Let's listen to me too

Source: US China Pharmaceutical source [news event] on December 1, 2017: today, Bruce booth, a famous biotechnology investor, published a blog to review the achievements of the pharmaceutical industry in 2017 With one month to go, the FDA has approved 40 new molecular drugs and two car-t cell therapies Given that December is the peak month for approval, this year is likely to break the record of 45 new drugs in 2015 (except for 1996, which is a special case) But booth also noted that only 19% of the drugs approved this year are first-time drugs, which is not only far lower than 51% in 2012, but also seems to be declining in the past five years (see figure below) He said that if this is a real trend, it will have some impact on the industry, such as the decline of the time of the first exclusive market, the increase of dependence on clinical development (to make a distinction), and the induced price war [drug source analysis]: first of all, there is no doubt that today is a harvest year This year's 45 or so new drugs are far higher than last year's 22, which is also close to the historical record It is gratifying As for whether there are too many me too many drugs, I think it's a little bit of a worry If that curve is a real trend, then there will be no me too drugs in the 1990s But I clearly remember that there were only about five first drugs every year in the early 21st century, and there were only two first drugs in one year In 2006, there were 1357 drugs at that time, but only 324 targets Without a calculator, it can be seen that me too drugs were also absolutely mainstream But now these me too are different from the ancient me too It used to be called me too A dozen beta blockers are on the market Some people are just starting to make new beta blockers Now, some people also fine tune macrolides and tetracyclines, but most of them are almost started at the same time It's just that there's a sequence of listings, and someone has to lose the game Another factor that causes multiple similar drugs to go on the market before and after is that the winning section of new drug competition is usually in the clinical development stage Many drugs enter the clinical practice but not necessarily develop at full speed Once someone makes a concept verification, there will be an originally uncertain project to keep up with Because the clinical development time is relatively short, it is more likely to cause the phenomenon that the same kind of drugs are listed successively within one or two years PARP and CDK4 / 6 inhibitors are very obvious examples Of course, there are also examples of PCSK9 high-speed competition, but not as many as before Most of the drugs on the market are me too, which does not mean that the pharmaceutical industry is not enterprising, nor that me too is a mainstream model In fact, a previous analysis by Futai scientists showed that more than 70% of the disease mechanism combination has only one project to explore, but the success rate of me too drug is high, so it is enriched in the drugs on the market Although the success rate of me too drug is significantly higher than that of the initial, the commercial return is usually lower than that of the initial, especially in the market where there is more than one drug on the market Even if PD-1 is the fourth or fifth target that hasn't been seen for many years, and it is only 2-3 years behind me too, it is difficult to compete with me too It is often forced to overtake in dangerous road corners, which is not easy In addition to the steady increase of new drug projects, FDA's relatively loose policies and incentives for innovation are also the reasons for the increase of drugs on the market Many new drugs will be given priority approval, breakthrough drugs and other special care even if they are not the first ones, and the approval date is usually much earlier than PDUFA date Many rare disease drugs are listed through the accelerated approval channel, which requires less evidence and shorter development time There are also controversial approvals, even for highly unmet medical needs This relatively loose approval environment has increased the voice of the payment department, which is one of the reasons why drugs have been forced to start the price war since they came into the market In any case, the pharmaceutical industry seems to be still discovering and marketing new drugs The reports of pharma’s death may be a bit exaggerated。