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[Pharmaceutical Network Industry News] Lung cancer is a cancer with a very high incidence, which seriously threatens national health
.
In 2016, there were about 828,000 new lung cancer cases in China
.
Non-small cell lung cancer (NSCLC) accounts for more than 80% of all lung cancer cases in China, and ALK-positive lung cancer accounts for about 3-5% of NSCLC cases
.
At present, there are nearly 35,000 new cases of ALK-positive lung cancer in China every year.
Due to the limitations of existing therapies for the treatment of ALK-positive non-small cell carcinoma, there is still a large unmet clinical need in this field
.
ALK inhibitors have a wider therapeutic range, lower toxicity, and higher specificity to tumor cells, etc.
, and are being favored by the pharmaceutical industry
.
At present, there are three generations of ALK inhibitors.
Among them, crizotinib launched by Pfizer is the first ALK tyrosine kinase inhibitor launched in the world, bringing a new treatment option for ALK-positive advanced non-small cell lung cancer
.
The second-generation ALK inhibitors include ceritinib, alectinib, brigatinib, and ensatinib, and the third-generation ALK inhibitor is Pfizer's lorlatinib
.
In China, only crizotinib, alectinib, and ceritinib are currently approved for marketing
.
The 2021 CSCO guidelines for lung cancer show that for patients with ALK fusion, alectinib, crizotinib, and ceritinib are the first-line options, and alectinib is the preferred recommendation
.
In recent years, with the growth of new cases of ALK-positive lung cancer, the ALK inhibitor market has expanded rapidly.
It is estimated that by 2024, the market size of ALK inhibitors in China will be about 7.
5 billion yuan, with a compound annual growth rate of about 30%
.
In this context, it has also stimulated the enthusiasm of many domestic and foreign pharmaceutical companies for R&D layout
.
For example, Takeda China recently announced that its new drug application for ALK inhibitor brigatinib has been approved by the State Food and Drug Administration, and the single drug is suitable for anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease.
treatment of patients with non-small cell lung cancer (NSCLC)
.
At present, brigatinib tablets have been approved in more than 40 countries and regions around the world, and have obtained FDA breakthrough therapy drug certification and orphan drug certification
.
Betta Pharmaceuticals also announced not long ago that the company's ensatinib hydrochloride capsule marketing authorization application has been approved, and the single drug is intended to be used for "anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cells.
" The treatment of lung cancer (NSCLC) patients will provide a better choice for the clinical treatment of ALK-positive lung cancer patients and better meet the clinical needs of Chinese patients
.
According to the Insight database, there are currently 4 ALK targets in clinical phase III of domestic new drugs involving Shouyao Holding, Chia Tai Tianqing, Sihuan Pharmaceutical and Fosun Pharma etc.
Among
them, Shouyao Holding is a second-generation ALK kinase multi-target inhibitor for the treatment of patients with advanced ALK-positive non-small cell lung cancer SY-707, is currently conducting a Phase II clinical trial for the second-line drug in patients with crizotinib-resistant ALK-positive non-small cell lung cancer and a Phase III clinical trial for the first-line drug in newly-treated ALK-positive non-small cell lung cancer patients
.
The prospectus released recently shows that in addition to SY-707, the company's ALK products under development also include SY-3505, which is the first domestically produced third-generation ALK inhibitor to undergo clinical trials in China.
It is mainly used for the treatment of first- and second-generation ALK inhibitors.
Drug-resistant ALK-positive non-small cell lung cancer
.
At present, only lorlatinib has been approved in the world but has not yet been marketed in mainland China.
SY-3505, as the first domestically produced third-generation ALK inhibitor to enter clinical research, has been studied in phase I clinical trials.
The efficacy of the drug is first seen in the drug-resistant patients, and its research and development progress is at the forefront of domestic clinical research
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
In 2016, there were about 828,000 new lung cancer cases in China
.
Non-small cell lung cancer (NSCLC) accounts for more than 80% of all lung cancer cases in China, and ALK-positive lung cancer accounts for about 3-5% of NSCLC cases
.
At present, there are nearly 35,000 new cases of ALK-positive lung cancer in China every year.
Due to the limitations of existing therapies for the treatment of ALK-positive non-small cell carcinoma, there is still a large unmet clinical need in this field
.
ALK inhibitors have a wider therapeutic range, lower toxicity, and higher specificity to tumor cells, etc.
, and are being favored by the pharmaceutical industry
.
At present, there are three generations of ALK inhibitors.
Among them, crizotinib launched by Pfizer is the first ALK tyrosine kinase inhibitor launched in the world, bringing a new treatment option for ALK-positive advanced non-small cell lung cancer
.
The second-generation ALK inhibitors include ceritinib, alectinib, brigatinib, and ensatinib, and the third-generation ALK inhibitor is Pfizer's lorlatinib
.
In China, only crizotinib, alectinib, and ceritinib are currently approved for marketing
.
The 2021 CSCO guidelines for lung cancer show that for patients with ALK fusion, alectinib, crizotinib, and ceritinib are the first-line options, and alectinib is the preferred recommendation
.
In recent years, with the growth of new cases of ALK-positive lung cancer, the ALK inhibitor market has expanded rapidly.
It is estimated that by 2024, the market size of ALK inhibitors in China will be about 7.
5 billion yuan, with a compound annual growth rate of about 30%
.
In this context, it has also stimulated the enthusiasm of many domestic and foreign pharmaceutical companies for R&D layout
.
For example, Takeda China recently announced that its new drug application for ALK inhibitor brigatinib has been approved by the State Food and Drug Administration, and the single drug is suitable for anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease.
treatment of patients with non-small cell lung cancer (NSCLC)
.
At present, brigatinib tablets have been approved in more than 40 countries and regions around the world, and have obtained FDA breakthrough therapy drug certification and orphan drug certification
.
Betta Pharmaceuticals also announced not long ago that the company's ensatinib hydrochloride capsule marketing authorization application has been approved, and the single drug is intended to be used for "anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cells.
" The treatment of lung cancer (NSCLC) patients will provide a better choice for the clinical treatment of ALK-positive lung cancer patients and better meet the clinical needs of Chinese patients
.
According to the Insight database, there are currently 4 ALK targets in clinical phase III of domestic new drugs involving Shouyao Holding, Chia Tai Tianqing, Sihuan Pharmaceutical and Fosun Pharma etc.
Among
them, Shouyao Holding is a second-generation ALK kinase multi-target inhibitor for the treatment of patients with advanced ALK-positive non-small cell lung cancer SY-707, is currently conducting a Phase II clinical trial for the second-line drug in patients with crizotinib-resistant ALK-positive non-small cell lung cancer and a Phase III clinical trial for the first-line drug in newly-treated ALK-positive non-small cell lung cancer patients
.
The prospectus released recently shows that in addition to SY-707, the company's ALK products under development also include SY-3505, which is the first domestically produced third-generation ALK inhibitor to undergo clinical trials in China.
It is mainly used for the treatment of first- and second-generation ALK inhibitors.
Drug-resistant ALK-positive non-small cell lung cancer
.
At present, only lorlatinib has been approved in the world but has not yet been marketed in mainland China.
SY-3505, as the first domestically produced third-generation ALK inhibitor to enter clinical research, has been studied in phase I clinical trials.
The efficacy of the drug is first seen in the drug-resistant patients, and its research and development progress is at the forefront of domestic clinical research
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
