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Recently, CDE's public information shows that Chengdu Beite Pharmaceutical Co.
, Ltd.
has submitted an application for generic marketing of dacomitinib tablet category 4
.
Dacomitinib is an oral, selective, adenosine triphosphate (ATP)-competitive, irreversible, small-molecule inhibitor of human epidermal growth factor receptor (HER, erbB) family receptor tyrosine kinases.
It exerts anti-tumor effect by inhibiting the tyrosine kinase activity of the EGFR family
.
The original research company of this product is Pfizer.
As a second-generation EGFR-positive lung cancer targeted drug, it was officially approved for marketing in China in 2019, and has been included in the new version of the National Drug List.
It is used as a single drug for epidermal growth factor receptor (EGFR) 19 First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with exon 21 deletion mutation or exon 21 L858R substitution mutation
.
The number of lung cancer patients in China is huge, and NSCLC patients account for about 80%.
These groups have a huge demand for lung cancer drugs
.
According to data from Minet.
com, in 2020, Dacomitinib tablets are rapidly increasing in the terminals of physical pharmacies in Chinese cities, and the sales have exceeded 110 million yuan.
In 2021, this figure may reach 190 million yuan
.
With the submission of the application by Chengdu Bite Pharmaceutical for the generic listing of dacomitinib tablets, if it is successfully passed, it may gain a market share of 100 million yuan
.
According to the data, Better Pharmaceuticals focuses on the development of the pharmaceutical industry.
Through a forward-looking strategic layout, it integrates R&D, production and sales, and has achieved a full ecological pharmaceutical industry chain coverage from intermediates, APIs to preparations
.
During the reporting period, the company sold more than 140 product specifications, covering multiple segments such as anti-infection, reproductive system, cardiovascular system, blood and hematopoietic system
.
The company has a professional R&D and innovation team of more than 1,000 people.
Taking "Imitation escort, innovation rush" as the R&D strategy guide, scientifically lay out the R&D pipeline, continue to build an innovative technology platform with a global perspective, adhere to independent innovation, and form a diversified Product system and rich pipeline of products under development
.
At present, it has more than 150 research projects, covering 10 national class 1 new drugs such as BT-1053 and BT-101, and many improved new drugs such as remazolam hydrobromide for injection and dexmedetomidine hydrochloride nasal spray.
, and a high-end generic drug pipeline with rich gradients
.
In 2021, Better Pharmaceuticals will have 13 generic drugs approved for marketing under the new registration category
.
Among them, in the field of protein kinase inhibitors, the company also won the production approval for lenvatinib mesylate capsules not long ago, and the dacomitinib tablets reported this time will also be the company's second tinib product
.
According to the data from Minet.
com, in 2021, lenvatinib and dacomitinib will be the major varieties in the field of protein kinase inhibitors in physical pharmacy terminals in Chinese cities, with huge market potential
.
In the field of cardiovascular system therapy, Better Pharmaceuticals has submitted a listing application for sacubitril and valsartan, which is expected to bring new reserves to the company's cardiovascular drug pipeline
.
It is understood that sacubitril-valsartan is a compound preparation composed of sacubitril and valsartan, which is a breakthrough innovative drug for the treatment of heart failure
.
According to Minet.
com, the global sales of Novartis’ sacubitril and valsartan in 2020 were $2.
497 billion
.
It is reported that in order to ensure the controllable cost and stable supply of products from the source, Better Pharmaceuticals adheres to the integrated layout of "APIs + preparations", and the main product APIs are independently produced
.
The company has 6 production bases in Chengdu, Haikou, Guang'an and other places in China, including 4 preparation production bases and 2 API production bases
.
, Ltd.
has submitted an application for generic marketing of dacomitinib tablet category 4
.
Dacomitinib is an oral, selective, adenosine triphosphate (ATP)-competitive, irreversible, small-molecule inhibitor of human epidermal growth factor receptor (HER, erbB) family receptor tyrosine kinases.
It exerts anti-tumor effect by inhibiting the tyrosine kinase activity of the EGFR family
.
The original research company of this product is Pfizer.
As a second-generation EGFR-positive lung cancer targeted drug, it was officially approved for marketing in China in 2019, and has been included in the new version of the National Drug List.
It is used as a single drug for epidermal growth factor receptor (EGFR) 19 First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with exon 21 deletion mutation or exon 21 L858R substitution mutation
.
The number of lung cancer patients in China is huge, and NSCLC patients account for about 80%.
These groups have a huge demand for lung cancer drugs
.
According to data from Minet.
com, in 2020, Dacomitinib tablets are rapidly increasing in the terminals of physical pharmacies in Chinese cities, and the sales have exceeded 110 million yuan.
In 2021, this figure may reach 190 million yuan
.
With the submission of the application by Chengdu Bite Pharmaceutical for the generic listing of dacomitinib tablets, if it is successfully passed, it may gain a market share of 100 million yuan
.
According to the data, Better Pharmaceuticals focuses on the development of the pharmaceutical industry.
Through a forward-looking strategic layout, it integrates R&D, production and sales, and has achieved a full ecological pharmaceutical industry chain coverage from intermediates, APIs to preparations
.
During the reporting period, the company sold more than 140 product specifications, covering multiple segments such as anti-infection, reproductive system, cardiovascular system, blood and hematopoietic system
.
The company has a professional R&D and innovation team of more than 1,000 people.
Taking "Imitation escort, innovation rush" as the R&D strategy guide, scientifically lay out the R&D pipeline, continue to build an innovative technology platform with a global perspective, adhere to independent innovation, and form a diversified Product system and rich pipeline of products under development
.
At present, it has more than 150 research projects, covering 10 national class 1 new drugs such as BT-1053 and BT-101, and many improved new drugs such as remazolam hydrobromide for injection and dexmedetomidine hydrochloride nasal spray.
, and a high-end generic drug pipeline with rich gradients
.
In 2021, Better Pharmaceuticals will have 13 generic drugs approved for marketing under the new registration category
.
Among them, in the field of protein kinase inhibitors, the company also won the production approval for lenvatinib mesylate capsules not long ago, and the dacomitinib tablets reported this time will also be the company's second tinib product
.
According to the data from Minet.
com, in 2021, lenvatinib and dacomitinib will be the major varieties in the field of protein kinase inhibitors in physical pharmacy terminals in Chinese cities, with huge market potential
.
In the field of cardiovascular system therapy, Better Pharmaceuticals has submitted a listing application for sacubitril and valsartan, which is expected to bring new reserves to the company's cardiovascular drug pipeline
.
It is understood that sacubitril-valsartan is a compound preparation composed of sacubitril and valsartan, which is a breakthrough innovative drug for the treatment of heart failure
.
According to Minet.
com, the global sales of Novartis’ sacubitril and valsartan in 2020 were $2.
497 billion
.
It is reported that in order to ensure the controllable cost and stable supply of products from the source, Better Pharmaceuticals adheres to the integrated layout of "APIs + preparations", and the main product APIs are independently produced
.
The company has 6 production bases in Chengdu, Haikou, Guang'an and other places in China, including 4 preparation production bases and 2 API production bases
.