美国提出六大生物制药领域反制措施

Core Viewpoint - The U.S. FDA has announced an immediate review of new clinical trials involving the transfer of live cells of American citizens to certain countries, including China, for genetic engineering, indicating a growing concern over China's biotechnology advancements and potential restrictions on its development [1] Group 1: U.S. Regulatory Actions and Concerns - The U.S. has introduced the "Biological Security Act" draft, which limits federal collaboration with foreign biotech companies, specifically naming five companies from China [2] - The NSCEB report highlights China as a significant strategic challenge in the global biotechnology landscape, reflecting the U.S. perception of China's rapid advancements in the sector [2][3] - The U.S. biotechnology market has seen a substantial increase in competition from China, with Chinese biotech companies' market capitalization growing 100 times from 2016 to 2021, reaching approximately $300 billion [2] Group 2: China's Biotechnology Industry Growth - China's share of global pharmaceutical production increased from about 5% in 2002 to nearly 25% in 2019, establishing itself as a major source of various drug raw materials [4] - The proportion of clinical trials conducted by Chinese biotech companies globally rose from 3% in 2013 to approximately 29% in 2023, surpassing North America and Europe [11] - The number of highly cited papers in synthetic biology has shifted dramatically, with China increasing its share from 13% in 2010 to 60% in 2023, while the U.S. share dropped from 45% to 7% [8] Group 3: Factors Contributing to China's Success - Policy support has been crucial, with significant investments in biotechnology since the inclusion of biomedicine in the "Made in China 2025" initiative [9] - China's clinical trial process has become more efficient, with trials starting in as little as 18 months compared to several years in the U.S., and costs for Phase I trials averaging one-third of U.S. costs [9][10] - The transition to an implied approval system for clinical trials has further accelerated the process, reducing the approval timeline from up to a year to 60 days [10] Group 4: U.S. Proposed Measures Against China - The NSCEB report suggests six measures for the U.S. to enhance its biotechnology capabilities and counter China's advancements, including establishing a national biotechnology coordination office and encouraging private investment [14][15] - The report emphasizes the need for the U.S. to integrate biotechnology innovation into national defense and strengthen research and development efforts [15][16] - Strengthening talent development and international cooperation with allies is also highlighted as essential for maintaining U.S. leadership in biotechnology [16][17] Group 5: Interdependence and Global Cooperation - Despite the competitive landscape, U.S. biotechnology heavily relies on Chinese capabilities, with 79% of U.S. biotech firms using cell lines or plasmids from China [17] - The U.S. faces significant costs and time delays if it attempts to replace Chinese production capabilities, with estimates suggesting a one-time cost of $18 billion and annual labor costs increasing by at least $12 billion [17] - The article advocates for international cooperation as a means to drive global biotechnology development rather than suppression and competition [18]