VenuSilk Launches China's First Injectable Silk Fibroin Gel into Clinical Trials

On December 15, 2025, led by Director Zhao Hongyi, Chairman of the Aesthetic Medicine Branch of the China Association of Medical Device IndustryClinical Study Kick-off Meeting for Injectable Silk Fibroin GelLaunched at Beijing Hospital of Traditional Chinese Medicine, Capital Medical University. This study was initiated by VenuSilk.China's FirstA Prospective, Multicenter, Randomized, Active-Controlled, Assessor-Blinded, Non-Inferiority Clinical Study of Injectable Silk Fibroin for Injection, Primarily Designed to Verify the Safety and Efficacy of Injectable Silk Fibroin Gel in Correcting Dynamic Forehead Wrinkles (Forehead Lines). This trial will be conducted simultaneously at five clinical trial centers across China.

(Kick-off Meeting for the Clinical Study of Injectable Silk Fibroin Gel, On-site Photos)

The initiation of this trial marks a new phase for China’s first injectable silk fibroin gel, bringing it one step closer to regulatory approval and market launch, accelerating its clinical application to benefit patients.

The Medical Aesthetics Materials Market Is Undergoing a Major Transformation.

The “Blue Book on the Current Development Status and Future Trends of China’s Aesthetic Injection Products Industry (2025),” released by Frost & Sullivan, shows that the retail market size of medical aesthetic injection products in China has increased from RMB 25.7 billion in 2018 to RMB 67.0 billion in 2023, with a compound annual growth rate (CAGR) of 21.1%. It is projected to reach RMB 147.0 billion by 2027, with a CAGR of 21.7%.

In this trillion-yuan market, hyaluronic acid, botulinum toxin, collagen, and regenerative materials, as the four major materials, currently account for the vast majority of market share. However, with industry development and technological breakthroughs, the market dominance of these materials is being disrupted. New materials such as silk fibroin are continuously challenging the hegemony of traditional materials with their differentiated advantages.

As the earliest medical aesthetic injectable material to achieve large-scale application, hyaluronic acid remains the mainstream in the field of dermal fillers. However, its limitations are increasingly being recognized: post-injection issues may include transient local edema and residual cross-linking agents, and it may even trigger the Tyndall effect (a bluish discoloration or translucency of the local skin) and "pillow face" (an excessive sense of swelling or puffiness in the face due to overfilling).

Botulinum toxin is another important product, offering advantages such as minimal invasiveness, rapid onset of action, and broad applicability. However, it has limitations, including a short duration of effect (3–6 months) and high long-term costs. Potential complications may include facial stiffness, brow ptosis, restricted brow movement, and eyelid drooping.

The recently emerging collagen-based and regenerative materials also present a variety of challenges. For instance, animal-derived collagen suffers from low yield and high cost; recombinant collagen has limited structural integrity, making it difficult to produce full-length molecules, and exhibits poor mechanical support. Regenerative material products such as PLLA and PCL cannot precisely control the regenerative stimulation effect, and are prone to causing side effects such as granulomas and excessive nodular stimulation.

In response to the rapidly growing market for medical aesthetic fillers and unmet consumer needs, numerous innovative startups and publicly listed companies are actively developing safer and more effective new materials for medical aesthetics, aiming to capture a significant share of this billion-dollar market. Among them, VenuSilk has chosen toSilk FibroinBreaking the Topic。

Silk fibroin is a natural polymer material extracted from silk, containing 18 amino acids found in the human body, primarily glycine, alanine, and serine. These components endow silk fibroin with unique biological activity and application potential, conferring excellent biocompatibility, low immunogenicity, and cell proliferation-promoting properties. It effectively reduces the risk of postoperative infection, and its degradation products are amino acids that can be naturally metabolized by the human body, offering significantly superior safety compared to some traditional materials.

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

Given the superior properties of silk fibroin, it is considered a promising candidate to become a blockbuster material in next-generation medical aesthetics.Currently, multiple innovative companies in the market are exploring the combination of silk fibroin and hyaluronic acid (HA) to form composite gels. Compared to traditional gels based solely on cross-linked hyaluronic acid, composite gels of silk fibroin and sodium hyaluronate (HA) can promote the gelation of high-molecular-weight hyaluronic acid and slow down its degradation rate, thereby optimizing filling effects and prolonging duration of action.

However, such products still fail to address the issue of residual cross-linking agents in hyaluronic acid and are unable to effectively leverage the superior mechanical properties of silk fibroin.

Addressing industry pain points, VenuSilk has launched China’s first injectable silk fibroin gel.

It is reported that this injectable silk fibroin gel utilizes VenuSilk’s proprietary technology to induce conformational changes in silk fibroin, enabling self-assembly into a biomimetic Voronoi nano-network structure. This structure mimics the efficient cellular arrangement found in nature, providing immediate structural support to the skin while promoting long-term collagen regeneration, thereby achieving the dual benefits of “instant filling + sustained regeneration.”

Notably, this innovative technology enables VenuSilk to produce pure silk fibroin gel with adequate structural support without the use of cross-linking agents, effectively avoiding issues associated with traditional filler materials, such as residual cross-linkers, the Tyndall effect, and high swelling rates.

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 to provide effective support and guide regeneration.

VenuSilk has been able to break through technical barriers and launch China’s first injectable silk fibroin gel, thanks to its strong R&D team and capabilities. For instance, Dr. Gong Zuguang, founder of VenuSilk, studied under Professor Shao Zhengzhong and has long been dedicated to research on silk fibroin-based medical hydrogels, bringing nearly two decades of experience in the R&D and industrialization of biomedical materials.

VenuSilk has also established collaborations with top-tier universities such as Southwest University and Fudan University. Professor Xia Qingyou of Southwest University, the Director of the State Key Laboratory of Silkworm Genome Biology, is a key contributor to China’s Silkworm Genome Project. The Biomacromolecule Research Group at Fudan University is a leading domestic laboratory for research on silk fibroin materials.

Backed by robust R&D capabilities, VenuSilk has established a systematic intellectual property barrier around pure silk fibroin gel materials, completing full-chain patent layout from raw material processing and core formulations to preparation processes, thereby laying a solid foundation for its technology translation and market competitiveness.

With the initiation of this clinical trial, the safety, efficacy, and clinical value of the injectable silk fibroin gel are expected to be validated. Should the clinical trials proceed smoothly, the product may receive regulatory approval for market launch at an early stage, providing a safer and more effective solution for aesthetic seekers in China.

In the field of medical aesthetics materials, the industry has consistently pursued: higher safety and lower incidence of adverse reactions; striving to overcome the "pillow face" phenomenon to achieve superior contouring results; flexibly addressing filling needs across different anatomical areas; and exploring more diverse functionalities, such as tissue repair, anti-inflammatory, and antioxidant effects.Therefore, injectable silk fibroin gel, which offers higher safety, a lower incidence of adverse events, and avoids issues such as residual cross-linking agents, the Tyndall effect, and high swelling rates, is poised to become a blockbuster next-generation material in medical aesthetics.。

VenuSilk is a medical aesthetics company that leverages a silk fibroin gel technology platform to develop Class III dermal filler injection products and Class II dressings. The company has established a production facility of over 1,000 square meters in Suzhou Industrial Park’s BioBAY for product R&D, clinical trials, and regulatory registration. In collaboration with Southwest University and Fudan University, VenuSilk has built comprehensive technological barriers spanning the entire value chain from raw materials to finished products.

Reference: “2025 In-Depth Market Research Report on China’s Medical Aesthetics Injectable Materials Industry: Market Size, Segments, and Market Structure,” Huajing Industry Research Institute.