美国会限制来自中国的创新药吗？

Core Viewpoint - The recent market turbulence in the innovative drug sector is attributed to reports of a potential executive order from the Trump administration, which aims to impose stricter reviews on U.S. companies acquiring Chinese innovative drugs and increase FDA scrutiny on Chinese clinical trial data [1][5]. Group 1: Market Reaction - After an initial drop of over 4% in the innovative drug sector index and a 7% decline in the Hang Seng Biotech Index, market panic subsided quickly [2]. - Analysts believe the likelihood of the executive order being implemented is low, suggesting that the immediate impact on innovative drug business development (BD) will be limited and primarily emotional [3][7]. Group 2: Implications of the Executive Order - The proposed executive order includes stricter reviews by the Committee on Foreign Investment in the United States (CFIUS) for U.S. multinational pharmaceutical companies acquiring pipelines from Chinese firms [5]. - In the first half of this year, the total value of BD transactions for Chinese innovative drugs reached nearly $66 billion, with projections indicating that by 2040, 35% of new drugs approved by the FDA could originate from China [5][6]. Group 3: Competitive Landscape - The executive order reflects a conflict between U.S. biotech companies, which lobby for restrictions, and multinational corporations (MNCs) that benefit from acquiring overseas assets [6]. - By 2035, $115 billion worth of drug patents will expire in Europe and the U.S., necessitating MNCs to seek new pipelines, with Chinese assets being a favorable option due to their quality and cost [6]. Group 4: Clinical Trial Data Scrutiny - The FDA's stricter scrutiny of clinical trial data from Chinese patients is seen as unlikely to change the current landscape, as the FDA has already been tightening its review processes [8][10]. - The high costs associated with conducting clinical trials abroad compared to domestic trials lead many Chinese firms to retain domestic rights while transferring overseas rights to MNCs [9]. Group 5: Future Outlook - Despite the potential for political interference, analysts believe there remains a 5-10 year window of opportunity for BD transactions, driven by the high demand from large pharmaceutical companies [11][12]. - The recent surge in large BD deals indicates a shift in perception regarding the value of Chinese assets, moving away from the notion of "selling assets cheap" to recognizing their quality and efficiency [13][14].