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Fibrin sealant (Chuangxufeng®)

上市日期: 2015-11-15

Fibrin sealant, also known as fibrin glue, is a biological product commonly used in surgeries. Its functional mechanism is simulating the final stage of human body’s blood clotting response: under the action of thrombin, the purified fibrinogen in high concentration is instantaneously transformed into fibrin network, which seals the surgical wound in the form of an absorbable film and plays the role of stopping bleeding, sealing the wound, and promoting healing. The fibrin glue will be decomposed to fibrin degradation products (FDP) and water in a few weeks and absorbed by the body.

Quick-dissolving freezing fibrin sealant for surgical purposes (brand name: Chuangxufeng®) is the bio-surgery product invented by P&P Biotech, and the company owns complete intellectual property rights over it.

Product description

Fibrin glue is widely used in various surgical departments, including general surgery, hepatobiliary surgery, cardiac surgery, thoracic surgery, brain surgery, orthopedics, plastic surgery, burns surgery, ENT surgery, oral surgery, and gynecology. According to clinical reports both at home and abroad, using fibrin glue in surgeries can:

1) Reduce postoperative blood loss (reducing an average of 161-223ml for each patient, approximately equivalent to an unpaid blood donation);

2) Reduce the blood transfusion rate by 32-37% (the product can reduce the volume of blood transfusion or even save the transfusion);

3) Shorten operation time;

4) Lower the incidence of postoperative infection;

5) Reduce adhesions;

6) Greatly lower the incidence of wound dehiscence after major surgeries;

7) Reduce scarring and promote healing of wound.

Studies in pharmacoeconomics indicate that using fibrin glue in surgeries can significantly improve outcomes after surgeries and reduce total cost.

According to American Encyclopedia of Surgery, the main applications of fibrin glue include:

1) Hemostasis:

 (1) For diffuse errhysis

 (2) For patients treated with anticoagulant  

 (3) For the bleeding parts that cannot be operated by traditional hemostasis methods

 (4) For endoscopic surgeries

 (5) Instill fibrin glue to the bleeding parts caused by peptic ulcers through endoscopes, in place of sclerotherapy.

2) Sealing:

 (1) Seal the anastomotic stoma and sutures on hollow tubular structures such as blood vessels, esophagus, intestinal tract, oviduct, and urethra.

 (2) Seal the sutures in pneumonectomy to reduce air leakage.

 (3) Seal dura mater to prevent leakage of cerebrospinal fluid after injuries or surgeries and repair dura mater defects.

 (4) Prevent seroma after incision/dissection of soft tissue.

 (5) Seal dead spaces, fistulous tracts, and fistulas.

3) Innovative applications:

 (1) Used as the device for targeted delivery of drugs to carry out local chemotherapy and anti-infection;

 (2) Used as the substrate for skin grafting after removing crusta caused by burns;

 (3) Used as the substrate in cell growth and tissue engineering.

An investigation in University of Virginia Hospital (US) in 2000 found that 90% of the surgeons who used fibrin glue were satisfied with the results. Journal of Biomaterials Applications has a high opinion of fibrin glue and states that: so far, fibrin glue is the most successful tissue sealant, which is significantly better than other sealants, like cyanoacrylate and marine biological sealant, in histocompatibility, biodegradation, hemostatic effect, and other aspects.

Development history of fibrin glue

In 1972, the first fibrin glue product came into the market in Europe (human blood-derived fibrinogen and ox blood-derived thrombin);

In 1978, this product failed to obtain the FDA certification (US), mainly because people worried about the human blood product’s risk of transmitting Aids;

In 1985, America began to make fibrin glue in hospital labs for clinical application (Hospital-based Program). They exacted fibrinogen by using the blood from blood banks or patients’ autologous blood, and purchased ox blood-derived thrombin;

In 1996, China’s first fibrin glue product (derived from pig blood) came into the market. One of the cofounders of P&P Biotech, Mr. He Hongbing, successfully developed the first-generation animal-derived fibrin glue for human use by replacing human blood with pig blood for the first time in the world, and founded Guangzhou Beite Biotech Co., Ltd. (later renamed Guangzhou Beixiu Biotech Co., Ltd.) to transform this technology into products. The company obtained the registration certificate issued by the original State Administration of Medical Devices for their products that were then put into clinical application in 1996. The fibrin glue extracted from animal blood can replace the similar products made from human blood, play an effective role in stopping bleeding, sealing the surface of wounds, and promoting the healing of wounds, reduce the cost largely, and avoid the potential risk of transmitting pathogenic microorganisms in human blood (like HIV, HBV, HCV, etc.). In 2012, Guangzhou Beixiu was purchased by Johnson & Johnson Pharmaceuticals Ltd. (US).

In 1998, the fibrin glue product was firstly approved to enter the market in America (human blood-derived fibrinogen and ox blood-derived thrombin). The product was required to pass through the two-step virus inactivation treatment. The strict virus inactivation process would damage the proteins and seriously affect the dissolution of fibrinogen while inactivating viruses. As a result, the dissolution time was prolonged to as much as 30-60 minutes, while surgical hemostasis is always needed urgently.

In 2003, ready-made fibrin glue was developed (derived from human blood; store the pre-made fibrin blue at -20oC and it only needs 10 minutes to dissolve the glue after taking it out). This product solved the problem of long dissolution time, but the storage condition of -20oC made it very inconvenient to store or transport the product. In 2008, Johnson & Johnson (US) purchased the ready-made fibrin glue technology with 420 million dollars and launched the product on the market. In 2013, the quick-dissolving fibrin glue developed by P&P Biotech entered the market. This product realizes instant dissolution and shortens the dissolution time to less than 3 minutes, and it is the only quick-dissolving fibrin glue in both domestic and foreign markets (brand name: Chuangxufeng®)

Chuangxufeng® is the new-generation fibrin glue developed by our company with new technology. Compared with the first-generation product, Chuangxufeng ® adopts a unique virus-inactivating patent technology, which can guarantee the stability of product quality and meanwhile get rid of the risk of being infected by zoonotic viruses. Thanks to the new technology that increases the concentration of fibrinogen by 67% compared with the first-generation product, the new products’ film-forming property and adhesion become better. In addition, the new technology also remedies the first-generation fibrin glue’s defects of slow dissolution and long preparation time, and achieves the effect of instant dissolution, thus providing a quick solution for the operations requiring emergency hemostasis and wound sealing.

Since the Chuangxufeng fibrin glue entered the market, it has been used in surgeries for more than 500,000 people. Because it can stop bleeding instantly, Chuangxufeng fibrin glue has become the necessary biological material for hemostasis in large surgeries and been listed in Directories of Insured Drugs of provinces and cities across China. It reduces or even saves the cost for blood transfusion and lowers the risk of being infected by HIV or other viruses, thus making surgeries safer.

P&P Biotech owns complete intellectual property rights over Chuangxufeng® and has obtained several patents of invention.

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