More than 6 years ago，Hutchison Huangpu Pharmaceutical Find Mu Yan who is engaged in the clinical development of anti -tumor drugs in the United States，At that time, their drug research and development pipeline was about to enter the clinic，Aware of the talents in this area。After ten months of repeated communication，Mu Yan gave up the position of Global Medical Director in Genick，Leaving the United States，Come to Shanghai。

 

  Mu Yan is an earlier group that returns to China from the United States、People with a clinical research and development background of drugs，It is also a relatively large pharmaceutical company in China，Very few as a clinical development background to do the head of pharmaceutical companies。If it is not someone in this industry，It may be difficult to understand what this small change means。Before that，Most of the pharmaceutical elites returning home are the front end of the pharmaceutical medicine，That is the background background of the drug。

 

  Join Hutchison Whampoa，Mu Yan helped them establish clinical research and registered departments，It guarantees that drugs enter clinical clinical，and progress smoothly。and Huang also quickly established a mechanism for domestic and foreign cooperation，successively and three multinational companies，Astrikan in the UK、Nestlé in Switzerland、Lilly in the United States established three strategic cooperation。The first，Hutchison Huangpu Pharmaceuticals will launch Chinese new medicines for the country，Develop with global giants。

 

  ​​February 2014，Mu Yan leaves and Huang，Add Yaoming Kangde，Hope to use their platform，Global innovative drugs introduced to China in the early stages，Realize global simultaneous development。Last year，Pharmaceutical Kant and the United States Lili Lai develop strategic cooperation on a new type of small molecular drugs in the field of cardiovascular disease in the field of cardiovascular disease，Make it enter China early，Simultaneous development in China and the United States。Mu Yan said，According to this mode，If the last successful，Chinese patients will use this new medicine with American patients。Patients in China before needing new drugs to be listed in the United States and wait for four or five years or even ten years.。

 

  Lost ten years

 

  August this year，Mu Yan joined the pioneer pharmaceutical，As the chief scientific officer and the president of R & D，This is the third company he worked after returning to China。

 

  Pioneer Pharmaceutical, established in 1995，Once a star company of China Pharmaceutical Industry。The R & D pipeline was once at the forefront，In 2011, there were 4 1.1 new categories of new drugs obtained the stake online sports bettingapproval of clinical trials of the State Drug Administration，Only 100%of the success rate of clinical trials of new drugs in the 1.1 type 1.1 of the year is only Herchi Whampoa and Xianyin Pharmaceutical。This is a very dazzling result for the company。

 

  But after the variety enters the clinic，Shengsheng starts to encounter various difficulties and challenges，Especially the lack of clinical research and development experience，As a new category 1.1 new medicine，It is still slow to advance to this day。This is also the situation faced by most Chinese companies。2008-2016，Domestic enterprise declaration clinical type 1.1 new drugs，At present, the third phase of the clinical clinical，less than 5%that has or about to reach the end，Only 15 of more than 300 new drugs come to the final stage。

 

  Another group of data display from McKinsey，In 2015, the market for innovative drugs around the world is nearly 600 billion U.S. dollars，and China only accounts for less than $ 10 billion，Among them, the 19 innovative products approved in China for the first time in China contributed less than $ 500 million。

 

  To a large extent，Pioneer represents an era，Research and Development of New Drugs、Especially in clinical development，Lack of sufficient experience，Caused the R & D of Chinese pharmaceutical companies in the past ten years。After these years of bumps，The pioneer pharmaceutical industry finally realized the importance of clinical development ability and talent construction，Starting to identify with the value of clinical development background talents。

 

  Mu Yan said，Clinical development is like a dammed lake，The new medicines are all blocked in it。In the research and development of new drugs，Concept verification test (Proof of Concept)，That is to verify its scientific principles and preliminary safety and effectiveness of disease treatment in clinical research，R & D personnel around the world are all difficulties。European and American mature pharmaceutical markets have accumulated years of experience，However, in China，It is the lack of clinical development experience and talents of European and American pharmaceutical companies，Companies that first applied for new drug clinical trials，All setbacks have been suffered later。Clinical approval obtained from 2010-2011，If you hand in the hands of clinical research and development experience，These drugs should be the slowest and the clinical stage of the third phase is the third phase。

 

