Looking at the opportunities of Chinese enterprises from the change of American generic pharmaceutical industry

[market analysis of chinapharma.com] in May 2017, Scott Gottlieb, the new director of FDA, advocated accelerating the approval process of generic drugs to break the monopoly of heavy original research drugs on the market, hoping to reduce the price of drugs after introducing competition The FDA's accelerated approval is a great opportunity for Chinese pharmaceutical companies to gradually start the process of internationalization, and the application for drug registration of Chinese enterprises in the United States is expected to accelerate approval (see the opportunities of Chinese enterprises from the change of American generic pharmaceutical industry picture source: Baidu picture) the share price of global generic giant Teva fell sharply last week The company released the second quarter financial report on August 3, saying that the earnings per share and operating income were lower than expected In the second quarter, Teva's revenue was US $5.69 billion, a year-on-year increase of 12.9%, which was US $40 million lower than expected; in the second quarter, Teva accrued US $6.1 billion in asset impairment, resulting in a net profit attributable to the parent of US $5.97 billion After deducting asset impairment, the net profit in the first half of 2017 was US $130 million, which was also less than the net profit of US $254 million in the same period of last year The decline of Teva's share price reflects the change of American generic pharmaceutical industry On the surface, the sharp drop of Teva is due to the unexpected performance of China Daily and the sharp reduction of dividend Looking at the long run, after August 2015, Teva's share price began to decline all the way On the one hand, due to its own factors, the core product, gratiray, is facing challenges and is likely to lose its product status In addition, it is also subject to strong competition from similar competitors, tecfidera In addition, the company spent money last year The US $40.5 billion acquisition of Actavis's generic pharmaceutical business bears a huge amount of debt The pressure of asset impairment and financial expenses will affect the company's net profit for a period of time Teva's share price also reflects the changes in the U.S generic pharmaceutical industry The performance of Teva's share price, more importantly, reflects the changes in the U.S generic pharmaceutical industry The drop was also attributed to mylan, a benchmark generic pharmaceutical company After the government came to power, it repeatedly criticized the high price of drugs and planned to implement drug reform FDA has also begun to greatly accelerate the approval of generic drugs to enhance competition to reduce drug prices Traditional generic drug companies in Europe and the United States are facing double pressures of price and sales volume Given the pressure on the generic industry, CEO Yitzhak Peterburg said Teva plans to close or sell six plants in 2017 and nine more in 2018, and decided to withdraw from 45 countries by the end of 2017 The acceleration of FDA approval has brought opportunities to the export of Chinese pharmaceutical products Since 2016, the efficiency of FDA approval has been greatly improved, with 835 drug approvals approved throughout the year, a new record Scott Gottlieb, the new FDA director in May 2017, advocates accelerating the approval process of generic drugs to break the monopoly of heavy original research drugs on the market, hoping to reduce drug prices after introducing competition The FDA's accelerated approval is a great opportunity for Chinese pharmaceutical companies to gradually start the process of internationalization, and the application for drug registration of Chinese enterprises in the United States is expected to accelerate approval It is suggested to focus on: Kanghong pharmaceutical, Yifan pharmaceutical, Huahai pharmaceutical and other A-share enterprises Risk tip: in addition to the review progress of FDA, the acquisition of drug approval documents is also related to the clinical results and GMP certification of drugs; the original research or first imitation price reduction will also cause pressure on subsequent manufacturers; there is greater competitive pressure on the approved varieties.