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The Arrival of New Opportunities

Pharmaceutical and Health Industry Special Study

Innovation-driven Transformation
By 2020, the R&D investment intensity of enterprises above the scale of the industry will reach more than 2%.

The target for R&D investment in the 13th Five-Year Plan formulated in 2016 is: by 2020, the R&D investment intensity of enterprises above the scale of the industry will reach more than 2%. The quality of innovation will be significantly improved, new drug registrations will account for a greater proportion of drug registrations, a number of high-quality innovations will be industrialised, and breakthroughs in international registration of new drugs will be achieved.

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Investment in Pharmaceutical R&D

During the Thirteenth Five-Year Plan period, investment in pharmaceutical R&D will continue to grow, with an average annual increase of about 8% in R&D investment by enterprises above the scale. The proportion of R&D expenditure of listed companies to sales revenue will exceed 6% in 2020. The number of new drugs under development The number of new drugs under development has jumped to the second place in the world, with more than 1,000 new drugs filed for clinical application and 47 domestic innovative drugs approved for marketing, doubling the number of the 12th Five-Year Plan.

The number of new drugs in research and development will be the second largest in the world, with more than 1,000 new drugs declared for clinical use and 47 domestic innovative drugs approved for marketing.

14th Five-Year Plan

Basic Principle: Innovation

At present, domestic and foreign countries are facing a new round of technological changes and cross-border integration accelerated background environment, around the new mechanism, new target drug The breakthroughs in basic research and translational applications of new mechanisms and new targets have been continuously achieved, and the deep integration of biomedicine and new-generation information technology The new generation of biotechnology, represented by gene therapy, cell therapy, synthetic biotechnology, bifunctional antibodies, etc., is becoming increasingly mature, providing a new opportunity for the pharmaceutical industry to develop a new generation of biotechnology. This has provided a wide scope for the pharmaceutical industry to seize the opportunities of the new round of technological revolution and industrial change. This provides a wide space for the pharmaceutical industry to seize the opportunities of the new round of technological revolution and industrial transformation. China's pharmaceutical industry should adhere to innovation to lead the way and make innovation the core task to promote the high quality development of the pharmaceutical industry. We should accelerate the implementation of the innovation-driven development strategy, build an open innovation eco-system, improve the quality and efficiency of innovation, and speed up the implementation of the innovation-driven development strategy. The new engine for the sustainable and healthy development of the pharmaceutical industry will be built. The new engine for the sustainable and healthy development of the pharmaceutical industry.
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Basic Principle Innovation

Accelerate technological breakthroughs in product innovation and promote the industrialization and application of innovative drugs

Promote enterprises to focus on unmet clinical needs and increase investment in the development of innovative products. Support enterprises to focus on new targets and new mechanisms based on local resources and advantages, and to face the global market Carry out R&D layout and actively lead innovation. Promote innovation in traditional Chinese medicine and develop products that are compatible with the clinical positioning of traditional Chinese medicine, reflecting its characteristics and The Chinese medicine industry has been developing new drugs that are compatible with its clinical positioning and reflect its characteristics and advantages. Improve the clinical value-oriented drug clinical research and development guidelines, strengthen information guidance, and promote the rational layout of R&D pipelines by enterprises. For The 14th Five-Year Plan provides detailed guidance for different types of drugs, and defines the direction of innovation. Development directions.

  • Chemical Medicine

  • Traditional Chinese Medicine

  • Biological Drug

  • Chemical Medicine
    Focuses on the development of a range of products that address the major clinical needs of tumours, autoimmune diseases, neurodegenerative diseases, cardiovascular diseases, diabetes, hepatitis, respiratory diseases, drug-resistant microbial infections and other major clinical needs. and rare diseases with new targets and new mechanisms. The development of antisense oligonucleotide, small interfering RNA The development of drugs based on novel technology platforms such as antisense oligonucleotides, small interfering RNAs and protein degradation technology (PROTAC). To develop precision therapeutics for specific disease subgroups based on the progress of disease segmentation and the need for precision medicine. To develop improved drugs with clear clinical value. Development of new and improved drugs with clear clinical value.
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  • Traditional Chinese Medicine
    The development of new Chinese medicines will be guided by clinical value and will be carried out in a variety of ways, such as the combination of disease and evidence, specific medicine for specific diseases or evidence-based Chinese medicines. The development of new Chinese medicines will be carried out in various ways, with emphasis on the development of compound preparations based on ancient classical prescriptions, and the transformation of Chinese medicine preparations in medical institutions into new Chinese medicines. and the transformation of Chinese medicine preparations in medical institutions into new Chinese medicine; in-depth research on the effective substances and pharmacology and toxicology of Chinese medicine We will also carry out basic research on the effective substances and pharmacology and toxicology of Chinese medicines; carry out secondary development of proprietary Chinese medicines and develop large varieties of Chinese medicines.
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  • Biological Drug
    In the field of antibody drugs, the focus is on the development of new antibody drugs for tumors, immune diseases, viral infections, hyperlipidemia and other diseases. The development of new antibody drugs for diseases such as oncology, immune diseases, viral infections, hyperlipidemia, new generation of immune detection site modulators, multifunctional antibodies, GPCR antibodies, antibody-coupled drugs (ADCs), and the development of antibodies and other drugs. G protein-coupled receptor (GPCR) antibodies, antibody-coupled drugs (ADCs), and the development of combination therapies between antibodies and other drugs. The development of combination therapies between antibodies and other drugs. In the field of vaccines, the focus will be on the development of novel neo-coronavirus vaccines, herpes vaccines, multivalent human papillomavirus (HPV) vaccines, and vaccines for the treatment of the disease. HPV vaccine and multi-drug polyvalent vaccines.
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The approval side and the payment side drive the industrialisation of innovation

