12 generic drugs are included in the priority review! But the generic drug declaration dropped by 60%, why?

On the one hand, 12 generic drugs have been included in the priority review list On the other hand, the generic drug application has declined precipitously Compared with 2015, the generic drug application dropped 66% in 2016 Why does this happen? Which generic drugs still have market? Sources: CFDA, Yangcheng Evening News, June 1, CDE website published the 18th batch of 12 drug lists to be included in the priority review process Among them, Guangdong dongyangguang Pharmaceutical Co., Ltd has 5 varieties Up to now, CDE has published 19 batches of lists, involving a total of 255 acceptance numbers The 18th batch of drug registrations to be included in the priority review process: China has long been the global supplier of cheap APIs and generic drugs However, relevant data show that in recent years, the popularity of China's generic drugs has gradually declined: generic drug applications have declined precipitously, while biopharmaceuticals have flourished According to the latest data released by the National Institutes of Health (NIH), China ranks second in the number of clinical trials of Biotherapy, second only to the United States With the improvement of the independent R & D ability of domestic pharmaceutical enterprises, multinational pharmaceutical enterprises that used to play the role of "seller" in the Chinese market and import innovative drugs to the market have also joined the ranks of "buyer" in recent years In China, the popularity of generic drugs is gradually decreasing According to the data of the State Food and drug administration, in 2016, there were only 647 generic drug applications and 196 approvals In 2015, 1905 generic drugs were declared and 739 were approved, with the declaration volume plummeting 66% year on year At the same time of the great decrease of generic drugs, biopharmaceuticals are booming According to data released by the National Institutes of Health (NIH), as of April 3, there were 2694 clinical trials of biotherapy in the world, with the United States accounting for half (51%) Although China's biological clinical trials are far lower than the United States, they still reach 11%, higher than developed countries such as the United Kingdom, ranking second in the world This phenomenon has attracted the attention of foreign media According to a recent report published on the website of the Wall Street Journal, China has emerged as a powerful biotech drug country "Ten years ago, China was not even in the field of biotechnology, but now it has become a force that can not be ignored," the article quoted a partner of venture capital fund who specializes in Chinese biotechnology start-ups as saying The reporter inquired relevant data and found that, especially in the field of anti-tumor, the R & D efforts of Chinese pharmaceutical enterprises have increased significantly, and more and more innovative enterprises have joined the ranks of anti-tumor new drug research According to the statistics of Weida data, from 2010 to February 2017, a total of 52 companies in China applied for 69 new class 1 anti-tumor drugs Multinational pharmaceutical companies began to buy and buy in China China is emerging as a major producer of such important new drugs as biotechnology drugs, which has attracted the attention of some large global pharmaceutical companies Many multinational pharmaceutical companies have joined the ranks of "buyers" in China to sell biotechnology drugs developed in China overseas Before that, multinational pharmaceutical companies usually acted as "sellers" in the Chinese market, importing innovative drugs into China In 2015, Lilly and Cinda biology signed a strategic cooperation agreement The two sides will jointly develop and commercialize three new bispecific tumor immunotherapy antibodies in the next decade All of the three antibodies use PD-1 monoclonal antibody independently developed by Cinda biology Among them, Cinda biology is mainly responsible for the production and sales of the Chinese market, while Lilly is mainly responsible for the overseas market According to the agreement, in addition to the milestone payment with a total amount of more than US $1 billion, Cinda biology will receive sales commission and other payments after the drugs are commercialized overseas This is also the largest cooperation between Chinese enterprises and multinational companies in new drug development At the same time, multinational pharmaceutical companies are seeking patent authorization of new drugs under research in China, and the mode of promoting to the world after cooperative development is becoming more and more popular Shanghai Asia bio is the first multinational pharmaceutical company to try this model In 2007, with a cost of US $28 million, Shanghai Asia obtained a global patent license for the innovative anticancer drug xidaban, independently developed by Shenzhen microchip This investment has also benefited Shanghai and Asia In 2016, Shanghai Asia transferred the rights of sidabamide in Asia to a Japanese enterprise, and obtained at least $280 million in return In the same year, Shanghai Asia signed an exclusive patent license with Fudan University for a new anti-tumor immunotherapy candidate drug If the clinical development and commercialization of the drug are successful, Shanghai Asia will pay a total of 65 million US dollars 3 the sale price of new drugs made in China is favored by multinational pharmaceutical companies It is undoubtedly a clear proof of the rapid development of local innovative pharmaceutical companies In recent years, several international cooperation projects are basically immunotherapy drugs, which is one of the hottest and most promising research and development directions in the world In order to win the patent authorization of new drugs in China, multinational pharmaceutical companies have made more "generous" efforts The amount has soared from tens of millions of US dollars at the beginning to hundreds of millions of US dollars After Hengrui pharmaceutical sold 800 million US dollars of PD-1 monoclonal antibody, Cinda biological's 1 billion US dollars has set a new record again The drugs in the pre clinical stage have already sold the international level Such international cooperation in new drugs is no longer an isolated case, but a trend Behind the increasing number of clinical trials of Biotherapy, the domestic pharmaceutical companies pay more and more attention to R & D and innovation According to Ifind data of tonghuashun, in 2016, R & D investment of A-share pharmaceutical listed companies reached 22.5 billion, up 15.7% year on year Many enterprises have maintained high R & D income for many consecutive years The reporter of Yangcheng Evening News found that the R & D amount of 10 pharmaceutical enterprises, such as Watson biology, Kangtai biology and Beida pharmaceutical, exceeded 10% of their business income for three consecutive years The R & D investment of Hengrui pharmaceutical, Fosun Pharmaceutical and other pharmaceutical enterprises last year has exceeded 1 billion yuan.