Boao Lecheng: World's #1 Prescription Outside Approval Country!
News source:hiHainan / By Li Xiang / 10 10,2020 17:46:00 / others

On Sep. 29th, Gavreto (Pralsetinib), a new medicine approved by the American FDA (Food and Drug Administration) was prescribed in the Boao Super Hospital in the Boao Lecheng International Medical Tourism Pilot Zone, marking the world's first prescription of Gavreto (Pralsetinib) outside the country of approval. Gavreto (Pralsetinib) was also the first truly innovative medicine to be marketed and used simultaneously in the international market.

 

On the morning of Oct. 10th, a news conference was held in Haikou on the worlds first use outside the United States of Gavreto (Pralsetinib), an NSCLC (Non-Small Cell Lung Cancer) targeted medicine, which was prescribed in Boao Lecheng.

 

 (Hainan Broadcasting Group)

 

In the field of precision therapy for lung cancer, RET fusion-positive NSCLC patients still have huge unmet clinical treatment demands, while Gavreto (Pralsetinib) has made a major breakthrough, with strong, lasting, and extensive anti-tumor activity, showing good clinical efficacy and tolerance with RET fusion NSCLC patients. The medicine was approved by the American FDA in early September and put into use in Lecheng on Sep. 29th this year.

 

The use of this medicine has created at least two "major firsts: Gavreto (Pralsetinib) is the first innovative medicine to be launched and used simultaneously in Lecheng and the international market in the same month. It is also the world's first time for this medicine to be used by a patient outside of the USA.

 

 

(Boao Lecheng)

 

 Thanks to the simplified examination and approval procedure for the import of licensed medicines, the medicine was flown directly from the United States to the patient in just three days!

 

At the press conference, Gu Gang, Secretary of the Party Committee and Director General of the Boao Lecheng International Medical Tourism Pilot Zone Administration spoke on three aspects of the significance of the smooth landing of China's first new RET targeted medicine:

 

First, it is of positive significance for Lecheng to become the world's leading center for the transformation and application of medicines. It is conducive to the construction of Lecheng Pilot Zone as a gateway for international advanced medicines to enter China, creating an exhibition center for international advanced medicines and a training center for domestic medical staff to use international advanced medicines and technologies, and building an international standard high-end medical tourism industrial park.


Second, it is a model of institutional integration innovation as well as a reflection of the early achievements of the Hainan Free Trade Port construction. The Integration, Innovation and Reform Plan for the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone System comprehensively promotes the reform of simplified examination and approval procedures for medical and health care, and pushes Lecheng to accelerate the implementation of synchronizing the three areas of medical technology, equipment, and medicines with the highest international levels. The international registration process for new imported medicines has been greatly accelerated, with the approval process of new medicines speeding up from the previous average of 27 working days to the current norm of 3 to 7 working days.

 

Third, it is conducive to providing better services for Chinese patients with the help of real-world dataresearch. The Lecheng Pilot Zone is the only pilot zone with "real-world data" application in mainland China. After the arrival of Gavreto (Pralsetinib), pharmaceutical companies will give full play to the Lecheng Pilot Zone preferential policies, carrying out scientific research and new medicine reviews using real-world data, which will greatly expedite the process for global innovative medicines to enter the Chinese market as well as the registration of new medicines.

 

 

(Hainan Broadcasting Group)

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