Natural hirudin is extracted from the salivary gland and saliva of Hirudinaria manillensis. It is a kind of single strand low molecular polypeptide containing 65 ～ 66 amino acid, universally known as the strongest natural anti-thrombin matter in the known matters in the world so far as well as the best drug for treatment of cardiovascular and cerebrovascular diseases. Statistics from the WHO show that about 17.00 million people die of cardiovascular and cerebrovascular diseases and the diseases, together with high blood pressure, have become the number one killer in China. In 2003, drugs sales amount totalled US$ 492 billion in the world (the sales amount concerning drugs for treatment of cardiovascular and cerebrovascular diseases was about US$ 45 billion, making up 12%), increasing by 9% over 2002. North America, Europe and Japan accounted for 4/5, becoming the main consuming area.
At present, foreign recomposed hirudin drug, which has been developed by way of gene engineering technology, has come into the market. Although recomposed hirudin is very similar to natural hirudin in the amino acid series and in the structure, 63-digit tyrosine residue has not been sulfated, making the inhibiting constant of recomposed hirudin against thrombin 90% less than natural hirudin. With another side effect of easily causing hemorrhage, recomposed hirudin is far beyond the natural one. Still with other defects such as short biological half-life period, high cost for treatment, it is difficult to promote the recomposed hirudin in clinic. Nonetheless, because of huge demand in the cardiovascular and cerebrovascular diseases market, recomposed hirudin products are still widely needed in the international market: Refludan of HMR Germany was permitted to go into the European market first in 1997. In 1998 and 1999, Refludan hit a big sale of US$ 9.00 million and US$ 14.00 million respectively in the worldwide market with an annual growth of 43%. According to the anticipation of HMR Germany, the potential sales amount for Refludan may reach US$ 235 million.
Natural hirudin has an obvious advantage on the anticoagulation drugs for it has the double functions of anticoagulation and anti-thrombus simultaneously. And what’s more, it seldom causes hemorrhage. So far, there is a tendency that the worldwide anti-thrombus drugs market is growing at a rate of 37%, for example, from US$ 6.7 billion in 1998 to US$ 9.3 billion in 2003.
At present, foreign recomposed hirudin drug, which has been developed by way of gene engineering technology, has come into the market. Although recomposed hirudin is very similar to natural hirudin in the amino acid series and in the structure, 63-digit tyrosine residue has not been sulfated, making the inhibiting constant of recomposed hirudin against thrombin 90% less than natural hirudin. With another side effect of easily causing hemorrhage, recomposed hirudin is far beyond the natural one. Still with other defects such as short biological half-life period, high cost for treatment, it is difficult to promote the recomposed hirudin in clinic. Nonetheless, because of huge demand in the cardiovascular and cerebrovascular diseases market, recomposed hirudin products are still widely needed in the international market: Refludan of HMR Germany was permitted to go into the European market first in 1997. In 1998 and 1999, Refludan hit a big sale of US$ 9.00 million and US$ 14.00 million respectively in the worldwide market with an annual growth of 43%. According to the anticipation of HMR Germany, the potential sales amount for Refludan may reach US$ 235 million.
Natural hirudin has an obvious advantage on the anticoagulation drugs for it has the double functions of anticoagulation and anti-thrombus simultaneously. And what’s more, it seldom causes hemorrhage. So far, there is a tendency that the worldwide anti-thrombus drugs market is growing at a rate of 37%, for example, from US$ 6.7 billion in 1998 to US$ 9.3 billion in 2003.
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