Amarin Corp Plc (AMRN)

[lettruthringout]

First approval of Vascepa in China

American cardiovascular drug Vascepa will enter Boao Lecheng

On the morning of January 17, the Vascepa clinical research kick-off meeting in Boao Lecheng Pioneer District was held at Boao Yiling Life Care Center. Liu Zhefeng, Deputy Director of Boao Lecheng International Medical Tourism Pilot Zone Administration; ...

This conference conducted in-depth discussions and exchanges on the research and practical application of Vascepa's real-world data, and jointly discussed the feasible path of Vascepa's clinical data collection and clinical research plan, and developed innovative ideas, unified and efficient actions, and worked together to accelerate the promotion of Vascepa in The domestic approval for listing also provides valuable experience for the regulatory model of innovative drugs and medical devices, allowing more domestic patients with cardiovascular and cerebrovascular diseases to use new, good, and assured drugs

At the meeting, Liu Zhefeng, deputy director of the Boao Lecheng International Medical Tourism Pilot Zone Administration, delivered a speech. He said that as the only "medical special zone" in the country and one of the key parks for the construction of Hainan Free Trade Port, Lecheng Pioneer Zone has always been a test field for bold experiments, bold breakthroughs, and independent reforms.

The implementation of the pilot work for the application of clinical real-world data in Boao Lecheng, Hainan, is to make full use of the advantages of the policy system and mechanism of the Lecheng Pilot Area, and is an extension of the policy of urgently needed imported licensed medicines and devices in Lecheng clinical.

Deng Jianwei, Vice President of Eton Pharmaceuticals, said: "We are pleased to see that Vascepa, a new drug that reduces cardiovascular risk, has been approved for first use. The U.S. Food and Drug Administration (FDA) approved Vascepa as a supplement to the maximum tolerance of statins In order to reduce cardiovascular risk, the introduction of this new drug is another successful practice of the licensing policy of the pilot zone. Looking forward to the future, Eton Pharmaceuticals will continue to introduce innovative drugs into the park at a faster rate, benefiting more Domestic patients."

"Before today's seminar, I have studied for many days and done a lot of homework." Yue Hongwen, director of Boao Yiling Cardiovascular and Metabolic Disease Prevention and Treatment Center, said with excitement, "At present, Boao Yiling Cardiovascular and Metabolic Disease Prevention and Treatment The center has established a special medical team to provide guarantee for the smooth implementation of the new drug introduced, and carry out comprehensive collection of patient feedback on clinical use, data statistics, real-world data research, etc. for the optimization of clinical pathways for chronic cardiovascular diseases. I also I very much hope that this new natural medicine, based on statins, can help more patients with chronic cardiovascular diseases, reverse coronary heart disease plaques (soft plaques), reduce the risk of cardiovascular malignant events, and unlock the heart of China A new era in the prevention and rehabilitation of chronic vascular diseases."

The introduction of Vascepa into Lecheng as the drug with the greatest tolerance to statins to reduce the cardiovascular risk of high-risk patients means that Chinese patients will simultaneously share this cutting-edge therapy with patients around the world. Professor Wu Yongjian from Fuwai Hospital of the Chinese Academy of Medical Sciences said that the advent of Vascepa further addresses the urgent need for excellent clinical efficacy in the field of cardiovascular therapy, and can effectively reduce the residual risk of a variety of major cardiovascular adverse events, in order to benefit more Chinese patients.

https://www.investorvillage.com/smbd.asp?mb=2294&mn=8066&pt=msg&mid=21582694