Medical aesthetic industry scandals exposed again on March 15: why are "no-3" products like "exosomes" able to circulate through medical aesthetic channels?

Cailian Press, March 16 — (Reporter Lu Afeng, He Fan) On the evening of March 15, the CCTV 315 Gala exposed chaos in the medical aesthetics field regarding the so-called “exosome miracle drug”: some companies are using methods such as applying for production licenses, packaging as “technical services,” and collaborating with medical institutions to “borrow a platform” for injections, injecting unapproved, clinically unverified, and even unlabeled “exosome raw liquids” into consumers, claiming they have anti-aging, beauty, or even multiple disease treatment effects.

At the regulatory level, China has not approved any exosome drugs for market listing. Yet, this cutting-edge technology still in the research phase has been excessively commercialized in the consumer market. An industry insider told Cailian Press that exosome-related projects have been around for four or five years, were very popular before, and the related project prices are not high.

It is worth noting that in recent years, the medical aesthetics industry has been repeatedly highlighted on the 315 Gala. Xiao Dong, founder of Jasmine Fragrance, told Cailian Press that in the consumer medical field, some institutions bypass stricter regulations through methods like “second-class medical device certificates,” allowing concept products like stem cells and exosomes to enter the market and be over-marketed. “Compared to Class III medical devices, Class II devices are relatively less regulated. Some institutions exploit this gray area to conduct business, which is one of the main reasons why chaos in medical aesthetics persists.”

Fake Certificates, Borrowed Platforms for Injections: The so-called “exosome miracle drug” enters the medical aesthetics market

The CCTV 315 Gala investigation shows that in recent years, projects like “exosome anti-aging” and “exosome repair” that have become popular in medical aesthetics clinics and online platforms are involved in fake certificate production and illegal promotion.

According to consumer-provided information, a product called “Qingcheng” exosome is produced by Haolin (Tianjin) Biotechnology Co., Ltd. Staff from the company said the core ingredient is “exosomes,” but due to difficulties in obtaining approval, the company produces and sells by “using the production license of collagen products.”

Meanwhile, some companies also evade regulation by packaging their products as “technical services” and cooperate with medical institutions to carry out injection services, known industry-wide as “borrowing a platform to do the injections.” Under covert investigation, the reporter saw that the so-called “medical-grade exosome frozen raw liquid” packaging lacked manufacturer information, approval numbers, or ingredient details, making it a typical “three-no product” (no manufacturer info, no approval, no ingredients).

Regarding charges, the relevant business owner said the treatment usually involves three injections, totaling about 6,000 billion particles, costing around 60,000 yuan.

The CCTV 315 Gala pointed out that compared to ordinary skincare products, injection-based medical aesthetic procedures carry significantly higher risks if sourced from unknown biological agents. The so-called “three-no exosomes” lack standardized production processes and quality control; their source cells, purification processes, and residual impurities cannot be confirmed. They may carry host cell DNA, RNA, or endotoxins, potentially causing infections, inflammation, or immune abnormalities. Many consumers on social media have complained about facial infections, severe acne, or allergies after receiving so-called “exosome anti-aging” treatments, indicating that these risks are already manifesting in reality.

According to media reports, the “Xinyang Anxinmei” mini-program shows that Xinyang offers the “Juluoshi AR exosome” project for sale at 999 yuan/3ml (950 yuan after coupons), with links to offline medical aesthetics clinics. However, after the 315 Gala exposure, Xinyang responded to media that all exosome projects have been taken down. Currently, searching for “exosome” on Xinyang’s mini-program and website yields no related products or content.

Cailian Press contacted Xinyang regarding this matter but has not yet received a response.

Similarly, searching for “exosome” on the “Gengmei” app, JD.com, Taobao, and Meituan shows no relevant information.

An industry insider told Cailian Press tonight that exosome-related projects were quite popular four or five years ago, and the related products are not expensive.

“From what I understand, there are many violations involving exosomes in the industry now,” Xiao Dong explained. “‘Exosome’ is a very hot concept worldwide, with many products. Its advantage lies in its strong signaling induction, which is very important for collagen or other nutrients—how they grow and where they grow. But domestically, no exosome product has been approved, and its stability, consistency, clear efficacy, and mechanism are all lacking unified standards. Different cell vesicles have different mechanisms, and defining whether exosomes are for wrinkle reduction, whitening, or anti-aging is difficult.”

