‘Twelve-Five’ transformation pays more attention to medical research and development New medicines will have a serious situation
<Pharmaceutical industry ‘Twelve-Five’ planning > is expected to be formally announced in September, planning core idea is the ‘industrial restructuring, technological upgrading’, promote the research and development of new medicines in ‘Twelve-Five’ period, focus on major infectious diseases like HIV/AIDS, viral hepatitis, tuberculosis and so on. Involved listed companies are Huahai pharmaceutical industry, Northeast Pharmaceutical, Changchun high-tech, Chongqing beer, Guangzhou pharmaceutical and so on. In addition, concentration of pharmaceutical industry will be further enhanced.
On August 19th, 2011, charger of National Ministry of Consumer Goods Division from National Industrial and Information Division revealed on release conference of pharmaceutical and retail information that ‘Twelve-Five’ planning is expected to be formally announced in September.
It is reported that during the period of ‘Twelve-Five, development target takes 20% for GDP growth in pharmaceutical industry, it is expected to reach to 3.1 trillion in 2015, industrial added value rate will be increase by 2% compared with the end of ‘Eleven-Five’ period. Planning core idea of ‘Twelve-Five’ is ‘industrial restructuring, technological upgrading’, we will not pursue both current speed and quantity, which has essential difference with ‘Eleven-Five’ planning.
<Planning> points out in creation of major new medicine that it is necessary to research and develop 30 new medicines, reconstruct about 200 medicine types, perfect creation of new medicines and modernization of important technology platform focusing on basic demands of the public, and the needs of fostering and developing pharmaceutical industry. It mainly focus on HIV/AIDS, viral hepatitis, tuberculosis and other major infectious diseases, break key technologies of detection and diagnosis, forecasting and early warning, vaccine development and clinical treatment, develop 150 kinds of diagnostic reagents, in which more than 20 of them have obtained registration certificate; More than 10 of new vaccines have already entered into the stage of clinical trials. Related listed companies are: Huahai pharmaceutical industry, Northeast Pharmaceutical, Changchun high-tech, Chongqing beer, Guangzhou pharmaceutical industry and so on.
In addition, key fields of technological innovation are also including biotechnology medicine, modern traditional Chinese medicine, advanced pharmaceutical apparatus, new pharmaceutical accessories, pharmaceutical equipment and packaging materials, in which pharmaceutical accessories, pharmaceutical equipments and packaging materials is the first time to get into the pharmaceutical industry development plan. Currently listed companies in this field are including Tofflon, CHINA SUN pharmaceutical machinery (pharmaceutical equipments); Er-Kang pharmaceutical (medicinal materials).
There are 4700-4800 pharmaceutical enterprises in China; rapid development of large enterprises can change organization of "many, small, scatter, low’ in pharmaceutical industry. Under the goal of improving industry concentration, pharmaceutical industry-related policy will also provide support. At present, medium-size pharmaceutical enterprises in China are mainly concentrated in between 1-4 billion Yuan, 6-10 billion Yuan sizes is in fault, if we want to have a reasonable scale, it is urgent to train a number of medium and large enterprises in China.
Data shows that the improvement of concentration in pharmaceutical industry is the trend in ‘Twelve-Five’ period, while <pharmaceutical industry ‘Twelve-Five’ planning>, <bio-pharmaceutical development ‘Twelve-Five’ planning>, are also pushing enterprises to become bigger and stronger at the policy level. Top 100 companies will develop over industry average growth rate; sales income will take 50% of total industry revenues. Average sales revenue of top 100 enterprises will amount to several billions Yuan, while the average sales revenue of top 10 will exceed 50 billion Yuan. Rapid development of large corporations is to promote industrial restructuring and upgrading, improve international competitiveness and further concentration of industry.
Problems in pharmaceutical new medicine research and development:
Bio-medicine as an important part of bio-industry is one of the strategic new pillar industries in rapid development of China, and is also the focus of current medicine and development projects. In recent years, development of China's biopharmaceutical industry has made great strides; its speed is faster than other pharmaceutical industry.
According to statistics, at present, China's biopharmaceutical industry enterprises are more than 700, total revenues in 2009 is about 75.3 billion Yuan. While we are pharmaceutical-like country, however, output value of Chinese medicine is rapidly increasing from Eleven-Five, but we are sure to experience a lot of bitterness from a doctrine to own research and development change.
China's biggest drawback of new medicine is the long waiting of approval. The processing period is 60 days to 90 days for applying to the State Food and Drug Administration to enter into clinical trials (that is clinical trials reporting of new medicines), but actually most enterprises have to wait 1 year to get approval. While United States clinical trials’ reporting only takes a month, India for several weeks to 30 days.
Second, we take ‘strict in and relax out’ policy, requires company to provide full production documents, make pre-clinical experiments for a long time, especially the long-term toxicity study, it is only allowed to enter into clinical period after thousands of success experiment; while it is relatively loose if you entered into the stage of clinical supervision, causing some medicine problems can be easily escaped. United States and other countries take the policy of ‘relax in and strict out’ on innovated medicine, as long as there is no big problem for a preclinical study of new medicine, it will be quickly to be approved into clinical stage; but if you enter into that stage, strict regulation and difficulties will be followed, if there are experimental data problems, it will be immediately halted, enterprises must bear relevant responsibility. This not only reduces medicine research and development time, but also improves company's sense of responsibility and quality awareness.
And more vulnerable, we always made mimicry medicine in the history of our country; it is mainly to solve the medicine problem for the public. Therefore, Food and Drug Administration established a set of rules based on mimicry medicine as a sample at the beginning and has been used ever since. And now our country promotes the research and innovation of new medicine, problems appeared. For example, it is completely different for experience and knowledge in reviewing mimicry medicine and in innovation medicine. As for mimicry medicines, there has reference standard, what we need to do is to borrow them to use according to China's national conditions without any risk. While new medicines are in trouble, there is no standard to refer to. It requires reviewing team has independent judgment, independent thinking and ability to bear risks. But now our reviewing officer's knowledge is failed to keep up with.
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