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Recently, reports have shown that the Hainan Provincial Food and Drug Administration has approved the use of Encorafenib, Infigratinib, Fortantinib, and Tebo in three medical institutions in the Boao International Hospital, Boao Super Hospital, and Hainan Provincial People’s Hospital Lecheng District.
Tinib has four clinically needed imported drugs that have not yet been registered in China
.
It is understood that, as a kinase inhibitor, terpotinib has a different target from other similar drugs and can provide a new option for the treatment of patients with metastatic non-small cell lung cancer
.
When Encorafenib is used in combination with Binimetinib, it can be used to treat adult patients with unresectable or metastatic melanoma with BRAF V600 mutation; when used in combination with cetuximab, it can be used to treat patients with metastatic colorectal Adult patients who have cancer with BRAF V600E mutation and have received systemic treatment.
.
.
The industry believes that the Hainan Provincial Food and Drug Administration once again approved the use of four clinically urgently needed imported drugs in order to ensure the special import policy of medical equipment granted by the State Council.
The implementation is in place, and in recent years, it has been caused by the innovation of the system and mechanism in many aspects such as medical device approval and supervision
.
It is understood that since the Hainan Provincial Food and Drug Administration approved five licensed drugs at the same time on November 26, the approval efficiency of clinically urgently needed imported drugs in the Boao Lecheng International Medical Tourism Pioneer Zone has been greatly improved
.
For example, not long ago, the Hainan Provincial Food and Drug Administration also approved 3 medical institutions in the Boao Lecheng International Medical Tourism Pioneer Zone to apply for the use of RAVICTI, CRESEMBA capsules and injections, PADCEV and ENHERTU and other 5 clinically urgently needed imported drugs totaling 223 boxes (bottles).
)
.
Analysts believe that this has greatly increased the enthusiasm of medical institutions in the Boao Lecheng Pioneer Zone to introduce clinically urgently needed innovative drugs, while also effectively improving the availability and benefit of clinically urgently needed imported drugs
.
It is worth mentioning that since the implementation of the new batch approval model, 21 varieties (including those not approved for the first time) of clinically urgently needed imported drugs have been approved in batches, of which 104 boxes were approved for one variety, compared with the previous " The review and approval model of "one person in a batch" greatly reduces the number of approvals and significantly improves the efficiency of approvals
.
Public information shows that Lecheng Pioneer Zone is the first "medical special zone" in my country, which was approved and established by the State Council in 2013
.
On April 2, 2018, the State Council issued the “Decision on Suspending the Implementation of the Regulations on the Supervision and Administration of Medical Devices in the Hainan Boao Lecheng International Medical Tourism Pioneer Zone”, clarifying that there is an urgent clinical need for medical institutions in the Pioneer Zone and there are none in China.
Medical devices of the same type that have been approved for registration shall be approved by the Hainan Provincial People’s Government for use in designated medical institutions
.
At present, Lecheng Pioneer District has become a multi-disciplinary medical highland, and has gradually become a gateway for world-class innovative medical equipment to enter China
.
In the future, as the policy points out, as Hainan Province continues to innovate the system and mechanisms in various aspects such as medical device approval and supervision, the industry is expected to have more medical institutions and multinational pharmaceutical companies stationed in Lecheng, and the number of licensed medical devices will continue to increase.
Millions of patients may benefit every year
.
At the same time, more new pharmaceutical equipment on the market abroad will also accelerate the pace of entering the Chinese market
.
Tinib has four clinically needed imported drugs that have not yet been registered in China
.
It is understood that, as a kinase inhibitor, terpotinib has a different target from other similar drugs and can provide a new option for the treatment of patients with metastatic non-small cell lung cancer
.
When Encorafenib is used in combination with Binimetinib, it can be used to treat adult patients with unresectable or metastatic melanoma with BRAF V600 mutation; when used in combination with cetuximab, it can be used to treat patients with metastatic colorectal Adult patients who have cancer with BRAF V600E mutation and have received systemic treatment.
.
.
The industry believes that the Hainan Provincial Food and Drug Administration once again approved the use of four clinically urgently needed imported drugs in order to ensure the special import policy of medical equipment granted by the State Council.
The implementation is in place, and in recent years, it has been caused by the innovation of the system and mechanism in many aspects such as medical device approval and supervision
.
It is understood that since the Hainan Provincial Food and Drug Administration approved five licensed drugs at the same time on November 26, the approval efficiency of clinically urgently needed imported drugs in the Boao Lecheng International Medical Tourism Pioneer Zone has been greatly improved
.
For example, not long ago, the Hainan Provincial Food and Drug Administration also approved 3 medical institutions in the Boao Lecheng International Medical Tourism Pioneer Zone to apply for the use of RAVICTI, CRESEMBA capsules and injections, PADCEV and ENHERTU and other 5 clinically urgently needed imported drugs totaling 223 boxes (bottles).
)
.
Analysts believe that this has greatly increased the enthusiasm of medical institutions in the Boao Lecheng Pioneer Zone to introduce clinically urgently needed innovative drugs, while also effectively improving the availability and benefit of clinically urgently needed imported drugs
.
It is worth mentioning that since the implementation of the new batch approval model, 21 varieties (including those not approved for the first time) of clinically urgently needed imported drugs have been approved in batches, of which 104 boxes were approved for one variety, compared with the previous " The review and approval model of "one person in a batch" greatly reduces the number of approvals and significantly improves the efficiency of approvals
.
Public information shows that Lecheng Pioneer Zone is the first "medical special zone" in my country, which was approved and established by the State Council in 2013
.
On April 2, 2018, the State Council issued the “Decision on Suspending the Implementation of the Regulations on the Supervision and Administration of Medical Devices in the Hainan Boao Lecheng International Medical Tourism Pioneer Zone”, clarifying that there is an urgent clinical need for medical institutions in the Pioneer Zone and there are none in China.
Medical devices of the same type that have been approved for registration shall be approved by the Hainan Provincial People’s Government for use in designated medical institutions
.
At present, Lecheng Pioneer District has become a multi-disciplinary medical highland, and has gradually become a gateway for world-class innovative medical equipment to enter China
.
In the future, as the policy points out, as Hainan Province continues to innovate the system and mechanisms in various aspects such as medical device approval and supervision, the industry is expected to have more medical institutions and multinational pharmaceutical companies stationed in Lecheng, and the number of licensed medical devices will continue to increase.
Millions of patients may benefit every year
.
At the same time, more new pharmaceutical equipment on the market abroad will also accelerate the pace of entering the Chinese market
.
