Amarin Corp Plc (AMRN)

[Tatsumaki]

For drugs developed and first approved overseas (6 years) or new indications to existing drugs first approved overseas (3 years), China uses those foreign approval dates as the start of their 6/3 exclusivity window. This rewards drugs or indications developed and first approved in China and penalizes foreign drug development there or pushes drug makers to concurrently pursue the China market. End result is Vascepa has 0 regulatory exclusivity in China on Marine/Reduce it indications.

Class 5.1 Innovative drugs marketed overseas seeking MA in China 6 years (China MA application acceptance date - First foreign MA approval grant date)
Improved new drugs marketed overseas seeking MA in China 3 years (China MA application acceptance date - First foreign MA approval grant date)

https://www.arnoldporter.com/en/perspectives/advisories/2025/04/china-new-regulatory-data-protection-and-exclusivity-mechanism