Hi Da Pu Ben, nine price HPV vaccine is finally on the market!

[policies and regulations of chinapharma.com] on April 29, CFDA issued a new "instruction" for nine valent human papillomavirus vaccine (Saccharomyces cerevisiae) (i.e HPV vaccine, cervical cancer vaccine): Nine valent human papillomavirus vaccine was conditionally approved for marketing Last month, the drug evaluation center (CDE) of the State Food and Drug Administration announced the acceptance of the listing application of the nine price cervical cancer vaccine According to CDE website, on April 20, the listing application of nine valent human papillomavirus vaccine (Saccharomyces cerevisiae) (i.e HPV vaccine, cervical cancer vaccine) of mosadong was accepted by CDE   According to the announcement, in order to speed up the process of new drug import registration and meet the public demand for drug use, in accordance with the relevant requirements of the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical medical devices issued by the general office of the CPC Central Committee and the general office of the State Council, on April 28, 2018, the State Drug Administration had the conditions to approve the listing of the nine valent human papillomavirus vaccine for the prevention of cervical cancer 。 At present, there are three kinds of HPV vaccines on the market in the world: bivalent, bivalent and jiuvalent The "valence" represents the preventable virus types of vaccines Among them, the bivalent vaccine can prevent the infection of HPV16 and HPV18, which is suitable for women aged 9 to 25 years; the bivalent vaccine can prevent the infection of HPV6, 11, 16 and 18, which is suitable for women aged 20 to 45 years Among them, HPV6 and HPV11 vaccines have been listed at home and abroad The bivalent vaccine is usually administered three times for six months to be effective The nine valent HPV vaccine approved in China consists of six, eleven, sixteen, eighteen, thirty-one, thirty-three, forty-five, fifty-two and fifty-eight HPV capsid proteins which are highly purified and mixed The vaccine is suitable for 16 to 26 year old women and is used to prevent cervical cancer, vulvar cancer, vaginal cancer, anal cancer, genital warts, persistent infection, precancerous or atypical lesions caused by HPV Research shows that the bivalent and bivalent vaccines currently on the market in China can prevent and control 84.5% of cervical cancer risk, while the bivalent vaccine can prevent about 90% of cervical cancer Patients can choose different vaccines according to different economic conditions and their own age Industry insiders pointed out that although the HPV vaccine has been on the market since 2007, it has been banned for some time due to the controversy of new drug evaluation standards In 2016, mainland China approved the listing of bivalent HPV vaccine in 2017, which was officially launched on July 31 Community hospitals and community health service centers in various cities can provide vaccination At present, hpv9 vaccine can be inoculated in Hong Kong As soon as the news that the nine price HPV vaccine was approved for listing came out, many netizens expressed their opinions, most of which were in agreement with the attitude "Good At least we can get women to get advanced vaccines in China without running to Hong Kong " "That's a good thing I've made an appointment."   　　.....   It is reported that after receiving the application for import registration of nine price HPV vaccine, the State Food and drug administration has incorporated it into the priority review procedure, communicated with enterprises on the overseas clinical data and post marketing safety monitoring of products for many times, and based on the previous four price HPV vaccine approval data, there are conditions to accept the overseas clinical trial data and bridge with the overseas clinical data In a short period of time, there are Conditions approve the import registration of products At the same time, the State Food and drug administration requires enterprises to formulate risk management and control plans and carry out post IPO research as required It can be predicted that after the nine price HPV vaccine goes on the market, it will bring more convenience for domestic women to vaccinate and further prevent the occurrence of cervical cancer!