Multiple Listed Companies Respond to "Universal Wonder Drug," Products Urgently Removed from Shelves

March 16, 2026

Word count: 1,459, estimated reading time: about 2 minutes

Author | First Financial News, Qian Tongxin

At this year’s 315 Gala, the so-called “万能神药” (Universal Miracle Drug) exosome was trending on social media. Exosomes are substances that have claimed to have anti-aging effects at the cellular level in recent years and are already in use abroad. In China, the National Medical Products Administration has issued a draft for public comment to include exosomes under drug regulation. However, exosomes are still in the research stage within the medical community, and their mechanisms and clinical effects are not yet clear. Currently, no exosome-based drugs have been approved for sale in China.

Although no exosome drugs have been approved domestically, due to promising market demand in consumer healthcare, well-known companies including XinYao have launched exosome-related aesthetic medical products. On the evening of March 15, XinYao responded that all related exosome projects have been taken off the shelves.

An investigation by CCTV found that because no exosome products have official approval, some circulating products on the market often bypass regulations through illegal “certificate stacking,” such as using a Class II medical device license for human-derived collagen, and illegally adding exosome ingredients. Class II medical devices are not permitted for injection into the human body; only Class III certificates are approved for injectable products.

In response, on March 16, Jinbo Biotech issued a statement saying that such “certificate stacking” behaviors not only seriously violate the “Regulations on the Supervision and Administration of Medical Devices,” but also involve the direct injection of substances without safety validation. Moreover, this malicious use of legitimate product registration certificates severely disrupts market order and damages the reputation of compliant human-derived collagen companies.

In recent years, the medical aesthetic consumer market has been booming, and with challenges in gene therapy, some CDMO (Contract Development and Manufacturing Organization) companies originally involved in cell and gene therapy (CGT) product preparation have also entered the exosome field. For example, publicly available information shows that last year, CGT-CDMO companies and Yuan Sheng Biological (688238.SH) established wholly owned subsidiaries and Yuanhe Meirui Regenerative Medicine Center to explore derivative businesses in cell therapy, involving exosomes and recombinant proteins, mainly targeting aesthetic medicine and consumer healthcare clients.

Kaineng Health (300272.SZ)’s wholly owned subsidiary, Hainan Kaineng Cells, acquired LaiSen’s original business, which includes stem cell therapy, NK cell activation, exosome therapy, NMN supplements, and other biotech solutions, primarily aimed at the pet anti-aging market.

Dongfulong (300171.SZ)’s subsidiary, Dongfulong Life Science, recently released solutions addressing the industrialization and storage bottlenecks of exosomes. Its self-developed serum-free lyophilization protectant and supporting processes claim to achieve a recovery rate of over 97% for lyophilized exosomes, providing key technological support for moving exosomes from laboratory research to large-scale application.

Meanwhile, medical device companies, facing growth bottlenecks due to recent centralized procurement policies, are also shifting toward the consumer healthcare market in hopes of rapid profitability through “dimensionality reduction” strategies. A manager of a medical device company told First Financial that his company began exploring the aesthetic medicine sector last year, focusing on exosomes. “This isn’t starting from scratch; many of the serious medical experiences and technologies can be applied to aesthetic medicine,” he said. “We mainly want to diversify our business, so we’re exploring consumer healthcare.”

Experts warn about the safety of injecting exosomes into humans. Yang Yue, a researcher at Tsinghua University School of Pharmacy, stated that all medical technologies and drugs must undergo rigorous preclinical and clinical research to verify safety and efficacy before human use. Using unapproved substances on humans without regulatory approval could cause damage to organs and functions, or even permanent harm.

The First Financial reporter found approximately 300 ongoing clinical trials related to “exosomes” registered with the China Clinical Trial Registry, with over 70 new registrations in the past year. These trials cover a wide range of diseases, including sensitive skin conditions, arthritis, pneumonia, rhinitis, hair loss, dry eye syndrome, and facial rejuvenation.

A manager of an aesthetic medical institution told First Financial: “Exosomes first gained popularity abroad, and it’s not entirely lacking scientific validation. But in China, the use of exosomes for disease treatment or medical aesthetics is not yet legally permitted. Further clinical data is needed to obtain official approval before they can be used in clinical practice.”