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  北京4月15日电(赵方园)近日,有消费者向媒体控诉可复美在一款产品中添加了表皮生长因子(EGF)。

  对此,可复美在官方微博发布《致广大可复美消费者的一封信》,称其旗下所有产品均未添加人表皮生长因子。经独立的双重检测,也未检出人表皮生长因子成分。

  目前,双方的争执点在于:可复美产品中是否有表皮生长因子,且双方均有相关检测结果支持各自的观点。

  可复美等化妆品被曝违规添加EGF

  据媒体报道,陕西西安秦女士(化名)称,她在2023年使用了“可复美重组胶原蛋白修复敷料(G型)”后,脸部皮肤出现发硬、肿胀的情况,就医后仍无法缓解。

  之后,秦女士自费将该产品送检,结果检测出了其在产品说明书中并没有标注的成分:“表皮生长因子(EpidermalGrowthFactor,EGF)”(下文简称EGF),且含量超过567pg/ml。同样,在“禁忌症”一项说明中也仅标注“对蛋白过敏者禁用”,并不显示使用表皮生长因子可能产生的其他副作用。秦女士还发现,这款产品在国家药品监督管理局备案中也并未显示有表皮生长因子成分。

  随后,接到秦女士爆料的媒体和知名打假人王海购买了秦女士使用的同款可复美产品送到第三方检测公司鉴定,均检测出EGF。

  “我们怀疑该类非法添加在行业当中普遍存在,于是对类似产品进行了大量检测。”王海团队工作人员向中新健康表示,分批送检了“薇诺娜”、“瑷尔博士”、“SK-II”、“欧莱雅”、“韩束”等22款产品中,都检测出了违法添加的表皮生长因子。

  对于产品涉嫌添加该违禁成分,4月12日,可复美公开回应称“旗下包括此产品在内的所有产品均未添加人表皮生长因子”。可复美还称,在获悉相关反馈后,已立即启动全面自查程序,为确保检测结果的客观性和权威性,公司委托了两家专业检测机构,分别采用两种检测方法对同批次产品进行独立检测,经过双重检测,结果一致表明:送检样品中未检出人表皮生长因子(EGF)成分。

  4月12日,薇诺娜回应中新健康,公司械字号产品“薇诺娜重组胶原蛋白敷料贴”含重组三型胶原蛋白,未添加任何EGF成分。其他在市产品中均不含任何”EGF"成分。薇诺娜表示,其产品在上市/变更前均严格遵循国家标准备案,具体以产品包装成分表为准。产品出厂前亦经过质量环节严格的检验检测,保障消费者使用安全性。

  4月15日晚,中国香妆协会委托发布公告称,针对有媒体关于表皮生长因子(EGF)的报道,协会委托第三方检测机构采样检测了报道中提及的产品和部分未提及的产品,结果显示未见异常。

  EGF到底是什么?

  根据国家药品监督管理局在2019年发布的《化妆品监督管理常见问题解答(一)》中,表皮生长因子(EGF)又被称为“人寡肽-1”,该成分未被收录在《已使用化妆品原料名称目录》(2015年版)中,一般在医学领域使用较多,临床适应症为外用治疗烧伤、创伤及外科伤口愈合,加速移植的表皮生长。由于分子量较大,EGF在正常皮肤屏障条件下较难被吸收,一旦皮肤屏障功能不全,可能会引发其它潜在安全性问题。

  中国人民解放军总医院第一医学中心整形修复科副主任医师陈犹白告诉中新健康,基于有效性及安全性方面的考虑,EGF不得作为化妆品原料使用。因为该成分的过度不当使用可能会导致组织增生,临床上有些患者在非医疗场所接受面部生长因子注射后,会出现组织增生、硬结、肉芽肿等病理性改变,部分病例甚至需通过手术才能修复。但如果在创面上,遵医嘱按疗程使用正规的EGF药品,则不会出现问题。

  “生长因子的副作用很好理解,就是分裂多了细胞,形成增生或者肉芽。”知名配方工程师言雨潇告诉中新健康,通常生长因子在普通激光美容后可以使用但是使用时间不能过长,且不能用于日常护肤使用,否则会导致皮下过度增殖。简单来说,就是我不需要这么多细胞,你帮我分裂出了额外的细胞,就会导致形成“馒化脸”或者增生肉芽。

  不过,多位业内专家在接受中新健康采访时认为,可复美等化妆品里故意添加EGF的可能性不大。

  言雨潇向中新健康举例,易孚®重组人表皮生长因子凝胶(酵母)是国家药监局批准的处方药,其标注浓度为200μg/20g,也就是200*1000000pg/20g,假设1g≈1ml,那易孚就是10000000pg/ml。而第三方检测显示,涉事妆字号产品中EGF含量仅为300-500pg/ml,不足处方药浓度的万分之一。

  “品牌冒着违规风险添加既无临床价值又需承担法律责任的微量成分,其商业逻辑难以自洽。”言雨潇说。

  可复美去年营收超45亿元

  可复美是上市公司巨子生物旗下的品牌。

  巨子生物财报显示,2024年营收约为55.39亿元,同比增长约57%;净利润约为20.62亿元,同比增长约42%。

  从品牌来看,巨子生物主要依靠可复美拉动业绩。2024年,可复美实现销售收入45.42亿元,同比增长62.9%,占总营收的比重从上年的79.1%上升至82.0%。

  然而,业绩高涨的背后也有隐忧。早期,巨子生物依赖经销商模式,上市前,巨子生物最大经销商为西安创客村电子商务有限责任公司曾贡献公司营收额超50%。

  据此前报道,西安创客村电子商务有限责任公司旗下“创客云商”平台采用分级代理模式:缴纳1.2万元成为创客,享受3.5折拿货价,拉新获2400元提成,高层级可抽下线销售额提成。因此曾被质疑传销。

  招股书中,巨子生物用近一页篇幅澄清称,西安创客村业务“不具备传销构成条件”,公司强调,已通过整顿减少依赖,2019-2021年终止66家经销商合作。

  近年来,巨子生物转向直销模式,并通过头部主播、KOL种草、明星代言等方式增强品牌影响力。

  伴随直销模式而来的便是销售费用激增。数据显示,巨子生物的销售费用从2023年的11.64亿元大幅上涨至2024年20.08亿元,增幅高达72.51%。公司净利率也从2020年的69.42%下降至2024年37.2%。

  此外,巨子生物一直呈现出重营销、轻研发的费用结构。巨子生物2024年的研发费用率为1.9%,2023年的研发费用率是2.1%,而锦波生物、华熙生物、贝泰妮2023年的研发费用率分别为10.89%、7.35%、6.07%。

  值得一提的是,虽然“进军医美”的口号已喊了数年,但截至目前,巨子生物还没拿到Ⅲ类医疗器械批文。同时可复美的产品结构相对单一,增长更多是依靠爆品的单打独斗。

  与此同时,外部竞争也威胁巨子生物的市场地位。2024年8月,某品牌对外宣称能将Ⅲ型重组胶原蛋白成本价格由8万元/公斤降至1万元/公斤。该公司亦宣布已完成天使轮融资,若产品开始量产,可能会对巨子生物造成冲击。(完) 欢迎加入军火运营商,探索最受欢迎的影视作品,尽享精彩视听盛宴!的相关文章 清华副研究员张龙加盟杭州师大的相关文章
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