Carrying out the consistency evaluation of the quality and efficacy of generic drugs can enhance the brand value of products and enhance the discourse power of the product market, so at present, in order to further force pharmaceutical companies to cohesion and enhance competitiveness, many pharmaceutical companies are accelerating the consistency evaluation of
generic drugs.
It is reported that recently, pharmaceutical companies have been evaluated for generic drugs, and the good news of being approved for the first generic has been continuous
.
Recently, Hanyu Pharmaceutical issued an announcement that the company received the "Drug Registration Certificate" issued by the State Medical Products Administration, and the company's hypoglycemic drug "vildagliptin tablets" was approved for marketing and deemed to have passed the consistency evaluation
.
Vildagliptin is indicated for the treatment of type 2 diabetes
.
The drug was developed by Novartis and approved for marketing in the European Union in 2007, and according to Minai.
com, Novartis' global sales of the product in 2019 were close to $1.
3 billion
.
In China, vildagliptin has entered the 2017 edition of the medical insurance catalog
.
In 2021, the sales of vildagliptin tablets in domestic sample hospitals (including urban public hospitals, urban community hospitals, county-level public hospitals, township health centers) and urban physical pharmacies were about RMB 150 million
.
On January 5, the State Food and Drug Administration showed that Suzhou Terui Pharmaceutical's nilotinib capsules were approved for production with generic 4 categories, the first imitation and the first to be evaluated
.
Nilotinib capsules are used to treat newly diagnosed adult patients with chronic myeloid leukemia (Ph+CML) chronically diagnosed Philadelphia
chromosome-positive.
Philadelphia stain resistant or intolerant to previous treatments, including imatinib
The drug was developed by Novartis, approved by the FDA in 2007, and entered the domestic market
in 2009.
Data show that the global sales of the product exceeded 2 billion US dollars in 2021, and the terminal sales of public medical institutions in China exceeded 600 million yuan, with a year-on-year increase of more than 10%
in the first half of 2022.
At present, there are 2 enterprises in the domestic market nilotinib capsules with production approvals, in addition to Suzhou Terui Pharmaceutical, which won the first generic and the first review, Qilu Pharmaceutical has also been reviewed for generic 4 types of production, and it is deemed to have been evaluated
after approval.
On the same day, NMPA released a new batch of drug approval certificate delivery information
.
Among them, Yangtze River Pharmaceutical's regorafenib tablets were approved for marketing, which is deemed to have passed the consistency evaluation, and also won the first generic drug
of the 700 million anticancer drugs in China.
According to public information, regorafenib tablets (Stivarga) is a new oral multi-kinase inhibitor that targets angiogenesis, matrix and oncogenic receptor tyrosine kinase (RTK).
Regorafenib tablets were originally developed from Bayer and were first approved by the FDA in September 2012
.
At present, it has also been approved for use
in more than 90 countries and regions such as the United States, the European Union and Japan.
It is reported that in 2011, Bayer's global sales of regorafenib tablets were 580 million US dollars
.
At present, in addition to Yangtze River Pharmaceutical, there are also a number of pharmaceutical companies are also deploying this variety, such as Nanjing Chia Tai Tianqing, Qilu Pharmaceutical, Kelun Pharmaceutical, Beijing Shuanglu, Shanghai Chuangnuo, Jiangsu Haosen Pharmaceutical, East China Pharmaceutical and other companies have been undertaken by CDE
.
In addition, BE trials by pharmaceutical companies such as Beijing Xuansheng Pharmaceutical and Chongqing Yaoyou Pharmaceutical are also underway
.
={"common":{"bdSnsKey":{},"bdText":"","bdMini":"1","bdMiniList":false,"bdPic":"","bdStyle":"0","bdSize":"32"},"share":{},"image":{"viewList":[" weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"],"viewText":"share:","viewSize":"24"},"selectShare":{" bdContainerClass":null,"bdSelectMiniList":["weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"]}}; with(document)0[(getElementsByTagName('head')[0]|| body).
appendChild(createElement('script')).
src='http://bdimg.
share.
baidu.
com/static/api/js/share.
js?v=89860593.
js?cdnversion='+~(-new Date()/36e5)]; 
