Enhancing the original innovation capability of the biopharmaceutical industry

For some time, regions such as Guangdong, Shanghai, and Henan have seized opportunities, focusing on advantageous fields such as biopharmaceuticals, chemical drugs, and medical devices, as well as future fields like synthetic biology and brain science, to promote the expansion of the biopharmaceutical industry and unleash productivity. The Third Plenary Session of the 20th Central Committee of the Communist Party pointed out the need to improve policies and governance systems that promote the development of strategic industries such as new generation information technology, artificial intelligence, aerospace, new energy, new materials, high-end equipment, biopharmaceuticals, and quantum technology, guiding the healthy and orderly development of emerging industries. The biopharmaceutical industry is an important component of strategic emerging industries and a key area for future industrial layout. It must promote the transformation of the biopharmaceutical industry towards high-end, intelligent, and green development through sound policies and governance systems.

Since the 18th National Congress of the Communist Party, China's biopharmaceutical industry has rapidly grown in overall scale, with significant improvements in innovative drug research and development capabilities. As of 2023, China has cumulatively achieved 169 domestic innovative drugs and 250 domestic innovative medical device products on the market. In 2023 alone, 35 domestic innovative drugs and 47 domestic innovative medical device products were approved for market launch, with the number of new drugs under research ranking second globally. The R&D strength of enterprises continues to improve, leading companies are rapidly growing, and a number of influential flagship products have emerged. For example, some specialized enterprises have developed new drugs for liver cancer that show product advantages in treating advanced liver cancer; some state-owned enterprises have significantly increased R&D investment in recent years to promote industrial structure optimization and upgrading in areas such as biological products, chemical pharmaceuticals, modern traditional Chinese medicine, and health sectors, reflecting strong innovation capabilities and development potential in the biopharmaceutical field.

In recent years, multiple policy documents supporting and regulating the biopharmaceutical industry have been issued at the national level, providing clear directions for industrial development and support frameworks. Currently, more than ten provinces (cities) have released normative documents to guide and promote high-quality development of the biopharmaceutical industry within their regions. For example, Guangdong Province has simplified certain import registration approval processes for traditional external Chinese medicines already on the market in Hong Kong and Macau to promote integrated development of traditional Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area; it has promoted clinical outcome transformation as an important basis for evaluating medical institutions' performance to better serve R&D and industrial development with clinical resources. Additionally, special funds have been established for R&D subsidies to play an important role in investing in basic research and strengthening the industrial chain.

It is important to note that there are still some urgent issues that need to be addressed in the development of China's biopharmaceutical industry. For instance, there is a high degree of reliance on imported raw material supply, relatively weak original innovation capabilities, and low efficiency in results transformation; there is a significant gap between high-level talents and innovative results compared to some developed countries; there is a relative lack of independent intellectual property rights for core technologies and key components; industry concentration is low with a lack of internationally competitive leading enterprises; institutional supply and policy regulatory environments need further improvement; etc. These issues have constrained the competitiveness enhancement and high-quality development of China's biopharmaceutical industry to some extent. In response to this, it is necessary to adhere to a problem-oriented approach and continuously release policy dividends from multiple levels including new drug R&D, complete synergy along the industrial chain, enterprise innovation capabilities, and market competitiveness to enhance the original innovation capabilities of the biopharmaceutical industry and lead high-quality development with new productive forces.

At the level of industrial policy, it is necessary to enhance the effective and balanced use of policy tools. Strengthen investment in basic research and platform construction to build a collaborative development industrial chain and innovation chain. Focus on basic disciplines and increase support for key laboratories and research centers while encouraging interdisciplinary research. Utilize advanced technologies to improve review efficiency and accuracy by establishing a fast-track priority review mechanism to enhance China's international review level. Accelerate the market launch cycle for innovative drugs while enhancing application promotion for pharmaceutical innovation products. Improve infrastructure construction for industries to promote technology sharing and market expansion while driving cluster development in the biopharmaceutical industry to form an industrial ecosystem characterized by close cooperation across the entire industrial chain with efficient resource allocation.

At the level of business entities, it is essential to enhance independent innovation capabilities among research entities while deepening integration between industry, academia, and research. Focus on tackling key technological challenges while actively cultivating high-end talents. Strengthen R&D breakthroughs in core technologies such as new reagents, new technologies, new instruments, and new equipment. Establish close cooperation mechanisms between enterprises and universities to achieve resource sharing and complementary advantages while promoting rapid transformation of scientific achievements. Follow internationally accepted quality standards and norms while strengthening management over procurement of raw materials, production process control, product inspection processes to ensure stable and reliable product quality while continuously enhancing corporate and industry brand image.