What is the progress of research and industry regarding the exosomes, the "miracle drug" named at the 315 Evening Gala?

Will exposing chaotic practices in AI accelerate the standardization of exosome technology?

21st Century Business Herald Reporter Han Liming

In recent years, as the public’s demand for medical aesthetics and anti-aging treatments has continued to rise, various new concept medical beauty products have rapidly gained popularity.

In the March 15th evening program, products labeled as “exosomes,” known as “anti-aging favorites,” were prominently exposed—these products are marketed as “万能神药” (all-purpose miracle drugs) that claim to combine beauty, anti-aging, and disease treatment effects, with high prices, making them one of the hottest categories in the medical aesthetics field.

CCTV investigations show that exosomes are bioactive substances secreted during stem cell cultivation. In the medical and academic communities, their mechanisms of action and clinical testing are still unclear, remaining mostly in the stage of academic and theoretical research.

By June 2025, the National Medical Products Administration’s Center for Drug Evaluation issued a draft for public comment, including exosomes with therapeutic functions relying on active ingredients into drug regulation. To date, no exosome drugs have been approved for market sale in China, and industry regulation is still being refined.

So, what companies are currently involved in the exosome field? What are the real progress and developments on the research and industry sides?

Multiple companies urgently issue statements

According to CCTV reports, marketing videos circulating on online platforms show that these unapproved “exosome anti-aging” products are falsely labeled as “Class II medical devices” and are used by various medical aesthetic institutions for beauty and anti-aging projects, with high pricing.

In fact, currently in China, no medical device products containing exosomes are approved for sale. For example, staff from Hao Lin (Tianjin) Biotechnology Co., Ltd. stated that there is no “exosome” category in the medical device classification. To evade market regulation, their exosome products have illegally used collagen medical device licenses.

On the morning of March 16th, Jinbo Biotech, known as the “first listed company for recombinant collagen,” issued a statement clarifying that products like “Qingcheng” produced by a certain biotech company, as reported on the evening of March 15th, are illegally using a human-derived collagen type II medical device license and illegally adding exosome components.

Jinbo Biotech emphasized that such “license fraud” behaviors not only violate the “Regulations on the Supervision and Administration of Medical Devices” but also involve injecting unverified substances into the human body, risking consumer health. Moreover, this malicious use of legal product registration certificates seriously disrupts market order and damages the reputation of compliant human-derived collagen companies.

“According to the regulations of the National Medical Products Administration, any medical device injected into human dermis or blood circulation is classified as a risk level III device, which must undergo rigorous pharmaceutical research, clinical trials, and review before obtaining the ‘械注准3’ registration certificate for market use. Class II medical devices are only suitable for non-invasive or superficial use and must not be used for injections,” further stated Jinbo Biotech.

License fraud, illegal addition, and illegal sales are just the tip of the iceberg in the chaos of exosome medical aesthetics. Some market players also engage in false advertising, claiming to treat various diseases. Since most of these companies lack medical qualifications, exosome injections can only be done through cooperation with medical institutions, a practice industry insiders call “借台代打” (using third-party platforms to perform procedures).

These so-called “exosome” products, which have no national approval, no clinical trial data, and no efficacy evidence, hide huge profits behind them. It is reported that “the first use involves 150 billion particles, the second 200 billion particles, and the third 250 billion particles. This gradual increase totals 600 billion particles, charging customers 60,000 yuan.”

Amid the chaos, consumer complaints and criticisms are frequent. Online, there are many negative reviews about “exosome anti-aging”: “I just had exosome treatment, and my whole face got infected with severe acne,” “I had an allergic reaction after the injection, and my face was inflamed for three months,” “Almost no effect at all, just a scam to make money”…

Following the exposure of the chaos in exosome medical aesthetics on the March 15th program, relevant platforms quickly took corrective actions. Data shows that the Xiaoyao Anxinmei mini-program once sold the Qiaoluo Shi AR exosome project and directed traffic to offline medical aesthetic clinics. In response, Xiaoyao Anxinmei has clarified that all exosome-related projects have now been taken down.

What about progress in research and industry?

In fact, violations related to exosomes also occur frequently worldwide.

