Since May 30, the nine price HPV vaccine can be injected in Hainan. How is the research and development progress of domestic enterprises?

According to Hainan Daily, from May 30, the United Family Medical Center of Boao super hospital can be injected with a nine valent HPV vaccine to prevent cervical cancer The injectable age was 16-26 years old After negotiation, the bidding price of domestic 9-price HPV vaccine is 1298 yuan / dose, and three doses are needed As early as May 23, Zhifei biology announced that the company had obtained the certificate of batch issuance of biological products for the 9-price HPV vaccine as an agreement agent, marking that the first batch of 9-price HPV vaccine could officially enter the market Southwest Securities pointed out that considering the global supply of HPV is in the order of tens of millions, it is estimated that it can contribute 1 million to the mainland in 2018 Because the price of 9-price HPV vaccine is much higher than that of 4-price HPV vaccine, the theoretical net profit of Zhifei biology is increased by 200-300 million yuan, and the conservative profit is also 100-200 million yuan The 9 price and 4 price HPV vaccines form a good complement, and the company's performance is about to explode At present, there are three kinds of HPV vaccines at home and abroad Domestic 2-valent HPV vaccine is produced by GSK, which can prevent more than 70% of cervical cancer caused by HPV, covering 9-25-year-old women, with a bid price of 580 yuan Domestic 4-price HPV vaccine is produced by mosadong and promoted by Zhifei biology as an exclusive agent In addition to its preventive and protective effect on more than 70% of cervical cancer, it can also prevent vulvar condyloma acuminatum, covering women aged 20-45, with a bid price of 798 yuan Domestic 9-valent HPV vaccine is produced by mosadong and promoted by Zhifei biology as an exclusive agent, which can prevent and protect more than 90% of cervical cancer Since GSK's bivalent HPV vaccine was approved and launched on the market, the concept of cervical cancer prevention has been rapidly promoted in the mainland market, which has also brought huge market volume, and led to an increase in the vaccination rate of HPV vaccine in Hong Kong and Macao At the end of 2017, due to the increase of mainland tourists to Hong Kong and Macao for vaccination, the supply of 9-price HPV vaccine in two places stopped on a large scale, and "one shot is hard to get" appeared for the first time The angel Cancer Society of Hong Kong is no longer accepting appointments from people with the first injection So far, it has been digesting previous appointments On May 11 this year, the organization announced that MSD was temporarily unable to supply the 9-price HPV vaccine normally, and all those who made an appointment for the second injection would be rescheduled, and the notice of the pharmaceutical factory on when to resume the supply would be required In the face of this situation, it is understood that the 9-price HPV vaccine in the mainland will be put on the market soon, and some people said that they would wait for the mainland to be put on the market before vaccination At the same time, it is still difficult to make an appointment for the domestic 4-valent HPV vaccine As a super heavyweight product, in China, for the 16-45-year-old female population, the stock market of Southwest Securities Analysis has reached 260 million people, even if it penetrates 10% conservatively, its market volume is also huge Although the 9-price HPV vaccine can be injected in the United Family Medical Center of Boao super hospital at the end of May, how to ensure the normal supply still needs to wait and see In the face of strong market demand, there are also experts who remind the vast number of vaccinated people that vaccines cannot prevent all, and vaccinators still need regular regular screening to really play a preventive role 12 domestic pharmaceutical companies have declared that in 2017, the cumulative sales volume of HPV vaccine exceeded 280 million, and the global market scale was close to US $2.5 billion, of which the high price HPV vaccine was more recognized by the market China's demand for HPV vaccine is in the stage of digesting the stock market Faced with such a large cake and the complexity of vaccine production process, only a few enterprises can provide vaccine products to solve the current market demand in China On May 24, at the media meeting of vaccine work held by the State Drug Administration and the National Health Commission, relevant departments announced the current progress of HPV vaccine research and development As of April 18, 2018, 12 domestic enterprises have successively declared their HPV vaccines (15 acceptance numbers), including 2, 3, 4, 6, 9, 11 and 14 price vaccines Among them, the first HPV vaccine (HPV16, 18) completed the clinical protection effect test, the second one was in the phase III clinical trial stage, and the others successively entered the clinical trial According to reports, the domestic 2-valent vaccine in research and the bivalent vaccine that GlaxoSmithKline has listed contain the same HPV type, and also contain the same HPV type as the 9-valent vaccine developed by mosadong, with the same coverage rate for cervical cancer The other 3 -, 4 -, and 6-valent vaccines have coverage rates between 2 - and 9-valent vaccines However, the coverage rate of 11 and 14 valent vaccines to cervical cancer is theoretically higher than that of 9 valent vaccines Luo Jianhui, director of the biopharmaceutical Department of the national drug review center, said that the drug review center strengthened communication and exchange with enterprises on R & D application, accelerated the review of HPV vaccine applying for marketing license, and expected that more and more HPV vaccines will be available to the public in the next few years Some research reports pointed out that among the 2-valent HPV vaccines, Xiamen Wantai applied for production on March 29, 2018; Watson biological bivalent HPV vaccine has entered the critical period of phase III clinical research, and is in the final stage of collecting and analyzing clinical results to determine the end-point case samples Among the 4-valent HPV vaccines, Chengdu Institute and Shanghai Bowei entered phase I clinical trials in September and December 2016 respectively, and Shanghai Institute was approved in January 2018 Among the 9-valent HPV vaccines, Xiamen Wantai, Watson biology and Shanghai Bowei were approved for clinical trials at the end of 2017 and the beginning of 2018 respectively In addition, the 14 price HPV vaccine of Beijing nuoling and the 11 price HPV vaccine of Zhongsheng biology were declared for clinical application in January and April 2018, respectively Recently, Wuhan bowo Biotechnology Co., Ltd has successfully signed a contract with the National Institutes of Health (NIH) of the United States, and obtained the global exclusive product development right, market right and patent use right of the new generation of human papillomavirus (HPV) vaccine development technology It can be seen that the research and development of multivalent HPV vaccine in China is still in the early stage In order to cope with the production capacity of digesting stock market in advance, some enterprises began to lay out production bases Watson bio implements the industrialization project of HPV vaccine in Yuxi base The project is designed and constructed according to the WHO pre certification standard and other international standards At present, the workshop has been completed and entered the trial production stage.