NIE 2023 | Jianxin Yang, Gilead Sciences: Innovative Drugs Going Global —— There Will Be a Time When the Wind Blows Strongly and the Waves Break

Dr. Yang Jianxin pointed out that the history of Chinese pharmaceuticals going global began with the overseas sales of bulk drugs. With the rapid development of China's chemical industry, bulk chemical drugs began to occupy a large share of the international market on a large scale. After 2005, China's generic drug regulation became increasingly standardized and China officially joined the International Council for Harmonization of Technical Requirements for Human Pharmaceuticals (ICH) in 2017, marking a successful entry into the global generic drug market. It was only in recent years that innovative drugs have truly started to go global, with several innovative drugs having successfully entered overseas markets, including overseas clinical trials and commercialization.

Dr. Yang Jianxin then analyzed why the number of drugs under consideration for overseas development has been climbing rapidly: Firstly, it is due to China's innovation drug research and development. After 2015, China's pharmaceutical regulatory policies were significantly standardized and improved, promoting innovation drug research and development, which led to a rapid increase in IND filings; secondly, the quantity and quality of clinical trials in China are also continuously improving; thirdly, the proportion of broad-spectrum first-in-class drugs in global clinical trials is constantly increasing; and finally, China's accession to ICH has aligned clinical trial design and quality with international standards.

When discussing the challenges faced by innovative drugs, Dr. Yang Jianxin proposed two points: First, with the significant reduction in medical insurance access prices, the domestic market survival space for innovative drugs has been further compressed; second, there is a significant gap in the payment capabilities of innovative drugs among countries, with great potential in overseas markets. Against the backdrop of China's strengthening of the innovative drug industry, aligning its regulatory system with international standards, high pressure to reduce domestic drug prices, and great potential in overseas markets, the time has come for Chinese pharmaceutical companies to go global.

When discussing the dilemma of innovative drugs going global, Dr. Yang Jianxin summarized it into four points:

The first dilemma is 'insufficient data'. The internationalization journey of innovative drugs in China is not a quick process and requires full alignment with international standards in clinical trial design, execution, and data quality.

The second dilemma is whether clinical development speed and breadth can 'go hand in hand'. With the race to 'go global', how to ensure that promising varieties are transformed into international products in a timely manner during the clinical phase is one of the pain points for many Chinese innovative drugs; the 'closing effect' is evident— if there is not much difference in efficacy, the first drug launched globally can capture about 64% of the market share, followed by about 25%, with those after that having a very limited chance to enter the global market.

The third dilemma is the concentration of target selection for innovative drug research and development, leading to intense homogenized competition. The popular targets for innovative drugs are mainly concentrated in the field of oncology; there is a 50% overlap between the popular target selections for innovative drugs in China and those globally; popular targets have relatively definite pharmaceutical properties, and the likelihood of successful clinical research and subsequent market launch is higher. Flocking to popular tracks is often the first choice for most innovative pharmaceutical companies.

The fourth challenge is that the domestic research ecosystem has not yet matured, leaving significant room for improvement among enterprises, research institutions, and the government. Overall, China's industrial transformation from mainly generic medicine to mainly innovative drugs has just begun, and a mature and diverse collaborative research ecosystem has not yet been formed. The R&D proportion of leading domestic enterprises has been able to catch up with some international leading multinational pharmaceutical companies, but the absolute value of R&D expenses of domestic pharmaceutical companies is still far behind that of foreign leading multinational pharmaceutical companies.

Dr. Yang Jianxin stated that to break through the dilemma of Chinese innovative drugs going global, several aspects need to be considered:

First, where to go global? How to go there? With whom? Dr. Yang Jianxin pointed out that going global to the United States is the most difficult, while the EU and the UK are relatively easier; export models can include independent clinical trials + commercialization, independent clinical trials + licensed commercialization, fully licensed clinical trials and commercialization; when choosing a partner for global expansion, it is not necessarily the only option to consider MNCs; local advantageous enterprises also need to be taken into account. It is necessary to carry out targeted international team and capability building, construct cooperation capabilities and risk response strategies.

Secondly, for innovative drugs going global, differentiated products, profound clinical/registration capabilities, a suitable commercialization model, and international talents are key to breaking through the constraints. Dr. Yang Jianxin took Cornerstone Pharmaceuticals as an example, introducing the company's significant progress from research to development and then to commercialization. He listed strategies and situations for products such as Sugilimab (PD-L1 antibody), Nofazinlimab/CS1003 (PD-1), and CS5001 (ROR1 ADC) to go global, using specific examples to analyze how Chinese innovative drugs can break through the difficulties in going global.

Finally, Dr. Yang Jianxin emphasized that in addition to the product itself, a strong team is also crucial for going global.