Xiao Dong added that exosomes have not been classified domestically. In June last year, the China Drug Evaluation (CDE) issued a draft for public comment, including extracellular vesicles (including exosomes) into the “Advanced Therapy Medicinal Products (ATMP)” category, alongside stem cells and gene therapy. Exosomes are injected into the skin via water-light procedures, called mesenchymal treatments, which globally fall under cosmetic medicine, but domestically are classified as medical devices. Therefore, exosomes are very complex: theoretically, they belong to medical devices based on treatment methods, but in terms of mechanism, they are considered drugs. “So I think if they are approved one day, it will likely be a combination of drug and device.”

Repeated 315 Exposures Highlight Medical Aesthetics Chaos, Regulatory Gaps and Responsibility Gaps Coexist

In fact, the chaos in the medical aesthetics industry has been repeatedly exposed on the 315 Gala in recent years. From “quick-fix beauty courses,” to the recent revelation of counterfeit hyaluronic acid entering the market, to some clinics exaggerating effects and illegally conducting injection procedures, serious medical accidents have occurred, and issues have been repeatedly exposed.

It is also noteworthy that, overall, the compliance risks in the industry are not isolated. Public data shows that among companies engaged in medical aesthetics, about 2.06% are involved in legal proceedings, 1.91% have abnormal business records, 2.12% have been subject to administrative penalties, and approximately 0.17% are listed as persons subject to enforcement, indicating ongoing regulatory challenges amid rapid industry expansion.

For example, one of the institutions exposed by the CCTV 315 Gala—Tianjin Hedong Meilai Medical Beauty Hospital Co., Ltd.—has been penalized multiple times. Public information shows that the company was established in March 2014 with a registered capital of 30 million yuan, jointly held by Meilai Medical Beauty Group Co., Ltd. and Xiamen Huayi Guan Investment Co., Ltd., and its scope includes medical beauty services, medical services, and cosmetic services.

Risk information from Tianyancha shows multiple administrative penalties: in July 2025, the company was fined for illegal advertising; in June 2024, it was fined for improper use of medical devices outside their scope; in April 2021, it was warned for not storing anesthetics and Class I psychotropic drugs according to regulations. The company has also faced numerous medical dispute lawsuits.

Regarding current chaos in the industry, Xiao Dong believes that a very serious problem exists across all consumer medical services in China—namely, the widespread use of second-class medical device certificates. Compared to third-class, second-class certificates are less regulated, leading to many incidents involving stem cells, imitation GLP-1 products, and more.

To reduce or eliminate industry chaos, Xiao Dong proposed two suggestions: first, upstream medical device manufacturers should bear more responsibility; relevant laws and regulations should be introduced to hold both manufacturers and institutions accountable when products are improperly used. Second, regulation should be proactive—such as managing exosomes before they become popular.

Exosome Industry Still in Early Stages, Multiple Domestic and International Companies Invest in R&D

In fact, in biomedical research, exosomes have become a focus of attention in recent years.

Exosomes are nanoscale extracellular vesicles released by cells, typically about 30–150 nanometers in diameter, formed by fusion of multivesicular bodies with the cell membrane. They can carry proteins, lipids, mRNA, miRNA, and other biomolecules, making them important mediators of intercellular communication.

With the development of regenerative medicine and cell therapy, exosomes have gradually become a research hotspot, with potential applications in regenerative medicine, disease treatment, and drug delivery. For example, in tissue repair, exosomes are believed to promote regeneration of skin, bone, and nerve tissues by modulating the cellular microenvironment; in disease treatment, their natural nanocarrier properties are being explored for tumor immunotherapy or nucleic acid drug delivery.

In the skincare field, currently, Korean companies like ExoCoBio have launched products such as ASCE+ and EXOMAGE, and domestic companies like Sanhe Medical, Yuanxiang Biological, Hanma Medical, Tianjin Exosome Technology, and BaiAo Medical have also commercialized related products in certain markets.

Meanwhile, many global biotech firms are advancing exosome drug development. For example, Evox Therapeutics is developing exosome-based nucleic acid delivery platforms; Capricor Therapeutics is pushing exosome vaccines and regenerative therapies into clinical trials; Aegle Therapeutics has developed stem cell exosome therapies for conditions like diabetic foot ulcers, now in clinical research.

However, overall, the industry is still in early exploration. Most exosome therapies worldwide remain in clinical research stages, and mature commercial drugs have yet to form.

On the regulatory front, the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has issued draft technical guidelines, proposing that exosome products with therapeutic functions and active ingredients should follow drug development and regulation pathways to prevent misuse.

(Reporter Lu Afeng, Cailian Press)

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