NIE 2024 | Dr. Anil Kane of Thermo Fisher Scientific: Deepening China's Biopharmaceutical R&D through International Experience to Facilitate Innovation and Internationalization

Key points from Dr. Anil Kane's speech:

Dr. Anil Kane first shared the main trends in China's pharmaceutical R&D. Looking at the number and scale of China's pharmaceutical R&D pipelines from 1995 to 2024, the number of active drug pipelines in China has grown rapidly over the past few years. China currently develops 26.7% of the world's active drugs, making it the second largest new drug R&D country globally. In addition, a total of 1,270 pharmaceutical companies have set up their headquarters in China, second only to the United States in number. These data indicate that a large amount of investment is entering the field of new drug R&D in China. The reason is China's policy environment that supports innovative development and its gradually maturing localized innovation capabilities. For example, China's '14th Five-Year Plan' focuses on drug innovation, technological breakthroughs, and global expansion, creating a favorable environment for international companies. The adjustment of the National Essential Medicines List (NRDL) rules has promoted innovation and development in China's pharmaceutical industry. With a series of policy guidance and institutional reforms implemented, as well as continuous improvement in technical capabilities, China has significantly accelerated the drug review and approval process, and the growth rate of R&D pipelines has remained at a high level. Subsequently, Dr. Anil Kane introduced four main ways for global pharmaceutical companies to enter the Chinese market, including acquisitions, new investments, joint ventures, and licensing rights. In recent years, it has been noted that licensing rights events have gradually emerged in China, showing a preference for this approach over other methods.

Dr. Anil Kane further analyzed the characteristics and trends of licensing transactions of Chinese pharmaceutical companies. Among the top 10 foreign licensing transactions in China's biopharmaceutical sector in 2023, there were multinational pharmaceutical companies such as Bristol-Myers Squibb, AstraZeneca, and Merck. Among the top 10 license-in events, many involved the transfer of clinical assets to regions around the world, and Chinese companies are actively seeking opportunities to enter global markets. Looking at the clinical stage of related licensing events, they mainly focused on drugs in the early clinical stage, covering various forms such as small molecules, biological products, antibody conjugates, and more. It can be seen that Chinese companies have achieved rapid growth in global licensing transactions, which has become an important path for them to enter global markets.

Dr. Anil Kane proposed six main value points around the value of global CDMOs as strategic partners. The first point is comprehensiveness of services, providing comprehensive services from drug R&D to commercial approval, covering preclinical, clinical, CMC activities, and application processes; second is professional advantage, leveraging expertise, global network, and infrastructure to help drugs move from concept to market; third is compliance, ensuring compliance with global quality and regulatory requirements; fourth is providing due diligence support in audits, inspections, and licensing transactions; fifth is promoting the success of new drug molecule clinical development through external cooperation; in addition, global CDMOs have a complete global supply chain, capable of providing end-to-end global clinical supply chain services.

When further discussing the industry role of global CDMOs, Dr. Anil Kane pointed out that CDMOs widely support large pharmaceutical companies, medium-sized enterprises, and biotechnology companies, which outsource more than 50% of their drug development work to CDMOs. At the same time, CDMOs support various drug development models, covering small molecule drugs, biological products, cell and gene therapies, viral vectors, and mRNA, indicating that CDMOs play a crucial role in global licensing transactions and new drug product approvals. In the future, cooperation between Chinese pharmaceutical companies and global CDMOs, as well as licensing events for clinical assets, will provide more development opportunities for Chinese pharmaceutical companies.

Subsequently, Dr. Anil Kane shared a representative case from Thermo Fisher's Patheon™ Pharmaceutical Services. In 2020, a Chinese pharmaceutical company entrusted the drug development, technology transfer, and Phase II clinical trials of a tumor drug molecule to Thermo Fisher's Patheon™ Pharmaceutical Services. Thermo Fisher's Patheon™ Pharmaceutical Services not only successfully transferred the manufacturing of multiple low-dose tablet products but also expanded production scale to meet the needs of Phase III clinical trials. After strict audits, inspections, and CMC work, the drug project was ultimately recognized globally. At the end of 2023, this product pipeline was successfully acquired by a globally renowned company for over $1 billion, highlighting the key value of CDMO services in drug development.