The United States and Europe are rolling out different solutions to check and catch up with China's rapidly growing biotech industry.
While the United States is focusing on blocking the inflow of capital and technology into Chinese biotech corporations by front-loading the Biosecure Act and investment controls, the European Union (EU) appears to be putting more weight on a strategy to raise drug development competitiveness itself by strengthening support for the clinical and research and development (R&D) ecosystem.
Industry officials say Korea, too, urgently needs a strategy to move beyond production-centered competition and accelerate clinical data generation and R&D speed.
According to the KoreaBIO Bioeconomy Research Center on the 27th, the United States and Europe have recently been pursuing different policy directions in response to the growth of China's biotech industry.
Chairperson John Moolenaar of the U.S. House Select Committee on the Strategic Competition between the United States and the Chinese Communist Party recently sent a letter to U.S. Treasury Secretary Scott Bessent urging that the biotech sector be included as a restricted category for investment under the Comprehensive Outbound Investment National Security Act (COINS Act).
The European Commission, by contrast, is pushing to enact a second EU Biotech Act, moving to strengthen the competitiveness of the biotech ecosystem from basic research through clinical development to commercialization.
◇ U.S. focuses on cutting off capital and controlling supply chains to check China
The U.S. strategy is centered on blocking the flow of capital and technology heading to China's biotech industry. In the letter, Moolenaar said, "The United States is engaged in fierce biotech competition with China, which has major implications for national security and economic security," adding, "Innovative drug development is the core axis of competition."
The Bioeconomy Research Center assessed that this move reflects caution over a surge in large-scale technology deals between U.S. pharmaceutical companies and Chinese biotech corporations. In fact, the size of global tech deals reached about $136 billion last year (206 trillion won), and the share of large contracts worth $50 million (about 76 billion won) or more jumped from 0% in 2020 to 48% last year.
Recently, Bristol Myers Squibb (BMS) signed a co-development deal worth a total of $15 billion (about 23 trillion won) with China's Hengrui Pharma, underscoring continuing technology collaboration between the two sides.
The United States views biotech as a strategic industry on par with semiconductors and artificial intelligence (AI), and is pursuing a supply chain reconfiguration strategy to reduce dependence on China in key areas such as biopharmaceutical contract development and manufacturing (CDMO) and genomic analysis through the Biosecure Act.
◇ EU strategy to strengthen industry competitiveness centered on R&D and clinical
Europe, by contrast, is taking an approach that checks China while building up the industry's competitiveness itself. The drafting of a second EU Biotech Act signals an intent to boost the speed and competitiveness of the biotech industry by strengthening support systems that cover the entire cycle from research to clinical development to commercialization. The European Commission is focusing on reducing inefficiencies in new drug development and ensuring that investment and technology circulate virtuously within Europe.
The first EU Biotech Act, announced in Dec. last year, included support measures such as regulatory sandboxes, fast-track approvals for industrial microorganisms, and streamlined permitting for biomanufacturing projects.
The second bill complements the existing strategy while focusing on creating an environment that secures business viability for biotech corporations within the EU. Notably, it expands the scope from a focus on medical and pharmaceutical (red biotech) to industrial biotech (white biotech), biomaterials (green biotech), and biomanufacturing, aiming to strengthen competitiveness across the industry.
The EU aims to attract the clinical trials and investments of global pharmaceutical and biotech corporations to Europe by improving clinical approval speed, expanding access to capital, and making regulations more flexible. In particular, shortening approval timelines for multi-country clinical trials and introducing regulatory sandboxes are seen as key incentives that could shift corporations' clinical execution and investment bases to Europe.
◇ "Korea faces limits to approval-centered policy; urgent need for a speed race in clinical and R&D"
The domestic pharmaceutical and biotech industry is also closely watching the recent trend. Although the size of new drug technology exports by domestic corporations surpassed a record 20 trillion won last year, the gap with China (about 100 trillion won) remains large.
The Korean government has also moved to improve regulations.
The Ministry of Food and Drug Safety said it will implement the Medical Product Marketing Authorization and Review Innovation Plan starting on the 1st of next month to shorten approval and review procedures for new drugs, biosimilars, and innovative medical devices. The centerpiece is to reduce the approval and review period to about 240 days by introducing pre-application face-to-face meetings, providing checklists, and adding 195 staff members. The review method will also shift from a serial focus to a concurrent and parallel review system.
However, industry voices say there are still limits because policy remains focused on the approval stage. The core of global competition lies in the speed of clinical trial approvals, which come before approval.
Lee Seung-gyu, vice chair of the KoreaBIO, said, "Global biotech competition ultimately comes down to who secures clinical data faster," adding, "Shortening new drug approval reviews is important, but it is also necessary to speed up clinical trial approvals that come before that so domestic corporations can swiftly enter global trials."