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As of October 29, 2021, data from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration show that a total of 5670 clinical trial applications have passed "implicit permission
.
" At present, the time has entered November, and it is reported that a number of blockbuster new drugs have been approved for clinical use
.
On November 1, Connoa announced that CM338 has obtained CDE clinical trial approval for the treatment of IgA nephropathy
.
CM338 is the first domestic innovative monoclonal antibody drug targeting MASP-2 and the second clinically approved MASP-2 inhibitor.
There is no drug with the same target on the market globally
.
Data show that lgA nephropathy (IgAN) is a common type of primary glomerulonephritis.
The main feature is renal IgA deposition.
The pathogenesis is related to the uncontrolled activation of the lectin pathway
.
As of 2020, the number of patients with IgA nephropathy in China has reached 8.
23 million, but due to the lack of therapeutic drugs, there is an urgent need for new treatment options to meet the unmet clinical needs
.
In this regard, the industry believes that if Connoa's CM338 can be successfully listed in the future, it will have huge room for development
.
On November 2, Kangfang Bio also announced that the new tumor immunotherapy drug AK112 (PD-1/VEGF bispecific antibody) has been approved by CDE, and the development of single-drug or combined chemotherapy neoadjuvant/adjuvant therapy can cut non-small cell lung cancer ( NSCLC) Phase II clinical study
.
It is understood that AK112 is a PD-1/VEGF double antibody designed based on Kangfang's TETRABODY technology, which can block the binding of PD-1 to PD-L1, PD-L2, and the binding of VEGF to VEGF receptors
.
At present, AK112 has become the first global bispecific antibody drug to enter Phase III clinical research
.
The industry believes that, as a whole, in recent years, as the reform of the drug review and approval system continues to deepen, the pace of new drug review and approval is accelerating
.
According to data, in 2020, the Center for Drug Evaluation has approved 1,435 IND (New Drug Clinical Trial) applications, an increase of 54.
97% over 2019; 208 NDA (New Drug Marketing Application) applications have been reviewed, an increase over 2019 26.
83%; 918 ANDA (generic drug listing applications) passed the review; 577 applications for consistency evaluation passed the review, an increase of 121.
92% over 2019
.
In 2020, the Center for Drug Evaluation passed the review of 20 NDA varieties of innovative drugs, and the review passed 72 varieties of NDA (including new-indication varieties) for overseas-produced original drugs
.
It is worth mentioning that, in the context of accelerating the review and approval of new drugs, the speed at which new drugs are approved for marketing is also increasing day by day
.
Data shows that as of October 20, there have been more than 25 new drugs on the market this year, including 22 new drugs in category 1 (excluding vaccines and new indications), 21 new domestic drugs and 2 proprietary Chinese medicines
.
In this regard, analysts pointed out that with the centralized procurement of generic drugs and the inclusion of innovative drugs in the new medical insurance, the Chinese pharmaceutical market is shifting to an innovation-driven market
.
At the same time, with the support of a series of policies such as speeding up drug approval, patent protection, and tax reduction, the development of innovative drugs is heating up and starting to promote the growth of the innovative drug market in the future
.
In short, the "new" era of medical innovation has arrived
.
The industry predicts that some early-stage R&D and innovation companies will gradually enter the harvest period in the future
.
Under the general trend of innovation and development, investment in innovative drugs will become the top priority of pharmaceutical investment.
Affected by this, more innovative drugs will continue to emerge in the future and continue to benefit patients at home and abroad
.
.
" At present, the time has entered November, and it is reported that a number of blockbuster new drugs have been approved for clinical use
.
On November 1, Connoa announced that CM338 has obtained CDE clinical trial approval for the treatment of IgA nephropathy
.
CM338 is the first domestic innovative monoclonal antibody drug targeting MASP-2 and the second clinically approved MASP-2 inhibitor.
There is no drug with the same target on the market globally
.
Data show that lgA nephropathy (IgAN) is a common type of primary glomerulonephritis.
The main feature is renal IgA deposition.
The pathogenesis is related to the uncontrolled activation of the lectin pathway
.
As of 2020, the number of patients with IgA nephropathy in China has reached 8.
23 million, but due to the lack of therapeutic drugs, there is an urgent need for new treatment options to meet the unmet clinical needs
.
In this regard, the industry believes that if Connoa's CM338 can be successfully listed in the future, it will have huge room for development
.
On November 2, Kangfang Bio also announced that the new tumor immunotherapy drug AK112 (PD-1/VEGF bispecific antibody) has been approved by CDE, and the development of single-drug or combined chemotherapy neoadjuvant/adjuvant therapy can cut non-small cell lung cancer ( NSCLC) Phase II clinical study
.
It is understood that AK112 is a PD-1/VEGF double antibody designed based on Kangfang's TETRABODY technology, which can block the binding of PD-1 to PD-L1, PD-L2, and the binding of VEGF to VEGF receptors
.
At present, AK112 has become the first global bispecific antibody drug to enter Phase III clinical research
.
The industry believes that, as a whole, in recent years, as the reform of the drug review and approval system continues to deepen, the pace of new drug review and approval is accelerating
.
According to data, in 2020, the Center for Drug Evaluation has approved 1,435 IND (New Drug Clinical Trial) applications, an increase of 54.
97% over 2019; 208 NDA (New Drug Marketing Application) applications have been reviewed, an increase over 2019 26.
83%; 918 ANDA (generic drug listing applications) passed the review; 577 applications for consistency evaluation passed the review, an increase of 121.
92% over 2019
.
In 2020, the Center for Drug Evaluation passed the review of 20 NDA varieties of innovative drugs, and the review passed 72 varieties of NDA (including new-indication varieties) for overseas-produced original drugs
.
It is worth mentioning that, in the context of accelerating the review and approval of new drugs, the speed at which new drugs are approved for marketing is also increasing day by day
.
Data shows that as of October 20, there have been more than 25 new drugs on the market this year, including 22 new drugs in category 1 (excluding vaccines and new indications), 21 new domestic drugs and 2 proprietary Chinese medicines
.
In this regard, analysts pointed out that with the centralized procurement of generic drugs and the inclusion of innovative drugs in the new medical insurance, the Chinese pharmaceutical market is shifting to an innovation-driven market
.
At the same time, with the support of a series of policies such as speeding up drug approval, patent protection, and tax reduction, the development of innovative drugs is heating up and starting to promote the growth of the innovative drug market in the future
.
In short, the "new" era of medical innovation has arrived
.
The industry predicts that some early-stage R&D and innovation companies will gradually enter the harvest period in the future
.
Under the general trend of innovation and development, investment in innovative drugs will become the top priority of pharmaceutical investment.
Affected by this, more innovative drugs will continue to emerge in the future and continue to benefit patients at home and abroad
.
