Influence geometry of priority evaluation of new 17 varieties

Source: pharmaceutical economic news, September 17, 2015, recently announced on the official website of the national health and Family Planning Commission, in order to speed up the output process of major special innovation achievements of major new drug creation technology, according to the expert review and selection suggestions, the major special implementation management office of major new drug creation technology recommendedct-707 of Beijing celental pharmaceutical, pyrrolidine maleate tablets of Hengrui pharmaceutical, etc.17 Drug varieties with special support are the priority ones Our reporter saw from the list of recommendations that in the shortlist, 12 varieties applied for clinical application, including Ximing pirui of Shanghai Institute of medicine, Chinese Academy of Sciences, Mibo for injection of Jiangsu aosaikang pharmaceutical, recombinant human albumin of Zhejiang Haizheng pharmaceutical, etc; In terms of production application, there are only five varieties, including Guangzhou Nanxin pharmaceutical's palamivir, Qilu pharmaceutical's clofarabine injection, etc It is reported that this is the third time for the national health and Family Planning Commission to publicize the drugs recommended for priority review this year In January this year, the national health and Family Planning Commission publicized 18 kinds of drugs, and in May, 21 kinds of drugs were published Currently, 56 kinds of drugs have entered the priority review list "From the publicity situation, I think that the selection criteria are mostly based on the actual needs of clinicians and the degree of market shortage, and the urgent need, necessity and necessity are the foothold of recommendation priority review." Shen Lingjia, a senior executive of an innovative pharmaceutical company in China, said The new 17 varieties, mainly concentrated in monoclonal antibody, recombinant human protein, TiNi drugs and other aspects, have urgent clinical needs "Compared with generic drugs, the review speed of new drugs is accelerating in recent years," Shen said As for the progress of specific varieties after they are recommended to enter the priority review list, he said that it is still in progress For new drugs, participating in the priority review can at least greatly reduce the queuing time of review and approval, and actively promote the marketization of innovative drugs It should be noted that since 2011, the number of pharmaceutical patent applications in China has ranked first in the world, but the transformation of new achievements is relatively weak Among the "pain points" of pharmaceutical innovation, the long time of review and approval is a major factor Many enterprises seek to apply for approval both in China and abroad To this end, the CFDA reform efforts have been strengthened and strategic considerations have been taken, including specific requirements on how to speed up innovation and how to evaluate generic drugs Some enterprise personage said, "the acceptance number is seriously overstocked If we don't take the green channel, it means extending the patent protection period in disguised form, which is unfair to domestic innovative enterprises Priority evaluation not only saves a lot of time and cost for enterprises, but also increases the selectivity of doctors' clinical medication, and also mobilizes the enthusiasm of pharmaceutical enterprises to invest in research and development " According to this person, measures such as centralized review and self-examination of clinical data can solve the problem of queue congestion and create conditions for speeding up the approval of new drugs It is also understood that in order to accelerate innovation and research and development, more than 200 new drug varieties are in the clinical trial stage On the day of the announcement of the priority review list of innovation, moshadong and Samsung Group's biopharmaceutical company announced that the bionic drug etanercept jointly developed by them was approved by South Korea At present, the biosimilars jointly developed by the two sides cover cancer, diabetes and other fields, and five biosimilars are in phase III clinical it happens that there is a similar case A few days ago, Hengrui authorized PD-1 McAb shr1210 to foreign innovative enterprise Incyte The former received a down payment of US $25 million, a milestone payment of US $770 million in total and a sales commission after overseas listing Hengrui pharmaceutical announced that it plans to invest 1.5 billion yuan to build a biomedical production base Innovation needs fulcrum From 2007 to now, the FDA has awarded 9 priority evaluation vouchers to encourage pharmaceutical giants to develop drugs with low economic benefits and neglected diseases, in exchange for accelerating the listing of high economic value heavy explosives Such policies have aroused the enthusiasm of drug research and development in pharmaceutical enterprises China also needs such support In the end, enterprises have a deeper demand for the rules of innovation and a reasonable return environment In an interview with the national development and Reform Commission, our reporter recently suggested that Anhui Province correct the illegal bidding of Bengfu drugs, many business people said frankly, "to truly make innovation, we need to use rules to move the industry forward." Li Meng, vice president of management headquarters of Yuanda Pharmaceutical Group, pointed out that China's industrial environment is not short of capital, especially in the pharmaceutical industry People's pursuit of health is the biggest driving force for capital to enter and obtain returns Nevertheless, he said, "we still face great uncertainty The bidding and procurement in different regions are independent, but the low price theory is still spreading, the reform of medical insurance payment lags behind, the separation of medicine is weak, and the registration and declaration are crowded, all of which increase the uncertainty of enterprise innovation Only through cooperation can innovation be achieved "