Nine -valent HPV vaccine expansion supply is not in short or intensified

On the evening of August 30, reporter Zhang Ling, a reporter from the Economic Observation Network, showed that the indication of Merida East Nine Valid Polygonum Virus Virus (wine yeast) (hereinafter referred to as "nine -valent HPV vaccine") was expanded. -26 years old expand to women 9-45 years old.

Cervical cancer is one of the most common gynecological malignant tumors. In 2021, ICO/IARC's HPV and related diseases in China showed that among women aged 15 to 44 in China in 2020, the incidence and mortality rate of cervical cancer ranked third in female tumors.

Human papilloma virus (HPV) is one of the world's most common sexually transmitted diseases. High -risk HPV repeated infections can cause female cervical cancer. In 2006, with the advent of the first HPV vaccine, cervical cancer became the only cancer in the world to prevent vaccines.

Meridadon told Economic Observation Network that it will continue to collaborate with the relevant parties of the internal and external stakeholders after the vaccine expansion to promote the timely supply of vaccines.

According to the virus subtype types covered by the vaccine, the HPV vaccine is divided into two -valent, four -valent and nine valence. Five HPV vaccines in China were approved to be listed: imported included Merhado quadrimal vaccine "Jiada Xiu", nine -valent vaccine "Jiada Xiu 9"; Grandulosk's two -valent vaccine "Herry"; domestic names include Wantai Bio -biomaley "Xin Kening" and Watson Bio's binary vaccine "Wawzawa".

As the highest -priced vaccine that can be used to protect HPV viruses on the market, in recent years, imported nine -valent HPV vaccines have always been "difficult to find". Taking Shenzhen as an example, the nine -valent vaccine needs to "make an appointment". The time for vaccination for vaccination in many places exceeds one year.

Several doctors and experts have publicly urged that they do not need to blindly pursue the nine -valent HPV vaccine, and should be vaccinated in time and as soon as possible.

Affected by this news, multiple vaccine stocks rose against the trend. On September 1, Zhifei Bio rose 5%, and Wantai Bio rose 3.02%.

The expansion of the aging allows the supply and demand to be further imbalanced

"Jiada Xiu 9" met with Chinese vaccination in April 2018. Its Chinese version shows that "this product is suitable for vaccination for women aged 16 to 26."

Why did not cover a wider age group at the beginning of approval? In October 2018, the "Report on the Review of the Listing Technology Review of the Nine Valid Polygonum Patroma Virus Virus Application of Popularity Patinoma Virus Virus" released by the National Food Supervision Bureau shows that the nine -valent HPV vaccine import registration application is based on overseas clinical research data and has not conducted clinical trials in China. Data Middle Eastern Asian people (especially Chinese people) have insufficient evidence of low age groups. In addition, the sexual life of Chinese women is late than Western countries. It takes into account many factors such as health economics.

Four years later, the expansion of "Jiada Xiu 9" allowed the target to vaccinate more than three times that of the original number. Vaccine expert Tao Lina believes that before the domestic nine -valent HPV vaccine was launched, the supply and demand imbalance of the imported nine -valent HPV vaccine will be intensified for a period of time.

He told the Economic Observation Network: "In the past, people who had peace of mind and quadrimal HPV vaccine would want to turn the nine -valent HPV vaccine, which will cause the nine -valent HPV vaccine to be more" more monks and less porridge. "

从接种年龄来看，除2022年3月新获批的“沃泽惠”接种对象为9至30岁女性外，另四款疫苗均已覆盖9至45岁女性；从免疫程序来看，除The age group of "Xin Kening" is 2 doses in the age of 9-14. The other four vaccines and "Xin Kening" are 3 doses of the ages of 15-45.

Judging from the price of HPV vaccines in Guangdong Province in 2021, the prices of domestic "Xin Kening" and "Wokuei" are 339/supporting 356 yuan/branch, and the imported "Herry" and "Jiada Xiu Xiu Xiu" and "Jiada Xiu Xiu" "590 yuan/branch, 810 yuan/branch, the only nine -price HPV vaccine" Jiada Xiu 9 "is as high as 1310 yuan/branch.

Many women would rather queue up and spend high prices, and they also chose to vaccinate the vaccine. In Tao Lina's view, this choice is not rational: "The price of the nine -valent vaccine is much more expensive, but the prevention effect will not be doubled. The binary vaccine can prevent 70%. It is said that the price / performance ratio of the second price is the highest. "

From the perspective of public hygiene, the age expansion provides options for more consumers, but for women between 27 and 45, inoculation of imported nine -valent HPV vaccine is still not easy: "The choice has increased, on average When everyone's vaccine is reduced, many people may be happy. Once the gap is large and the waiting time is too long, many people will continue to choose the second price and four -price price. "Tao Lina said.

So, what about the market share of the nine -valent HPV vaccine on the market share of domestic binary HPV vaccines?

