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Why Going Global Is Harder Than It Looks for Chinese Biotech

More Chinese pharma and biotech companies are pursuing international expansion — aiming for FDA/EMA approvals, global trials, or out-licensing deals. The science is there. The ambition is clear. The investment is growing.

But the execution? Often far more complex than expected.

Here are 5 common challenges that surface in global R&D programs:

1️⃣ Cross-Cultural MisalignmentWestern and Chinese teams may interpret timelines, decisions, and risk differently — often without realizing it until there’s a delay.

2️⃣ Global Regulatory MisstepsFDA and EMA expectations go beyond data quality — it’s about how data is generated, documented, and defended.

3️⃣ Joint Venture FrictionMany alliances are formed quickly but lack clear governance, operational clarity, or mutual trust — leading to tension and lost time.

4️⃣ Communication BreakdownEven strong bilingual teams struggle with nuance — especially when working across time zones, functions, and stakeholder expectations.

5️⃣ Missing the Western MindsetTo license or launch globally, it's not just the asset that must be ready — the entire program (CMC, clinical, safety, strategy) must meet global investor and regulatory standards.

These challenges don’t mean failure — but they do require careful planning, the right structure, and, often, a different lens on execution.

🔍 Curious to hear: What has surprised you most about global expansion or cross-border collaboration in the pharma world?

 
 
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