Evolution of globalization: Chinese healthcare companies have moved from transactional exports and licensing to becoming globally integrated players—pursuing co-development, overseas manufacturing, acquisitions, and ecosystem partnerships. Licensing surge: Driven by higher-quality Chinese innovation (e.g., ADCs, oncology) and MNCs’ need to fill pipelines. Licensing validates technology and provides capital, but deeper co-development and strategic collaborations are emerging. Key US market challenges: Regulation is just one piece. Success requires navigating a complex ecosystem (payers, providers, investors, patient groups, media) and building trust, credibility, and stakeholder relationships, especially amid geopolitical sensitivities. Beyond FDA approval: FDA is only the start. Companies need a clear market-entry strategy, value story, and proactive engagement with policymakers, investors, and communities. Trust has become a strategic asset. Geopolitical impact: Heightened scrutiny on supply chains, data governance, and national security means companies must integrate business strategy with government affairs and risk monitoring.MedAsian’s role: Helps bridge business strategy with policy, stakeholder, and reputation management—offering government affairs, strategic communications, and ecosystem mapping to build long-term US presence. Future winners: Will combine scientific excellence with governance, trust, policy navigation, and capital discipline. Government affairs increasingly creates value (predictability, investor confidence) not just manages risk.