"14th Five-Year" Pharmaceutical Industry Development Plan: Innovation and Internationalization as the Main Melody

On January 30, 2022, the Ministry of Industry and Information Technology and other nine ministries and commissions jointly issued the "14th Five-Year Plan for the Development of the Pharmaceutical Industry". The plan emphasized the important position of the pharmaceutical industry in the national economy, people's livelihood and economic development, and raised it to the national The height of the security strategy, in order to make the pharmaceutical industry closely follow the process of my country's second century-old goal under the new environment and new conditions, the plan indicates the main direction, specific objectives and key contents of the development of the pharmaceutical industry during the 14th Five-Year Plan period. According to the logic that downstream demand drives upstream development, the plan is not only for biopharmaceutical companies, but also for the biopharmaceutical upstream industry.

* The purple part of the following article is the original planning text.

emphasizes "insisting on innovation and leadership", and at the same time, it also puts forward the key content of the plan."Promote enterprises to focus on unmet clinical needs, increase investment and carry out innovative product development. Support enterprises to base themselves on local resources and advantages, face the global market, focus on new targets and new mechanisms of drugs to carry out research and development layout, and actively lead innovation".In the industrialization project of pharmaceutical innovation products, the key development areas of chemical and biological drugs are pointed out in detail, including"new technology platform drugs such as antisense oligonucleotides, small interfering RNA, protein degradation technology (PROTAC)", and "antibody drugs, vaccines, recombinant protein drugs, and other cell therapy and gene therapy for new targets and new indications" in biological drugs ".

as a whole, me too and fast follow pharmaceutical companies are relatively common in China's pharmaceutical industry at present. China's local innovative drugs are mainly in the gradual innovation stage of rapid follow-up. New drug research and development are mainly focused on hot targets. The number of first in class and me better pharmaceutical companies is limited. The "innovation leading" proposed in the 14th Five-Year Plan encourages biological pharmaceutical companies, in particular, leading enterprises that can achieve first in class and best in class can continuously increase innovation investment and accelerate innovation-driven transformation, thus playing a leading role in the whole industry.

From the perspective of specific key drugs, small molecule targeted drugs are one of the research hotspots in the domestic and foreign markets in recent years. Antisense oligonucleotides and small interfering RNA are the main forms of RNA targeted drugs developed in clinical practice in recent years. Eight related drugs have been approved for listing, and protein degradation technology has developed rapidly in recent years. Domestic pharmaceutical companies such as Baekje Shenzhou have invested a lot of research and development costs in protein degradation technology. Other biological drugs, including gene therapy and vaccines, are also key research and development varieties. This indicates that biopharmaceutical companies should make reasonable adjustments to their R & D layout, focusing on these new targets and new mechanism drugs that have not yet met clinical needs.

upstream enterprises should always pay attention to the adjustments made by downstream enterprises in drug research and development, grasp the changes in the demand of downstream enterprises for consumables, reagents, raw materials and technical services, and constantly upgrade their own products and services to meet the needs of each other.

Fourteenth Five-Year Plan states that:"We will enhance the ability to guarantee the supply of drugs that are prone to shortage, support the development of drug supply guarantee consortia, expand the coverage of varieties in centralized production bases for small varieties of drugs (drugs in shortage), and deepen supply chain collaboration. We will dynamically adjust the Rare Disease Catalogue, study and formulate incentive policies for the development of rare disease drugs in terms of review and approval and patent period extension, implement preferential tax policies, and encourage enterprises to speed up the development of relevant varieties.", in addition to vaccine development:"Improve vaccine emergency research and development and production capacity, in response to potential infectious disease risks, accelerate the establishment of nucleic acid vaccines and other new vaccine technology platforms to meet emergency research and development and production needs." and encourage vaccine manufacturers and key raw materials, consumables, equipment enterprises to strengthen collaboration, in response to the emergency situation may appear in the peak demand, improve the supply chain emergency adaptation capacity.

