However, compared with the biopharmaceutical industry in the advanced countries of the world, China's biopharmaceutical industry is still in the early stage of development, and its development is also facing a series of challenges.
Emphasis on generic drug development strategy
According to the U.S. pharmaceutical and biotechnology information agency FiercePharma, the sales of drugs due to patent expiration in 2014*** amounted to 34 billion U.S. dollars, which is higher than 28 billion U.S. dollars in 2013 and lower than 55 billion U.S. dollars in 2012, and in 2015 this figure is expected to climb to 66 billion U.S. dollars. billion.There are 10 patent expiration drugs that will be genericizable in 2014, such as Novartis, which will lose its patents on both the drugs Sandostatin and Exforge.Allergan's Lumigan is also set to expire in August 2014.Essentially all of WarnerChilcott's drugs are set to expire in 2014.This is the first time that a patent expiration is expected to take place in a year. Therefore, timely selection of expiring generics and preparation of filing documents in advance will surely lead to profitable business opportunities.
For small molecule generic drugs, to carry out generic drug quality consistency and clinical consistency evaluation, to comprehensively improve the quality of generic drugs is an important task of the "National Drug Safety" Twelfth Five-Year Plan, but also an effective means to continuously improve the quality of medicines, and to enhance the overall standard of the pharmaceutical industry, to protect the safety of the public medication is of great significance. The company's products and services have been widely recognized as the best in the world for their quality.
Pharmaceutical companies are the main body to carry out generic drug quality consistency evaluation, must fully realize that the generic drug quality consistency evaluation to ensure drug quality and safety, and promote the pharmaceutical economic restructuring and industrial upgrading is of great significance, but also will enhance the international competitiveness of China's pharmaceutical industry.
Because of China's new drug research and development and the ability to create the industry's short board, China's pharmaceutical industry has always maintained the status quo of "big country of generic drugs". The consistency evaluation of generic drug quality actually requires companies to re-examine the scientific and rational nature of their products. If the state can fully reflect the value of generic drugs in ensuring medical needs in evaluation, pricing, bidding, health insurance, etc., establish a catalog of generic reference preparations, gradually improve the evaluation system of the quality of generic drugs, and eliminate varieties that fail to meet the requirements of intrinsic quality and clinical efficacy, it will undoubtedly promote the improvement of the overall standard of China's generic drugs, so as to reach or approach the international advanced level.
Chinese drug companies lack competitiveness in the international arena and should start with generic drugs. The patented drugs of multinational pharmaceutical companies in China now account for only 30 percent of the drugs circulating in the market. A more realistic path for pharmaceutical companies is to start by copying international drugs and improving their generic standards. In this regard, Israel and India's drug companies are doing better, the quality is also higher, some can also be certified by the U.S. FDA, in the international community.
Israel, India and other drug companies are worth learning from the model, they will be two or three years before the expiration of the patent ahead of the scientific research on the preparations, once the patent lapses immediately launch new drugs. China's drug companies only through the imitation of profit accumulation, have a certain strength, before they can slowly carry out the real original drug, and seek higher profits.
In order to avoid homogeneous competition, Chinese pharmaceutical companies also need to consider the following issues: first of all, the identification of large varieties, tracking and analysis of expired or about to expire product information, make full use of patented technology, patent expiration and claim points, at the same time, but also pay attention to the international rules of the game of intellectual property rights research, focus on the study of conflicts between intellectual property rights law and the accessibility of generics, the use of intellectual property rights, the relevant international regulations as well as bilateral laws and regulations, the existence of a new drug. relevant international regulations as well as the problems existing in bilateral laws. The second is to pay attention to the development strategy, and should organize the demonstration of training programs for talents in medicine, pharmacy, economics, and intellectual property rights, which is especially important for the development of complex biosimilar drugs. The third is to enhance the comprehensive development capacity, utilizing the lower human capital and production cost in China, and to develop with foreign enterprises to rapidly accumulate experience and enhance the development production capacity. The fourth is to introduce laws, regulations and guidelines related to biosimilar drugs to facilitate the enhancement of the scientific R&D foundation and the sustainable development of the industry. The fifth is to cultivate the medication habits of doctors, pharmacists, and patients in using biosimilars, and to introduce relevant policies to encourage the use of generics to replace original drugs, and to reduce the support of pharmaceutical costs. The last is to pay attention to international production certification, actively utilize multi-channel financing modes such as venture capital, actively explore the international market, and merge and reorganize to form international enterprises.
