--- title: "Uncovering the \"Exosome\" Scam: Counterfeit Certificates, Proxy Testing, Unapproved Products - Industry Claims \"Three No's\" Products Used in Medical Aesthetics Will Be Completely Banned" type: "News" locale: "en" url: "https://longbridge.com/en/news/279277581.md" description: "The 2026 CCTV \"3·15\" Gala revealed the hidden rules of the exosome market, where many companies utilize exosomes for medical aesthetics without the necessary drug or medical device approvals. Industry insiders indicate that regulation will become stricter, and exosomes must be regulated as drugs, with unapproved \"three no\" products being banned. Research on exosomes is still in the experimental stage, and incidents of abuse are frequent, prompting regulatory agencies to strengthen warnings and oversight" datetime: "2026-03-16T13:38:15.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/279277581.md) - [en](https://longbridge.com/en/news/279277581.md) - [zh-HK](https://longbridge.com/zh-HK/news/279277581.md) --- > Supported Languages: [简体中文](https://longbridge.com/zh-CN/news/279277581.md) | [繁體中文](https://longbridge.com/zh-HK/news/279277581.md) # Uncovering the "Exosome" Scam: Counterfeit Certificates, Proxy Testing, Unapproved Products - Industry Claims "Three No's" Products Used in Medical Aesthetics Will Be Completely Banned Every reporter: Chen Xing Every editor: Yang Jun The 2026 CCTV "3.15" Gala has unveiled a glimpse of the exosome market. Investigations by reporters have found that in the absence of any national drug or medical device approvals, "certificate production," "concept substitution," and "platform proxy" for exosomes have become industry unspoken rules, with some companies even openly claiming that exosomes can be graded for cancer treatment. An industry insider interviewed by the Daily Economic News stated: "Before the exposure, many companies were skirting the edges (selling exosomes with Class II medical device certificates). After the exposure, regulatory trends will become clear; any exosomes with therapeutic functions that rely on active ingredients must be regulated as drugs and must undergo strict clinical validation before being marketed. This means that the channel for 'three-no' exosomes used in medical aesthetics will be completely closed." ## **No exosome drugs or medical devices approved for sale yet** According to an article published by the Guoke public account, exosomes are substances naturally produced by cells and expelled from inside to outside the cells. Research has found that exosomes can be likened to "express deliveries" sent between cells, allowing cells to transfer substances and information, and due to their complex composition, they can also convey intricate information. Therefore, enabling exosomes from specific cells to perform the functions of those cells and accurately load drugs for delivery into cells are current research directions being explored. However, these studies are still in the laboratory and clinical trial stages. The broad range, complex composition, and difficulty in standardization of exosomes are significant reasons why they have not yet moved towards practical application. However, during the research process, there have already been numerous incidents of exosome abuse, and regulatory agencies can only strengthen oversight through warnings and other means. For example, in 2019, the FDA (U.S. Food and Drug Administration) issued a public warning on its official website regarding exosome products, citing that multiple patients in Nebraska experienced serious adverse events after receiving treatment with unapproved products containing exosomes. In 2022, the Guangdong Drug Administration also issued a warning regarding "exosome cosmetics." The tightening of regulations is further reflected in the fact that in June 2025, the National Medical Products Administration's Drug Evaluation Center had already released a draft for public consultation, proposing to include therapeutic exosomes under drug regulation to prevent abuse risks. In summary, as of now, there are no exosome drugs or medical devices containing exosomes that have been approved for sale in China. CCTV reporters discovered that a product named "Qingcheng" is selling explosively in medical aesthetic institutions, even labeled as a "Class II medical device." However, staff from the manufacturer Haolin (Tianjin) Biotechnology Co., Ltd. candidly stated: "The certificate we are currently using is for collagen." The staff admitted that this move is to evade market regulation. ## **Industry insiders: "Many companies are skirting the edges"** Reporters learned from medical aesthetic platforms that exosome products and services have indeed existed in the medical aesthetic industry for quite some time. Some are manufacturers specializing in medical aesthetic products, while others have a pharmaceutical background but have also expanded exosomes into the medical aesthetic field The reporter from the Daily Economic News noted that the aforementioned companies exposed during the 2026 CCTV "3·15" Gala all claim to have a formal research background and high technical strength. Among them, Haolin (Tianjin) Biotechnology Co., Ltd. claims to be an international high-end biotechnology company focused on the development and industrialization of "best & first-in-class" gene-engineered drugs, biomedical devices, and organoids, dedicated to becoming a leading enterprise in innovative therapy research. The company also claims to rely on the Institute of Biophysics of the Chinese Academy of Sciences, the Institute of Microbiology of the Chinese