Recently, nine departments including the Ministry of industry and information technology, the national development and Reform Commission, the Ministry of science and technology, the Ministry of Commerce, the National Health Commission, the emergency management department, the medical insurance bureau, the drug administration and the administration of traditional Chinese medicine jointly issued the “14th five year plan” for the development of pharmaceutical industry (hereinafter referred to as the “plan”).
The plan points out that the pharmaceutical industry is a strategic industry related to the national economy and the people’s livelihood, economic development and national security, and an important foundation for the construction of a healthy China. The 14th five year plan is the first five years for China to embark on a new journey of building a modern socialist country in an all-round way and march towards the goal of the second century. It is also the key five years for the pharmaceutical industry to transform to innovation driven and achieve high-quality development. Therefore, the above-mentioned plan is formulated.
Compared with the previous five-year plan, the plan has fundamental changes in many aspects. For example, the emergency management department, the medical insurance bureau and the administration of traditional Chinese medicine are new to the joint printing and Distribution Department this time; From “quality first” and “supply guarantee” to “life first”; From “innovation driven” to “Innovation led”.
However, the plan also points out that during the 14th Five Year Plan period China Meheco Group Co.Ltd(600056) industrial development opportunities outweigh challenges and are still in an important period of strategic opportunities. Facing the new situation and new tasks, it is necessary to speed up the resolution of some prominent problems restricting the development of the industry. Therefore, the 14th five year plan has made important strategic guidance, including: improving the ability of technological innovation; Improve the industrial chain and supply chain; Improve the supply guarantee mechanism; Improve manufacturing level; Strengthen industrial upgrading and enhance international competitiveness.
new situation and new requirements
The pharmaceutical industry includes chemical preparations, raw materials, Chinese herbal pieces, Chinese patent medicines, biological drugs, excipient packaging materials, pharmaceutical equipment, medical devices, sanitary materials, etc. it is a strategic industry related to the national economy and the people’s livelihood, economic development and national security, and an important foundation for the construction of a healthy China.
Since the 13th Five Year Plan period, under the strong leadership of the CPC Central Committee and the State Council and with the joint efforts of all parties, China Meheco Group Co.Ltd(600056) industry has made outstanding achievements, with a more solid development foundation, a stronger driving force for development, a new level of overall development, new breakthroughs in industrial innovation, an increasing level of supply guarantee and an accelerating pace of internationalization, It has made outstanding contributions to covid-19 epidemic prevention and control.
During the 13th Five Year Plan period, the added value of the pharmaceutical industry above designated size increased by 9.5% annually, 4.2 percentage points higher than the overall industrial growth rate, and the proportion in the total industrial added value increased from 3.0% to 3.9%; The operating income and total profit of Enterprises above designated size increased by 9.9% and 13.8% annually, ranking the forefront of all industrial industries. The scale of leading enterprises has grown and the industrial concentration has increased. In 2020, the proportion of operating revenue of top 100 enterprises will exceed 30%.
At the same time, new breakthroughs have been made in industrial innovation during the 13th Five Year Plan period. Pharmaceutical R & D investment continues to grow, with an average annual growth of about 8% for Enterprises above designated size. In 2020, R & D expenses of listed companies accounted for more than 6% of sales revenue. The number of new drugs under development jumped to the second in the world, more than 1000 new drugs were applied for clinical application, and 47 domestic innovative drugs were approved for listing, double that of the 12th Five Year Plan. A number of high-end products in the fields of medical devices, pharmaceutical equipment and production consumables fill the gap in China.
However, the problems restricting the development of the industry are still prominent, the original innovation ability of cutting-edge fields is still insufficient, the industrial ecology of coordinated development has not yet been formed, the supply risk of small-scale seed drugs still exists, the quality control level in the fields of generic drugs, traditional Chinese medicine, auxiliary materials and packaging materials needs to be improved, and the international competitive advantage of high value-added products is not strong.
At the same time, the global pharmaceutical industry is facing adjustment. Since the outbreak of covid-19 pneumonia, countries have paid more and more attention to the strategic position of the pharmaceutical industry, and the international competition in talent and technology has become increasingly fierce; It has accelerated the expansion of China’s traditional export chain and brought challenges to China’s traditional economy.