The U.S. Food and Drug Administration (FDA) issued a notice in 2019 indicating that a patient in Nebraska experienced serious adverse events after using unapproved products claiming to contain exosomes. The FDA reminded that exosomes used for treating human diseases and related conditions fall under drugs and biological products, requiring regulatory oversight and pre-market review and approval. However, some clinics provide exosome products to patients, claiming these have potential to prevent, treat, or cure various diseases or conditions.

Despite frequent chaos, the scientific value of exosomes cannot be ignored. According to publicly available information, exosomes are natural nanovesicles derived from cells. Due to their unique intercellular communication functions and molecular delivery capabilities, they are gradually becoming an important bridge connecting biological therapy and drug delivery technology, attracting widespread attention in the global biopharmaceutical field.

Brainstorm Cell’s President and Chief Medical Officer Dr. Ralph Kern once shared publicly, “Research in neurodegenerative diseases, eye diseases, retinal diseases, and even acute respiratory distress syndrome (ARDS) has demonstrated that using exosomes for targeted drug delivery has profound effects on reducing tissue damage and inflammation.”

However, the 21st Century Business Herald has learned from multiple industry insiders that, globally, no approved therapeutic exosome drugs are currently on the market. Development remains at the laboratory and clinical trial stages. On one hand, research and commercialization of exosomes involve compliance risks, especially regarding the legality of human cell sources. On the other hand, the quality of exosomes is difficult to guarantee. Shenzhen Kenuo Medical Testing Laboratory recently published an article stating that methods for analyzing the quality of exosome preparations or extracellular vesicles remain a global challenge.

A 2024 article published in Clinical and Translational Science states that a therapeutic drug based on exosomes must clarify its molecular composition and structure, demonstrate pharmacokinetics, and prove therapeutic efficacy before obtaining clinical approval. Validating pharmacokinetics and efficacy remains a challenge for regulators.

Despite many bottlenecks, research and industry exploration of exosomes have not stopped. According to data from Pharma Magic, there are currently 293 innovative exosome drugs worldwide.

Image source: Pharma Magic

Public information shows that on March 10, 2026, Capricor Therapeutics, focused on developing rare disease cell and exosome therapies, announced that the U.S. FDA had withdrawn its previous Complete Response Letter (CRL) and resumed review of its Biologics License Application (BLA) for Deramiocel.

Deramiocel (CAP-1002) is composed of allogeneic cardiac progenitor cells (CDCs). These rare cardiac cells have been shown in preclinical and clinical studies to protect heart and skeletal muscle function in Duchenne muscular dystrophy (DMD) and other muscular dystrophies through potent immunomodulatory and anti-fibrotic effects. CDCs exert their effects by secreting extracellular vesicles called exosomes, which can target macrophages and alter their expression profiles, transforming them into a repair phenotype rather than a pro-inflammatory one.

In China, many companies are also involved in the exosome field. For example, Sinovac announced in September 2025 that its research exosome raw materials had recently been officially registered with the U.S. FDA under Type II drug master file (DMF) (file number: 042265). This achievement not only signifies that the company’s exosome technology meets international standards but also lays a foundation for its global expansion in the exosome field.

Additionally, Enze Kangtai’s official WeChat account recently announced that L’Oréal’s R&D and Innovation Center published a groundbreaking original study in the renowned journal Frontiers in Cell and Developmental Biology, exploring the significant role of stem cell exosomes (extracellular vesicles, EVs) in skin regeneration and anti-aging within a 3D full-layer reconstructed skin model. The stem cell exosome products and miRNA sequencing services used in this study were provided by Enze Kangtai.

An industry insider told the 21st Century Business Herald that current market hype and marketing around exosomes have already caused negative effects. “This chaos may lead the public to misunderstand and resist this promising treatment direction, making the development path of the exosome field more difficult and hindering the industry’s long-term healthy growth.”

The insider also emphasized that the development of frontier technologies like exosomes depends on regulatory standards. “With the government elevating biopharmaceuticals to a pillar industry in this year’s government work report, and the simultaneous exposure of multiple illegal health products on the March 15th program, this trend is encouraging—more regulation means healthier, sustainable development, and it reflects the increasing importance the country places on the biopharmaceutical industry.”