China's First Pure Silk Fibroin Gel Completes Phase I Clinical Trial, 100% Improvement with No Product-Related SAE

VCBeat recently learned that the first domestically produced injectable silk fibroin gel independently developed by VenuSilk has achieved preliminary results in clinical trials:The product has completed the enrollment of all participants in Group A, initiated the procedures for Group B, and enrolled dozens of subjects.

It is reported that this clinical trial was launched on December 15, 2025, and is chaired by the理事长 of the Plastic Surgery Branch of the China Medical Device Industry Association.ZHAO HongyiLed by the director, simultaneously conducted at five clinical trial centers across China.

This clinical study is the first clinical research in China on injectable silk fibroin, utilizing a prospective, multi-center, randomized, positive parallel control, evaluator-blinded, non-inferiority design. It primarily aims to verify the safety and efficacy of injectable silk fibroin gel for correcting dynamic wrinkles on the forehead.

This clinical study sets up Group A and Group B to enhance the evaluation of the investigators' injection techniques and the observation of safety indicators. The first or the first two eligible subjects screened by each clinical trial institution's injection investigator will automatically enter Group A and receive treatment with the trial device; the subsequent treatment and follow-up process will be the same as the experimental group in Group B. The completed clinical trial results of Group A show that VenuSilk injectable silk fibroin gelThe safety profile was favorable, with the severity of adverse product events not exceeding Grade 2, and no product-related SAEs were observed.The completed short-term follow-up shows,The subjects' forehead wrinkles showed an overall improvement trend, with a 100% improvement rate in Global Aesthetic Improvement Scale (GAIS).

The successful completion of full enrollment in Group A and multiple enrollments in Group B marks another step forward in the registration and approval process for VenuSilk's injectable silk fibroin gel, which is expected to offer aesthetic seekers a safer and more effective innovative option.

The mainstream materials in medical aesthetics (hyaluronic acid, botulinum toxin, collagen, regenerative materials) all have significant pain points:

Unlike the filler products available on the market, VenuSilk has chosen to use the emerging material silk fibroin. Silk fibroin is a natural polymer material extracted from silk, containing 18 amino acids found in the human body, which endows silk fibroin with unique bioactivity and application potential. It exhibits excellent biocompatibility, low immunogenicity, and the ability to promote cell proliferation, offering significantly higher safety compared to some traditional materials.

Meanwhile, silk fibroin exhibits excellent mechanical properties and physicochemical characteristics, such as remarkable flexibility, tensile strength, breathability, moisture permeability, and sustained-release performance.

Based on the excellent properties of silk fibroin, it is considered to have the potential to become the next-generation blockbuster medical aesthetics material.

In addition to using next-generation materials, the key difference lies in the technological approach. VenuSilk has chosen a completely different path of technological innovation—pure silk fibroin.Currently, there are several innovative companies exploring the combination of silk fibroin and hyaluronic acid (HA) to form composite gels. However, these products still fail to address the issue of residual cross-linking agents in HA and cannot effectively leverage the excellent mechanical properties of silk fibroin.

VenuSilk's domestically developed first injectable silk fibroin gel induces a conformational change in silk fibroin proteins through its proprietary technology, self-assembling to form a biomimetic Voronoi nanonetwork structure. This structure mimics the efficient cell arrangement found in nature, providing immediate support to the skin while promoting long-term collagen regeneration."The triple effects of immediate filling + non-inflammatory regeneration + highly effective anti-aging"Effectively avoid problems such as cross-linking agent residue, Tyndall effect, and high swelling rate from the root cause.

Compared with silk fibroin and hyaluronic acid composite gel products on the market, VenuSilk's silk fibroin gel is a pure silk fibroin product with a single component, which can fully leverage the material advantages of silk fibroin and achieve effective support and guided regeneration.

In summary, through material innovation and technological innovation, VenuSilk has independently developed the first injectable silk fibroin gel in China. The emergence of this product is expected to bring a safer, less side-effect, and more effective innovative solution for those seeking beauty.

VenuSilk is a company that develops Class III injectable filling products based on a silk fibroin gel technology platform. The company has over 1,000 square meters of production workshop space at Biobay in Suzhou Industrial Park, which is used for product research and development, clinical trials, and registration.

Dr. Gong Zuguang, the founder of the company and a student of Professor Shao Zhengzhong, has long been deeply engaged in the research of silk fibroin medical hydrogels, with nearly two decades of experience in the research, development, and industrialization of biomedical materials.

VenuSilk has also reached cooperation with top universities such as Southwest University and Fudan University. Among them, Professor Xia Qingyou from Southwest University is the director of the State Key Laboratory of Silkworm Genome Biology and a major contributor to China's silkworm genome project. The Fudan University biomacromolecule research group is a leading laboratory in China for the study of silk fibroin protein materials.

Backed by strong R&D capabilities, VenuSilk has built a systematic intellectual property barrier around its pure silk fibroin gel material, completing a full-chain patent layout from raw material processing, core formulation to preparation technology, laying a solid foundation for its technological transformation and market competition.