To this end, the plan points out that during the 14th Five Year Plan period, the internal and external environment for the development of the pharmaceutical industry is facing complex and profound changes, the construction of a healthy China has been promoted in an all-round way, and the cause of health has changed from treating diseases to people’s health; The formation of a new development pattern with China’s big cycle as the main body and the mutual promotion of international and Chinese double cycles has accelerated, and the China Meheco Group Co.Ltd(600056) market has entered a high-quality development stage; A new round of technological change and cross-border integration have accelerated, big data and artificial intelligence have been deeply integrated into all links of the development of the pharmaceutical industry, and innovative new drug creation technologies, innovative therapies and new drugs have emerged. The new development stage puts forward higher requirements for the pharmaceutical industry. The pharmaceutical industry urgently needs to speed up the reform of quality, efficiency and power, so as to provide strong support for the construction of a new development pattern.
The plan also puts forward six specific objectives, including the steady growth of economies of scale, the achievement of innovation driven transformation, the stability and controllability of industrial chain supply chain, the continuous enhancement of supply guarantee capacity, the improvement of manufacturing level system, and the overall acceleration of international development.
adhere to innovation leading
In terms of innovation, it has changed from “adhering to innovation driving” in the 13th five year plan to “adhering to innovation leading” in the 14th five year plan. In fact, this is the transformation of the R & D end of the pharmaceutical industry from “me better” to “FIC (first in class)”.
During the 13th Five Year Plan period, a large number of traditional pharmaceutical enterprises accelerated their innovation and transformation, significantly increased innovative and entrepreneurial enterprises, and significantly increased the number of new drugs entering the clinical stage and R & D investment. During the 14th Five Year Plan period, a large number of pharmaceutical innovation achievements will complete clinical research and apply for listing. The pharmaceutical industry will also continue to increase innovation investment and accelerate innovation driven transformation.
Therefore, the plan proposes that the R & D investment of the whole industry will increase by more than 10% annually during the 14th Five Year Plan period; By 2025, the proportion of new sales of innovative products in the increment of operating revenue of the whole industry will further increase.
The report “building an China Meheco Group Co.Ltd(600056) Innovation Ecosystem – Part 2 of a series of reports: promoting basic research and activating the source of innovation” jointly issued by the China Meheco Group Co.Ltd(600056) innovation promotion association and the pharmaceutical research and development industry committee of China Association of foreign invested enterprises (rdpac) points out that from the perspective of the proportion of China’s current R & D investment, Although the proportion of China’s basic research in the total R & D investment reached 6% in 2020, there is still a significant gap with the level of more than 15% in the world’s leading biomedical countries; Similarly, the proportion of Applied Research in China’s total R & D investment is 11%, which is far behind the average level of nearly 20% of the world’s leading biomedical countries.
In the plan, it is encouraged to strengthen the technical cooperation between industry, University, research and medicine. Support leading pharmaceutical innovation enterprises to strengthen cooperation with national laboratories, national scientific research institutions, high-level research universities and other institutions, take the lead in integrating and gathering innovation resources, lay out and build a national manufacturing innovation center in key sub sectors, and strengthen key common technology research in the industry.
Song Ruilin, executive president of the innovation promotion association, pointed out in an interview with the 21st Century Business Herald, “in the 14th five year plan, the first priority determined by the state is to establish strategic scientific and technological innovation capacity. Basic research is now our weakness. We should strengthen cooperation in industry, University and research and strengthen basic research.
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internationalization goes deep
The overall acceleration of international development is one of the six specific objectives put forward in the plan.
For the goal of internationalization, the goal of the 13th five year plan is: the export of medicine will grow steadily, the proportion of export delivery value in sales revenue will strive to reach 10%, the export structure will be significantly improved, and the export proportion of preparations and medical equipment will be increased. The scale of overseas investment has been expanded, international technical cooperation has been deepened, and the ability of international development has been greatly improved.
The internationalization of the 13th five year plan also handed in the answer: the average annual growth of export delivery value was 14.8%, and the international registration of innovative drugs made a breakthrough. Foreign investment of enterprises has been active, the introduction of products and technologies has increased, and the effective use of international resources has accelerated development.
