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According to the FDA's definition, a drug granted First-in-class qualification refers to a drug that uses a new and unique mechanism of action to treat a certain disease
.
In recent years, as local innovative drug companies have increased their R&D investment and their strength has continued to rise, more and more Chinese companies have regarded the FDA as the main destination for overseas clinical research of First-In-Class new drugs and submitted new drug proposals to the US FDA.
Clinical research application materials, and many innovative drugs have been gradually advanced to the late clinical stage, entering the market application stage
.
For example, Legend Bio’s CAR-T therapy Cidacchi Orenxa, Hutchison’s Sofantinib, Junshi Bio’s Teriplizumab, Wanchun Medicine’s Pranabrin, etc.
have all submitted to the U.
S.
FDA A new drug listing application (NDA/BLA) has been approved; Hengrui Medicine’s Carrelizumab and Lugu Pharmaceutical’s Mannite Sodium Capsules are conducting international multi-center phase III clinical studies, including the United States
.
In late November this year, Inming Bio announced that its first-in-class tumor immune target HPK1 small molecule inhibitor PRJ1-3024 has also passed the US FDA's IND program and officially launched a phase I clinical trial in the United States
.
In addition, many local innovative drugs have obtained a number of accelerated approvals and orphan drug qualifications from the US FDA
.
For example, just recently, Reindeer Medical announced that it has received an official written reply from the FDA Orphan Drug Development Office, granting the company's self-developed fully human anti-CD19 and CD22 dual target chimeric antigen receptor autologous T cell injection (CT120) orphan Drug qualification certification for the treatment of acute leukemia; Junshi Bio announced on the evening of November 15 that the company’s subsidiary FDA officially responded that teriprizumab for the treatment of esophageal cancer was approved by the FDA for orphan drug certification, which is also Teriplizumab received the fourth FDA orphan drug designation
.
Relevant statistics show that from 2019 to 2020, there are 7 local innovative drugs that have obtained FDA breakthrough therapy, 3 have been accelerated approval, 9 have been fast-tracked, and 15 have obtained orphan drug certification
.
However, the road to clinical approval of First-In-Class new drug by FDA is not so smooth
.
In recent news, Wanchun Medicine announced that it has received a complete response letter (CRL) from the FDA for its marketing application for the treatment of chemotherapy-induced neutropenia (CIN)
.
According to the announcement, the FDA believes that the current single phase III registration clinical trial (106 phase III study) of ponabrin could not fully prove the benefit of treatment, so it failed to approve the listing application and required the company to conduct a second registration clinical trial in order to obtain There is ample evidence to support the approval of the CIN indication
.
According to data, Pranabrin is a First-In-Class new drug independently developed by Wanchun Pharmaceutical.
This product can be different from G-CSF (granulocyte colony stimulating factor, which can promote the proliferation and differentiation of neutrophils).
Mechanism of action to prevent CIN (neutropenia caused by chemotherapy)
.
Wanchun Pharmaceutical stated in the announcement that it firmly believes that the combined application of punabulin and G-CSF has great potential to improve the treatment of CIN
.
At the same time, the company is still confident in the efficacy and safety data of prinabulin combined with G-CSF in preventing CIN, and plans to maintain close communication and cooperation with the FDA and consider adding a clinical study
.
It is not only Wanchun Pharmaceutical that has suffered setbacks in international multi-center clinical research.
For example, in April 2021, Kang Hong Pharmaceutical issued an announcement stating that it would stop the global multi-center clinical trial of its leading product, Conbercept ophthalmic injection
.
According to the company, the reason is that due to the impact of the epidemic, a large number of subjects have deviated from the trial's prescribed dosing regimen, which has hindered clinical research
.
Not only domestic pharmaceutical companies, but also multinational pharmaceutical giants have also experienced ups and downs
.
On November 19, Bristol-Myers Squibb announced that the FDA has extended the new drug application (NDA) review period for mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) by 3 months, and the new PDUFA date is 2022 April 28
.
Some analysts pointed out that in addition to being affected by the epidemic, it is difficult for First-in-Class itself to be approved.
According to incomplete statistics, in the 20 years from 1999 to 2018, the FDA approved a total of 620 new drugs and was granted First-in-class qualifications.
