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In recent years, it has become a general trend for pharmaceutical companies to develop innovative therapi.
At present, many pharmaceutical companies are trying to speed up their deployment in this fie.
According to data, in 2021, the FDA has approved a total of 50 innovative treatments (53 in the same period last yea.
It is worth noting that many pharmaceutical companies are still accelerating their deployment in this field, and a series of new developments have emerg.
Recently, there have been new developments in the listing of a number of innovative therapi.
For example, on the 17th, Travere Therapeutics announced that the US FDA has granted the company priority review status for the new drug application submitted by the company for the investigational therapy sparsentan for the treatment of IgA nephropat.
It is understood that IgA nephropathy is due to the accumulation of IgA in the kidney, which leads to the destruction of the normal filtering mechanism of the kidney, resulting in hematuria and proteinur.
Other symptoms include kidney pain, edema and high blood pressu.
IgA nephropathy is one of the main causes of end-stage renal disea.
Sparsentan is a dual mechanism endothelin/angiotensin receptor antagonist (DEAR.
Preclinical data suggest that it reduces proteinuria, protects podocytes, and prevents glomerulosclerosis and mesangial cell proliferation by blocking the endothelin A and angiotensin II type 1 pathwa.
If successfully approved, sparsentan may become the first non-immunosuppressive therapy approved by the FDA for the treatment of IgA nephropat.
Recently, there is also news that the FDA has approved Eli Lilly's glucose-dependent insulin-stimulating polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor dual agonist tirzepatide (trade name: Mounjar.
It is reported that the drug is a new type of diabetes drug, which is injected only once a week to supplement diet and exercise to improve blood sugar control in adults with type 2 diabet.
Innovative therapies have attracted much attention and have attracted a large number of domestic pharmaceutical compani.
It is reported that at the beginning of this year, Shenzhen Xinhe Biomedical Technology .
, L.
and PhoreMost Limited, a British biopharmaceutical enterprise dedicated to non-drugable target drugs, jointly announced that the two parties will use PhoreMost's SITESEEKER technology platform and Xinhe Bio's RNA drug design platfo.
Signed a research and development cooperation agreement to jointly carry out research on innovative therapeutics for anti-tumor dru.
On May 12, Hengrui Medicine conducted an evaluation of the efficacy and safety of camrelizumab combined with apatinib versus sorafenib in the treatment of patients with unresectable or metastatic hepatocellular carcinoma who had not received prior systemic thera.
The primary endpoint of the randomized controlled, open-label, international multicenter Phase III clinical trial reached the pre-set superiority standa.
At present, the domestic marketing application of the therapy has been accepted by the State Food and Drug Administration, and the company plans to submit a communication application for the new drug marketing to the US FDA in the near futu.
If the therapy is successfully approved, it will refresh the existing first-line treatment of hepatocellular carcinoma and bring good news to the majority of hepatocellular carcinoma patien.
According to the data, NMPA actually accepted a total of 101 NDA applications for innovative drug projects between 2010 and 2020, of which 58 innovative drugs were approv.
In recent years, the number of NDAs submitted and approved has grown steadi.
Especially after the reform of drug administration, the number of approvals of innovative drugs in China has increased significant.
Especially in 2021, the number of innovative drugs applied for listing in China reached a new high, reaching 83, including 51 domestic new drugs and 32 imported new drugs; including 38 chemical drugs, 33 biological drugs (covering antibodies, recombinant proteins, ADCs) , vaccines, cell therapy, allergen products) and 12 varieties of traditional Chinese medici.
It is worth mentioning that at present, not only the number of innovative drugs in China continues to grow, but also the innovative forms are more diverse, the products cover a variety of technical routes, and the disease field is also expandi.
In addition, the company is also actively exploring innovative drug payment and medical insurance, and is constantly improving the accessibility of domestic innovative dru.
Conclusion The industry believes that the reason why innovative therapies have become the current research and development hotspots of pharmaceutical companies is that innovative therapies are easier to obtain special qualifications from the FDA, which can speed up the review of therapies; and innovative therapies are the treatment of patients with specific genetic varian.
precision therapy, resulting in better curative effects that can benefit more patien.
On the whole, CAR-T and ADC have become the main hot spots for pharmaceutical companies to focus on innovative therapi.
