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On March 1, Innovent Bio and Baoyuan Pharmaceutical jointly announced that talatinib has been included in the list of breakthrough therapy drugs by the Center for Drug Evaluation of the State Food and Drug Administration, and the proposed indication is a ROS1 tyrosine kinase inhibitor that has not been previously (TKI) therapy and ROS1 fusion-positive non-small cell lung cancer patients previously treated with a ROS1 TKI
.
According to public information, tabratinib is a new generation of ROS1 and NTRK highly selective tyrosine kinase inhibitors under development
.
The original research company of the product is Daiichi Sankyo, and Baoyuan Pharmaceutical obtained the global development, production and commercialization rights of the drug in December 2018
.
Then in June 2021, Baoyuan Pharma announced that it would join hands with Innovent Bio to jointly develop and commercialize talatinib in Greater China (including mainland China, Hong Kong, Macau and Taiwan)
.
Lung cancer can be divided into small cell lung cancer and non-small cell lung cancer, of which the incidence of non-small cell lung cancer accounts for 85% of the total number of lung cancers
.
In recent years, the incidence of non-small cell lung cancer in China has continued to increase
.
According to data, there were about 760,000 new cases of non-small cell lung cancer in China in 2019.
It is expected that the number of new cases of non-small cell lung cancer in China will continue to increase in the future, and will exceed 1 million by 2030
.
It is understood that ROS1 fusion mutation is a subtype of non-small cell lung cancer (mutation frequency 1%-2%), and this patient group has a greater demand for medical treatment
.
Previously, Baoyuan Medicine stated in a press release that taraytinib can target ROS1 mutations with high selectivity, and has the potential to become an effective treatment for ROS1-positive cancer patients who have not received TKI therapy or who have failed TKI therapy
.
Taratinib was included in the Breakthrough Therapy category based on the results of the Phase 2 TRUST trial of its use as a next-generation potent ROS1 inhibitor in patients with ROS1 fusion-positive non-small cell lung cancer
.
Phase 2 trial data showed encouraging results with few adverse events
.
In addition, tabratinib was well tolerated, and its treatment-related adverse events mainly included gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevations
.
Breakthrough therapy drugs refer to drugs that are used for the prevention and treatment of diseases that seriously affect the quality of life or are seriously life-threatening and for which there is no effective prevention and treatment method, or there is sufficient evidence to show that they have obvious clinical advantages compared with existing treatment methods
.
Breakthrough therapy drug qualification is an important review process for the FDA to accelerate drug development and review, requiring the FDA to fast-track approval for those drugs that have great prospects and treat serious or fatal diseases
.
In August 2020, the breakthrough therapy drug qualification certification was opened, and a number of drugs have been included since then
.
Since 2022, in addition to talatinib, there are many other drugs included in the list
.
For example, Aficamten (CK-3773274) proposed by Keixing Pharmaceutical for the treatment of obstructive hypertrophic cardiomyopathy; Mavacamten (CK-3773274) of Liantuo for the treatment of diseases in which excessive cardiac contraction and impaired diastolic filling are intrinsic causes; AbbVie Telisotuzumab Vedotin (ABBV-399), intended for the treatment of non-small cell lung cancer with C-MET overexpression; DZD9008 from Dizhe Pharmaceuticals, which is indicated for the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutation; BeiGene's DZD9008 Baiyueze (zanubrutinib), indications for adult chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), as well as Johnson & Johnson's Nipocalimab injection, Hutchison Whampoa's HMPL-523 acetate tablets, etc.
.
The industry said that a drug that has received breakthrough therapy designation means that its therapeutic potential is recognized, and it is also expected to improve investor confidence and increase the company's investment amount
.
.
According to public information, tabratinib is a new generation of ROS1 and NTRK highly selective tyrosine kinase inhibitors under development
.
The original research company of the product is Daiichi Sankyo, and Baoyuan Pharmaceutical obtained the global development, production and commercialization rights of the drug in December 2018
.
Then in June 2021, Baoyuan Pharma announced that it would join hands with Innovent Bio to jointly develop and commercialize talatinib in Greater China (including mainland China, Hong Kong, Macau and Taiwan)
.
Lung cancer can be divided into small cell lung cancer and non-small cell lung cancer, of which the incidence of non-small cell lung cancer accounts for 85% of the total number of lung cancers
.
In recent years, the incidence of non-small cell lung cancer in China has continued to increase
.
According to data, there were about 760,000 new cases of non-small cell lung cancer in China in 2019.
It is expected that the number of new cases of non-small cell lung cancer in China will continue to increase in the future, and will exceed 1 million by 2030
.
It is understood that ROS1 fusion mutation is a subtype of non-small cell lung cancer (mutation frequency 1%-2%), and this patient group has a greater demand for medical treatment
.
Previously, Baoyuan Medicine stated in a press release that taraytinib can target ROS1 mutations with high selectivity, and has the potential to become an effective treatment for ROS1-positive cancer patients who have not received TKI therapy or who have failed TKI therapy
.
Taratinib was included in the Breakthrough Therapy category based on the results of the Phase 2 TRUST trial of its use as a next-generation potent ROS1 inhibitor in patients with ROS1 fusion-positive non-small cell lung cancer
.
Phase 2 trial data showed encouraging results with few adverse events
.
In addition, tabratinib was well tolerated, and its treatment-related adverse events mainly included gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevations
.
Breakthrough therapy drugs refer to drugs that are used for the prevention and treatment of diseases that seriously affect the quality of life or are seriously life-threatening and for which there is no effective prevention and treatment method, or there is sufficient evidence to show that they have obvious clinical advantages compared with existing treatment methods
.
Breakthrough therapy drug qualification is an important review process for the FDA to accelerate drug development and review, requiring the FDA to fast-track approval for those drugs that have great prospects and treat serious or fatal diseases
.
In August 2020, the breakthrough therapy drug qualification certification was opened, and a number of drugs have been included since then
.
Since 2022, in addition to talatinib, there are many other drugs included in the list
.
For example, Aficamten (CK-3773274) proposed by Keixing Pharmaceutical for the treatment of obstructive hypertrophic cardiomyopathy; Mavacamten (CK-3773274) of Liantuo for the treatment of diseases in which excessive cardiac contraction and impaired diastolic filling are intrinsic causes; AbbVie Telisotuzumab Vedotin (ABBV-399), intended for the treatment of non-small cell lung cancer with C-MET overexpression; DZD9008 from Dizhe Pharmaceuticals, which is indicated for the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutation; BeiGene's DZD9008 Baiyueze (zanubrutinib), indications for adult chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), as well as Johnson & Johnson's Nipocalimab injection, Hutchison Whampoa's HMPL-523 acetate tablets, etc.
.
The industry said that a drug that has received breakthrough therapy designation means that its therapeutic potential is recognized, and it is also expected to improve investor confidence and increase the company's investment amount
.
