Shanghai Industry Association Issues First-Ever Technical Standard for Plant-Derived Exosome-Like Nanovesicles
核心洞察
The Shanghai Yangtze River Delta Medical Device Industry Promotion Association (搜索) released T/SDMDA 003-2026, the first general technical standard for industrial production of plant-derived exosome-like nanovesicles (搜索) (PELNVs), effective August 1, 2026.
The standard sets baseline quality requirements including a minimum purity of 70% and a minimum particle concentration of 10⁹ particles per milliliter across cosmetics, medical devices, foods for special medical purposes, and pharmaceutical development.
Hangzhou Omni Dynamics Biotechnology Co., Ltd. (搜索) served as the principal drafting organization, with four organizations already committed to implementing the standard in its first phase.
A Chinese industry association has issued the first general technical standard governing the industrial production of plant-derived exosome-like nanovesicles (搜索) (PELNVs), a class of naturally occurring nanoscale carriers attracting growing commercial interest across skincare, wound care, and functional nutrition.
The standard, designated T/SDMDA 003-2026 and titled "General Technical Guidelines for the Industrialization of Plant-Derived Exosome-Like Nanovesicles (搜索) (PELNVs)," was released July 20 in Shanghai by the Shanghai Yangtze River Delta Medical Device Industry Promotion Association (搜索). It takes effect August 1, 2026. Hangzhou Omni Dynamics Biotechnology Co., Ltd. (搜索) served as the principal drafting organization.
What PELNVs Are and Why Standardization Matters
PELNVs are nanoscale vesicles extracted from plant material, featuring a lipid bilayer membrane and typically measuring between 30 and 500 nanometers in diameter. They naturally carry proteins, nucleic acids, and metabolites, and researchers have studied them for their ability to transport bioactive compounds between cells.
Until now, companies working with the material lacked a shared technical reference for defining product quality. The new standard addresses this gap by setting baseline requirements including a minimum purity of 70 percent and a minimum particle concentration of 10⁹ particles per milliliter. It also covers production, testing, and quality-evaluation methods across four application categories: cosmetics, medical devices, foods for special medical purposes, and pharmaceutical development.
"When quality specifications for a new raw material are established, downstream companies gain a common technical language for product registration and filings," said Dr. Qian Xueqing, chief executive of Hangzhou Omni Dynamics Biotechnology and the standard's principal drafter. "That is what a document like this is for."
Lin Senyong, president of the Shanghai Yangtze River Delta Medical Device Industry Promotion Association (搜索), said the standard is intended to give the sector consistent terminology and quality-evaluation criteria, which he described as having been a barrier to commercial adoption.
Company Background and Development Timeline
Hangzhou Omni Dynamics Biotechnology was established in 2025, though its founding team had worked on plant-derived vesicle technology for approximately four years prior to incorporation. Drafting of the standard took place over roughly three years. The company says its development work draws on genomics, metabolomics, and spatial proteomics platforms, with validation testing conducted in collaboration with research teams at Shanghai Jiao Tong University, Fudan University, and Jiangnan University.
Runda Medical Technology Co., Ltd. (搜索) (SH: 603108) holds a 20 percent equity stake in Hangzhou Omni Dynamics through a subsidiary.
Applications and Regulatory Status
The company has described technical work in four areas at differing stages of development. In cosmetics, vesicle-based ingredients for transdermal delivery of active compounds are intended for filing as a cosmetic raw material and supply to skincare brands and contract manufacturers. In medical devices, dressings targeting acne (搜索), dermatitis (搜索), and post-procedure skin recovery are under development; the company says it has held preliminary discussions with China's National Medical Products Administration regarding a Class III drug-device combination pathway, though no regulatory application has been approved to date.
For foods for special medical purposes, oral formulations aim to improve the bioavailability of compounds such as NMN and curcumin, subject to registration requirements for medical foods. In pharmaceuticals, early-stage exploratory work is examining vesicles as a biological delivery vehicle, though this remains at a research stage with no drug candidate having entered clinical development.
Market Context and Scientific Validation
The four application areas addressed by the standard together represent end-markets in China worth more than RMB 2 trillion (approximately USD 280 billion) annually. China's cosmetics market recorded transaction value of RMB 1.07 trillion (approximately USD 149 billion) in 2024, according to the China Association of Fragrance, Flavour and Cosmetic Industries. The medical device market exceeded RMB 1.09 trillion in 2024, while the market for foods for special medical purposes reached RMB 23.2 billion, up 24 percent year over year.
Within the cosmetics sector, functional skincare — the segment most directly relevant to PELNVs — was estimated at approximately RMB 48.7 billion. Globally, the cosmetic active ingredients segment was valued at approximately USD 24 billion in 2024. Regulatory filings for new cosmetic ingredients in China reached 90 in 2024, a record high, signaling accelerating industry interest in novel raw materials.
At the release event, Professor Liu Yun of the Shanghai Cancer Institute presented research on vesicle applications in anti-inflammatory activity, antioxidant effects, gut health, and delivery of bioactive compounds. Professor Ma Gang of the Bio-X Institute at Shanghai Jiao Tong University, citing work in psoriasis (搜索) models, noted that source control and batch-to-batch consistency remain central obstacles to commercial translation — an issue the new standard is intended to address.
Four organizations have committed to implementing the standard in its first phase: Shanghai Runda Rongjia Biotechnology Co., Ltd.; Hangzhou Omni Dynamics Biotechnology Co., Ltd. (搜索); Shanghai Dongli Health Research Institute Co., Ltd.; and Minuo (Shanghai) Exosome Biomedicine Co., Ltd. Few companies in China currently produce PELNVs at commercial scale, and Hangzhou Omni Dynamics says it has established production capacity intended to supply raw material to manufacturers in China and abroad.