Amarin Corp Plc (AMRN)

[Whalatane]

For new drugs approved for marketing in China that were not developed domestically, China provides data exclusivity periods as follows:
If the drug application in China is filed within 1 year of the first approval in the EU, US or Japan, the data exclusivity period is:
6 years for chemical drugs containing a new chemical entity
6 years for therapeutic biological products
12 years for orphan drugs for rare diseases
If the drug application in China is filed more than 1 year after first approval in the EU, US or Japan, the data exclusivity period is reduced accordingly for any delay exceeding 1 year.
For drugs approved outside of China before the implementation of these data exclusivity regulations, no data exclusivity protection is provided.

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VASCEPA (icosapent ethyl) was recently approved by China's National Medical Products Administration (NMPA) for the indication of reducing triglyceride levels in adult patients with severe hypertriglyceridemia (=500 mg/dL) as an adjunct to diet.

The approval was granted on June 1, 2023 to Amarin's commercial partner in China, EddingPharm (EDDING).

Following this regulatory approval, EDDING is now focusing on obtaining National Reimbursement Drug Listing (NRDL) and preparing for the commercial launch of VASCEPA in mainland China, which is expected by the end of 2023.
EDDING is also working on advancing the regulatory submission and review process for an additional indication of VASCEPA in cardiovascular risk reduction (CVRR) in China.
It's worth noting that VASCEPA was previously approved in Hong Kong, China for the CVRR indication in February 2022.
However, the recent approval in mainland China is specifically for the triglyceride-lowering indication as an adjunct to diet in patients with severe hypertriglyceridemia.

Kiwi