While achieving the world's first successful filing of NK cell exosomes in the U.S. FDA DMF archive ( [Major News] Shenzhen Cell Valley Becomes the First Company Globally to Obtain U.S. FDA DMF Filing for Natural Killer (NK) Cell-Derived Exosomes ） ), Shenzhen Cell Valley also conducted multiple safety and functional uation experiments on injectable and topical NK cell exosomes. Among these, in the continuous topical application model of exosome repair for drug-induced dermatitis in rat skin, NK exosomes demonstrated significantly better skin improvement effects compared to saline and umbilical cord mesenchymal stem cell (MSC) exosomes.

Overview of Experimental Design

· Animal Model: Chemical-induced dermatitis, SD rats, n=3

· Experimental Treatment: Continuous topical application of exosomes for 3 days

· Control Group: Saline

· Experimental Groups: NK exosomes, MSC exosomes

· Observation Time Points: Day 1 and Day 4 after application

· uation Metrics: Skin integrity, inflammatory response, wound color changes, epidermal repair status

*Experimental Results Display (Unpublished images provided by Shenzhen Cell Valley, unauthorized reproduction prohibited)

The above shows the actual photographic results of the three animal model groups at Day 1 and Day 4 after application:

1. Saline Group (Control)

· Day 1: Clear wound area, limited epidermal protection

· Day 4: Obvious wound redness and inflammation, limited repair effect

2. NK Exosome Group

· Day 1: Smooth skin surface, mild inflammation, overall good performance

· Day 4: Significant wound contraction, low redness and swelling, clear and even repair area

· Overall Performance: Fastest repair speed, best skin integrity, and mildest inflammatory response among the three groups (Experimental results show NK exosomes significantly promote skin barrier repair)

3. MSC Exosome Group

· Day 1: Flat skin, mild reaction

· Day 4: Better repair than saline but significantly weaker than the NK exosome group

Summary: NK Exosomes Exhibit Stronger Skin Repair Capabilities

In this 3-day continuous topical application experiment:

· NK exosomes demonstrated the best wound closure and inflammation control effects

· · Significantly superior to MSC exosomes

· · Far superior to the saline control group

This data further proves that NK exosomes, as a next-generation bioactive delivery vehicle, have broad application prospects in topical formulations for skin repair, anti-inflammation, and anti-aging.

Further Reading

NK Exosomes Are Naturally Rich in:

· Cytotoxic granules (granzyme, perforin micro-signals)

· Anti-inflammatory factors

· Extracellular matrix regulatory molecules

· A combination of miRNAs that promote tissue healing

These collectively exert significant effects at the repair site:

· Suppressing local inflammatory outbreaks

· Enhancing skin barrier integrity

· Accelerating keratinocyte migration

· Promoting a more standardized re-epithelialization process

NK exosomes are not only "safe" but also "highly active," serving as a natural skin regeneration regulatory system.

This animal study demonstrates that NK exosomes can be used not only for injectable drugs but also "topically effective"—significantly expanding their commercial potential:

· The first validation of the dermatological effects of NK exosomes for topical use

· Providing foundational evidence for future development of high-end skincare products, medical-grade repair products, post-operative repair dressings, and topical biologics

NK exosomes stand out as one of the few triple-tier platforms possessing "pharmaceutical value + medical device value + skincare value."

Shenzhen Cell Valley will leverage pharmaceutical-grade NK cell exosomes to expand into:

· Medical applications: Skin damage, radiation dermatitis, diabetic wounds, post-operative repair

· Aesthetic medicine: Anti-inflammatory soothing, barrier repair, anti-aging, precision skincare

· Consumer market: Premium active exosome skincare brands

Experimental data and FDA DMF filing form a "scientific + regulatory" dual certification, creating the world's first standardized pathway

The value of the experimental results lies not only in research but also in regulatory approval:

· NK exosomes have already obtained FDA DMF filing (DMF 043001)

· Now supported by in vivo data proving "topical efficacy"

· This makes it the world's first NK exosome product registered with the FDA and validated for in vivo skin repair

We welcome global partners to utilize GMP-grade NK exosomes produced by Cell Valley for:

· Directly referencing the DMF for U.S. clinical trials

· Serving as a foundation for exosome drug development targeting dermatological conditions

· Acting as a core functional ingredient for aesthetic/repair products

Implications for regulation and industry

This marks the world's first NK exosome raw material recognized by a regulatory entity (FDA) with in vivo efficacy validation, setting a replicable industry benchmark for exosomes as both a "novel drug carrier + skin repair ingredient."