In the future, pharmaceutical companies may have great prospects in these fiel.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
At present, many pharmaceutical companies are trying to speed up their deployment in this fie.
According to data, in 2021, the FDA has approved a total of 50 innovative treatments (53 in the same period last yea.
It is worth noting that many pharmaceutical companies are still accelerating their deployment in this field, and a series of new developments have emerg.
Recently, there have been new developments in the listing of a number of innovative therapi.
For example, on the 17th, Travere Therapeutics announced that the US FDA has granted the company priority review status for the new drug application submitted by the company for the investigational therapy sparsentan for the treatment of IgA nephropat.
It is understood that IgA nephropathy is due to the accumulation of IgA in the kidney, which leads to the destruction of the normal filtering mechanism of the kidney, resulting in hematuria and proteinur.
Other symptoms include kidney pain, edema and high blood pressu.
IgA nephropathy is one of the main causes of end-stage renal disea.
Sparsentan is a dual mechanism endothelin/angiotensin receptor antagonist (DEAR.
Preclinical data suggest that it reduces proteinuria, protects podocytes, and prevents glomerulosclerosis and mesangial cell proliferation by blocking the endothelin A and angiotensin II type 1 pathwa.
If successfully approved, sparsentan may become the first non-immunosuppressive therapy approved by the FDA for the treatment of IgA nephropat.
Recently, there is also news that the FDA has approved Eli Lilly's glucose-dependent insulin-stimulating polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor dual agonist tirzepatide (trade name: Mounjar.
It is reported that the drug is a new type of diabetes drug, which is injected only once a week to supplement diet and exercise to improve blood sugar control in adults with type 2 diabet.
Innovative therapies have attracted much attention and have attracted a large number of domestic pharmaceutical compani.
It is reported that at the beginning of this year, Shenzhen Xinhe Biomedical Technology .
, L.
and PhoreMost Limited, a British biopharmaceutical enterprise dedicated to non-drugable target drugs, jointly announced that the two parties will use PhoreMost's SITESEEKER technology platform and Xinhe Bio's RNA drug design platfo.
Signed a research and development cooperation agreement to jointly carry out research on innovative therapeutics for anti-tumor dru.
On May 12, Hengrui Medicine conducted an evaluation of the efficacy and safety of camrelizumab combined with apatinib versus sorafenib in the treatment of patients with unresectable or metastatic hepatocellular carcinoma who had not received prior systemic thera.
The primary endpoint of the randomized controlled, open-label, international multicenter Phase III clinical trial reached the pre-set superiority standa.
At present, the domestic marketing application of the therapy has been accepted by the State Food and Drug Administration, and the company plans to submit a communication application for the new drug marketing to the US FDA in the near futu.
If the therapy is successfully approved, it will refresh the existing first-line treatment of hepatocellular carcinoma and bring good news to the majority of hepatocellular carcinoma patien.
According to the data, NMPA actually accepted a total of 101 NDA applications for innovative drug projects between 2010 and 2020, of which 58 innovative drugs were approv.
In recent years, the number of NDAs submitted and approved has grown steadi.
Especially after the reform of drug administration, the number of approvals of innovative drugs in China has increased significant.
Especially in 2021, the number of innovative drugs applied for listing in China reached a new high, reaching 83, including 51 domestic new drugs and 32 imported new drugs; including 38 chemical drugs, 33 biological drugs (covering antibodies, recombinant proteins, ADCs) , vaccines, cell therapy, allergen products) and 12 varieties of traditional Chinese medici.
It is worth mentioning that at present, not only the number of innovative drugs in China continues to grow, but also the innovative forms are more diverse, the products cover a variety of technical routes, and the disease field is also expandi.
In addition, the company is also actively exploring innovative drug payment and medical insurance, and is constantly improving the accessibility of domestic innovative dru.
Conclusion The industry believes that the reason why innovative therapies have become the current research and development hotspots of pharmaceutical companies is that innovative therapies are easier to obtain special qualifications from the FDA, which can speed up the review of therapies; and innovative therapies are the treatment of patients with specific genetic varian.
precision therapy, resulting in better curative effects that can benefit more patien.
On the whole, CAR-T and ADC have become the main hot spots for pharmaceutical companies to focus on innovative therapi.
In the future, pharmaceutical companies may have great prospects in these fiel.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
