The biological medicine,as the product of the biotechnology revolution in the 70 's of the last century, is the developing center of the global pharmaceutical market,which is represented by the protein drugs; For the advantages of high activity, less dosage, and less toxicity, which has strong advantage in market competition compared with the traditional chemical medicine. These drugs are the patient's life-saving medicine in many major diseases, such as cancer, immune diseases, diabetes, etc. As the representative of new biological drugs, the monoclonal antibody, which occupied seven places in the largest 10 drugs of global sales in the 2012, and the average annual sales of single species for $7.34 billion, far more than the traditional Blockbuster drugs ($1 billion / year).

Nearly 400 kinds of biotech drugs are approved listed in our country, but about 94.5% of which is the generic varieties of early biological drugs. Most of the new type of biopharmaceutical is in clinical stage, almost all of which are biosimilars. Biotech drugs belong to macromolecules, the structure is high complexity, and can not be modelled on chemical drugs to achieve the same imitation. The subtle differences in process conditions can result in dramatic changes in the nature of the drug, and cause adverse reactions. Therefore, the single biosimilar projects usually need to invest in a hundred million dollars, the production process is complex, causing the price of biosimilar is still high, which is not suitable to China's national conditions.

Therefore, the current application rate of biological medicine in China is far lower than the average level of the developed countries. For example, Enbrel, ACE drug in the treatment of rheumatoid arthritis, a course of treatment costs reached more than 100 thousands, after the listing of China's own generic drugs, will spend down to 22 thousands, but still exceeded the majority of the patients economic affordability. According to statistics, only 1-2% patients actually received the kind of biological drug treatment for drug treatment of rheumatoid arthritis patients in the urban areas of our country, in sharp contrast, the rate of the treatment for rheumatic arthritis was 8% in the German, 10% in the UK, while 17% reached in Spain.

In summary, it is urgent need to develop the biological drug for the national conditions of our country in the most of major diseases. According to statistics, China's pharmaceutical market size has reached 926.1 billions in 2012 , which will exceed 2 000 billions in 2020. However, the proportion of the biological medicine market remained at about 5%, far below the international level (19%). This means that about 300 billions of domestic biological drug demand is not released because of the price, close to 2 times of the total value of the current biopharmaceutical industry. From another point of view, China's per capita GDP is only $4300 in 2011 , while the per capita GDP is about $15000 in the United States, Japan, Korea and other countries,which reached a similar level of aging, the per capita real purchasing power is more than 5 times.

The bio innovative medicine wll facing a great market in the future for a long time, the key is depending on the ability to develop a variety suitabled our country.