On December 31, the State Drug Administration announced that it had recently approved Xiamen Wantai Canghai Biotechnology Co., Ltd.'s application for the registration of a bivalent human papilloma virus vaccine (E. coli) (trade name: Xinconing Cecolin). The vaccine is the first domestically approved HPV (human papilloma virus) vaccine, and is suitable for women aged 9-45.
According to the report, the vaccine is the first cervical cancer vaccine independently developed by China, which is jointly developed by Wantai Company and Xiamen University and transformed by Wantai, which will become the third HPV vaccine in the world and the first in China. , Meaning that China's cervical cancer vaccine will end its history of dependence on imports only.
The human papilloma virus (HPV) vaccine, commonly known as the cervical cancer vaccine, can be used to prevent cervical cancer in women, male and female genital cancer, and genital warts. At present, there are three types of HPV vaccines that have been marketed globally. They are the bivalent vaccines for HPV16 and 18 produced by GlaxoSmithKline in the United Kingdom, and the four-valent vaccines for HPV6, 11, 16, and 18 produced by Merck in the United States. Nine-valent vaccine against HPV6, 11, 16, 18, 31, 33, 45, 52, 58 types.
Consumers receive nine-valent HPV vaccine in Hainan (Photo / PA Images)
According to statistics, the most common cervical cancer caused by human papillomavirus is the fourth most common cancer in women. In 2018, there were approximately 570,000 new cases of cervical cancer and 311,000 deaths worldwide.
The bivalent human papilloma virus vaccine (E. coli) approved this time was targeted at HPV16 and 18 and was included in the national special new drug development support. After being approved for listing, it will further meet public demand and improve product accessibility.
HPV vaccine is difficult to find a shot is expected to improve the situation
Compared with imported vaccines, domestic HPV vaccines are more affordable.
According to the WeChat account of Xiamen University, Xinkening is priced at 329 yuan / piece. Women 9-14 years old need only 2 shots for a total of 658 yuan; women 15-45 years old get 3 shots for a total of 987 yuan.
How much does the imported bivalent HPV vaccine cost? Taking Beijing as an example, the price is 580 yuan per stick, and three shots during the vaccination process total 1,740 yuan.
"The approval of the vaccine to market indicates that China has begun to break the long-term monopoly status of HPV vaccine production by foreign countries. The situation of a difficult HPV vaccine with a gap of 1 billion will gradually improve." Xiamen University WeChat public account article said.
Aiming at the question of when women of the right age can be vaccinated, Xiamen University revealed in WeChat account that it is estimated that people may get vaccines in community health service centers in various places this May.
The market gap exceeds 1 billion, and the price advantage is obvious
According to media reports, since the world's first HPV vaccine was launched in 2006, the cumulative sales volume of HPV vaccine is about 350 million.
At present, the annual demand is increasing day by day, and the global demand is about 100 million. But the world's annual supply capacity is only 30 million doses, about one-third of the total demand. In China, data from China Food and Drug Research Institute show that China issued 1.46 million HPV vaccines in 2017, 7 million in 2018, and 8.7 million in January-November 2019.
Based on the calculation of 356 million females of the same age in China with 3 needles per person, the market gap exceeds 1 billion. In terms of price, the price of imported HPV vaccine is generally high. For example, the full cost of a nine-valent vaccine is about 4,000 yuan, and an imported bivalent vaccine is nearly 2,000 yuan.
According to the price of domestically produced HPV vaccine of 329 yuan / bill, the full course of vaccination for 9 to 14 years old costs 658 yuan, and the older age vaccination is 987 yuan, which is half the price of imported bivalent vaccine.
HPV market for multiple companies
In fact, in the domestic HPV vaccine market, GlaxoSmithKline and Merck still occupy most of the advantages, but in recent years, with the continuous increase of the Chinese market penetration and the support of related policies, in order to allow Chinese people to use the price Reasonable HPV vaccine, while solving the supply problem, domestic alternative HPV vaccine companies have been deployed, trying to seize the 10 billion market.
China Bio's 11-valent HPV vaccine was declared clinical in April 2018. On February 19, China Bio announced that the 11-valent recombinant human papilloma virus (HPV) vaccine had obtained clinical trial approval from the State Drug Administration.
