Controversy PD-1 / L1: R & D surplus or promising

Source: medical economic news 2016-12-6 Some experts in the industry have used an image metaphor to describe the style of domestic and foreign enterprises: if a gas station is opened in a certain place, the idea of foreign enterprises is to open supermarkets and hotels around the gas station, and the idea of domestic enterprises is to open another gas station near the gas station This metaphor is used to describe the current situation of new drug research and development in China Even with the warning of "interferon blowout" and "TiNi explosion", the research and development of biological similar drugs and innovative drugs are still in full swing Take the most popular PD-1 / PD-L1 drug as an example According to insiders, the internal research results show that 80 domestic enterprises are involved in this field Some insiders also say that the real number is far more than 80 It can't help asking: do we really need so many PD-1 / PD-L1 drugs? What kind of "homogenization" dilemma? ● a large number of repeated projects and blind capital investment will cover up real good projects; ● when the products following the hot spot are not enough to form differentiation, the situation of the underachievers is more severe Some experts try to analyze the reasons for the above phenomena to the reporters: first, domestic enterprises lack sufficient judgment in target selection, and many traditional pharmaceutical enterprises may choose to enter the bio pharmaceutical market from the field of PD-1 / PD-L1; Secondly, domestic capital covets both innovative drug market and risk control, and PD-1 / PD-L1 drug is undoubtedly the first choice for investment; in addition, colleges and universities research institutes (institutes) take hot fields as research objects, and the possibility of obtaining various subsidies will also be greatly improved In fact, PD-1 / PD-L1 drug clustering is only a microcosm of the homogenization of domestic R & D, and this long-standing disadvantage is just "changing soup without changing medicine" under different R & D upsurge "Homogeneous competition leads to people using subsidies to earn money and rob customers, and finally to the end of several failures, such as the merger of" fast "and" didi "in the Internet industry." Xu Ting, President and chairman of Corning Jerry, told the pharmaceutical economic news that the development of new drugs is similar "Taking PD-1 / PD-L1 antibody as an example, it's not difficult to get an antibody, but it's difficult to make an antibody new drug." Although regulators are happy to see the survival of the fittest in the market competition, the consequences of homogenization cannot be underestimated On the one hand, the limited clinical resources are wasted on a large number of duplicated R & D projects; on the other hand, capital blind investment leads to bubbles, covering up good projects Real value drugs are likely to face low price competition in the market, and can not play their due value "People focus on PD-1 / PD-L1, which can inhibit the originality of other varieties." Said Xu Ting In essence, experts are concerned that the homogenization research and development represented by PD-1 / PD-L1 drugs is more derived from "our understanding of biological drugs is only the tip of the iceberg"“ Small molecule drugs can achieve a better degree than the first generation by reducing toxicity and improving specificity However, even if large molecule antibody drugs modify antigen epitope, affinity, glycosylation and so on in the design, the real difference in activity can only be verified in human clinical trials " If it is reflected in the market share, when the products are not enough to form differentiation, the situation of the underachievers is more serious Take TNF - α antagonists as an example From July 2014 to June 2015, the global market size was about 34.3 billion US dollars The top three companies in terms of sales volume, i.e aimira, Johnson REMICADE and Amgen Enbrel, have shared about 77% of the market share These companies are also the first three approved companies in this field, while the rest approved companies can only seek a place in the remaining 23% through fierce competition "Once the advanced entrants have established themselves in the market, it will be impossible to adopt similar business models later." Xu Ting pointed out that from the mature experience of the European and American markets, their enterprises have very strong innovation ability, and will not join the giant Card Battle rashly when the progress is a few years late See the link: http://