The rise of domestic Tini, anti-tumor drugs gradually gas
March 10, 2016 Source: New Kangjie
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};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)];Anti-tumor drugs have an important position in clinical treatment and have been the main target at home and abroad for many years. From 2002 to 2008, domestically marketed tyrosine kinase inhibitors (hereinafter referred to as "Tini") have five drugs. During the “Twelfth Five-Year Plan†period, the State Food and Drug Administration has approved seven new tini drugs, and the number of drugs used in clinical use has reached 12, which is an important part of the anti-tumor drug market.
| Small molecule targeted anti-tumor drugs are sought after
It is worth mentioning that since the “Twelfth Five-Year Plan†period, the State Food and Drug Administration approved the production of the national class I innovative drugs ectinib and apatinib. situation. At the same time, the success of imatinib and dasatinib brand generic drugs has promoted the bold attempt of localization of small molecule targeted therapeutic drugs, and has become a variety of grounding gas in the anti-tumor clinical drug market.
According to the statistics of China Medical Industry Information Center, in 2014, the anti-tumor market of sample hospitals in 22 key cities reached 14.32 billion yuan, an increase of 14.14% over the previous year; the anti-tumor TOP10 drugs were paclitaxel and pemetrexed, respectively. Docetaxel, tigeol, oxaliplatin, rituximab, capecitabine, trastuzumab, gemcitabine and imatinib. The analysis shows that the compound annual growth rate of the sample hospital anti-tumor market reached 14.5% between 2010 and 2014.
With the launch of a new generation of domestic tini drugs, the market share of small molecule targeted drugs has increased year by year. In the first three quarters of 2015, domestic Tini-like drugs in the sample hospitals accounted for 20% of the total market of Tini. At the end of the "Twelfth Five-Year Plan", domestic small molecule targeted drugs have become a new bright spot in the market.
| Ekterinib, apatinib "for the country"
As we all know, China's first small molecule targeted anti-tumor drug with completely independent intellectual property rights is the Ektinib developed by Zhejiang Beida Pharmaceutical Co., Ltd., which was approved by the State Food and Drug Administration at the beginning of the 12th Five-Year Plan for late use. Non-small cell lung cancer, trade name "Kemena".
Ektinini is an outstanding achievement of the national “Eleventh Five-Year Plan†and “Twelfth Five-Year Plan†major scientific and technological projects. It has made a major breakthrough in the independent research and development of new drugs and was awarded the first prize of the National Science and Technology Progress Award. This is the first time that China's chemical pharmaceutical industry has won this award. Ektorini has Chinese, American and international patents. It is similar to gefitinib and erlotinib in terms of chemical structure, molecular mechanism and efficacy, but it has better safety. Highly evaluated by international clinical oncologists. Under the impetus of domestic “Tini†clinical drugs, it gradually broke the situation of western drug monopoly market.
Statistics show that in the first three quarters of 2015, the market for Ektinib in the sample hospitals in key cities in China has reached 138 million yuan. It is expected that the hospital market will exceed 200 million yuan in the whole year, which is more than 40% year-on-year.
Another small molecule targeted anti-cancer drug in China with completely independent intellectual property rights is apatinib. This is the world's first small molecule anti-angiogenic targeting agent that has proven to be safe and effective in advanced gastric cancer, and is a targeted oral drug that significantly prolongs patient survival after failure of standard chemotherapy for advanced gastric cancer.
On December 13, 2014, apatinib developed by Jiangsu Hengrui Pharmaceutical was approved for marketing, and the trade name was “Aitanâ€. Aitan is one of the special projects for the creation of major new drugs in the “Eleventh Five-Year Plan†and “Twelfth Five-Year Planâ€. The new drugs have achieved good returns after they are listed. According to the data, in the first three quarters of 2015, the market for apatinib in the sample hospitals in key cities in China was 52.1 million yuan. It is expected that the market for sample hospitals in key cities in the whole year will exceed 100 million yuan.
| "Made in China" rises, Gleevec is no longer the only one
At the same time, the State Food and Drug Administration approved the imatinib tablets of Jiangsu Haosen Pharmaceutical Co., Ltd. (trade name: Wei Wei) and the imatinib capsule of Zhengda Tianqing Pharmaceutical Co., Ltd. in June 2013 (trade name: Mud can be listed. In October 2014, the imatinib tablet (trade name: Nolinin) of Shiqi Pharmaceutical Zhongqi Pharmaceutical Technology Co., Ltd. was approved for listing, breaking the monopoly of Gleevec of Switzerland Novartis. .
According to the data, in the first three quarters of 2015, the market for imatinib in the sample hospitals in key cities in China was 320 million yuan, of which Novartis’s original research drug Gleevec accounted for 91.86%, and domestic generic drugs accounted for 8.14%. Share. Among them, Jiangsu Haosen Pharmaceutical’s “昕维†accounted for 6.88%, Jiangsu Zhengda Tianqing Pharmaceutical’s “Gemu Ke†and Shijiazhuang Group’s Zhongqi Pharmaceutical’s “Nuo Lining†accounted for 1.25% and 0.02% respectively. . After imatinib enters the “Medical Insurance Catalogue†of several provinces and cities, it is the driving force for market growth. Under the price advantage, domestic imatinib will further promote the rapid growth of the local tenicol market, and fundamentally solve it. The current situation of the use of medicines for ordinary people with special diseases and the difficulty of using medicines has promoted the innovation and upgrading of the pharmaceutical industry.
API Powder (Active Pharmaceutical Ingredient)
Active Pharmaceutical Ingredients refer to the raw materials used in the production of various preparations. They are the effective ingredients in the preparations. They are various powders, crystals, extracts, etc., prepared by chemical synthesis, plant extraction or biotechnology, but Substances that the patient cannot take directly.
According to its source,Active Pharmaceutical Ingredients are divided into two categories: synthetic chemical drugs and natural chemical drugs.Chemical synthetic drugs can be divided into inorganic synthetic drugs and organic synthetic drugs. Inorganic synthetic drugs are inorganic compounds (extremely elements), such as aluminum hydroxide and magnesium trisilicate used to treat gastric and duodenal ulcers; organic synthetic drugs are mainly composed of basic organic chemical raw materials, through a series of organic Drugs made by chemical reactions (such as aspirin, chloramphenicol, caffeine, etc.).
Natural chemical drugs can also be divided into biochemical drugs and phytochemical drugs according to their sources.Antibiotics are generally made by microbial fermentation, which belongs to the category of biochemistry.In recent years, many semisynthetic antibiotics are the combination of biosynthesis and chemosynthesis.Among APIs, organic synthetic drugs account for the largest proportion in variety, yield and output value, which is the main pillar of chemical pharmaceutical industry.The quality of API determines the quality of preparation, so its quality standards are very strict. All countries in the world have formulated strict national pharmacopoeia standards and quality control methods for its widely used API
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