Review policy or major adjustments
On January 12, the official website of the national health and Family Planning Commission released the announcement on the priority evaluation of drug varieties to be recommended for major special projects of major new drug creation technology. According to the announcement, it is proposed to recommend 18 special supported drug varieties of Hengrui medicine (38.91, - 0.080, - 0.21%), Baiji Shenzhou, Institute of toxicants and drugs of the Academy of Military Medical Sciences, such as famitinib, bgb-283, and hydroxypiperone hydrochloride, as the priority evaluation varieties.
As the priority review varieties, the drug review center shall give priority to the review of drug registration applications that have no objection. Industry insiders believe that this is a positive signal released by the health and Family Planning Commission to "encourage R & D innovation". Of the 18 drugs receiving this treatment, 8 are macromolecular protein drugs, and 3 are small molecule targeted drugs, which are concentrated in the fields of anti-tumor, diabetes, antidepressant and other major diseases.
In the view of the insiders, the significance of priority review is more than that. In the future, there may be significant adjustments in drug review policies. "The competent department is understaffed and the new drug application cycle is too long. This priority review may be a major attempt by the competent authorities to speed up the review and shorten the application cycle of new drugs. " According to industry insiders, generic drugs may benefit from the adjustment of drug review policies.
According to the above analysis, in the future, the review authority of six generic drugs may be delegated to the provincial drug supervision department, and the drug review speed is expected to accelerate. Secondly, the drug review center may increase its staff. Compared with the 3000 drug review teams of FDA in the United States, the core review team of China's drug review center is only about 200, which is the root of the backlog of drug review.
Innovative drug companies benefit significantly
Industry insiders said that no matter how the policy is adjusted, the guiding ideology of "encouraging innovation" and "high quality and good price" at the national level will not change. In the future, the pharmaceutical market is expected to return to the virtuous circle of "high investment and high return, R & D driven profit growth".
It is generally believed in the industry that large-scale pharmaceutical enterprises that stick to R & D investment for a long time and are healthy in the research product echelon will perform the theme of "strong and strong". For example, Hengrui pharmaceutical, Shiyao group, Huahai pharmaceutical, humanwell pharmaceutical and other companies are expected to win in the long run.
Innovative drug companies often get good policies recently. In addition to encouraging innovation at the national level, the national development and Reform Commission earlier announced the abolition of the establishment of the maximum retail price of drugs, which also cheered innovative drug companies for a while.
In recent years, the pricing of innovative drugs has been almost driven out of good money by bad money. The bidding idea of "only low price is to take" basic drugs and non-basic drugs makes many innovative drug companies "fall to the ground". After the price liberalization, enterprises can set their own prices according to the cost and market situation, which means that the five finger mountain of "price control" has finally been moved away.
As for the impact of deregulation of drug prices on innovative drug companies, industry insiders believe that innovative drugs have the pricing power of "taking the lead in the world", while generic drugs face fierce price competition. After 2016, the number of patent drugs expired will be drastically reduced, and generic drugs will not be available. Therefore, the large-scale enterprises are increasing the research and development of innovation.
Taking Hengrui medicine as an example, in the long run, the company completed the transformation from me better medicine to the first small molecule medicine in 2013, and carried out the research and development of biomacromolecule medicine. Monoclonal antibodies and antibody conjugates are also one of the research directions of the company. These are all heavy-duty products with a bright future. In the short term, apatinib, the 1.1 new drug of Hengrui pharmaceutical, will be on the market at the end of the year, which may arouse investors' enthusiasm for the innovative medicine sector. (source: China Securities Journal Author: Dai Xiaohe)
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