Emphasis on drug formulation research and development
Drug release technology is the key to the development of China's high-end drug formulation research and development, from the strategic considerations of industrial development, preparation is a high-tech industry, is a low-energy and low-pollution industries, but also high-value-added industries, but also China's production of raw materials from the big country to the development of the pharmaceutical industry powerhouse the way to go.
From the perspective of the strategy for the development of the preparation industry, we should develop high-end innovative preparations with core competitiveness, adopt a variety of flexible cooperation methods, make full use of domestic and foreign resources and cost advantages, and find new directions and ideas for development.
Combined with the international drug formulation development dynamics and frontiers, the development of new formulations in China should pay attention to the following issues.
The first is to emphasize the transformation and development. The world's pharmaceutical companies have compressed R & D funds, closed R & D organizations, or cut R & D personnel, most companies focus on the development of new drug delivery system (drugdeliverysystem, DDS). The market size of new DDS in the United States in 2011 has reached $153.5 billion, with an average annual growth rate of nearly 16% compared with the previous five years. Therefore, it can be assumed that DDS is significantly better than the development of new entity drugs in terms of enhancing the speed of R&D, reducing the development cycle, lowering the risk of R&D, and improving the profits of enterprises. For example, Elan, a small U.S. company, has developed five nano-formulations, including Hapamune, using nanotechnology, which have been continuously approved by the U.S. FDA.
The second is to encourage enterprises with a foundation to go out. In the process of going out, enterprise state key laboratories can play a leading role. For example, Shandong Greenleaf has launched a number of new preparations, some of which have been approved by China's FDA and the U.S. FDA to enter clinical research. In the context of globalization development, the company's independent intellectual property rights of the varieties to become internationalized new drugs is entirely possible.
The third is to study the application basis of new formulations as well as industrialization and development. China's DDS R & D shortcomings are still a lot of theory, technology, excipients, technology, equipment and other issues are key constraints on its development. The state in the "Eleventh Five-Year Plan" and "Twelfth Five-Year Plan" period has increased support, greatly mobilizing the enthusiasm of R & D institutions and enterprises. In terms of nanomedicine preparations, the U.S. FDA has approved a variety of types of nanomedicine on the market, and small companies can also carry out innovative research and development through the preparation route. Although China is a "nano-research paper" production of large countries, but China has not been approved by a nanomedicine.
Lastly, it is to strengthen the research and development and industrialization of pharmaceutical excipients. At present, the domestic drugs are basically all generic drugs, of which more than 95% are ordinary tablets, capsules, etc., often more than 100 or even more than 200 enterprises to produce the same variety of drugs, while the production of slow-release, controlled-release, intelligent preparations, such as high-end products of very few enterprises, the production of children's preparations is not a lot of enterprises, engaged in the research and development of the professional organizations are very few.
Pharmaceutical excipients are the key to the quality, safety and efficacy of preparations. China's pharmaceutical excipients are still relatively backward, first, the quantity is small, second, there is no excipient research organization in China, and third, the quality of excipients is poor, and the choice is small. At the same time, China's pharmaceutical excipients quality management regulations and policies introduced more, difficult to implement.
The author believes that the research and development of China's pharmaceutical excipients should start from the foundation, application, materials, technology and quality of multiple pathways, can not rely on foreign countries, it is recommended that the national R & D program. In addition, the use of foreign useful materials, technology for domestic enterprises to reduce restrictions, encourage international cooperation, learning from the United States to adopt the "recognized safe substances" can be used as excipients of the principle of new drug research and development to give more freedom.