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Healtech Suzhou CDMO Center's Silk Fibroin Dressing has Received Certification

Healtech Suzhou CDMO Center's Silk Fibroin Dressing has Received Certification

2025-05-12

Introduction

The Silk Fibroin Dressing developed by Healtech Suzhou CDMO Center was approved to be listed by the NMPA.

On April 22, 2025, after the public announcement of the National Medical Products Administration, the Silk Fibroin Dressing (苏械注准 20252140672) developed by Healtech Suzhou CDMO Center was approved to be listed by the NMPA, and the product was approved for the national registration certificate of Class II medical device.

Silk Fibroin Dressing

Silk fibroin Dressing, which is made of non-woven fabric impregnated with silk fibroin solution, is suitable for the coverage and care of non-chronic wounds. The launch of this product will bring more choices in the field of wound treatment, and its excellent clinical therapeutic effect will greatly improve the quality of life of patients.

Technological Advantages:

(1)The 18 amino acids in the composition of silk fibroin are similar to the composition of human skin, and the internal structure of silk is 87% similar to human skin, which makes the film less irritating to human skin, with high biosafety and good biocompatibility.

(2)Relative to the certified product silk fibroin wound dressing products, the use of this product can reduce the doctor's operating procedures, reduce the patient's cost of expenditure, and use more convenient, faster, to meet the doctor's needs for a small range of wound dressings.

(3)This product is sterile, no preservatives, no flavors, no fluorescents, no coloring,and no chemical additives.


Healtech CDMO Center

Healtech Tissue Engineering and Regenerative Medical Biomaterials Laboratory has undertaken the special project of "National 13th Five-Year Key R&D Plan for Biomaterials Research and Development and Organ Repair Replacement", and has achieved the transformation of scientific and technological achievements in "Engineering Preparation Technology and Product Development of Low Immunogenicity Collagen and Silk Fibroin". It holds core patents for extracellular matrix(ECM) and silk fibroin(SFM), and has also developed various research and development technologies of new generation mainstream medical materials such as hyaluronic acid, PLA, PLLA, glucan, PCL, peptides, polyethylene, PVA, polyurethane, polytetrafluoroethylene, microcrystalline calcium, chitosan, hydroxyapatite, humanized collagen, etc.

The laboratory has developed over 80 technology projects, applied for 37 national patents, obtained 12 national invention patent certificates and 7 medical device registration certificates. It provides technical upgrades and new project reserves services for manufacturers and distributors, with strategic partnerships established globally with listed companies such as Fosun Pharma, Double Crane Pharma, and So-Young Group.

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