The hottest insiders predict that pharmaceutical o

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Insiders predict that pharmaceutical outsourcing will become a new way for China's pharmaceutical development

the development of China's pharmaceutical industry is accelerating the pace of integration with the world, while foreign pharmaceutical outsourcing production with considerable development foundation is also attracting domestic attention, and some pharmaceutical enterprises have begun to explore. Pharmaceutical manufacturers, distributors and pharmaceutical experts who participated in the 54th national pharmaceutical fair believe that pharmaceutical outsourcing production will become a new way for China's pharmaceutical development and promote a new round of development of China's pharmaceutical economy

according to Huang Pinqi, deputy general manager of North China Pharmaceutical Group, outsourcing has become an important economic phenomenon in the world pharmaceutical industry. At present, most of the outsourcing business in the pharmaceutical field occurs in the pharmaceutical R & D field, and the pharmaceutical giants basically transfer the pharmaceutical R & D outsourcing business to small and medium-sized enterprises or R & D institutions. Because the research and development of new drugs is a costly, long-term and high-risk business, which generally takes 8-14 years, with an investment of 800-1 billion US dollars. No company in the world today can have all the expertise and capabilities required for innovation. About 50% of new chemical individuals (NCE) are found by small R & D companies. More and more small R & D companies are engaged in early product development, while the number of projects of large pharmaceutical enterprises engaged in early product development is decreasing. They generally look for opportunities to buy early developed products from small companies and engage in later development

in the tide of economic globalization, outsourcing is the best choice for pharmaceutical giants. Outsourcing can enable them to focus on their core business, use external resources and technology, speed up the speed of product launch, control costs, and improve cost-effectiveness. More and more large pharmaceutical companies are looking for small biotechnology companies and experts to fill the gap in drug development, and biotechnology companies are also willing to cooperate with pharmaceutical companies to add value to their innovation. According to the statistics of British antisoma company, 35% of the world's pharmaceutical companies are outsourcing for the study of the brittleness of refractory compounds, and this figure is expected to rise to 47% by 2008. At the same time, biotechnology companies also work with contract research institutions (cros) to develop new drugs. Especially in the early development stage, more and more biotechnology companies choose cros for clinical testing and research outsourcing, which not only saves time, but also realizes risk sharing. At present, the growth rate of expenditure for this outsourcing is twice that for independent work, and the expenditure for clinical testing and research outsourcing has also accounted for more than 25% of R & D expenditure

yaochangjun, general manager of Chongqing Changye pharmaceutical company, introduced that according to Intertek's Market Research Report, the cost of outsourcing services in the world pharmaceutical industry has reached $30billion. Pharmaceutical outsourcing has involved the following stages: early drug discovery, pharmacological toxicity, dosage form, formula development, process development, intermediate products and API (effective drug ingredients), analysis and testing, phase I ~ III clinical research, policy and regulation consultation, product physical molding, packaging, promotion, marketing, product release and sales support, pharmacoeconomic evaluation, business consultation and efficacy tracking. It is estimated that the global pharmaceutical outsourcing market is US $billion in the R & D stage of new discovery, preclinical development and clinical development; The potential market in the development of processing process and the production of pharmaceutical ingredients is about 50billion US dollars; The potential market in the stage of dosage form development, dosage form production and packaging is US $billion. Outsourcing business is showing a trend of global growth. Its development in Europe and the United States has entered a mature stage, while it is still in the development stage in the Asia Pacific region, so there is huge room for development

in order to reduce the growing cost of new drug development, some large pharmaceutical companies in Europe and the United States are interested in outsourcing some new drug development work to low-cost countries such as India and China. In the "outsourcing" market competition, Asia is increasingly attracting the attention of multinational groups, and India and China are their preferred places. In Hyderabad, gene Valley, India, many biomedical companies are carrying out outsourcing business, with a good momentum of development. For example, shantha biotechnology company not only develops its own drugs, but also manufactures enzyme products for Merck's calbiochem company; Bioinformatics software company ocium biosolutions sold the software to dowagrosciences in the United States, which would otherwise cause excessive deviation in sensor accuracy or damage, and established a cro branch in Indianapolis