On September 6, the Phase I clinical trial of the national first-class new drug "11-valent recombinant human papilloma virus (HPV) vaccine" jointly developed by the Chinese Biological Research Institute and Chengdu Company was launched.
In January 2018, the "recombinant human papilloma virus nine-valent virus-like particle vaccine" (9-valent HPV vaccine) independently developed by Yunnan Watson Bio won the "Clinical Drug Approval for Drugs" issued by CFDA.
Wantai sea creatures
In March 2018, Wantai Canghai Biology officially reported the application for marketing of bivalent cervical cancer vaccine to the State Food and Drug Administration, and was listed as a priority review product.
Beijing Nonin's fourteen-valent HPV vaccine was declared clinical in January 2018. In the 27th batch of drugs announced by the former State Food and Drug Administration to be included in the list of priority review procedures, it was mentioned that the domestic recombinant 14-valent HPV vaccine developed by Beijing Noning Biotechnology Co., Ltd. and Shenzhou Cell Engineering Co., Ltd. was a major project Its new drug clinical trial application was included in the priority review.
The clinical application of Shuanglu Pharmaceutical's 4-valent HPV vaccine is still under review and approval in the first half of the year, but the company made a comprehensive decision by considering various factors such as product input and output, market competition, and other issues. It can be adjusted to start again.
As of April 30 this year, Jiangsu Ruike Biotechnology Co., Ltd. is still in the reporting stage.
With more and more domestic HPV vaccine companies participating in research and development, and with the help of the green channel for review, if the market can be successfully marketed in the future, the price of HPV vaccine will be greatly reduced through the methods of price negotiation and centralized procurement, benefiting more patients. However, vaccine companies also need to consider the characteristics of long R & D cycles, large investment, and high risks in drug research and development, and plan carefully.
9-14 year old women need only two shots
At present, the price of the nine-valent HPV vaccine is about 1300 yuan / needle, the price of the four-valent HPV vaccine is about 800 yuan / needle, and the price of the two-valent HPV vaccine is about 600 yuan / needle. The corresponding total vaccination costs are 4,000 yuan, 2400 yuan, and Around 1800 yuan. In the face of several products that have been marketed in the Mainland and have first-mover advantages, the protection rate for Xinkening is 329 yuan / branch. The cost of a two-vaccination vaccination is 660 yuan and three vaccination is about 1,000 yuan. The price advantage is considerable. Both the British GlaxoSmithKline approved by the State Food and Drug Administration and Merck's HPV vaccine require three shots, while Xinkening only needs two shots for a 9-14 year old female group.
"It's a new year for the new year." Netizens in the Mainland are very happy about the ??百乐宫网上游戏?? of the approval of the first domestic HPV vaccine that came out on the first working day of 2020. Some female netizens said that the team that has been in the line for six months has not been able to make an appointment and will not have to wait so long in the future. For the price of about 320 yuan each, netizens commented that they expressed their conscience and stated that they would go for vaccination with their friends.
Previously, Hong Kong and Macau were the first destinations for HPV vaccines for many mainland consumers. In addition to doubling the injection cost for the agency, consumers also have to bear the transportation and accommodation costs for three trips to and from Hong Kong. The cost of vaccination is very high. Ms. Wang told reporters that she has always wanted to vaccinate, but because of high costs and time-consuming reasons, it has been postponed, and last year, there was a storm of amendments in Hong Kong. This plan was postponed indefinitely. Although the Mainland can currently be vaccinated against imported quadrivalent vaccines, it is still hard to find. The launch of domestic vaccines is indeed good ??百乐宫网上游戏??, giving mainland consumers another choice.
First domestically produced thirteen-valent pneumococcal vaccine
Another domestically approved thirteen-valent pneumococcal polysaccharide conjugate vaccine is mainly used for infants and children from 6 weeks to 5 years old to prevent the invasiveness caused by 13 pneumococcal types including pneumococcal type 1 and 3 disease. At present, the 13-valent pneumococcal conjugate vaccine that has been marketed worldwide is only produced by Pfizer. The domestically-produced 13-valent pneumococcal polysaccharide-conjugated vaccine was approved for marketing, which will break the monopoly of the international vaccine giant and become the world's second and China's first 13-valent pneumococcal polysaccharide-conjugated vaccine.