Long term challenges for Chinese innovative drugs going global: Experts call for accumulating global experience and seeking diversified cooperation
2026-02-03
Recently, the Haiyan Salon event with the theme of "Exploring New Paradigms for China's Biopharmaceutical Going Global" was held at Deloitte Park in Pudong, a subsidiary of Pudong Development Group. Dozens of CEOs of listed biopharmaceutical companies, founders and representatives of biotechnology companies, as well as industry experts from law firms, banks, and investment institutions, jointly interpret the new paradigm of China's biopharmaceutical going global from the perspectives of industry empowerment, legal models, and capital insights. With the continuous growth of China's foreign authorized transactions, 'China Strategy' has become a core issue of concern in the international investment field. ”Huang Ke, the head of the Global Strategy and Development Investment Department of WuXi Biologics, stated that at the same time, global cooperation has become one of the core strategies in China's biopharmaceutical industry. However, the export of innovative drugs is not an easy path. Huang Ke introduced the main challenges faced by Chinese biopharmaceutical companies entering regions such as the United States and Europe, such as the mature market environment, fierce competition, high requirements for technology and clinical innovation in the United States, strict regulatory and approval processes for biopharmaceuticals by the US Food and Drug Administration, and a success rate of only 0.4% for Chinese biopharmaceutical products from clinical phase 1 to market in the United States; The European healthcare security system is complex and diverse, with significant differences in drug reimbursement and pricing mechanisms, requiring differentiated market access strategies. The European Medicines Agency has strict approval requirements for bio innovative drugs, with a long centralized approval process and strict requirements for Good Manufacturing Practice (GMP) for drug production. In 2023, Chinese companies only obtained 44 GMP certificates, while European companies obtained 1857 certificates. In countries such as Japan and South Korea, the pharmaceutical market is mature, and Chinese pharmaceutical companies need to overcome strict regulatory and approval standards, compliance requirements, etc. to go global. Huang Ke stated that, given the complexity of the global market and the differences in asset valuation standards for going global, seeking partners with global experience and recognition is the key to improving the success rate of asset going global. In 2025, the total amount of overseas authorized transactions for innovative drugs in China will be approximately 2.5 times that of 2024. The number of transactions, total down payment amount, and down payment amount of the top ten transactions have all reached new highs. Gu Yang, a partner at Hankun Law Firm, believes that the establishment of new company models and new transaction structures such as monetization of franchise fees have continuously become new choices for Chinese pharmaceutical companies to go global, marking the evolution of Chinese pharmaceutical companies towards a global "ecological partner" identity. Innovative pharmaceutical companies can enhance their understanding of diverse cooperation methods, obtain funding support for diversified pipeline layouts, and reduce future risks. Enterprises should actively explore various possibilities for international cooperation and investment opportunities, actively expand diversified financing channels, in order to increase their ability to resist risks. Wang Yongjie, Deputy Administrative Head of the Healthcare Industry Department at Guotai Haitong Investment Bank, stated that the engineering of underlying technologies in the pharmaceutical industry is China's advantage in this field, and fully embracing AI is the biggest trend of the times. In addition to breaking through the single link of authorized amount when going global, enterprises can also seek full chain collaboration in clinical and sales. China has the most complete R&D industry chain in the world, and the price of innovative drugs is about one tenth of that of the United States. Relying on engineering technology, it can still become the source of global innovative drugs. At the roundtable forum, industry experts believe that the core cornerstone of successful overseas expansion is meeting current clinical needs, providing differentiated innovative products, and conducting solid clinical research. The longer-term challenge of reaching a deal is to cultivate international composite talents and build a matching management and innovation system. (New Society)
Edit:WENWEN Responsible editor:LINXUAN
Source:Science and Technology Daily
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