The first cervical cancer vaccine officially launched in China

On July 31, GlaxoSmithKline (GSK) announced the official launch of the first approved cervical cancer vaccine in China Previously, on May 18, jiadaxiu, a quadrivalent cervical cancer vaccine owned by Merck, an old rival of GSK, was approved in China According to the announcement issued by Zhifei biology, the exclusive agent of Merck, "it is estimated that it will take about six months for the vaccine to get the registration approval and go on sale." One year later, GSK announced on the last day of July that China's first approved cervical cancer vaccine, cerix, was officially launched on the market "Recently, the first batch of imported cerix has passed the inspection and release of China's relevant quality inspection departments, and is now being supplied to the national market The health institutions that provide sirix vaccination, like other vaccines, are community hospitals in various cities and Community health service center " On July 18, 2016, GSK official Xuan xiruishi obtained the CFDA listing license, becoming the first approved HPV vaccine for cervical cancer prevention in China The approved HPV vaccine "is registered in the mainland of China for the vaccination of 9 to 25-year-old women, using a three dose vaccination procedure." Compared with the price of HK $2400-4000 for GSK vaccination in Hong Kong, the winning price of GSK in the mainland has an advantage at present GSK said that in the provinces that have won the bid, the bid price of Hirsch is 580 yuan / piece, and 1740 yuan for three pieces, "but according to the policies of local governments in each province, the final payment price of vaccinators will be different." Globally, currently, there are two pharmaceutical companies approved for listing of HPV vaccine, MSD and GSK On May 18, 2017, Gardasil jiadasheu, a tetravalent cervical cancer vaccine of MSD, was approved in China for vaccination of women aged 20-45 years The same three dose vaccination procedure will be used to prevent cervical cancer, cervical intraepithelial neoplasia (cin1 / 2 / 3) and adenocarcinoma in situ (AIS) caused by human papillomavirus (HPV) 16 and 18 "At present, MSD is preparing for the listing of jiadasheu, actively cooperating with the approval and issuance process of CFDA and provincial bidding." As of the first quarter of 2017, more than 227 million doses had been inoculated globally, according to Mercer Oriental GSK and MSD have been approved successively, which is regarded as a great advantage in the industry According to the huge population capacity of China's market, about 356 million people are suitable for HPV vaccination in China According to the female vaccination rate of 5% and the male vaccination rate of 0.5%, and the total amount of three injections is about 2400 yuan, it can provide HPV vaccine companies with a market with a stock of 23 billion yuan and an annual increase of about 2 billion yuan HPV is the most likely cancer to be eliminated Studies have shown that a total of 14 types of HPV are classified as "high risk" and lead to almost all cervical cancers Among them, HPV11 and HPV6 are closely related to condyloma acuminatum HPV16 and HPV18, the two virus strains with the highest risk, can cause about 70% of cervical cancer cases GSK's approved Hirsch is the HPV vaccine against these two virus types, known as bivalent vaccine, which was approved by the European Union in September 2007 and approved by the FDA in October 2009 Currently, there are three types of HPV vaccines on the market in the world, namely bivalent, tetravalent and ninvalent In 2006, Gardasil, the fourth price HPV vaccine in the east of Mosa, became the first human papillomavirus vaccine in the world, which can prevent HPV6, 11, 16 and 18 In 2014, MSD added 31, 33, 45, 52 and 58 subtypes of HPV on the basis of the fourth price, and launched the ninth price vaccine "jiadaxiu 9" HPV is mainly transmitted through sexual contact, so every sexually active woman is at risk of cancer causing HPV infection If the infection is high-risk HPV, it may develop into high cervical lesions or even cervical cancer Cervical cancer is the second most common cancer among Chinese women aged 15 to 44, with about 130000 new cases per year Cervical cancer cases in China account for more than 28% in the world Globally, on average, one new case is detected every minute, and one woman dies of cervical cancer every two minutes Before the vaccine came out, the main way to prevent cervical cancer was through cervical screening The vaccine is one of the most effective ways to eliminate diseases The advent of HPV vaccine has greatly reduced the incidence rate of cervical cancer There are age limits for HPV vaccination, and there are differences in age recommendations for HPV vaccination among countries and institutions 9-45 years worldwide; FDA approved 9-26 years The age limit is not absolute The key is whether there is sexual behavior HPV vaccine has the best effect on women with asexual life history The probability of HPV infection of women with sexual life has increased significantly From the perspective of pharmacoeconomics, the older, the less effective and the less cost-effective GSK said that the approved indications for Hirsch in mainland China are suitable for women aged 9-25, which is the same as that in the United States; the approved indications in the EU and Hong Kong are women over 9 years old In addition, HPV