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On April 14, AstraZeneca announced that its targeted drug Teresa (osimertinib mesylate tablets, osimertinib) has been formally approved by the National Medical Products Administration (NMPA) for use in patients who have received tumor resection treatment.
Early (stage IB/II/IIIA) epidermal growth factor receptor mutation (EGFRm) non-small cell lung cancer (NSCLC) patients.
This is the third indication that Teresa has been approved in China, and it is also another important achievement of this product as an adjuvant therapy for lung cancer after it was approved in the United States in December last year for the adjuvant treatment of early-stage EGFR-mutant lung cancer patients.
Lung cancer is one of the most common malignant tumors in the world, and has become the leading cause of death from malignant tumors in our urban population.
Non-small cell lung cancer accounts for about 80% of all lung cancers.
About 25-30% of NSCLC patients can be diagnosed early and treated with surgery, but most patients will experience cancer recurrence within five years.
Among the patients with NSCLC in my country, about 40% have EGFR mutations.
Teresa is an irreversible third representative dermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) with clinical activity against CNS metastasis.
In 2015, only two and a half years after the product entered clinical trials, it was approved by the U.
S.
Food and Drug Administration (FDA) and became the fastest new drug project in the history of AstraZeneca.
It was also the first approved drug project in the world.
Tumor drugs for locally advanced or metastatic non-small cell lung cancer with positive EGFR T790M mutation.
Since then, Teresa has made great achievements frequently.
From second-line drugs approved for advanced NSCLC to first-line drugs, from late-stage NSCLC drugs to early-stage drugs, the EGFR medication system is constantly being reshaped.
With the continuous increase of indications and market development, the sales of this product have been increasing year by year, and it has become AstraZeneca's core product with the highest sales in the past two years.
The global revenue in 2020 will exceed 4.
3 billion.
The approval of Teresa for the adjuvant therapy of early lung cancer in China is based on the positive results of the global phase III registered clinical study ADAURA.
According to data released by AstraZeneca in May 2020, in patients with stage II and stage IIIA NSCLC, adjuvant teresa treatment reduced the risk of cancer recurrence or death by 83%.
Two years after teresa treatment, 89% of patients were still alive and disease-free, which was much higher than the 53% of the placebo group.
The main efficacy results of the ADAURA clinical trial At present, my country has approved 3 EGFR-TKIs, namely AstraZeneca’s Osimertinib, Hausen Pharmaceutical’s Ametinib and Iris’ Vometinib, the first two The product has been successfully included in the national medical insurance catalogue.
At the same time, Aisen Bio's Avitinib and Betta Pharmaceuticals' Befortinib are expected to be approved for marketing this year.
There are also a number of third-generation EGFR-TKIs in different clinical stages.
End reference materials: [1] AstraZeneca official website [2] https://mp.
weixin.
qq.
com/s/zSjIh43kFRFGWzigs674KA
Early (stage IB/II/IIIA) epidermal growth factor receptor mutation (EGFRm) non-small cell lung cancer (NSCLC) patients.
This is the third indication that Teresa has been approved in China, and it is also another important achievement of this product as an adjuvant therapy for lung cancer after it was approved in the United States in December last year for the adjuvant treatment of early-stage EGFR-mutant lung cancer patients.
Lung cancer is one of the most common malignant tumors in the world, and has become the leading cause of death from malignant tumors in our urban population.
Non-small cell lung cancer accounts for about 80% of all lung cancers.
About 25-30% of NSCLC patients can be diagnosed early and treated with surgery, but most patients will experience cancer recurrence within five years.
Among the patients with NSCLC in my country, about 40% have EGFR mutations.
Teresa is an irreversible third representative dermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) with clinical activity against CNS metastasis.
In 2015, only two and a half years after the product entered clinical trials, it was approved by the U.
S.
Food and Drug Administration (FDA) and became the fastest new drug project in the history of AstraZeneca.
It was also the first approved drug project in the world.
Tumor drugs for locally advanced or metastatic non-small cell lung cancer with positive EGFR T790M mutation.
Since then, Teresa has made great achievements frequently.
From second-line drugs approved for advanced NSCLC to first-line drugs, from late-stage NSCLC drugs to early-stage drugs, the EGFR medication system is constantly being reshaped.
With the continuous increase of indications and market development, the sales of this product have been increasing year by year, and it has become AstraZeneca's core product with the highest sales in the past two years.
The global revenue in 2020 will exceed 4.
3 billion.
The approval of Teresa for the adjuvant therapy of early lung cancer in China is based on the positive results of the global phase III registered clinical study ADAURA.
According to data released by AstraZeneca in May 2020, in patients with stage II and stage IIIA NSCLC, adjuvant teresa treatment reduced the risk of cancer recurrence or death by 83%.
Two years after teresa treatment, 89% of patients were still alive and disease-free, which was much higher than the 53% of the placebo group.
The main efficacy results of the ADAURA clinical trial At present, my country has approved 3 EGFR-TKIs, namely AstraZeneca’s Osimertinib, Hausen Pharmaceutical’s Ametinib and Iris’ Vometinib, the first two The product has been successfully included in the national medical insurance catalogue.
At the same time, Aisen Bio's Avitinib and Betta Pharmaceuticals' Befortinib are expected to be approved for marketing this year.
There are also a number of third-generation EGFR-TKIs in different clinical stages.
End reference materials: [1] AstraZeneca official website [2] https://mp.
weixin.
qq.
com/s/zSjIh43kFRFGWzigs674KA
