Recently，Shanghai Food and Drug Administration, a paper publication，unveiled the first batch of crabs & rdquo;。

 

  "List of the Pilot Variety of the Pilot Reform of the Pilot Reform of a Pharmaceutical Listing of Pharmaceutical Lisity" announcement，As of September 30, 2016，There are 9 drug research and development institutions、11 pharmaceutical manufacturers submitted 12 varieties to the Shanghai Food and Drug Administration to participate in the application information of the pilot reform of the drug listing license holder system，Many pharmaceutical companies with advanced R & D level have received admission vouchers。

 

  Innovative drugs and generic drugs are equal to

 

  In the selected application company，You can see a lot of familiar faces in the field of new drug research and development，Ruchi Shenzhou、Ding Ding、Hutchison Whampoa, etc.，The applicant of the Scientific Institute as the applicant is Shanghai Haihe Pharmaceutical Research and Development Co., Ltd., co -founded by the Shanghai Institute of Pharmaceutical Research and Shanghai Zexi Investment Management Co., Ltd.。Among the trustee production enterprises，There is Bolinger Yin Gehan Biopharmaceutical、Hye Pharmaceutical、Minsheng Binjiang、Omini、Green Valley Pharmaceutical, etc.，and the entrusted companies are not all located in Shanghai，Some from other pilot provinces。

 

  From the perspective of senior consultant of Chinese medicine holding，These applicants and trustees and entrusted enterprises stake betting appoverseas holding、There are more companies in Taiwan -Hong Kong -Macao joint ventures，Rulai Whampoa、Shanghai Omini and Suzhou Omini, etc.;，Ru Di Sino and Shanghai Chuangnuo; also cooperated with their subsidiaries and domestic large circulation companies，Ru Guo Pharmaceutical Holdings and Hutchison Whampoa。

 

  Where，The proportion of innovative drugs and generic drugs is equivalent，1 biotechnology、5 1 type of drugs and 6 imitation medicines。PD-1 monoclonal anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-anti-BGB-A317 of PD-1 Monopoly on the treatment of advanced physical tumors obtained the clinical trial batch of drugs issued by CFDA，Mainland China has become Australia、New Zealand、After the fifth region of BGB-A317 after the United States and Taiwan, the United States and Taiwan, BGB-A317。and HMS5552 and its tablets of Huading Pharmaceutical Technology Co., Ltd. completed the phase II clinical trial in September。It is understood，Because Roche decided to abandon the development of drugs in the field of diabetes due to strategic adjustment，Huaguan Pharmaceutical obtained the global development authorization of HMS5552 from Roche。and imitation drugs，R & D drugs involve asthma、Chronic renal failure, etc.。

 

   & ldquo; These varieties that obtain MAH pilots are in line with the current development direction of domestic disease treatment，If immune therapy、Oncology drugs、asthma and diabetes, etc.，But each is still in different clinical research stages，So can it be developed and listed on the last，There is still a certain risk。& rdquo; Qian Rongfu mentioned。He is also optimistic about BGB-A317 injection、HMS5552 and its tablets、ZL-2303 market prospects for salt hydrochloride，Guess the ZL-2303 hydrochloride of ZL-2303 hydrochloride in cooperation with Kaile Ying may be exported in the form of raw medicines。and both from Omini and Shangyin Chuanguo Pharmaceutical Co., Ltd. produced and developed under the same company system，It can be seen that the purpose of the company is to obtain a greater market discourse right。

 

  Cooperation water to the channel

 

  The development of the pilot work of the MAH system seems natural。From the selection of varieties to become applicants、Find a trustee manufacturer stake online sports bettingto complete the clinical trial，To commercialized production、Buy commercial insurance or provide a guarantee agreement，After some question，The company interviewed said & ldquo; All of this is natural & rdquo;。The applicant finds a cooperative company，Most of them are manufacturers that have already cooperated before，Under the MAH system，The trust relationship between the establishment of long -term cooperation between enterprises is particularly important。

 