The above content instructs biopharmaceutical companies, medical institutions, etc. to improve their own reserve system, and key companies should maintain a certain scale of emergency reserves to respond to major public health emergencies. At the same time, it also points out the current situation of drug shortage in some key areas in China, which mainly includesdrugs for children and rare diseases, the research and development of such drugs is difficult and costly. Therefore, many companies have given up the development of drugs in this area and turned to more cost-effective products. The 14th Five-Year Plan pointed out that they will be introduced in the research and development and marketing of such drugs. Various incentive policies encourage companies to adhere to the research and development of such drugs.

vaccine research and development has become an important area under the new coronary pneumonia epidemic, and its research and development, production process and other processes will be more stringent than other common drugs. The 14th Five-Year Plan calls for strengthening contacts and collaboration with enterprises of important raw materials, consumables, production equipment and packaging materials,Upstream enterprises should focus on the consumables and equipment required for the development and production of new vaccines, and monitor the inventory and production line status at any time to ensure sufficient inventory and stable supply.

at the same time, improving the supply guarantee capacity also involves domestic enterprises to solve the problem of key technology "stuck neck. The overall market size of global biopharmaceutical equipment and consumables is about US $20 billion, with a growth rate of over 10%. Therefore, the state's support for supply chain enterprises is not only a strategic need, but also because of its broad market prospects. Referring to the UVL incident of Yao Ming Bio, the development of China's pharmaceutical industry has encountered bottlenecks in some fields, including technical problems of upstream equipment consumables. Although domestic related enterprises such as Cobaxt and Le Chun Bio have achieved results in related fields, the degree of localization in the process of domestic drug research and development and production is still not high. For CDMO enterprises, 60%-70% of the culture medium needs to use imported products in the middle and late stages of the project. For foreign suppliers who have established good commercial relations with domestic pharmaceutical enterprises,still need to adhere to technological innovation, emphasize the advantages of products, upgrade products on the basis of full understanding of downstream demand, pay attention to the progress of competing products, and at the same time guarantee the supply capacity during the epidemic.

points out the need to cultivate high-quality market players in different fields:"Cultivate emerging forces for industrial development, and support the development of specialized and new" little giant "enterprises that focus on subdivided fields, have a high level of specialization, and have strong innovation capabilities.", optimize the regional layout of the industrial chain:"implement major national strategies such as the coordinated development of Beijing-Tianjin-Hebei, the development of the Yangtze River Economic Belt, the construction of the Guangdong-Hong Kong-Macao Greater Bay Area, and the integrated development of the Yangtze River Delta, and promote the rational layout and orderly transfer of the pharmaceutical industry nationwide. Focus on supporting about 10 cities with a good foundation for pharmaceutical innovation and concentrated scientific and technological resources to develop into the main engines of new industrial momentum."

mainly emphasized the merger and reorganization of "big eat small" enterprises, while in the 14th Five-Year Plan, it emphasized the cooperation and coordination between large enterprises and "small giant" enterprises. This enlightens domestic pharmaceutical enterprises, large and small, should give full play to their respective advantages in innovation ability, technology level, market capital and other fields, deepen cooperation, jointly promote the development process of key drugs and innovative drugs, and win-win cooperation, the formation of a healthy competition situation, in the process is bound to stimulate the demand for upstream products, will bring dividends for upstream enterprises.

in terms of the regional layout of the industrial chain, compared with the usual emphasis on the Yangtze River Delta, the Pearl River Delta, the Bohai Rim, the 14th Five-Year Plan also proposed to focus on supporting about ten high-level pharmaceutical innovation cities, the follow-up may continue to introduce relevant policies to increase support for the pharmaceutical industry in such cities. The demand for upstream products in such major pharmaceutical provinces is often in the forefront, such as Shanghai, Jiangsu, Shandong, Beijing, etc. With the support of national policies, it is bound to increase investment in innovation and research and expand production capacity. Upstream companies need to focus on policy updates and build close business ties with pharmaceutical companies.

