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Recently, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that Novo Nordisk has declared an oral preparation NNC0385-0434 targeting PCSK9, which has obtained the implied license for clinical trials and is planned to be developed for use in: Treatment for lowering low-density lipoprotein cholesterol (LDL-C) in adult patients with zygotic familial hypercholesterolemia, confirmed cardiovascular disease, or high cardiovascular risk, used alone or in combination with statins
.
In July this year, Novartis announced at a press conference that its new siRNA therapy lipid-lowering drug Inclisiran (Leqvio) had completed its first injection in the country on July 1 at Boao Super Hospital, Lecheng Pioneer District, Boao, Hainan
.
Soon afterwards, Novartis re-published the new progress of Inclisiran.
The results showed that receiving Inclisiran twice a year can continuously reduce atherosclerotic cardiovascular disease (CeVD) and polyvascular disease (PVD).
ASCVD) Low-density lipoprotein cholesterol (LDL-C)1,2 in patients
.
It is reported that as early as the end of 2020, Inclisiran has been approved by the European Commission for the treatment of adult hypercholesterolemia and mixed dyslipidemia
.
Cardiovascular disease is a very common disease.
The prevalence of this type of disease in China is showing an increasing trend.
At present, the number of cardiovascular disease patients in China has reached 330 million
.
Clinical studies at this stage suggest that there is a positive correlation between the reduction of low-density lipoprotein (LDL-C) and the reduction of cardiovascular risk
.
The industry pointed out that statins and fibrates are common and important drugs in the field of lowering blood lipids, but high-dose statins are more likely to have some side effects than other groups, such as the risks of rhabdomyolysis and liver function abnormalities caused by drugs, so patients There is an urgent need to find a safe, effective and highly compliant lipid-lowering drug
.
The emergence of proprotein convertase subtilisin 9 (PCSK9) has become a research direction to overcome this problem.
.
It is understood that currently three innovative therapies targeting PSCK9 have been approved globally, among which the earlier approved include: Sanofi/Regeneron’s alisiyuumab and Amgen’s PCSK9 inhibitor iloyudan These two PSCK9 inhibitors are monoclonal antibodies, which have the advantages of strong targeting, high specificity, and clear mechanism of action.
However, because they are administered by subcutaneous injection, they have high requirements for patient compliance.
.
In China, the currently used injectable lipid-lowering drug PCSK9 inhibitors in China include: iloyuumab, which was marketed on October 21, 2018, and ascilimumab, which was marketed on December 28, 2019
.
The method of use is subcutaneous injection once every two weeks
.
It is worth mentioning that due to the huge potential of PSCK9 as a targeted therapy in the field of lowering blood lipids, in addition to multinational pharmaceutical companies, domestic pharmaceutical companies are also actively deploying PCSK9 inhibitors, such as Hengrui Medicine, Junshi Biotech, Many of the candidate drugs of Cinda Bio, Kangfang Bio, etc.
have entered the clinical stage
.
From the perspective of progress, domestic pharmaceutical companies have made rapid progress including: Cinda Bio-developed monoclonal antibody IBI-306 targeting PCSK9.
The phase 3 clinical study of this product for the treatment of heterozygous familial hypercholesterolemia in China has been completed.
Reached the main research endpoint; Junshi Bio plans to develop a recombinant humanized anti-PCSK9 monoclonal antibody for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, which is currently undergoing phase 3 clinical trials in a wider patient population Research
.
In addition, Hengrui Medicine disclosed in its annual report that its anti-PCSK9 monoclonal antibody SHR-1209 is undergoing three clinical studies, of which the treatment of hypercholesterolemia has entered phase 3 clinical trials
.
.
In July this year, Novartis announced at a press conference that its new siRNA therapy lipid-lowering drug Inclisiran (Leqvio) had completed its first injection in the country on July 1 at Boao Super Hospital, Lecheng Pioneer District, Boao, Hainan
.
Soon afterwards, Novartis re-published the new progress of Inclisiran.
The results showed that receiving Inclisiran twice a year can continuously reduce atherosclerotic cardiovascular disease (CeVD) and polyvascular disease (PVD).
ASCVD) Low-density lipoprotein cholesterol (LDL-C)1,2 in patients
.
It is reported that as early as the end of 2020, Inclisiran has been approved by the European Commission for the treatment of adult hypercholesterolemia and mixed dyslipidemia
.
Cardiovascular disease is a very common disease.
The prevalence of this type of disease in China is showing an increasing trend.
At present, the number of cardiovascular disease patients in China has reached 330 million
.
Clinical studies at this stage suggest that there is a positive correlation between the reduction of low-density lipoprotein (LDL-C) and the reduction of cardiovascular risk
.
The industry pointed out that statins and fibrates are common and important drugs in the field of lowering blood lipids, but high-dose statins are more likely to have some side effects than other groups, such as the risks of rhabdomyolysis and liver function abnormalities caused by drugs, so patients There is an urgent need to find a safe, effective and highly compliant lipid-lowering drug
.
The emergence of proprotein convertase subtilisin 9 (PCSK9) has become a research direction to overcome this problem.
.
It is understood that currently three innovative therapies targeting PSCK9 have been approved globally, among which the earlier approved include: Sanofi/Regeneron’s alisiyuumab and Amgen’s PCSK9 inhibitor iloyudan These two PSCK9 inhibitors are monoclonal antibodies, which have the advantages of strong targeting, high specificity, and clear mechanism of action.
However, because they are administered by subcutaneous injection, they have high requirements for patient compliance.
.
In China, the currently used injectable lipid-lowering drug PCSK9 inhibitors in China include: iloyuumab, which was marketed on October 21, 2018, and ascilimumab, which was marketed on December 28, 2019
.
The method of use is subcutaneous injection once every two weeks
.
It is worth mentioning that due to the huge potential of PSCK9 as a targeted therapy in the field of lowering blood lipids, in addition to multinational pharmaceutical companies, domestic pharmaceutical companies are also actively deploying PCSK9 inhibitors, such as Hengrui Medicine, Junshi Biotech, Many of the candidate drugs of Cinda Bio, Kangfang Bio, etc.
have entered the clinical stage
.
From the perspective of progress, domestic pharmaceutical companies have made rapid progress including: Cinda Bio-developed monoclonal antibody IBI-306 targeting PCSK9.
The phase 3 clinical study of this product for the treatment of heterozygous familial hypercholesterolemia in China has been completed.
Reached the main research endpoint; Junshi Bio plans to develop a recombinant humanized anti-PCSK9 monoclonal antibody for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, which is currently undergoing phase 3 clinical trials in a wider patient population Research
.
In addition, Hengrui Medicine disclosed in its annual report that its anti-PCSK9 monoclonal antibody SHR-1209 is undergoing three clinical studies, of which the treatment of hypercholesterolemia has entered phase 3 clinical trials
.