  As a subsidiary of Yin Ming Kant，Hequan Pharmaceutical has three cooperation projects this time entered the list。CEO Chen Minzhang, CEO Chen Minzhang, was interviewed by a reporter from the "Medical Economic Daily" and said: & ldquo; Since the company has been producing raw materials for foreign pharmaceutical companies abroad，Quality management system has reached international standards，Therefore, there are long -term cooperative relationships with new drug research and development companies in China。This MAH system pilot，We have developed with new drugs in China about the follow -up commercial cooperation.。& rdquo;

 

  From Chen Minzhang's view，This is the participation of the MAH pilot for the company that commissioned production，The biggest difference。Except for small tests in different clinical trial stages、Trial cooperation，In the future，R & D companies do not need to change the production location。

 

  It is understood，early 2016，The Changzhou base in the company's construction began to conduct trial operation of the first workshop，The total reaction volume of the workshop is 220 cubic meters，​​It will be mainly used for commercial production of GMP products。

 

  According to the provisions of Shanghai's "Application of the Pharmaceutical Listing Owner to Application for Office"，Enterprises that apply to become the holder need to submit a commitment to the risk responsibility for the clinical trials of the drug、Guarantee agreement or insurance contract、Drug quality and safety responsibility commitment letter。Therefore, 12 companies have signed insurance contracts for this time，or provide a guarantee agreement to ensure the ability of the enterprise's quality and safety liability。It is understood，At present, 3 companies have signed insurance contracts with Anda Insurance，Another stake online sports bettingtwo companies are still in the stage of talking about cooperation。The relevant person in charge mentioned，Government allows enterprises to provide guarantee agreements or buy commercial insurance，The purpose is to remind the enterprise to have the ability to bear risk。At present, it is not enough for some companies to buy product liability insurance，Need a professional danger in the field of life sciences。

 

  MAH system pilot made many insurance companies want to move，It is said，two companies, two companies of Renfei and Pacific Insurance, are currently designing insurance species specifically targeted at the field of life sciences。

 

  Imitation of VS creation, who has seen it first?

 

  Previous，The content of Beijing -Tianjin -Hebei on the internal meeting of the MAH system pilot in the work of the Beijing -Tianjin -Hebei，Pilot varieties in the clinical trial stage，Can it be listed within the specified time，Is the current attention in the industry。& ldquo; This depends on the progress of the government's rapid approval of the government's pilot to the MAH system。& rdquo; The person in charge of the above company told reporters，& ldquo; Now the estimation of the actual results is an imitation medicine。& rdquo;

 

  He thinks，The newly batch of generic drugs passed the consistency evaluation，It can be replaced with the original drug in clinical practice，A practical significance，Reduce the burden on national medical insurance and the burden of the people。If the generic drug can be approved，The original drugs that replaced the patent expiration in clinical practice are all good things，Can promote powerful R & D units to make some efficacy medicines，Let the people use cheap as soon as possible、Drugs with efficacy。

 

  At the same time，Encouraging innovation is still the main theme。Look from the list，Many applications for enterprises belong to a lot of joint ventures and foreign capital，while the entrusted production enterprises have joint ventures and state -owned enterprises，But these companies are relatively advanced domestic research and development capabilities and production levels，You can also see the encouragement of innovation in Shanghai。

 

  Most of the varieties applying for enterprises are in the clinical research stage，Some scientific research institutions told reporters before，My stake betting appAfter product research and development to a certain stage，Consider your own conditions，still tend to transfer products。and Qian Rongfu also analyzed，MAH system，There should still be companies choose to transfer varieties，So due to the early investment of R & D enterprises，If the product is transferred，So once the variety is listed，There will be a certain profit division。

 

  The MAH system is rolled out of the country，At the beginning, it will also experience multiple companies and scientific research institutions as product holders，But after a period of market competition，Small R & D companies will be merged by large companies，or small companies gradually develop and grow，Have your own production line，The more important significance of the MAH system in China is，The free transfer of the approval number and the reasonable allocation of the resource。

 

  This point，From this time the list of pilot varieties can also be seen。Shanghai Chuangnuo Pharmaceutical Group and Omini Pharmaceuticals are also the advantages that can be transferred freely by using approvals，Reasonable allocation of internal resources of the company。