Academician Liu Changxiao: industrial transformation drives local pharmaceutical innovation

Source: China Science Daily / Liu Changxiao 2015-03-04 through the "11th Five Year Plan" and "12th Five Year Plan" drug innovation national action incentives, China's domestic drug advantages gradually appear From 2011 to 2014, the growth momentum of domestic and imported drugs in first tier urban hospitals was stable, and the growth proportion of domestic drugs in basic drugs and medical insurance drugs was significantly higher than that of imported drugs From the analysis of the number of new drugs to be approved and under research, there will be more new drugs coming on the market in the next 2-3 years than in 2014, giving patients with different levels of needs more choices Therefore, how to adapt to the current situation and drive by industrial transformation is very important Facing the test of transformation and development, China's biomedical enterprises are facing the test of transformation from low-end to high-end, from imitation to innovation, and from domestic demand market to international market In particular, the innovation ability of large state-owned enterprises is obviously insufficient, and it is more difficult to rely on new products to improve the competitiveness of enterprises There are four major problems in the research and development of new products of pharmaceutical enterprises: first, the overcapacity of China's low-end pharmaceutical industry far exceeds the global demand; second, as a special commodity, the research and development of new pharmaceutical products is becoming more and more important with people's higher and higher requirements for the quality of life; third, the form of government support for major innovation will be from the platform The change from support to variety support or follow-up support is difficult to have the basis of innovative products and brand products under the condition of insufficient innovation ability Fourthly, in today's fierce market competition environment, most enterprises are facing the pressure of increasing cost, reducing profit space and shortening product life cycle The product management of pharmaceutical manufacturers focuses on innovative products and brand products, and increases investment in new product development In 2014, there were 184 M & A cases of listed companies, 24% higher than that in 2013; in 2014, there were 19 pharmaceutical related enterprises listed at home and abroad, a significant improvement over previous years In the future, as the total volume of the pharmaceutical market is increasing, it is very important to further speed up the pace of integration in the field of pharmaceutical health, seize the opportunities of the three transformations, deploy the development strategies of the three major industries of chemical medicine, biological medicine and traditional Chinese medicine, and find a breakthrough After nearly 10 years of exploration, some enterprises have obtained successful transformation experience Looking back on the examples of innovation and development transformation of local pharmaceutical industry in 2014, four pharmaceutical enterprises with successful transformation and good innovation performance are Haizheng, Kangyuan, hisic and Shuanghe Their R & D investment exceeds 10% of sales, reaching 14.9%, 11.4%, 11.0% and 10.6% respectively Haizheng pharmaceutical industry is good at seizing the three transformation opportunities, so that it has the ability to develop a class of new drugs with high difficulty and new high-quality pharmaceutical products Kangyuan focuses on the in-depth research and development of traditional Chinese medicine preparations, making its annual research and development investment in the forefront of Chinese medicine enterprises On the premise of ensuring output value and profit, state-owned enterprises should innovate in management, operation, incentive and cooperation mechanism and play the main role With the development of biotechnology in the past 30 years, many new drugs have been introduced from abroad or developed in China At present, the market share of biopharmaceuticals in China is too small (2%) and the treatment needs high-quality and affordable biopharmaceuticals However, the principle of special evaluation of biopharmaceuticals has not been formally introduced The research and development of biological similar drugs in China is facing industrial changes First, the production capacity of enterprises is small, the quality is far away from international standards, and they are at a disadvantage in low price competition Second, faced with regulatory problems, China's food and drug administration has published a draft of technical guidelines for the review of biological similar drugs Third, after the formulation of the standard, how to not only reduce the application procedures of enterprises, but also ensure the consistency with the original research drug will face challenges Some private enterprises with capital, technology and international cooperation ability in China have promoted their biological drugs to the international market For example, the recombinant red blood cell growth factor (epiao) of Sansheng company, yisapu of CITIC Guojian have entered Latin American countries, and the cooperation between Haizheng pharmaceutical and foreign countries will promote the entry of four biological similar drugs such as rituximab into more than 30 national pharmaceutical markets It can be said that China's biopharmaceutical industry is at a new turning point, and their performance will become the driving force of biopharmaceutical innovation It is the key to the transformation of large pharmaceutical countries to attach importance to the research and development of pharmaceutical preparations Considering the strategy of industrial development, local pharmaceutical enterprises must attach importance to the research and development of pharmaceutical preparations to promote the transformation of China from a large pharmaceutical country to a large pharmaceutical country We are well aware that the pharmaceutical products of the world's super pharmaceutical enterprises entering China are not APIs with high cost, high harm, high energy consumption and high pollution, but pharmaceutical products with high technology, high added value, low energy consumption and low pollution FDA approved drugs are publicized as preparations rather than APIs The development of China from a big producer of APIs to a powerful pharmaceutical industry depends on the development of pharmaceutical preparation industry, and drug release technology is the key to the development of high-end pharmaceutical preparations in China From the perspective of development strategy of pharmaceutical industry, we should develop high-end innovative pharmaceutical products with core competitiveness In combination with the development trend and frontier of international pharmaceutical preparations, we should pay attention to the following five issues in the development of new pharmaceutical preparations in China First, attach importance to the transformation and development of enterprises Many pharmaceutical companies in the world have successively reduced their R & D funds, closed their R & D institutions, or reduced their personnel Most of them pay attention to the development of new drug delivery systems (DDS) The market size of new DDS in the United States in 2011 was US $153.5 billion, with an average annual growth rate of nearly 16% Therefore, it can be considered that DDS is superior to new entity drugs in terms of improving R & D speed, reducing development cycle, reducing R & D risk and improving enterprise profits Five nano preparations developed by elan, a small American company, using nanotechnology have been approved by FDA Second, encourage the enterprises with foundation to go out During the 12th Five Year Plan period, led by the State Key Laboratory of Tianjin Pharmaceutical Research Institute, an innovation alliance was established to organize 11 state key laboratories to overcome the difficulties of innovative preparations and excipients, and effectively improve the technical level of preparations in China For example, in the process of several new preparations going out of Shandong green leaf company, some preparations have been approved by CFDA and FDA for clinical research The third is to pay attention to the research of the short board of the industrialization research and development of new preparations, whose theory, technology, auxiliary materials, technology, equipment and other issues are the key to restrict the development During the 11th Five Year Plan and the 12th Five Year Plan, the state has increased its support and mobilized the enthusiasm of research and development institutions and enterprises In terms of nanopharmaceuticals, FDA has approved the listing of various types of nanopharmaceuticals, and small companies can also carry out innovative research and development through pharmaceutical channels Although China is a big country of "nano papers", no nano drugs have been approved for marketing Fourth, promote the research and development of innovative preparations to meet different medical needs: at present, domestic drugs are basically generic drugs, more than 95% of which are ordinary tablets, capsules, etc., often more than 100 or even 200 Many enterprises produce the same kind of drugs, but few produce high-end products such as slow-release, controlled-release and intelligent preparations, few produce children's preparations, and few professional research and development institutions Fifth, encourage the research and development and industrialization of pharmaceutical excipients At present, China's pharmaceutical excipients are still relatively backward Compared with 3000-4000 kinds of common excipients in Europe and America, there are only 132 kinds of excipients in 2010 edition of Chinese Pharmacopoeia and 271 kinds in 2015 edition The research and development of pharmaceutical excipients in China should start from the basis, application, materials, technology and quality, etc it is suggested that the State encourage project approval, international cooperation and introduction of useful pharmaceutical materials and technologies to serve domestic enterprises.