  Introduction to Mu Yan，What is the characteristics of a drug，How to absorb the drug after entering the human body、distribution、metabolism、Expedition of this situation，All need to be deepened in the clinical stage、System research。There are many examples in history，The situation when the new drug enters the human body is very different。So human research is a very important step，Especially the first study，Technical requirements are high。Pharmacokinetics、Pharmacy、Safety control、Preliminary testing and evaluation of early efficacy or efficacy signals，These are very technical jobs。

 

  So，Clinical research is an indispensable stage of the development of new drugs，Also one of the most important parts。Is a new drug successful，It must be authenticated by clinical research。Globally，A new drug research and development of all stages，Clinical R & D is the biggest stage of both time and money。The founders of the two innovative pharmaceutical companies in the Ge Li Biomedical and Idea of ​​the reporter's contact with the ideas have also expressed this view，& ldquo;，The founder of the song ceremony Wu Jinzi said。Success or failure is often here。

 

  Clinical Talent Refllectual and Pharmaceutical Reform

 

  stake sports betting app2010 can be regarded as a turning point.

 

  The return of the pharmaceutical elite，It started to become large and frequent in 2010，They started to participate more in the research and development of domestic pharmaceutical companies，or independent entrepreneurs。A batch of enterprises obtained the new drug clinical trial certificate around 2010，Judgment according to normal rules，to the end of 2016，If it belongs to the drug of Me TOO or Me Better，This batch of medicines can basically be listed or close to the market。This means starting from next year，There will be more and more innovative drugs to go public in succession。

 

  As mentioned above，The bottlenecks of Chinese pharmaceutical companies in the past ten years, especially in recent years, have mainly come from clinical research and development，The lack of experience in clinical research and development is closely related to corporate errors and lack of talents。In this industry that highly rely on the talent system，With the right talent，Enterprises can soberly develop a drug research and development strategy。

 

 On the day of the reporter's interview，October 25，Merck's PD-1 antibody drug has just been approved by the FDA for first-line treatment of PD-L1 expression level & GE; 50%and no EGFR or ALK gene mutations.，Mu Yan takes this as an example，Emphasize the importance of clinical research and development strategies。In the PD-1/PD-L1 market，The earliest choice for the melanoma for melanoma，Merhadon seeks breakthrough on non -small cell lung cancer，Roche chose the target of PD-L1，The first indicator is bladder cancer。From this，Three multinational companies formed a three -legged trend in this segment。

 

  Another typical case is，Hutchison Huangpu Pharmaceutical that Mu Yan once worked was developing a VEGFR inhibitor 呋喹 呋喹，Also made a strategy to choose different indications。In the field of VEGFR inhibitors，Domestic in front of Hengrui Pharmaceutical is Apatinib，Compared with Huang Huang at least two and a half years，The first indicator of Hengrui made is gastric cancer，Mu Yan and colleagues judge that following Hengrui gastric cancer is not competitive。After careful analysis，They chose Hengrui's slowdown in coach cancer，and persuaded the American Lilly Company，Choose colorectal cancer as the first indication of the two parties to jointly develop 呋喹ntinib，呋喹 呋喹ibicin has entered the third phase clinical trial stage of treating colorectal cancer last year。

 

  The formulation of these clinical research and development strategies，It is difficult to go smoothly without sufficient professional background and experience。

 

  Among the three companies that Mu Yan returned to China，Hutchison Whampoa chose the road from low -risk mature drug targets to high -risk new targets to gradually advance。Yaoming Kant is committed to introducing global innovative drugs in early China，Realize global simultaneous development。Xianmin Pharmaceuticals selects project introduction、Strategy of strategic cooperation development and investment mergers and acquisitions。Today's Pioneer Pharmaceutical，There are more than a dozen pipelines in research，Among them, there are two of them have been clinical in the third phase。

 

  Now，China's pharmaceutical industry has a deeper understanding of clinical research。When Mu Yan returned to China in 2010，Few people with the same background as him，There are few talents in clinical development。Many companies cannot recognize the importance of clinical research，Think to find a drug R & D service company (CRO) and hospital，It is enough to do clinical research and development。Pharmaceutical companies that are still the first echelon in China，After paying the painful price，Make adjustment in time My stake betting appto maintain the advantage。major pharmaceutical companies such as Hengrui Medicine、Haosen、Qilu、Luo Xin、Four Rings, etc.，Now I am also vigorously strengthening clinical research teams and abilities。

 

  Just adjust the strategy in time in the first batch of innovative pharmaceutical companies、At the same time of taste the results，Good news also follows。

 