vaccine can only be used for prevention and has no therapeutic effect on patients who have been infected with related virus "The vaccine has been upgraded and the price type has been expanded In terms of the scope of protection, the fourth price is broader than the second price Currently, the nine valent HPV vaccine of MSD is widely used in the United States, because the protection of high-risk types of HPV related diseases is more extensive " Li Zhengqing, global vice president of MSD, said in an interview with jiadaxiu that "the introduction of the nine price vaccine into China has been included in the company's plan, but it has not yet entered the stage of clinical trial and approval, because of the particularity of the vaccine, it requires a complex registration and approval process." "We are pleased to announce that Hirsch is now available in the Chinese market to help young women resist the threat of cervical cancer," said the old rival's competition in the new market "At the same time, we are launching a series of activities, including public disease education, adult vaccine support platform, professional training for vaccinators and so on," said Wei Liansheng, general manager of prescription medicine and vaccine Department of GSK China GSK said that at present, Hirsch has completed the bidding access work in 17 provinces across the country, "we are actively shipping according to the orders of disease control units in various local districts and counties At the same time, we are also actively applying for supplementary bids in the areas where we have not yet invited bids to meet the vaccination needs of women The schedule of vaccine bidding and procurement varies from place to place, and community hospitals and community health service centers can be consulted for specific arrangements " It has been ten years since the approval of Mercer Dongjia to go public in the United States However, the Chinese vaccine, which has been waiting for ten years, was delisted in the United States last year In October 2016, GSK announced that Hirsch would withdraw from the U.S market, and the product stopped supplying to the U.S after August 31 GSK said: "due to similar products in the U.S market, the market demand for Cervarix is very low, so GSK decided to delist it from the U.S market However, the FDA's listing license is still valid Cervarix has been approved by 107 regulatory agencies to supply 136 countries around the world The decision on the U.S market will not affect the supply of other markets " On the other hand, in order to improve the vaccination rate of HPV vaccine, CDC has only purchased 9-valent HPV vaccine since April 2016, because its two doses of immunization procedures help to improve the vaccination rate By the end of 2016, both GSK 2 and MSD 4 HPV vaccines were no longer available in the U.S market Judging from the current process of the two markets in China, delisting has not caused too much impact on their listing in China, and the greater impact comes from the market competition after listing HPV vaccine is one of the highest sales vaccines in the world According to the financial statements of the two companies, the total global sales revenue of the three HPV vaccines that have been listed in 2016 exceeded $2.2 billion Cervarix's global sales were $135 million in 2015 and $111 million in 2016 Although GSK currently holds the first position, its market share is far lower than that of its rivals, MSD The market share of four and nine vaccines under MSD is about 95% In 2015, its sales volume reached USD 1.908 billion; in 2016, its competitors' delisting led to a favorable growth of 14% According to MSD's 2016 financial report, its global sales volume reached USD 2.173 billion; in the first quarter of 2017, it reached USD 532 million, and in the second quarter, it reached USD 469 million However, according to the announcement issued by its exclusive agent, Zhifei biology, "it is estimated that the vaccine will take about 6 months from obtaining the registration approval to going on the market, and the final time for the product to go on the market is uncertain." "In terms of global vaccine market situation and prevention scope, the range of four price and nine price vaccines in MSD is larger, and many people may choose four price vaccines when the price is similar." One industry analyst said, "like the global trend, vaccines will reach a peak in three to five years after they are listed in the mainland However, due to age recommendations and restrictions on HPV vaccines, the stock will lead to a decline in sales after digestion for a period of time, and the annual increase in population in the future In addition, vaccine sales channels have not been very smooth, and HPV vaccine is only easy to promote in the first and second tier cities " In addition to the two companies are about to compete in the domestic market, domestic companies that develop HPV vaccines are also closely behind Among them, Watson biology and Xiamen Wantai have completed the clinical phase III trial vaccination Some insiders believe that the approval of imported vaccine is also expected to promote the approval progress of domestic HPV vaccine "According to the current progress, domestic manufacturers will not be approved until the end of 2017 and 2018 at the earliest It is a good thing for the public that foreign companies are approved first Objectively, they will also share the domestic stock market ".