Home > Chemial News > Policies > Interpretation of The 'Notice on The Implementation Plan for Promoting The High-quality Development of The API Industry'

Interpretation of The 'Notice on The Implementation Plan for Promoting The High-quality Development of The API Industry'

ECHEMI 2021-11-22

APIs are a key link in the upstream supply chain of the pharmaceutical industry chain. 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. Facing the new changes and new needs of the international competitive landscape and the domestic development situation, my country's API industry still needs to further enhance its green and low-carbon development capabilities and continuously improve the modernization level of the industrial chain and supply chain. Recently, the National Development and Reform Commission and the Ministry of Industry and Information Technology jointly issued the "Implementation Plan on Promoting the High-quality Development of the API Industry" (hereinafter referred to as the "Implementation Plan"), proposing to insist on innovation-driven and accelerate the green and low-carbon transformation of APIs. Promote the construction of a new development pattern for the API industry.


1. The development foundation of China's API industry is relatively good

my country'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. Since the "Thirteenth Five-Year Plan", the scale of my country's API industry has continued to grow, and its status as the world's largest producer and exporter has been gradually consolidated. In 2020, the main business income of my country's raw material drug production enterprises was 394.5 billion yuan, and the total profit reached 52.5 billion yuan, an increase of 23.9% year-on-year, and the profit margin reached 13.3%, an increase of 5.7% over 2015.

Driven by the rapid development of the industry as a whole, the structure of my country's API products has been continuously optimized. Bulk APIs are my country's traditional advantage field. The output and export scale of vitamins, antibiotics and other products are in a leading position in the world, becoming an important source of APIs in countries such as India. In terms of specialty APIs with high added value and higher thresholds, the competitiveness of our country's products is also increasing. Some specialty APIs such as penem, pruri, and sartan are widely supplied to the global market. Since the outbreak of the new crown epidemic, my country has increased its export of raw materials, which has effectively alleviated the tight global supply of raw materials.

Under the guidance of policy incentives such as the state's support and encouragement of innovation and 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. For example, in terms of specialized contract R&D and production services, my country has already had a number of high-quality companies participating, which has strongly promoted my country's drug R&D innovation and industrialization, and has deeply integrated into the global pharmaceutical R&D chain.


2. Challenges and opportunities faced by the development of the API industry 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. They have met the requirements for high-quality development, and promoted the transformation of the API industry from large to strong, and accelerated the process of moving towards the high-end of the global value chain. Challenges and opportunities.


(1) Increased competitiveness in the international market.

Affected by various factors such as the rise of protectionism and unilateralism in the pharmaceutical trade of relevant countries, and the tight global supply of medical drugs during the epidemic, the demand for diversified and autonomous supply of raw materials has been rising. Since the epidemic, countries in Europe and the United States have announced the expansion of raw materials production capacity. At the same time, it is studying and formulating policies related to carbon border tax. my country's APIs will face more intense competition in the international market.


(2) Product competitiveness needs to be improved.

Chinese companies rely on the huge domestic consumer market and have a broad development space. However, due to their late start and the constraints of multinational companies’ patents and technology monopoly, their products are mainly bulk raw materials, with low added value, strong substitutability, and high-end products. The R&D and innovation capabilities of APIs still need to be improved. Some preparation companies choose to import APIs to enhance the resilience of their supply chains, exposing shortcomings in the supply chain of my country's API industry chain.


(3) The pressure for green and low-carbon development is increasing.

Since the production process requires the use of a variety of organic solvents, the "three wastes" emission intensity of API companies is relatively high, which has always been the focus of environmental protection supervision in various regions. With the in-depth implementation of the carbon-neutral strategy of carbon peaking, the environmental protection constraints faced by the development of API companies will become more stringent, and the green and low-carbon transformation of the industry is imminent.


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


(1) Do everything possible to make up for the shortcomings of the industry chain and improve the stability of the API supply chain.

APIs are a key ingredient of drugs and are related to drug supply and price stability. Advantageous companies must be encouraged 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. The "Implementation Plan" proposes to implement a major project for the high-quality development of APIs, promote the integration of production, education and research, upstream and downstream linkages, and face 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.


(2) Conform to the needs of transformation and upgrading, and promote the green and low-carbon development of API companies.

Under the guidance of policy constraints such as industry and environmental protection, the structure of my country'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. With the continuous advancement of carbon peaks and carbon neutrality, my country'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. 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.


(3) 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. In recent years, as the innovation environment continues to improve, the demand for high-end APIs in my country has increased rapidly, attracting multinational companies to transfer patented API technology, promoting the development of my country's API industry to the upstream of the global pharmaceutical value chain, creating conditions for deep embedding in the global pharmaceutical industry chain . The "Implementation Plan" proposes measures to enhance industrial innovation capabilities from three aspects. The first is to strengthen the company’s main position in innovation and promote comprehensive innovation including process innovation and model innovation; the second is to vigorously optimize product structure and improve innovative products and high The proportion of 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.

Promoting the high-quality development of the API industry is a systematic project. 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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