caidongchen, chairman of Shijiazhuang Pharmaceutical Group, introduced that Novartis and Sanofi Aventis successively announced that they would set up R & D centers in China in July 2005. Previously, Roche, while the light utilization of graphene is civilian oriented, which can quickly realize productization and bring higher cost performance to consumers. Pharmaceutical giants such as Lilly have established R & D centers in Shanghai. This shows that large international pharmaceutical enterprises have begun to pay attention to the existence of professionally trained Chinese scientists with low human costs, strong scientific research foundation in some fields and rich and unique disease resources. The conditions for China to carry out biomedical outsourcing business are ripe. Previously, the Shanghai biomedical outsourcing service base and the Shanghai Pudong biomedical R & D outsourcing service center, which were established in February this year, are striving for various drug development contracts worldwide, hoping to form a branch of the biomedical industry with an annual output value of more than 2billion yuan within five years, and introduce more than 5billion yuan of new domestic and foreign biotechnology investment. In March this year, Guangdong South China Pharmaceutical Group Co., Ltd. signed a contract with Shanghai worry free consulting Pharmaceutical Service Co., Ltd. South China Pharmaceutical outsourced all its OTC sales management business to worry free consulting for two years. The outsourcing Party promised to cultivate South China Pharmaceutical into a professional OTC team that can operate independently at non-standard experimental speed in the test process during this period, and help South China Pharmaceutical increase the sales volume and total product volume of some drug varieties by more than 50%. The outsourcing business in the pharmaceutical field began to outsource its OTC business sales management from the pharmaceutical research and development field to Chinese pharmaceutical enterprises

in fact, clinical research outsourcing in China began to appear in the 1970s. At that time, it only provided small-scale clinical testing services. By 2001, the outsourcing amount had reached US $9.3 billion, and it is expected to reach US $36billion by 2010, with an average annual growth rate of 16.3%. In 1992, 7million patients were registered in clinical research institutions, and in 2001, the number had reached 20million, It is a rapidly developing industry in the world pharmaceutical outsourcing industry, and it is also an industry with certain advantages in China. At present, typical enterprises that carry out API outsourcing in China include Shandong Meiji Lukang (colistin sulfate), Dalian Pfizer Pharmaceutical (cefoperazone), arabindou (Datong) biopharmaceutical Co., Ltd. (6-APA), Zhangjiakou jist brocades Pharmaceutical (penicillin industrial salt), Shandong Xinhua Pharmaceutical (ibuprofen), etc. The products of these enterprises are produced at designated points and used exclusively by foreign pharmaceutical enterprises. The quality, process and management are implemented according to the requirements of foreign enterprises

According to the analysis of insiders, China's pharmaceutical outsourcing is still in its infancy on the whole, and there is a huge gap with foreign countries. There are three main problems:

first, a large number of local cro companies in Beijing, Shanghai and other places lack professionalism, and the service content is mainly concentrated in the clinical trial stage, and some even play the role of public relations companies, The clinical trial resources provided are far behind foreign companies in terms of authenticity and reliability

second, for a long time, China's pharmaceutical R & D work has been mainly concentrated in scientific research institutes, and pharmaceutical enterprises themselves do not have R & D capabilities. However, many Chinese biomedical R & D institutions are committed to the research and development of original drugs. They believe that outsourcing is a low-end job and are unwilling to participate in it

third, in China's investment in biotechnology industry, the proportion of public investment is quite large, but the efficiency is low and the waste is serious. Many biotechnology companies invested by the government and colleges and universities have invested in a full set of facilities, trying to establish a "large and comprehensive" business system to obtain all profits from research and development to production and sales, rather than outsourcing some links they are not good at

they suggested that China should accelerate the development of pharmaceutical outsourcing and promote the growth of Pharmaceutical Economy: first, outsourcing service institutions should be established. Gather more than 1000 biomedical R & D institutions scattered in many R & D institutions in China, establish outsourcing service centers, carry out intermediary services, distribute outsourcing services that can be provided by new drug R & D enterprises, integrate into the global outsourcing service market, and finally form an outsourcing service chain covering all stages of new drug R & D, and explore new growth points of drug R & D. Secondly, establish Sino foreign joint venture outsourcing enterprises. Encourage cooperation with biomedical enterprises in developed countries to establish Sino foreign joint venture outsourcing enterprises, so as to learn from foreign advanced operation and management experience, master the information and trends of international new drug research and development, organize and manage outsourcing business according to international standards, and improve the level of research and development. At the same time, further strengthening the construction of intellectual property rights is conducive to European and American Biomedical enterprises to confidently hand over an intermediate link of R & D projects to Chinese enterprises, or jointly develop biomedical projects. Finally, strengthen the construction and management of clinical bases. At present, the number of domestic clinical trial bases is far from meeting the increasing demand for product research and development. Compared with foreign countries, there is still a large gap in the methods of clinical trials, the standardized management of clinical bases, and the construction of enterprise clinical supervision personnel

source: Xinhua News Agency

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