The era of innovative medicine is coming at an accelerated speed, with three major development trends at present

[pharmaceutical network market analysis] with the development of Chinese pharmaceutical industry, a large number of APIs and generic drugs have entered the European and American markets But in the field of innovative medicine, Chinese pharmaceutical companies have been in the "follow-up" stage But a few days ago, news came from the other side of the ocean that Xuanning, an innovative drug independently developed by Shiyao group, was reviewed and approved by the US Food and Drug Administration (FDA) So far, this innovative drug developed by local enterprises in China has been fully approved by FDA for the first time, and obtained the pass for global sales This major event also shows that in recent years, under the national advocacy of innovation research and development, the development of innovative drugs has gradually begun to see results Taking this opportunity, the author also summarizes the development trend of innovative drugs in the industry and shares with you Accelerated development of chemical and biological innovative drugs: compared with generic drugs, the research and development of chemical and biological innovative drugs is difficult, high investment and long time, which makes the research and development of them mainly focus on scientific research institutes for a long time In recent ten years, foreign chemical and biological innovative drugs have shown good efficacy and economic benefits in the market, and have attracted more and more attention As these drugs gradually enter the domestic market, further stimulating the domestic pharmaceutical enterprises, more and more enterprises began to increase the research and development of chemical and biological innovative drugs In the field of chemical innovative drugs, R & D investment has been increasing in recent years, from 4.652 billion yuan in 2013 to 18.473 billion yuan in 2018, with a growth rate of nearly four times in five years As a popular pharmaceutical product, biopharmaceutics is also regarded as a sunrise industry in China, with a rapid development momentum With the continuous breakthrough of biomedical industry technology and the increasing investment in research and development of pharmaceutical enterprises, according to iqvia, China's biomedical market may become the global pharmaceutical market next to the United States by 2020 Thanks to a good market environment and a large amount of R & D investment from enterprises, there were 133 applications for drug registration in a week last month alone, including 94 applications for chemical drugs, 32 applications for biological drugs and biological products, and 7 applications for traditional Chinese medicine According to the application categories, there are 78 supplementary applications for drugs, 27 imported drugs in total (22 import registrations + 5 re registrations), 14 domestic new drug registrations and 10 generic drug registrations At present, the domestic sales of domestic chemical and biological innovative drugs are over 5.5 billion yuan, with CAGR of 35.3% and 21.3% respectively in 2012-2018, which are higher than the overall market growth of medicine In the future, this growth rate may continue to be maintained and accelerated Key points of research and development of anti-tumor drug companies: according to the statistical data of China biomedical industry strategic planning and enterprise strategic consulting report released by prospective industry research institute, from the perspective of the specific application of new drugs approved, In 2018, the FDA new drug review center (CDER) approved 59 new drugs, including 42 new molecular entities and 17 biological products, breaking the record of 53 new drugs approved in 1996 It can be seen from the treatment field of approved new drugs that anti-tumor new drugs are currently an important area of concern In addition to only 5 new anti-tumor drugs approved in 2016, the number of new anti-tumor drugs approved by FDA has steadily increased since 2014 Among the 16 new tumor drugs approved by FDA in 2018, the proportion of new solid tumor drugs is more than 50% However, it is worth noting that there are also cases of declaration of the same target in the industry, especially in the target or technical field represented by PD-1 / L1 and car-t In addition, from the current research and development of anti-tumor drugs, pharmaceutical companies may usher in the harvest period of research and development Take Baiji Shenzhou as an example On November 22, it officially SOLD zebutini, a new anti-cancer drug developed by itself, in the United States A large number of innovative drugs will be approved At present, the development of domestic innovative drugs is entering an accelerated period Before that, the first original new drug for Alzheimer's disease in China, ganlute sodium capsule (trade name "nine phase one"), was approved for market conditionally, filling the gap of no new drug market in the field in the world for 17 years; the core research of the third phase clinical trial of dual mechanism glucokinase activator, a new diabetes drug independently developed by the Chinese team, reached the main efficacy end point, which is expected to be the sugar in the future In the hot PD-1 tumor immunotherapy drug "track", in addition to the imported two drugs (K and o), the other three drugs that have been listed are from local Junshi, Xinda and Hengrui medicine It is expected that by 2020, a large number of pharmaceutical companies will be approved to create new drugs, such as zebutinib in Baji, ensatinib in Beida, Nila Paley in zaiding and fluzol Paley in Hengrui On the whole, China has taken a solid step from a big country of generic drugs to a big country of innovative drugs But from the current innovation to the global innovation in the future, it needs a process, which can not be achieved overnight In the future, benefiting from the implementation of catalysis and consistency evaluation of domestic pharmaceutical innovation policies, domestic pharmaceutical enterprises will continue to maintain high-intensity R & D investment, and accumulate strength for the innovation drug achievements.