How is the progress of domestic substitution of API? Which fields still rely on imports?
Active Pharmaceutical Ingredient (API) is the core raw material for drug manufacturing, and its quality and supply stability are directly related to the pharmaceutical industry and public health and safety. In recent years, as the country attaches great importance to the independent control of the pharmaceutical industry, domestic substitution of API has become an important strategic direction for China's pharmaceutical industry. This article will comprehensively sort out the progress of domestic substitution of API, analyze the existing bottlenecks and challenges, and focus on analyzing which key fields still rely heavily on imported API.
1. Strategic background of domestic substitution of API
1. Increased demand for safety and independent control of the pharmaceutical industry
China is the world's second largest pharmaceutical market, but API supply is highly dependent on imports, especially some key APIs. The outbreak of the COVID-19 pandemic in 2019 exposed the fragility of the global supply chain. The obstruction of imports had a serious impact on the safety of domestic drug supply, and strengthened the strategic urgency of domestic substitution.
2. Increased national policy support
The Chinese government has intensively introduced policy measures to support the localization of API, such as the "14th Five-Year Plan for the Development of the Biopharmaceutical Industry" and the "Opinions on Promoting the Evaluation of the Quality and Efficacy Consistency of Generic Drugs", to promote industrial upgrading and innovation capabilities. The centralized drug procurement policy has also promoted the standardization and centralization of the domestic API supply chain.
2. The current situation and progress of domestic substitution of API
1. The localization of traditional API has been basically achieved
Most traditional chemically synthesized APIs have been domestically produced on a large scale, forming a relatively complete industrial system. For example, for commonly used generic APIs such as amoxicillin, cephalosporins, lovastatin, and metformin, domestic companies have sufficient production capacity and strong price competitiveness.
Complete industrial chain: Possessing full-chain production capacity from intermediates to APIs;
Improved technical level: The production process is becoming mature and meets GMP standards;
Significant cost advantage: The labor and raw material costs are lower than imported products.
2. Steady progress in the localization of innovative drug APIs
In recent years, with the acceleration of innovative drug research and development, a number of high-end complex APIs have begun to achieve domestic substitution. Some domestic companies producing new drug raw materials such as cephalosporins, anti-tumor drugs, and antiviral drugs have gradually mastered key technologies and obtained approval documents from the Food and Drug Administration.
Key technological breakthroughs: such as asymmetric synthesis, biosynthesis and other technical applications;
Multi-variety pipeline construction: focus on key areas such as tumors, cardiovascular, diabetes, etc.;
Cooperative innovation: joint development between enterprises and universities and research institutes.
3. Rapid development of biological APIs and macromolecular drug APIs
The rapid development of biopharmaceuticals has promoted the growth of demand for domestic production of biological macromolecular drug APIs. Domestic biological API companies have gradually achieved large-scale production of recombinant protein and antibody drug raw materials through technology introduction and independent innovation.
III. The main challenges and bottlenecks of domestic substitution of APIs
1. Limited core technology of high-end complex APIs
The technical threshold of some APIs with complex molecular structures, high purity and multi-step synthesis is high, and domestic companies have insufficient R&D investment, and it is still difficult to break through key synthesis routes and processes.
2. Quality consistency and stability issues
The quality of some domestic APIs has not yet fully reached the international advanced level, and there are challenges in purity, impurity control and stability, which affect their entry into the high-end generic drug and innovative drug market.
3. Low industrial concentration
The domestic API industry is small, scattered and weak, with insufficient large-scale production and technological innovation capabilities, making it difficult to form leading companies with international competitiveness.
4. Intellectual property barriers and international standard gaps
Internationally renowned APIs are mostly protected by patents, and domestic companies face difficulties in technology introduction and patent authorization; at the same time, the international market has increasingly stringent API quality standards, and domestic APIs need to accelerate standard upgrades.
4. Analysis of key API fields that rely on imports
Although domestic substitution has made significant progress, some key areas still have a high degree of import dependence, mainly including the following categories:
1. Innovative drugs and high-end APIs
Antitumor drug APIs: For example, APIs for some targeted drugs and immune checkpoint inhibitors still rely on imports.
Antiviral drug APIs: The supply of APIs for some new antiviral drugs (such as some new crown treatment drugs) lacks domestic substitution.
Biomacromolecule drug APIs: The production technology of recombinant proteins, peptides, and antibody drugs is complex and relies heavily on imports.
2. Scarce complex intermediates and raw materials
Some API synthesis requires reliance on special intermediates, catalysts or raw materials. These intermediates and key reagents have long relied on imports, forming a supply chain bottleneck.
3. Emerging high-tech APIs
For example, raw materials and reagents related to cell therapy and gene therapy, domestic technology is still in its infancy and relies on imported technology and products.
V. Key measures to promote domestic substitution of API
1. Strengthen technological innovation and R&D investment
Enterprises need to increase investment in new technology R&D, focus on high-end complex API synthesis processes, and improve quality control and process stability. The government should support the construction of innovation platforms and promote the deep integration of industry, academia and research.
2. Improve industry concentration and integrate resources
Promote industrial mergers and reorganizations, support leading enterprises to become stronger and bigger, create industrial clusters with international competitiveness, and improve economies of scale and R&D capabilities.
3. Improve regulations, standards and quality systems
Accelerate the alignment of API pharmacopoeia standards with international standards, improve the construction of quality management systems, and ensure that the quality of domestic APIs reaches international advanced levels.
4. Optimize industrial chain layout and supply chain security
Strengthen the localization capabilities of key raw materials and intermediates, build a stable and diverse supply chain system, and ensure continuous and stable production.
VI. Future Outlook
With the continuous support of national policies and technological progress, domestic substitution of APIs will be further accelerated, especially in the fields of innovative high-end APIs and biological raw materials. The quality and technical level of domestic APIs will gradually approach international advanced standards, and the scale and competitiveness of the industry will be significantly improved.
However, in the face of complex API synthesis, international patent protection and global market competition, domestic substitution still needs to overcome difficulties, continue to deepen technological innovation, promote industrial upgrading, and ensure the independent security and sustainable development of China's pharmaceutical industry chain.
VII. Summary
API domestic substitution has been basically achieved in the field of traditional chemical synthesis API, and has been steadily advancing in the fields of innovative drugs and biological API;
Domestic substitution faces challenges such as technical difficulties, quality control and insufficient industrial concentration;
High-end APIs such as anti-tumor, antiviral, and biomacromolecules are still heavily dependent on imports;
It is necessary to increase R&D investment, enhance industrial integration, improve the quality system, and ensure supply chain security.
