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Table 4 Tissue engineering products approved for marketing by the SFDA

From: Regenerative medicine in China: main progress in different fields

Company Time Name Constitute Application Registration No.
Beijing Jieya Laifu Biotechnology 2006 J-1 allogeneic acellular dermal matrix The donation of human body’s skin, removed the host immune rejection of all cells, while keeping intact the original structure with the same extracellular matrix To repair oral mucosal defects, soft tissue defects. SFDA (quasi-) word No. 2000
No. 346027, and No. 2006 3460430
2010 AlloDerm The donation of human body’s skin, removed the host immune rejection of all cells, while keeping intact the original structure with the same extracellular matrix To repair defect of human dermal SFDA (quasi-) word No. 2010 No. 3461247
Beijing Qingyuan Albert tissue engineering biological technology 2007 Rhino (acellular dermal matrix medical tissue patch) Acellular dermal matrix derived from donated human skin that undergoes a multi-step proprietary process that removes both the epidermis and the cells that can lead to tissue rejection To repair various causes of oral mucosa and soft tissue defect. Closing the wound, dental implantation, hernia repair, urethral SFDA (quasi-) word 2004 No. 3460736
Chongqing Zongshen Junhui Biotechnology 2007 Artificial skin – gene transfection pigskin The product performance and composition with fresh skin tissue taken from Bama miniature pig as basic material, and through the introduction of technology and gene transfection of CTLA4Ig gene research. To repair burns and other trauma wound coverage, to promote wound healing, prevention of microbial infection The Food Drug Armed (quasi) Word 2007 No. 3461287
Qidong Oriental Medicine Research Institute 2010 Acellular dermal matrix dressings Pigskin as raw material, such as viral inactivation process with acellular prepared from a pig dermal extracellular matrix, is a porous three-dimensional network structure; mainly composed of collagen. To repair superficial II degree burn wounds, donor site wounds, deep cut (cut) scab wound granulation wounds and other wounds. SFDA (quasi-) word No. 2010 No. 3641111
Shaanxi Eyre skin Biological Engineering 2007 Tissue engineering skin A bilayer artificial skin substitute: epidermal layer is composed of human epidermal cells, dermal fibroblasts from human and bovine collagen. To repair deep II degree burn wound, not more than III degree burn wound 20 cm2 (diameter less than 5 cm) The Food Drug Armed (quasi) Word 2007 No. 3461110
BiotechnologyYantai Zhenghai 2009 Skin repair film Cattle skin tissue after treatment prepared by a series of acellular dermal matrix is composed primarily of collagen To repair various causes dermal wound repair defects. SFDA (quasi-) No. 2009, No. 3460425
2009 Biofilm Cattle skin tissue processed through a series of prepared acellular dermal matrix is composed primarily of collagen, collagen retains the unique three-dimensional structure To repair a variety of causes dura (spinal) membrane defects SFDA (quasi-) No. 2009, No. 3460602
2009 Dental film The leather prepared after a series of acellular dermal matrix, whose main ingredient is collagen, sterilized by radiation, one-time use To repair various causes shallow intraoral soft tissue defect repair SFDA (quasi-) No. 2009, No. 3460404
Biological Technology of Guangdong Grandhope 2007 General thoracic surgical repair film Pig tissue membranes crosslinked epoxy chemical reagents and biochemical transformation of materials made of surgical repair To repair chest wall, bronchial stump, diaphragmatic, visceral capsular defect, etc. SFDA (quasi-) word No. 2007, No. 3461317
2009 Sterile biological care record film The pig offal film, by the addition of antigen and a series of biochemical treatment and viral inactivation and made Skin burn, burn and trauma, skin defects SFDA (quasi-) No. 2009, No. 3640426
2011 Biotypes dura (spinal) membrane patch Pig membranous tissue as raw material, processed into biotechnology, should be finished smooth side, the other side is allowed villous or striped or grid-like native structure To repair hard brain (spinal) membrane defect SFDA (quasi-) word 2008 No. 3460637
Beijing Datsing Bio-Tech 2011 Allogeneic bone grafts Cadaveric bone usually obtained from a bone bank Dental implants, to repair broken bones that have bone loss, and repair broken bone that has not yet healed Fresh Armed State Drug Administration (prospective) ganxibaoNo.3460627 (2011)