  • Approval Side

    Accelerate the industrialisation of new products

  • Payment Side

    Promote the application of innovative products

  • Figure

    Statistics on the number of innovative drugs approved in China over the years

The 14th Five-Year Plan emphasizes the importance of open development, win-win cooperation, and actively responding to the new situation of the reshaping of the global pharmaceutical innovation chain, industry chain and supply chain. The 14th Five-Year Plan stresses the importance of open development, cooperation and win-win cooperation, actively responding to the new situation of reshaping the global pharmaceutical innovation chain, industry chain and supply chain, deepening international cooperation, accelerating the cultivation of new competitive The 14th Five-Year Plan stresses the importance of open development and cooperation.

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Attracting global pharmaceutical innovation elements to China

Based on the large domestic pharmaceutical market, we will attract innovative drugs and medical devices from around the world to be registered in China first, so as to shorten the time gap between domestic and international launches of innovative products. Support domestic clinical research institutions to actively participate in and organise Support domestic clinical research institutions to actively participate in and organize international multicenter clinical research, and enhance the internationalization of clinical research. Encourage multinational companies to set up R&D centres and innovative drug production bases in China. Encourage multinational companies to set up R&D centres and innovative drug production bases in China. Guide domestic enterprises to introduce advanced foreign technologies through joint development, technology licensing and other means to improve the quality of innovative medicines. The Chinese government should also encourage domestic enterprises to introduce advanced foreign technologies through collaborative development and technology licensing, so as to improve the efficiency of innovation and narrow the gap with the international advanced level. The The Hainan Free Trade Port policy will facilitate the importation of licensed drugs that have been marketed abroad and are not yet available in China. The government of Hainan is also committed to facilitating the importation of foreign licensed medicines that are not yet available in China.

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Promoting a higher level of access to international markets for Chinese pharmaceutical companies

Support enterprises to carry out simultaneous registration of innovative drugs at home and abroad, conduct global multi-centre clinical studies for developed markets, and realise the value of innovative drugs in a wider space. To realize the value of innovative drugs in a broader space. Grasp the opportunities in the international market for biosimilars The Chinese government should encourage vaccine manufacturers to carry out international certifications and produce and export vaccines in accordance with international vaccine procurement requirements. The number of generic registrations in developed countries should be increased. Increase the number of generic drug registrations in developed countries, and increase the proportion of high value-added products such as first generic drugs and complex formulations. The proportion of high value-added products such as first generic drugs and complex preparations should be increased. Accelerate the global layout of the industry chain, encourage enterprises to improve their international market operation capabilities and Strengthen investment and cooperation with the "One Belt, One Road" countries and actively explore emerging pharmaceutical markets.

International Cooperation

Actively promote participation in the International Pharmaceutical Inspection Cooperation Scheme (PIC/S) to facilitate the harmonisation of domestic and international regulations, mutual recognition of standards and mutual trust in quality. Promote cooperation and mutual recognition of drug regulations with key regions to create conditions for pharmaceutical products to reach international markets more easily. Strengthen exchanges and cooperation with the International Regulatory Cooperation in Herbal Medicine (IRCH) to To play a leading role in global Chinese medicine standards. Promote trade promotion, information exchange, industry self-regulation and The Chinese medicine industry will also strengthen exchanges and cooperation in the areas of trade promotion, information exchange, industry self-regulation and dealing with frictions, and build a public service platform for international cooperation in medicine.Registration of Pharmaceutical Products for Human Use (ICH) guidelines

Strengthen international pharmaceutical cooperation, participate in international regulatory coordination mechanisms, play an important role in the development of the International Co-ordinating Committee for the Registration of Pharmaceutical Products for Human Use (ICH) guidelines

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