问题。 目前,上城区卫生监督所已对杭州思达芮医疗美容诊所立案调查。而这背后,"菲林普利"是否构成"超适应证"使用?羟基磷灰石类材料在医美领域的类似应 用是否存 ...
5万元美容针竟是骨科材料,医美行业再爆黑幕
21世纪经济报道· 2025-11-19 10:35
Core Viewpoint - The article highlights the misuse of hydroxyapatite (CaHA) in the medical beauty industry, particularly focusing on a case where a patient was charged for a treatment that was not properly administered, raising concerns about regulatory compliance and the potential for "off-label" use of medical materials [4][5][7]. Group 1: Case Study - A patient in Hangzhou spent 50,830 yuan on a treatment using a product called "Filinpril," which was later found to lack the necessary qualifications for facial aesthetic injections [4][5]. - The clinic failed to provide detailed information about the injection sites and the number of injections, leading to complaints from multiple patients about being charged for services not rendered [5][6]. Group 2: Regulatory Concerns - The article discusses the ongoing investigation by the health supervision authority into the clinic's practices, questioning whether the use of "Filinpril" constitutes "off-label" use [7]. - There is a growing concern about the widespread use of hydroxyapatite materials in aesthetic applications that may not align with their registered medical purposes, which primarily focus on orthopedic and dental applications [9][10]. Group 3: Market Potential and Product Approval - Despite the controversies, the market potential for hydroxyapatite in the medical beauty sector is viewed positively, with expectations for increased regulatory approvals for compliant products by 2025 [13][14]. - Recent approvals include Aphranel® and Radiesse, which are now recognized for use in facial soft tissue filling, marking significant milestones in the regulatory landscape [12][14]. Group 4: Industry Regulation and Compliance - The article emphasizes the need for stricter regulations and compliance measures in the medical beauty industry to address the misuse of products and ensure patient safety [16][18]. - Various local governments have initiated actions to combat illegal medical beauty practices, highlighting the importance of regulatory frameworks in maintaining industry standards [17][18].
美容护理行业周报:国内首款CaHA面部填充剂获批,关注美护新品发布情况
Shanghai Securities· 2025-03-03 03:03
Investment Rating - The industry investment rating is "Increase" (maintained) [9] Core Viewpoints - The report highlights the approval of China's first CaHA facial filler, Aphranel® by Moyang Bio, which is expected to perform well in the market due to its innovative micro-sphere structure and high biocompatibility [2] - Jinbo Bio reported a significant revenue increase of 85.40% year-on-year, reaching 1.447 billion yuan, with a net profit growth of 144.65% to 733 million yuan, driven by new product development and market expansion [3][4] - The report emphasizes the long-term potential for medical aesthetics penetration to continue increasing, suggesting a focus on companies like Giant Bio, Jinbo Bio, and others in the sector [9] Summary by Sections New Product Approvals - The report discusses the approval of Aphranel® as the first CaHA injection in China, noting its superior clinical performance and safety profile [2] - Jinbo Bio launched the world's first collagen net product, targeting eye area rejuvenation through advanced technology [4] Financial Performance - Jinbo Bio's financial results for 2024 show a revenue of 1.447 billion yuan, marking an 85.40% increase, and a net profit of 733 million yuan, reflecting a 144.65% growth [3] Market Trends - The report indicates a growing trend in the medical aesthetics market, with an expectation for increased penetration rates and competitive dynamics among brands [9] - It highlights the differentiation in cosmetic channels and the competitive landscape, suggesting that leading domestic brands are likely to continue outperforming [9]