Dr. Gottlieb on China's biotech strategy: China has become very adept at following U.S. discoveries

Industry Trends & Competitive Landscape - China is gaining ground in biotech due to lower costs, not superior science [1] - U S drugmakers are increasingly licensing early-stage compounds from China, driven by cost advantages [5][6] - Approximately one-third of new compounds licensed across the pharmaceutical sector last year were from China [6] - Venture capital investors are concerned that sourcing innovation from China could hollow out the U S biotech sector [5] - U S companies are increasingly conducting Phase 1 and Phase 2 clinical trials in places like Australia due to regulatory complexities in the U S [13][14] Regulatory & Clinical Trials - The FDA previously rejected a drug from Lilly due to misconduct found in late-stage clinical trials conducted in China [4] - Current regulatory processes in the U S make it difficult to initiate Phase 1 clinical trials [9][14] - Regulatory reform is needed to make the U S more competitive in early-stage drug development by lowering hurdles for Phase 1 clinical trials while maintaining patient safety [15] - Extending the Phase Zero microdosing trial framework to new formulations like ASOs, mRNA, and antibody-based drugs could improve efficiency [17][18] Innovation & Intellectual Property - China is adept at copying U S Western discoveries, synthesizing molecules to hit biological targets quickly and inexpensively [5] - China primarily focuses on developing fast followers or slightly improved molecules based on U S patents, rather than novel compounds [8][9]