"I don't think it will have much impact. The supply of imported nine -valent HPV vaccines is definitely not enough, but the market is very large. You cannot stare at the high -end market. This is wrong. "Tao Lina said.

Domestic vaccine companies are also optimistic. Wantai Bio told Economic Observation Network: "WHO and China are very concerned about the prevention of cervical cancer. After several years of publicity and education, everyone is more willing to accept and vaccine. Women are a very good thing, but it has been inadequate for a long time in supply. "

As for the influence of the age expansion on the sales of domestic binary HPV vaccines, Wantai Bio believes that the subsequent market performance needs to be seen: "The vaccinator will comprehensively consider quality, protection rate, company, and price. "Increasing supply is also difficult to meet the market

On August 30, Tian Anna, a senior vice president of Global Global and Chinese president, said that Merck will enhance the development of HPV vaccines through measures such as expanding global production capacity and increasing supply in the Chinese market and supporting the development of China's public health.

Meridon's supply of HPV vaccines in the Chinese market has remained increasing year by year. As of June 2022, more than 25 million Chinese women have vaccinated the four -price and nine -valent HPV vaccine of Merck. In the first half of 2022, the number of quadrangers in China increased by more than 90%year -on -year.

In China, the HPV vaccine of Merida East is an exclusive agent by Zhifei Biology. Zhifei Biological reports from the 2022 semi -annual report showed that from January to June 2022, the number of nine -valent HPV vaccines reached 9.2987 million, an increase of 379.34%year -on -year.

However, even if the supply is increased, the nine -valent HPV vaccine is still in short supply.

In November 2020, the World Health Organization released the "Accelerating the Elimination of Global Strategy for Cervical Cancer", which is recommended that 90%of girls at the age of 15 completed HPV vaccination before the age of 15. China stated in December 2020 to support this strategy. In addition, since 2020, the global vaccine confidence has been significantly improved, and it has pushed up the demand for HPV vaccine in various countries.

According to the national routine immune statement data, from 2018 to 2020, the number of HPV vaccines increased year by year, from 3.417 million doses in 2018 to 12.279 million doses in 2020. Even so, the HPV vaccination rate of women's HPV vaccine is still at a lower level, and the growth space of the demand side is large. The data given by Professor Qiao Youlin of the School of Medicine and Public Health of the Chinese Academy of Medical Sciences of China is less than 1%.

Merid Dongxiang Economic Observer said that in recent years, it has invested more than $ 1 billion in the production capacity of existing HPV vaccine production facilities and built new production facilities. From 2017 to 2020, the supply of HPV vaccines in Meridodon has doubled by nearly double. It is expected that from 2020 to 2023, Merck's global HPV vaccine supply will doubler.

Affected by factors such as strains, it is not easy to increase the supply of nine -valent HPV vaccine. "After the production capacity is increased, it must be allocated globally. Even if the supply is increased to China, the absolute number is still not enough." Vaccine expert Tao Lina pointed out.

Experts call on domestic approval to speed up

Many domestic nine -valent HPV vaccines have entered the third phase of the clinic.

Pharmaceutical clinical trial registration and information publicity platform shows that five companies including Chinese recreation, Wantai Biological, Boyi Biology, Ruico Biological, Zerun Bio, etc. are conducting the third phase of clinical trials of the nine -valent HPV vaccine. The maximum is 45 years old.

Tao Lena judged that the first domestic nine -valent HPV vaccine will be approved quickly: "Just in the past two years, I think the possibility of 2024 is relatively high. For example faster."

The Economic Observation Network was informed that the nine -valent HPV vaccine of Wantai Biological and the nine -valent HPV vaccine of Merida's nine -valent HPV vaccine has completed the clinical trial site and specimen testing. Essence

Wantai Bio told Economic Observation Network that the company's nine -valent HPV vaccine is currently clinical in Phase 3, and further progress will continue to announce, but the company cannot predict the specific year of the vaccine to be listed.

The Kangle Guardian, which also entered the third phase of the clinical period, has a nine -valent HPV vaccine phase 3 clinical trial has completed the three doses of the subject and is conducting case monitoring and follow -up. According to the R & D plan of the Kangle Guard, the Nine -Valental HPV (female indications) will be approved in 2027, and the nine -valent HPV vaccine (male indications) will be approved in 2028.

In April 2018, Merck's nine -valent HPV vaccine "Jiada Xiu 9" was approved for listing in China and was approved for vaccination for women aged 16 to 26. This vaccine is only 8 days from the application for listing to approval.

Tao Lina called on the country to speed up the review and approval of the domestic nine -valent HPV vaccine.

He told the Economic Observation Network: "The national approval of the standard for nine -valent vaccines can be lower. Scientifically, as long as the antibodies that can be confirmed are the same, it can be used for the virus. Observing the preliminary lesion of cancer, it is also possible to observe the decline in infection rate. "

At that time, the entry of domestic nine -priced HPV vaccines will have a greater impact on Merhado, and it can also make up for the vaccination gap of women's appropriate age.

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