The pharmaceutical industry has seen an increasing number of orphan drugs in the pharmaceutical industry on June 14, and the enthusiasm for immune-cancer drugs has increased. While keeping a close eye on hotspot research and development, companies should try to exercise restraint and ensure that r&d activities are moving in the right direction. 

 

In this paper, we will sequence the different functions and targets of Pharmaprojects database, and then analyze the research and development trends that are included in the research and development. 

 

Mechanism Top 25: anti-cancer immunotherapy develops and develops a storm 

 

From the point of the mechanism of action of drugs in development, currently ranked in the top five mechanisms including immune stimulants (1736), cancer immunotherapy (889), immunosuppressants (215), angiogenesis inhibitors (179) and VEGF receptor antagonist (123). By analyzing the mechanism of drug action, we can understand the development strategy of the drug and the new treatment of the disease. 

 

Anti-cancer immunotherapy is classified as a new addition to the role in early 2015, which includes immune-cancer drugs and some related drug strategies. New cancer drugs have been discovered that can be introduced into the body's own immune system to treat cancer, and the drug can be used in a range of targets in the body. Therefore, antitumor immune mechanism applies to all cancer drugs, including the mechanism of about 40 different kinds of drugs, such as PD - 1 antagonist, TIM3 antagonists, and a series of CD cells subtypes antagonists, etc. 

 

At present, the number of drugs in development of the class, has increased from 399 in 2016 to 2017 in 889, by up to 123%, in such a short time in such a high growth, is also unprecedented. 

 

It is important to note that these drugs, only about 2.1% of the drug in the registration, registration, or public stage before, if more successful listing of drugs or continue to maintain such a high growth rate, the future research and development of these drugs may bring about a storm. The development of immune-oncology is so rapid that it is likely to produce similar results in the future. 

 

Compared with previous years, the number of other categories has not changed significantly, and many have only added some candidates. Perhaps more attention should be focused on the main targets for drug development. Interestingly, the immune-tumor mechanism was so diverse that the immune-tumor target was not seen in the drug target's Top 25 list. 

 

 

 

Top 25: innovation is above the 10-year average 

 

From the perspective of a drug target proteins, main targets for pain, opioid receptors mu, is still the most important role in target drugs in development, in 2017 the number of drugs in development compared with the data in 2016, has decreased from 156 to 156. The glucocorticoid receptor remained in second place, with 123 active ingredients. The tumor necrosis factor, her-2 and prostaglandin oxidative cyclase 2 (cox-2) were ranked third to fifth. 

 

In the Top 10 drug target protein, the more obvious target is the cancer target. For example, effects on vascular endothelial growth factor [VEGF - A], the number of active drug has increased from 2016 in 80 to 105, by up to 31.3%, its ranking has risen from ninth to sixth in 2016. 

 

In addition, the higher ranked target and the amyloid precursor protein (APP) gene, which has jumped from 27th to 17th in 2017. The target is associated with alzheimer's disease treatment targets, but related to the target therapy drug Solanezumab Ⅲ period clinical research has been lilly failed. Because in disease pathology, the accuracy of the amyloid hypothesis there is still considerable controversy, so people in some places is not really ignore these failures, for the target, industry continues to invest a lot of money. 

 

 

 

In the current research and development pipeline, all target proteins involved in the drugs in development, a total of 1672 and the number of target proteins have been confirmed so far has reached 2774. 

 

The number of new target proteins each year can serve as an important indicator of innovation in new drug research and development. Over the past 12 months, the number of new targets found in the industry has been 116, roughly in line with last year's data (113). From 2005 to 2016, the change of the number of target protein analysis, the target innovation, the overall performance of 2016 industry better than the average nearly ten years, industry is gradually accelerated drug innovation. 

 

 

 

The "fast lane" : the number of "orphan drugs" is reduced, but it is still a shortcut 

 

In all respects, the pharmaceutical r&d industry is expanding, and the r&d pipeline is expanding further. On the other hand, the recognition of the increasing difficulty of r&d innovation in the pharmaceutical industry has been recognized by many in the industry. There is no doubt that there is also a survival and selective pressure in the pharmaceutical industry. Fortunately, the pharmaceutical industry has focused on rare diseases or areas of disease that do not meet clinical needs. 

 

Pharmaceutical research and development companies around the world are looking for ways to speed up the approval of drug reviews in order to promote the release of drugs as soon as possible. At present, the world is used to speed up the drug approval measures mainly include obtaining orphan drug status and drug fast review qualification in two ways, such as "rapid review qualification" and "breakthrough therapy". 

 

Statistics show that in 2013-2016 per year for orphan drug and rapid review qualification of drugs number increases year by year, the number of orphan drug has increased from 2013 in 299 to 2016 in 369, a quick review of drugs has increased to 2016 from 2013, 50, 188. Although compared with the data in 2015, 2016, the number of orphan drug fallen slightly, but the "orphan drug" identity qualification for quick review of the way, still is an effective way for pushing drugs to market more quickly. 

 

 

 

In addition to the "quick review qualification" and "breakthrough therapy" that the current drug fast review mechanism include: the current priority review of clinical development plan, accelerate the examination and approval, flexible and qualified certification product (QIDP) qualification such as system of infectious diseases, the acceleration of the European Union imposed the review system, as well as the UK's breakthrough innovation drugs (PIM) system. 

 

From the current pharmaceutical research and development and current situation of drug approval for examination and approval, for the pharmaceutical research and development enterprise, all of these system and has great appeal. 

 

epilogue 

 

Given the health policy change might bring some uncertainty to the global drug development pattern, the pharmaceutical research and development enterprise should maintain a cautious attitude, fully understand the world in the research of new drug development characteristics, combined with their own advantages and disadvantages, the development of the reasonable adjustment of product development pipeline, actively reduce the existing various risks in the process of new drug research and development, improve the return on research and development. Research and development enterprise at the same time of laying solid foundation product research and development, also should pay attention to product development strategy and commercial application of m&a strategy, should be paid attention to and improve the structure of products pipeline in a number of ways, constantly improve the comprehensive competitiveness of enterprises of new drug research and development.