Academy of Sciences, the Institute of Nanomaterials, and the Protein Science Center for result transformation. Yuan Chuang Gene Technology Co., Ltd., located in a city in Central China, should refer to Zhengzhou Yuan Chuang Gene Technology Co., Ltd. (hereinafter referred to as Yuan Chuang Gene), which has a more explicit "research color." According to a report by Dahe Caifang in April 2025, "Yuan Chuang Gene is a high-tech enterprise headquartered in the Zhengzhou Airport Economic Zone, founded by postdoctoral Zhao Hui from Columbia University. From its inception, Yuan Chuang Gene has set two major missions: to build a bridge for the industrialization of cell therapy and to construct a full-process technical service platform." In 2024, Yuan Chuang Gene took over the operation of the first provincial-level biopharmaceutical CXO (Contract Research Organization) integrated pilot base in Henan Province, focusing on the CDMO (Contract Development and Manufacturing Organization) platform for cell and gene therapy. The article also stated that Yuan Chuang Gene has established a three-in-one research and production matrix in three locations, possessing over 500 sets of cutting-edge equipment, forming three major product systems: stem cells, immune cells, and exosomes. In addition, the company has established clinical collaborations with more than 20 top-tier hospitals and participated in 12 provincial key research projects. A person in charge of a medical beauty platform in the industry, interviewed by the Daily Economic News, stated that the chaos surrounding exosomes exposes a dual problem of "innate deficiencies + acquired deformities." The innate deficiency refers to the fact that the exosome industry is in the early stages of research, lacking sufficient evidence-based medical support for its commercial application, which is a fundamental scientific shortcoming. The acquired deformity refers to the rush to market driven by commercial interests under the condition of innate deficiencies, cutting corners in the production process, ignoring safety bottom lines, exaggerating publicity, and abusing applications beyond scope, which is a market chaos driven by short-term gains. "The choice to expose this field during the 2026 CCTV '3·15' Gala sends a very clear signal: for any new technology applied in the medical beauty field, two bottom lines must be adhered to—safety is the legal red line, and evidence-based practice is the scientific bottom line. This also reminds the entire industry that it is time to return to rationality, using a scientific attitude and rigorous clinical research to truly explore the value of exosomes, rather than continuing to quench thirst with concept hype," the person in charge stated. At the same time, he emphasized that from the perspective of industry regulation, exosomes currently face the dilemma of "identity definition." When exosomes are used to treat diseases (such as neurodegenerative diseases, cancer, tissue repair) through intravenous injection or targeted drug delivery, they exert pharmacological, immunological, or metabolic effects, which fully aligns with the definition of drugs. However, there has yet to be any exosome new drug officially approved for market launch globally When exosomes are combined with medical devices, such as dressings loaded with exosomes or exosome formulations used with hydrating injection devices, if their effects go beyond merely assisting the functions of the devices, they may be classified as combination products for regulatory management. Specifically, as cosmetic ingredients—this is the area with the lowest threshold and currently the most concentrated market chaos. From a global perspective, the United States, Japan, and South Korea have all opened applications for human-derived exosomes as cosmetic ingredients, but they generally adopt strict pre-review processes rather than mere filing. However, the existing market practice of using low-threshold "cosmetic registration" to package high-concept "exosomes" is essentially a form of regulatory arbitrage. Products that claim to be under the "cosmetic registration" banner can obtain registration because they have swapped concepts in their ingredient lists. For example, some products claiming to contain "animal exosomes" actually list "animal umbilical cord extract" as their registered ingredient; those claiming "plant exosomes" merely add a certain plant extract. Although these ingredients are compliant, they are not exosomes at all. Merchants are simply using low-cost registered ingredients to hype a concept that sounds very high-end. Products disguised under the "cosmetic registration" label that promote medical terms such as "cell-level repair" or "activation and regeneration" constitute false and exaggerated claims that imply medical effects, which are explicitly targeted by regulatory authorities as illegal and non-compliant behavior. "Before the exposure, many companies were skirting the edges (selling exosomes with Class II medical device certificates). After the exposure, the regulatory trend will be clear: any exosomes with therapeutic functions that rely on active ingredients must be regulated as drugs and must undergo strict clinical validation before they can be marketed. This means that the channel for 'three-no' exosomes used in medical aesthetics will be completely shut down," said the aforementioned individual. Daily Economic News ## Related News & Research - [Lupin to Up Stake in Philippines Unit](https://longbridge.com/en/news/281487478.md) - [Todd H. 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