Recently，WHO (World Health Organization) released the new experimental technical specifications of HPV vaccine，It is clearly suggested that regulators in various countries in the clinical evaluation of the HPV vaccine，You can use & ldquo; virus continuous infection & rdquo; as the end indicator of the validity of the vaccine。

 

  The reporter learned，As of now，It has been 10 years since the first HPV vaccine listed in the world，However, due to the review of the vaccine of the Vaccine (CFDA) to review the data of the vaccine;，This clinical trial process takes 10 to 20 years，As a result, HPV vaccine is still blank in my country。

 

  It is worth noting that it is，If CFDA uses the new specifications proposed by WHO this time，Use continuous infection data as the stake sports betting appindicator，stake betting appThe existing data is enough to support the relevant test，This may make the market schedule of HPV vaccine, especially domestic HPV vaccines, greatly advance。

 

  July 11，The reporter repeatedly called the CFDA News Propaganda Department to know if my country will apply this new specification，The phone has been in a busy line or unattended status。Although the sound of the regulatory layer is unknown，But the contest between pharmaceutical companies has begun。

 

  HPV vaccine listing process or speed up

 

  The reporter learned，Cervical cancer is a common malignant tumor，and human papilloma virus (HPV virus) infection is almost all causes of cervical cancer cases。According to WHO data，More than 500,000 women in the world are diagnosed with cervical cancer，up to 270,000 women die for illness。Chinese new 150,000 patients per year in China，Cause 80,000 people to die，and the patient tends to be younger。

 

  2006，HPV vaccine Gardasil and CERVARIX developed by Merhado and GlaxoSmiths are listed one after another，The two vaccines have the protective effect on the two subtype viruses of HPV 16 and HPV 18, reaching 99%，These two subtype viruses have led to about 70%of the world's cervical cancer。

 

   & ldquo; HPV vaccine has been implemented in many countries around the world。Hong Kong, China has been listed around 2007，But Mainland China is not in the list。& rdquo;，The key point of the card shell of the Chinese listing process of the HPV vaccine is the end indicator。

 

  It is understood，The clinical trials before the listing of HPV vaccines include three steps，The first two steps are safety indicators and immune indicators，The third step is the validity indicator，Whether it can resist infection and can prevent My stake betting appcancer。stake betting app& ldquo; Food and Drug Administration evaluated the effectiveness of HPV vaccine validity.，This indicator is to prove that the vaccine can prevent cancer or block the cancer，But this lesion process needs almost 10 years to wait。& rdquo; Qiao Youlin, Director of the Popular Diseases Research Office of the Academy of Medical Sciences on the Academy of Medical Sciences。

 

  Qiao Youlin thinks，WHO's new technical specifications are more suitable for reality。& ldquo; Whether the vaccine has validity，Can you resist infection at a glance，The second is to see if it can prevent cancer，Using virus continuous infection as the ultimate indicator，You don't need to wait for a long time to wait for the cancerous lesions，This will greatly reduce the clinical trial process & rdquo;。

 

  Domestic and foreign pharmaceutical companies secretly self -wrestling

 

  The reporter learned，As early as 2013 Merhado has handed over the clinical experimental data of the Gardasil vaccine to CFDA for approval; the clinical trial part of the Cervarix vaccine of Glaxo Sons also ended in 2013，At present, it has been submitted to the listing license application，State in the review & rdquo; status。

 

  Domestic pharmaceutical companies in the market also have several families，Listed companies include Wantai Biopharmaceutical Co., Ltd. (referred to as & ldquo; Wantai Biological & RDQUO;)，and Shanghai Zerun Biotechnology Co., Ltd. (referred to as & ldquo; Zerun Biological & RDQUO;) all have entered the third phase of clinical clinical。

 

  Many people in the industry think，Vaccinations of Merhado and GlaxoSmiths have listed experience in many countries around the world，and completed the clinical trial，Has stake sports betting appoccupied My stake betting appthe market opportunity，It is expected to be listed before next year; but if CFDA uses a new specification proposed by WHO，will greatly shorten domestic pharmaceutical companies to greatly shorten the clinical trial process，Reduce the time difference between the market between the market and the marketing vaccine，It will be favorable for domestic pharmaceutical companies。

 

   & ldquo; For Merhado and GlaxoSmot，This time difference means hundreds of millions of yuan in revenue。& rdquo;，2014 Gardasil vaccine global sales exceeded $ 1.7 billion，Global sales of the Cervarix vaccine are also over 100 billion US dollars，China's potential inoculation population is large，The sales of these two vaccines may be hundreds of millions of yuan a year after listing。

 

  The reporter also learned，Mainland tourists who have gone to Hong Kong to inject HPV vaccines have increased day by day，up to 2 million people per year，Based on the Hong Kong HPV vaccine injection price of 3,000 Hong Kong dollars，If the vaccine is listed in the Mainland，Its potential market size may reach billions of yuan。

 

  & ldquo; If the regulatory layer uses a new technical specification proposed by WHO，This is indeed a good thing for domestic HPV vaccine research and development。& rdquo; The Watson Biological Directors Office said that the electricity personnel said，Specific situation needs to be replied to the company's director，Then the reporter sent an interview letter to the mailbox provided by it，But as of press time，Not received a reply。

 

  In addition，For Zhifei creatures that have obtained the Merck HPV vaccine in China as early as 2012，The possible changes will stake online sports bettingstake online sports bettingalso affect its agency performance commission。

 

  & ldquo; I have noticed this news，But I didn’t go deeply，Even if the food and drug supervision department will use WHO's suggestion，It will also involve the sound of relevant laws and regulations，This takes time。& rdquo;，The company recently communicated with the HPV vaccine with Merck，But the details are inconvenient to disclose。