Amidst the rapid growth of the efficacy skincare and medical aesthetics markets, the demand for active ingredients is shifting from basic "hydration and moisturization" towards high-performance directions such as "deep repair, long-lasting maintenance, and active revitalization." Achieving precise control over transepidermal absorption and significantly enhancing enzymatic resistance—key to meeting the clinical needs of aesthetic consumers—has therefore become a central focus for the industry. Addressing this challenge, Topscience Biotech leverages its profound expertise in hyaluronic acid technology to introduce Medical Device Grade Sodium Acetylated Hyaluronate. This launch represents a dedicated effort toward application advancement and efficacy innovation, providing cutting-edge material support for the next generation of medical aesthetic solutions.

What is the Scientific Rationale Behind This Advancement? Studies indicate that acetylation modification introduces hydrophobic acetyl groups into the HA molecule, transforming it from completely hydrophilic to amphiphilic. This, in turn, weakens the targeted attack of hyaluronidase on the molecular glycosidic bonds, achieving resistance to enzymatic degradation. Hyaluronidase (HAase) exhibits strong degradative effects on natural HA, but its degradation capacity for modified AcHA is significantly reduced. This demonstrates that the chemical modification of AcHA effectively shields the recognition sites of HAase, greatly enhancing its stability against enzymatic degradation (Iaconisi et al., 2023). This, precisely, is the cornerstone for achieving long-lasting repair.

Reference: Iaconisi, G. N., Lunetti, P., & Gallo, N. (2023). Hyaluronic acid: A powerful biomolecule with wide-ranging applications—A comprehensive review. International Journal of Molecular Sciences, *24*(12), 10296.

Breaking Through Traditional Material Limits to Set a New Standard for Advanced Medical Devices

Building upon mature research on Sodium Acetylated Hyaluronate, Topscience Biotech has systematically redesigned and significantly elevated its quality according to the stringent standards of medical device grade. Not only have we precisely controlled the acetyl groups on the molecular chain to construct a stable and reliable amphiphilic (hydrophilic/lipophilic) structure, but we also prioritize biosafety. Through innovative patented processes, we accurately control bacterial endotoxins, meeting the rigorous requirements for medical device applications and complying with European Pharmacopoeia standards.

Medical Device Grade Sodium Acetylated Hyaluronate achieves a unity of performance and safety: excellent tissue affinity ensures long-lasting retention, while its unique acetylated modification structure grants the material superior resistance to enzymatic degradation, making it an ideal core ingredient for wound repair and post-procedure care.

Core Advantages Include:

01 Doubled Moisturizing Efficacy – Acetyl groups enhance skin affinity and adsorption, forming a breathable hydrating film that minimizes moisture loss.
02 Enhanced Stability – Slows enzymatic degradation, extends in vivo half-life, and ensures longer-lasting effects.
03 Optimized Compatibility – Exhibits stable miscibility with oil phases, supporting versatile formulation development.

Topscience Biotech Secures China's First Master File for Medical Device Grade Sodium Acetylated Hyaluronate

The newly launched "Medical Device Grade Sodium Acetylated Hyaluronate" strictly adheres to medical device regulatory and quality requirements and can be applied in Class II and Class III medical device fields. Relying on our independently developed patent (Patent No.: ZL202510290861.6), this product has completed master file registration (Master Files Registration No.: M2026011-000). It has undergone comprehensive and rigorous biological evaluations, including tests for cytotoxicity, sensitization, intracutaneous reactivity, pyrogens, acute systemic toxicity, and genotoxicity, ensuring safety and reliability for clinical applications. This provides solid and dependable technical and regulatory support for downstream customers' product registration and submissions.

According to publicly available information from the National Medical Products Administration's Medical Device Master File Database, Topscience Biotech is the first enterprise in China to complete the master file filing for Medical Device Grade Sodium Acetylated Hyaluronate. This marks a significant breakthrough for our company in achieving compliance and standardization of this raw material within the medical device field.

From basic hydration to deep repair, from daily skincare to professional medical devices, Topscience Biotech with the unique medical device grade quality of its Medical Device Grade Sodium Acetylated Hyaluronate, is pioneering an innovative path for the application of sodium hyaluronate in medical aesthetics. Innovation goes beyond the ingredient itself; it lies in providing verifiable and trustworthy solutions for the industry. Topscience Biotech looks forward to collaborating with industry peers to explore the new future of medical aesthetics together.