points out that it is necessary to attract global pharmaceutical innovation elements to gather in China:"Attract global innovative drugs and medical devices to be the first to register in my country; encourage multinational companies to set up R & D centers and innovative drug production bases in China; guide domestic companies to introduce advanced foreign technologies through cooperative development, technology licensing, etc., to narrow the gap with the international advanced level.", to promote a higher level of domestic pharmaceutical enterprises to enter the international market:"Support enterprises to carry out simultaneous registration of innovative drugs at home and abroad, carry out global multi-center clinical research for developed country markets, encourage vaccine manufacturers to carry out international certification, produce and export vaccines in accordance with international vaccine procurement requirements, and strengthen investment cooperation with the joint construction of" the belt and road initiative "countries to actively explore emerging pharmaceutical markets.", and strengthen international cooperation in drug administration, deeply participate in the international regulatory coordination mechanism, play an important role in the formulation of relevant guidelines of the international technical coordination organization (ICH) for human drug registration, actively promote the participation in the international drug inspection cooperation program (PIC/S), and promote the integration of domestic and foreign laws and regulations, mutual recognition of standards and mutual trust in quality.

internationalization is a key sector in the 14th Five-Year Plan. Compared with the previous 13th Five-Year Plan,has changed the previous single "going out" thinking and put "bringing in" in a more important position,is to attract global pharmaceutical innovation elements to gather at home, which will greatly enhance my country's pharmaceutical research and development capabilities, enhance the space for internationalization, and develop China into a key link in the global pharmaceutical innovation chain. For domestic biopharmaceutical enterprises, cooperation with foreign pharmaceutical enterprises or R & D institutions is an important means to open up the international market, so as to carry out clinical trials abroad, obtain marketing license and realize internationalization. In 2021, Sino-foreign co-developed oncology drugs such as Ociperlimab, Vidicetuzumab and Trellizumab all achieved a turnover of more than $2 billion. At the same time, the 14th Five-Year Plan requires more comprehensive internationalization of the pharmaceutical industry, which is not only product License-out, but also requires pharmaceutical enterprises.has the ability of research and development, production and commercialization on a global scale, and enters the international market with higher quality,, domestic pharmaceutical companies can consider gradually developing the road of globalization through investment and mergers and acquisitions. Upstream enterprises speed up the process of internationalization and establish their own production and R & D bases around the world to meet the product needs of downstream enterprises in many countries around the world.At the same time, the integration of domestic and foreign regulations also puts forward higher requirements on the product quality of upstream suppliers.

states that medicine should enhance the level of financial support:"Implement supporting policies such as the deduction of research and development expenses and the simple collection of value-added tax on anti-cancer drugs and rare disease drugs. Guide early investment to support scientific and technological innovation in the pharmaceutical industry and broaden financing channels for pharmaceutical enterprises.", in addition to standardizing the order of market competition and strengthening the construction of the medical talent team, it also made instructions. With the support of a number of policies, whether it is reducing R & D costs or accelerating the listing of drugs, it will further reduce the R & D pressure of biopharmaceutical companies, alleviate funding problems, and help companies accelerate the process of product innovation and R & D.

defines the main development goals and key development contents of the biomedical industry during this period,to "innovation" and "internationalization" as the main tone,innovation is to encourage pharmaceutical companies to carry out independent innovation in research and development, improve their own scientific research level and innovation capabilities, and enhance the internal circulation; internationalization not only attracts global innovative drugs to register in my country, but also supports domestic companies to carry out global multi-center clinical research for developed country markets. In particular, vaccines are used as a breakthrough to "go out" to form an external cycle of the pharmaceutical economy.biomedical upstream enterprises need to actively study the changes of product demand in the process of R & D and production, so as to continuously upgrade their existing products, especially local enterprises need to strengthen the breakthrough of key technical problems. At the same time, we should also pay attention to the trend of digitization, informatization and internationalization.