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Recently, Wanchun Medicine issued an announcement stating that the marketing application of Pranabrin for the treatment of chemotherapy-induced neutropenia (CIN) has received a complete response letter (CRL) from the US FDA
.
Specifically, the FDA pointed out in the review opinion that the data from only one registered clinical study (Prinabulin 106 Phase III clinical study) is not enough to fully confirm the clinical value of Prinabulin, and a second controlled registered clinical trial is needed.
Research to provide sufficient evidence to support NDA (New Drug Application) for the prevention of chemotherapy-induced neutropenia
.
Based on current data, the FDA is unable to approve the NDA
.
It is worth noting that as soon as this news came out, Wanchun Pharmaceutical plunged 60%, and its market value fell to less than 200 million US dollars
.
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)
.
.
Currently, Wanchun Pharmaceutical is preparing a response to the FDA's review comments, and plans to apply for a communication meeting with the FDA
.
The analysis believes that, although Wanchun Medicine is considering adding a confirmatory phase III clinical study, and the time will not be too long, the time to market for the CIN indication of ponabrin is expected to be delayed
.
It is worth noting that Wanchun Medicine is not the only frustrated international multi-center clinical research.
On November 19 this year, Bristol-Myers Squibb announced that the FDA will use mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The new drug application (NDA) review period of the company has been extended by 3 months, and the new PDUFA date is April 28, 2022
.
In April, Kanghong Pharmaceutical also 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
.
The analysis pointed out that it is obvious from the above that the risk of new drug research and development is high and full of uncertainties.
.
In this context, pharmaceutical companies need to be more "flexible" in their innovation and transformation
.
It is understood that with the rise of local innovation forces, many domestic pharmaceutical companies are already conducting differentiated innovations
.
For example, Hengrui is redefining innovation and internationalization in its R&D strategy
.
The first is to explore new targets, take on higher R&D risks, and solve unmet clinical needs; the second is to fully explore the potential of the targets under research in a variety of indications and explore new indications; the third is to deploy a variety of diseases in the field of treatment Products with different mechanisms of action form complements and gains; fourth, multiple platform technologies support in-depth research, and continue to produce global equity projects; fifth, strengthen cooperation with biomedical companies, improve pipelines, and accelerate internationalization; sixth, establish overseas clinical teams , Cultivate internal capabilities and accelerate overseas clinical development and product launches
.
Among them, Hengrui's more frequent action is to spend a lot of money to buy promising products from other pharmaceutical companies
.
Up to now, Hengrui has introduced 4 oncology drugs this year, mainly Yingli Pharmaceutical for the PI3kδ inhibitor YY-20394, Dalian Wanchun GEF-H1 activator punabulin, and Tianguangshi for the third-generation anti-CD20 Antibody MIL62, CStone's anti-CTLA-4 monoclonal antibody CS1002
.
On the whole, the industry generally understands the authorized introduction of cooperation between domestic pharmaceutical companies such as Hengrui
.
For a long time, new drug research and development have been characterized by large investment, long cycle, and high risk
.
Therefore, in the future, buying products that are about to go on the market from other sources and obtaining a faster return on investment may become a major trend for pharmaceutical companies to accelerate their innovation and transformation in the future
.
However, some analysts also indicated that the innovative drug companies that will be able to break out of the siege in the future are companies that independently follow the path of difficult differentiation, and the other is the path of integrated pharmaceutical companies that focus on both domestic and overseas, technology and business balance
.
No matter which path is taken, the test will be the true innovative research and development capabilities of pharmaceutical companies
.
.
Specifically, the FDA pointed out in the review opinion that the data from only one registered clinical study (Prinabulin 106 Phase III clinical study) is not enough to fully confirm the clinical value of Prinabulin, and a second controlled registered clinical trial is needed.
Research to provide sufficient evidence to support NDA (New Drug Application) for the prevention of chemotherapy-induced neutropenia
.
Based on current data, the FDA is unable to approve the NDA
.
It is worth noting that as soon as this news came out, Wanchun Pharmaceutical plunged 60%, and its market value fell to less than 200 million US dollars
.
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)
.
.
Currently, Wanchun Pharmaceutical is preparing a response to the FDA's review comments, and plans to apply for a communication meeting with the FDA
.
The analysis believes that, although Wanchun Medicine is considering adding a confirmatory phase III clinical study, and the time will not be too long, the time to market for the CIN indication of ponabrin is expected to be delayed
.
It is worth noting that Wanchun Medicine is not the only frustrated international multi-center clinical research.
On November 19 this year, Bristol-Myers Squibb announced that the FDA will use mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The new drug application (NDA) review period of the company has been extended by 3 months, and the new PDUFA date is April 28, 2022
.
In April, Kanghong Pharmaceutical also 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
.
The analysis pointed out that it is obvious from the above that the risk of new drug research and development is high and full of uncertainties.
.
In this context, pharmaceutical companies need to be more "flexible" in their innovation and transformation
.
It is understood that with the rise of local innovation forces, many domestic pharmaceutical companies are already conducting differentiated innovations
.
For example, Hengrui is redefining innovation and internationalization in its R&D strategy
.
The first is to explore new targets, take on higher R&D risks, and solve unmet clinical needs; the second is to fully explore the potential of the targets under research in a variety of indications and explore new indications; the third is to deploy a variety of diseases in the field of treatment Products with different mechanisms of action form complements and gains; fourth, multiple platform technologies support in-depth research, and continue to produce global equity projects; fifth, strengthen cooperation with biomedical companies, improve pipelines, and accelerate internationalization; sixth, establish overseas clinical teams , Cultivate internal capabilities and accelerate overseas clinical development and product launches
.
Among them, Hengrui's more frequent action is to spend a lot of money to buy promising products from other pharmaceutical companies
.
Up to now, Hengrui has introduced 4 oncology drugs this year, mainly Yingli Pharmaceutical for the PI3kδ inhibitor YY-20394, Dalian Wanchun GEF-H1 activator punabulin, and Tianguangshi for the third-generation anti-CD20 Antibody MIL62, CStone's anti-CTLA-4 monoclonal antibody CS1002
.
On the whole, the industry generally understands the authorized introduction of cooperation between domestic pharmaceutical companies such as Hengrui
.
For a long time, new drug research and development have been characterized by large investment, long cycle, and high risk
.
Therefore, in the future, buying products that are about to go on the market from other sources and obtaining a faster return on investment may become a major trend for pharmaceutical companies to accelerate their innovation and transformation in the future
.
However, some analysts also indicated that the innovative drug companies that will be able to break out of the siege in the future are companies that independently follow the path of difficult differentiation, and the other is the path of integrated pharmaceutical companies that focus on both domestic and overseas, technology and business balance
.
No matter which path is taken, the test will be the true innovative research and development capabilities of pharmaceutical companies
.
