Expand advantages and accelerate the construction of a new development pattern for the API industry

APIs are a key link in the upstream supply chain of the pharmaceutical industry chain
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In recent years, China's API industry has developed vigorously, the industrial structure has continued to be optimized, and the export scale has continued to expand

A few days ago, the National Development and Reform Commission and the Ministry of Industry and Information Technology jointly issued the "Notice on the Implementation Plan for Promoting the High-Quality Development of the API Industry" (hereinafter referred to as the "Implementation Plan"), proposing to persist in innovation and lead and accelerate the green and low-carbon transformation of APIs , To promote the construction of a new development pattern for the API industry
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Good foundation for industrial development

China's fine chemical industry has a good foundation, and the scale of the pharmaceutical market is second only to the United States.
A complete industrial chain covering key intermediates, APIs and preparations has been formed, providing strong support for the high-quality development of the API industry
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Since the "13th Five-Year Plan" period, the scale of China's API industry has continued to grow, and the status of the world's largest producer and exporter has gradually consolidated

Driven by the rapid development of the industry as a whole, the structure of China's API products has been continuously optimized
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Bulk APIs are China's traditional advantage field.

In terms of specialty APIs with high added value and high threshold, the competitiveness of our country's products is also increasing.
Some specialty APIs such as Penem, Puri, and Sartan are widely supplied to the global market
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Since the outbreak of the new crown pneumonia epidemic, China has increased its export of raw materials, which has effectively alleviated the tight global supply of raw materials

Under the encouragement and guidance of policies such as national support and encouragement of innovation, a large number of high-level R&D personnel have returned to the country to start businesses, and the development of new models and business forms of the API industry has made positive progress, which has fostered new momentum for industrial development
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For example, in terms of specialized contract R&D and production services, China has already had a number of high-quality companies participating, which has strongly promoted China's drug R&D innovation and industrialization, and is deeply integrated into the global pharmaceutical R&D chain

Industrial development opportunities and challenges coexist in the new era

In recent years, the internal and external development environment of the API industry has undergone profound changes, the economic operation is unstable, and uncertain factors have increased, meeting the requirements for high-quality development, promoting the transformation of the API industry from large to strong, and accelerating its move to the high-end of the global value chain.
Facing new challenges and opportunities
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Increased competitiveness in the international market

Affected by various factors such as the rise of protectionism and unilateralism in pharmaceutical trade in relevant countries and regions, and the tight global supply of medical drugs during the epidemic, the demand for diversified and autonomous supply of raw materials has been increasing
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Since the outbreak of the new crown pneumonia epidemic, countries and regions such as Europe and the United States have announced the expansion of API production capacity.

Product competitiveness needs to be improved 

Chinese enterprises rely on the huge domestic consumer market and have broad room for development
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However, due to the late start and the constraints of multinational companies' patents and technology monopolies, the products are mainly bulk API products, with low added value and strong substitutability, and the R&D and innovation capabilities of high-end APIs still need to be improved

Increased pressure for green and low-carbon development 

Because the production process requires the use of a variety of organic solvents, the emission intensity of the "three wastes" (waste water, exhaust gas and solid waste) of API companies has been high, which has always been the focus of environmental protection supervision in various places
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With the in-depth implementation of the carbon peak and carbon neutral strategy, the environmental protection constraints faced by the development of API companies will become more stringent, and the industrial green and low-carbon transformation is imminent

Take multiple measures to promote the high-quality development of the industry

Do everything possible to make up for shortcomings in the industry chain to improve the stability of the API supply chain 

APIs are a key ingredient of drugs and are related to drug supply and price stability.
We must encourage superior companies to grow bigger and stronger, continuously increase the proportion of new APIs and high value-added products, reduce drug production costs, and enhance the resilience of the supply system
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To implement major projects for the high-quality development of APIs, it is necessary to cultivate an innovation system that combines production, education and research, and upstream and downstream linkages, and is geared to the needs of clinical drugs and cutting-edge technology fields, accelerate the development of advanced production technology and equipment, and improve the production efficiency and quality control of APIs
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Conform to the needs of transformation and upgrading, and promote the green and low-carbon development of API companies 

Under the constraints and guidance of policies such as industry and environmental protection, the structure of China's API industry has been optimized, advanced production capacity has been continuously released, and backward production capacity has been eliminated and exited in an orderly manner
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With the continuous advancement of carbon peaks and carbon neutrality, China's green and low-carbon circular economy system will be further improved, and higher requirements will be put forward for the green and low-carbon development of enterprises
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The "Implementation Plan" clearly puts forward important principles and major tasks such as strict energy efficiency and environmental protection standards, promotion of green and low-carbon technology and equipment, and building a green supply chain.
Strive for the initiative in competition and cooperation
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Enhance industrial innovation capabilities and actively integrate into the global industrial chain value chain 

High-end APIs such as innovative APIs and specialty APIs have high added value and strong growth potential, and are important areas to enhance market competitiveness
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In recent years, as the innovation environment continues to improve, the demand for high-end APIs in China has increased sharply, attracting the technology transfer of patented APIs from multinational companies, and promoting the development of China's API industry to the upstream of the global pharmaceutical value chain, which is deeply embedded in the global pharmaceutical industry chain.
Created the conditions
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The "Implementation Plan" proposes measures to enhance industrial innovation capabilities from three aspects.
The first is to strengthen the position of the enterprise as the mainstay of innovation and promote comprehensive innovation including process innovation and model innovation; the second is to vigorously optimize product structure and improve innovative products, The proportion of high value-added products; the third is to strengthen the sharing of advanced technologies in related industries and enhance the level of industrial integration and innovation
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Promoting the high-quality development of the API industry is a systematic project
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The issuance and implementation of the "Implementation Plan" is based on the actual development of the industry and is in line with the industry development trend.
With the gradual implementation of key tasks such as accelerating advanced technology research and development, promoting green and low-carbon transformation, promoting concentrated agglomeration development, and guiding high-level open cooperation, raw materials The resilience of the supply system of the pharmaceutical industry will be significantly enhanced, and the overall competitiveness of the industry will be greatly improved, providing strong support for the development of the pharmaceutical industry
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