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Company A, a domestic botulinum toxin developer, recently received approval from the U.S. ...
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Fusion42 · 12 July 2026 · Fusion42 review
South Korean botulinum toxin makers lose 90-100 billion won annually due to mandatory government pre-export approvals for a 'core national technology' designation imposed in 2010-2016, despite the toxin being public knowledge since the 1940s and already regulated through six ministries and seven laws. One company took 14 years to reach FDA approval partly due to these delays, whilst a competitor missed market timing and had to launch 45% below competitors' prices.
This Wire brief sits within Fusion42's coverage of Digital Health.
◆ ◆ The Wire takeaway
If you're a South Korean biotech founder exporting botulinum toxin or similar 'core technologies', the government's pre-approval requirement is costing your industry 90-100 billion won yearly in missed market windows—and the Lee government is actively revisiting that rule right now. Call your trade ministry contact this week; the window to reframe this as deregulation rather than security is open.
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1 source · 12 Jul 2026
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