  Dr. He Ruyi, the new chief scientist of the State Food and Drug Administration (CDE)，Based on his many years of experience in FDA in the United States，It is promoting drug review and approval work with international standards，Establishing a dynamic review and dynamic supervision of the clinical trial application (IND)，and formulate a series of technical guides，These measures will change the previous inefficient drug review approval。

 

  Li Qing, Director of the Medical Health Technology Development Research Center of the Health and Family Planning Commission，It also revealed that some of the major new drug creation of national new drug creation strategies that are expected to be released in early November to point out the policy direction of the new drug creation strategy。

 

  Future，New drug creation strategy Future investment focus will emphasize the development stage，Especially after entering the clinical research and development。and result -oriented，I hope to truly develop a large variety that provides actual great help to Chinese patients。On the other hand，During the 13th Five -Year Plan period, major special projects will pay attention to the phases of the development of new drugs，Increase investment in the clinical development stage，and continue to encourage、Support China's new drug research and development。

 

   & ldquo;

 

  China seems to be about to usher in a blow -up new drug listing wave。

 

  Apart from Mu Yan's effectiveness，Hangzhou's song ceremony is expected to be listed in the first half of next year; Hutchison Huangpu's Vegfr inhibitor 呋喹 呋喹nib has entered the third phase of the clinic last year; Hengrui 34 innovative pipelines，8 have already been clinically at the third phase、Application for new drugs，Even listing; Kanghong's Corpoxip's FDA Clinical Phase III。

 

  But Mu Yan expressed it very carefully，& ldquo; Tanjing spray is still early。& rdquo;

 

  Most of the existing innovative medicines in China still stay in the so-called Me-TOO，ME-Better's follow-up innovation stage，From this stage to the first-in-class stage，There is a qualitative leap，Mu Yan thinks，Only enterprises attach importance to clinical research and development、Scientific and effective new drug approval and major national special support are far from enough。

 

   & ldquo; New drug development is a comprehensive、System Engineering。& rdquo; Mu Yan said，If it is said ten years ago，China does not have the ability to do global innovative drugs，So now，Some companies have already begun to have this ability at the Drug Discovery stage。What is urgent to improve next is the development stage，It is also the change that innovative pharmaceutical companies on the front line are being made。

 

  To continue to go，Find a completely innovative drug by yourself，that is First-in-Class，Mu Yan's frank rate representation，Chinese pharmaceutical companies still have no such ability。This not only depends on the company's own construction，Also through strategic cooperation with the world's top companies，Learning and accumulation experience。A result he left when Hutchison Huangpu and Yaoming Kanto，is to promote them to establish strategic cooperation with global companies、Mode to develop synchronous development。

 

  Also in the first voice，Mu Yan except in charge of the entire R & D system，It must also be in charge of business expansion and international business，stake online sports bettingIncluding the current international business of the US branch in Boston and New Jersey。

 

  More importantly，New drug research and development This system engineering requires the entire country、Provides a comprehensive support for the industrial system。The source of innovation is in basic research、Need government investment，The transformation of results is invested by the enterprise。The United States with the highest degree of drug innovation，The government has a lot of investment in basic research，The National Institute of Health (NIH) has tens of billions of dollars every year for investment。Although transformed from basic research to actual results，There are high risks in the process，But because the government has laid a solid foundation，Social capital can find sufficient opportunities。

 

  When Mu Yan worked at Genick Company in the United States，One of the Bervaabs that has inhibit and block tumor new blood vessels engaged in tumor -proof，Research from Professor Fokman, a Harvard University who has passed away。Professor Fokman's work is quite basic research。Gene Tick will transform basic research quickly，Through strong research and development capabilities，Finally successfully transformed into a product listing。

 

  This is a clear、A good division of labor industrial system。Give basic research to top universities and research institutions，During the research and development stage，The core competitiveness of each company is different，Some companies are good at discovering pilot drugs，Some companies focus on pre -clinical pharmacology and toxicology research，Of course, there are pharmaceutical giants with strong clinical development ability and comprehensive risk control capabilities。

 

  Mu Yan, who had refused to recruit the Harchi Huangpu at first，Now it is very optimistic about China's pharmaceutical prospects。Starting from the major special special of new drugs in 2008，The Chinese government has invested huge sums of money in the development of innovative drugs。China's top universities and research institutions have also begun to publish more papers in international A publications。He thinks，The next task is to establish a complete set of industrial chain，Reasonable division of labor in industry, university and research。