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Author: Jun Chen Zuo Shi
A few days ago, Suzhou Terui Pharmaceutical Co.
, Ltd.
was accepted by the CDE for the application of nilotinib capsules submitted for imitation of category 4, making it the first domestic company
.
According to data from Minai.
Source: CDE official website
Nilotinib is a second-generation BCR-ABL tyrosine kinase inhibitor developed by Novartis.
It was approved by the FDA in October 2007 and entered the domestic market in July 2009.
The global sales in 2020 will be close to 2 billion.
US dollars
.
According to Meinenet data, in 2020, China’s urban public hospitals, county-level public hospitals, urban community centers, township health centers (referred to as Chinese public medical institutions), and China’s urban entity pharmacies terminal nilotinib capsules total sales of nearly 900 million yuan in 2020.
A year-on-year increase of 34.
23%
.
Currently, only Novartis' nilotinib capsules are on sale in China
.
On September 15th, Suzhou Terui Pharmaceutical's listing application for Nilotinib capsules submitted for imitation of category 4 was accepted by the CDE.
In the field of chronic myelogenous leukemia (CML) treatment, BCR-ABL tyrosine kinase inhibitors have entered the second-generation nilotinib, dasatinib and the new second-generation fluma from the first-generation imatinib Tinib, and strides forward to the third generation
.
Imatinib developed by Novartis is the first marketed drug for the BCR-ABL target, which opened the prelude to tumor TKI targeted therapy
.
Both the imatinib mesylate capsules of Jiangsu Zhengda Tianqing Pharmaceutical and the imatinib mesylate tablets of Hausen Pharmaceuticals were approved for marketing in 2013, breaking the monopoly of the original research
Approval of imatinib generic drugs
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
Among the second-generation BCR-ABL tyrosine kinase inhibitors, Dasatinib developed by Bristol-Myers Squibb was approved to enter the domestic market in 2011, and Chia Tai Tianqing's product was approved for marketing in 2013, making it the first domestic imitation
.
According to data from Meinenet, in 2020, the total sales of dasatinib tablets in Chinese public medical institutions and physical pharmacies in Chinese cities will exceed 500 million yuan, a year-on-year increase of 21%
Dasatinib generic drug application status
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
In addition, the new class 1 drug flumatinib developed by Hausen Pharmaceuticals for more than ten years is optimized on the molecular structure of nilotinib and is considered an upgraded version of imatinib
.
The product was approved for listing in December 2019.
Among the three generations of BCR-ABL tyrosine kinase inhibitors, Yasheng Pharmaceutical’s class 1 new drug nectinib tablets (HQP1351) has been submitted for marketing applications for the treatment of resistance and/or resistance to first- and second-generation tyrosine kinase inhibitors Intolerant chronic myelogenous leukemia (CML)
Source: Mi Nei.