There are only 194 products, accounting for about 30%, and most of the regular customers are products of major pharmaceutical companies
.
.
In recent years, as local innovative drug companies have increased their R&D investment and their strength has continued to rise, more and more Chinese companies have regarded the FDA as the main destination for overseas clinical research of First-In-Class new drugs and submitted new drug proposals to the US FDA.
Clinical research application materials, and many innovative drugs have been gradually advanced to the late clinical stage, entering the market application stage
.
For example, Legend Bio’s CAR-T therapy Cidacchi Orenxa, Hutchison’s Sofantinib, Junshi Bio’s Teriplizumab, Wanchun Medicine’s Pranabrin, etc.
have all submitted to the U.
S.
FDA A new drug listing application (NDA/BLA) has been approved; Hengrui Medicine’s Carrelizumab and Lugu Pharmaceutical’s Mannite Sodium Capsules are conducting international multi-center phase III clinical studies, including the United States
.
In late November this year, Inming Bio announced that its first-in-class tumor immune target HPK1 small molecule inhibitor PRJ1-3024 has also passed the US FDA's IND program and officially launched a phase I clinical trial in the United States
.
In addition, many local innovative drugs have obtained a number of accelerated approvals and orphan drug qualifications from the US FDA
.
For example, just recently, Reindeer Medical announced that it has received an official written reply from the FDA Orphan Drug Development Office, granting the company's self-developed fully human anti-CD19 and CD22 dual target chimeric antigen receptor autologous T cell injection (CT120) orphan Drug qualification certification for the treatment of acute leukemia; Junshi Bio announced on the evening of November 15 that the company’s subsidiary FDA officially responded that teriprizumab for the treatment of esophageal cancer was approved by the FDA for orphan drug certification, which is also Teriplizumab received the fourth FDA orphan drug designation
.
Relevant statistics show that from 2019 to 2020, there are 7 local innovative drugs that have obtained FDA breakthrough therapy, 3 have been accelerated approval, 9 have been fast-tracked, and 15 have obtained orphan drug certification
.
However, the road to clinical approval of First-In-Class new drug by FDA is not so smooth
.
In recent news, Wanchun Medicine announced that it has received a complete response letter (CRL) from the FDA for its marketing application for the treatment of chemotherapy-induced neutropenia (CIN)
.
According to the announcement, the FDA believes that the current single phase III registration clinical trial (106 phase III study) of ponabrin could not fully prove the benefit of treatment, so it failed to approve the listing application and required the company to conduct a second registration clinical trial in order to obtain There is ample evidence to support the approval of the CIN indication
.
According to data, Pranabrin is a First-In-Class new drug independently developed by Wanchun Pharmaceutical.
This product can be different from G-CSF (granulocyte colony stimulating factor, which can promote the proliferation and differentiation of neutrophils).
Mechanism of action to prevent CIN (neutropenia caused by chemotherapy)
.
Wanchun Pharmaceutical stated in the announcement that it firmly believes that the combined application of punabulin and G-CSF has great potential to improve the treatment of CIN
.
At the same time, the company is still confident in the efficacy and safety data of prinabulin combined with G-CSF in preventing CIN, and plans to maintain close communication and cooperation with the FDA and consider adding a clinical study
.
It is not only Wanchun Pharmaceutical that has suffered setbacks in international multi-center clinical research.
For example, in April 2021, Kang Hong Pharmaceutical issued an announcement stating that it would stop the global multi-center clinical trial of its leading product, Conbercept ophthalmic injection
.
According to the company, the reason is that due to the impact of the epidemic, a large number of subjects have deviated from the trial's prescribed dosing regimen, which has hindered clinical research
.
Not only domestic pharmaceutical companies, but also multinational pharmaceutical giants have also experienced ups and downs
.
On November 19, Bristol-Myers Squibb announced that the FDA has extended the new drug application (NDA) review period for mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) by 3 months, and the new PDUFA date is 2022 April 28
.
Some analysts pointed out that in addition to being affected by the epidemic, it is difficult for First-in-Class itself to be approved.
According to incomplete statistics, in the 20 years from 1999 to 2018, the FDA approved a total of 620 new drugs and was granted First-in-class qualifications.
There are only 194 products, accounting for about 30%, and most of the regular customers are products of major pharmaceutical companies
.
