2014，A love relay activity for & ldquo; gradually frozen people & rdquo;，Furious globe in a blink of an eye，Under the common participation of well -known people around the world，People with muscle atrophy side sclerosis (ALS) have received global attention，This also makes more rare diseases know。

 

  Definition given by the World Health Organization (WHO)，Rare disease refers to a disease with the total population of 0.65 & Permil; -1 & Permil;，Common leukemia、Hematomy disease、Phenyleneuroururia、Belief disease、Bone inconvenience、Ge Xie disease, etc.。Although there are certain differences in the identification criteria of rare diseases in different countries，There is no clear definition in our country，But there are nearly 7,000 kinds of rare diseases in the world.，and 80%of them are hereditary diseases。

 

  Due to the cost of the development of drugs，The cost of drug research for rare diseases is too high，Market demand is too small，Under normal circumstances, it is difficult to recover the cost of Stake Sports BettingMy stake betting appdrug development，Therefore, no enterprise is willing to develop and produce rare diseases，Caused the scarcity of drugs and expensive prices，The treatment drugs for rare diseases are also called orphan drag (ORPhan Drug)。

 

  Current，There is no official definition of a clear rare disease，There is no clear number (incidence) to divide rare diseases and general diseases，Plus a national policy without any support，Reimbursement without medical insurance，Rare disease therapy in my country is in three non -state。

 

  According to incomplete statistics，The total population of rare diseases in our country is about 16.8 million，Among them, 95%of the disease has no treatment method，At present, the R & D of my country & ldquo; orphan medicine & rdquo;，The treatment drugs for patients with rare diseases basically depend on imported abroad，As a result, many patients with rare diseases can only choose expensive imported drugs or even have no medicine to be available。

 

  With the increase in social awareness、Support policy introduction、Diagnostic and treatment means increased，The wind direction in the rare disease field is warming，The orphan drug market will usher in an era of rapid rising and high -speed development。

 

  Explore the orphan drug strategy of exploring the global synchronization channel

 

  October this year，FDA officially approved YS-ON-001 by YS-ON-001 independently developed by my country Yisheng Biology.，Once approved to be listed，It will enjoy the 7 -year US market exclusive period。Dested，Use the regional differences of orphan drugs，It is one of the strategies for the simultaneous development of many companies in recent years，The relatively loose access conditions and short approval time of orphan drugs，It will become a shortcut for my country's pharmaceutical companies to go to the world。

 

  As the chairman and CEO of Yisheng Biopharmaceutical Co., Ltd. said，From the stake online sports bettingperspective of investment My stake betting appreturn，The benefits of developing orphan drugs in the United States are reflected in four aspects: low development costs、Pricing high、Profit high、The development cycle is relatively short。Another，Due to the mature policy incentive system and accepting approval procedures，There are more than 30 years of experience in orphan drug approval experience and the world's largest medical market，Make it the first choice for the implementation of orphan drugs global synchronization development strategies。

 

  Forecast analysis of the orphan drug market

 

  1, countries around the world have introduced incentive policies

 

  In order to encourage developers to invest in resource development orphans，All countries have issued some R & D and production incentive policies。The United States promulgated the orphan drug bill in 1983，According to this bill，Orphan drugs can get fast approval、Disable taxes、Exempted declaration fee、R & D subsidies and seven -year market exclusive rights。Before the bill was promulgated，There are only 38 orphan medicines in the United States，and from 2011 to 2014，FDA approved all innovative drugs of innovative drugs account for 30%to 40%，Display in the data released by the FDA in January this year，Orphan drugs approved for listing in 2015 even reached 21 kinds，accounting for 47%of the total 2015。

 

  The medical care level has been at the world's highest level.，So far, nearly 200 orphans have been approved，Among them, it is generally developed by foreign companies，enough to explain the success of foreign companies' research and development of orphan drugs in Japan。

 

  February 26 this year，CFDA released the "Opinions on Solving Pharmaceutical Registration Application for Rejuvenation and Approval for Revolution of Perception"，The file is clearly expressed，Pharmaceuticals with obvious clinical advantages can enjoy the registration My stake betting appapplication for priority stake sports betting appreview and approval。In the representative disease that it raised，Rare disease is in the column。This will undoubtedly convey a good signal for the research and development and approval of Chinese orphan drugs。

 

  2. Low input, high return, short development cycle

 

  In the development of new drugs，6 to 80 % of the expenses are spent on clinical trials，and often a large number of patients for clinical trials，Not only invests huge，and the cycle is long (generally 8-10 years)，The risk is also high。and orphan medicines not only have funding support for incentive policies in the research and development，and the instant in the phase III clinical trial and only dozens of patients may be approved for listing，greatly reduced R & D risk。

 

  In addition，The pricing of orphan drugs is generally high，A commercial insurance company is willing to pay for in Europe and the United States，greatly reduced risk。early 2015，Reuters related data show，The average annual growth rate of orphan drug sales over the past 10 years is better than non -orphan medicine，and seven of the top ten best -selling drugs in the world in 2015 are orphan medicines。

 

  Many professional institutions also predict that the orphan drug market will become one of the most profitable sectors in the pharmaceutical industry，Many international large pharmaceutical companies have also tried to test the orphan drug market。

 

  3, huge market space

 

  Current，Nearly 400 orphan drugs in the world have been listed，Another 450 drugs are under research and development。Even in the United States，Most of the rare diseases are still no cure to date，But this also shows that there is still a lot of market space in orphan drugs。

 

  4. Concerning the concept and technology development of the era of precision medicine

 

  Thanks to gene sequencing、Mass spectrum analysis、Information Analysis and other technologies Tell the development，Many people My stake betting appthink that precision is the main mode of rare My stake betting appdisease treatment in the future，So，These technologies will also quickly promote the development of orphan drugs。

 

  Conclusion:

 

  The development of the orphan drug market is a good thing for patients with rare diseases and even the entire society。But China has not yet clearly defined rare diseases，Most orphans drugs are high，Not included in the scope of medical insurance，So many patients with rare diseases face & ldquo; no medicine & rdquo; and & ldquo; helplessness & rdquo;。Solve this dilemma，Need government agencies、Non -Government Organization (NGO)、Patient Organization、Pharmaceutical companies and other aspects work together。