In the plan, there is no specific data on internationalization, but the specific goal is to comprehensively accelerate the development of Internationalization: maintain the growth of pharmaceutical exports; Breakthrough in “going out of Chinese patent medicine”; Cultivate a number of world-famous brands; A number of large pharmaceutical enterprises with global layout of R & D and production and high proportion of international sales have been formed. Among them, the breakthrough of “going out” of Chinese patent medicine was put forward for the first time.
From the perspective of the plan, in terms of internationalization, the plan from the 13th five year plan to the 14th five year plan is progressive at all levels.
At present, in order to create new advantages in international competition, the plan points out that we should actively respond to the new situation of reshaping the global pharmaceutical innovation chain, industrial chain and supply chain, deepen international industrial cooperation, accelerate the cultivation of new competitive advantages, and integrate into the global innovation network and industrial system at a higher level.
The plan proposes to attract global pharmaceutical innovation elements to gather in China, based on the China Meheco Group Co.Ltd(600056) big market, attract global innovative drugs and medical devices to register in China first, and shorten the time difference between the listing of innovative products outside China as a whole.
Support Chinese clinical research institutions to actively participate in and organize international multi center clinical research and improve the internationalization level of clinical research. Encourage multinational corporations to set up R & D centers and innovative drug production bases in China. Guide Chinese enterprises to introduce foreign advanced technology through cooperative development and technology licensing, improve innovation efficiency and narrow the gap with the international advanced level. Give full play to the policy advantages of Hainan free trade port to facilitate the clinical urgent need of licensed drugs and instruments that have been listed abroad but not listed in China.
According to the 21st Century Business Herald, the reporter learned from the administration of Lecheng Pioneer District that the landing of international innovative drugs and equipment in Lecheng has been accelerating. In January 2020, Lecheng imported more than 50 licensed drugs and equipment, and by January this year, it has exceeded 200, which indicates that Lecheng has basically realized the “three synchronization” of medical technology, equipment and drugs with the international advanced level. This is nearly three years ahead of the expected 2025 goal, so that Chinese people can use the most advanced drugs and equipment in the world without going abroad.
At the same time, promote China Meheco Group Co.Ltd(600056) enterprises to enter the international market at a higher level. Including supporting enterprises to carry out synchronous registration of innovative drugs outside China, carrying out global multi center clinical research for the markets of developed countries, and realizing the value of innovative drugs in a broader space. Seize the international market opportunities of biological analogues, encourage vaccine manufacturers to carry out international certification, and produce and export vaccines in accordance with international vaccine procurement requirements. Increase the number of generic drugs registered in developed countries and increase the proportion of high value-added products such as first generic drugs and complex preparations. One belt, one road, will speed up the global layout of the industrial chain, encourage enterprises to improve their international market operation capability, and strengthen joint investment in “one belt and one road” investment, and actively explore new pharmaceutical markets.
In addition, consolidate the foundation of international pharmaceutical cooperation, strengthen international drug administration cooperation, deeply participate in the international regulatory coordination mechanism, play an important role in the formulation of relevant guidelines of the international organization for the coordination of human drug registration technology (ICH), actively promote the participation in the international drug inspection cooperation plan (PIC / s), and promote the integration of laws and regulations, mutual recognition of standards and mutual trust in quality between China and foreign countries. By promoting drug regulatory cooperation and mutual recognition with key regions, we will create conditions for more convenient access of pharmaceutical products to the international market. Strengthen exchanges and cooperation with the international herbal medicine Regulatory Cooperation Organization (IRCH) and give play to the global leading role of traditional Chinese medicine standards. We will promote exchanges and cooperation between Chinese and foreign industry organizations in trade promotion, information exchange, industry self-discipline and dealing with frictions, and build a public service platform for international cooperation in medicine.
The plan mentioned that looking forward to 2035, China Meheco Group Co.Ltd(600056) industrial strength will achieve an overall leap; The innovation driven development pattern has been fully formed, and the number of original new drugs and “leading” products has increased, becoming an important source of world pharmaceutical innovation; Prominent industrial competitive advantages and upgrading of industrial structure occupy an important position in the global pharmaceutical industry chain; With a wide range of products and excellent quality, we can achieve a higher level to meet the health needs of the people and provide a solid guarantee for building a healthy China in an all-round way.
