"Nine -valent HPV vaccine is free" is not so simple, the first batch of aged agents need to wait until 2023
Author:Cover news Time:2022.09.12
Cover news reporter Bian Xue
On the last working day before the Mid -Autumn Festival, Xu Mengyan still failed.
From the summer solstice to the beginning of the autumn, she is less than a year before the age of 26. She is anxious every day and a day. "Friends of the same age around me have hit nine -valent (HPV vaccine), and there are all kinds of channels from public hospitals and private hospitals."
Xu Mengyan is not an example. As the highest -price vaccine that can protect HPV virus on the market, Merida's nine -valent papilloma virus vaccine (brewing yeast) (referred to as nine -valent HPV vaccine) has become the vaccine industry " The hottest one is still in short supply.
On the evening of August 30, the website of the State Drug Administration showed that the nine-valent HPV vaccine was expanded. The applicable population expanded from the previous 16-26 years old women to a 9-45-year-old female vaccination. This means that women who need to vaccinate the vaccine like Xu Mengyan in the 26 -year -old "watershed" like Xu Mengyan no longer need to worry about age.
“但在小范围适龄女性接种疫苗的情况下，我都抢不到疫苗，范围现在扩大这么多，我岂不是更难抢了？”9月10日，徐梦妍抢秒的APP上显示，目前疫苗The age that can be vaccinated is still restricted to within 26 years.
When will the nine -valent HPV vaccine be implemented? "Optimistic estimation, in the first quarter of 2023, the expanded women can start to make an appointment with the nine -valent HPV vaccine." Dr. Bao, deputy chief physician Bao, who has been engaged in vaccination and management in Shanghai for many years, told the cover reporter that the domestic nine -valent HPV The vaccine has entered the phase III clinical trial, and it will be put into the market around 2026.
On September 11, the nine -valent HPV vaccine still had age restrictions on the vaccine. (Photo confession in the respondent)
"Before expanding the age, I can't grab the vaccine"
Regardless of the first -tier cities in the north, Shanghai, Guangzhou and Shenzhen, or inland provinces such as Guizhou and Inner Mongolia, the nine -valent HPV vaccines have the same dream, which is "vaccine freedom".
However, reality is always more cruel than dreams. According to the National Economic and Social Development Statistics of the National Economic and Social Development issued by the National Bureau of Statistics, as of the end of 2021, the female population in my country was 6894.9 million, and the total population of women in 9-45 years old was about 340 million. About 62 million branches (3 branches are one person), and the cumulative penetration rate of the stock is only 6.07 %.
In the huge gap, most women who can't grab seedlings are the majority. Different from Xu Mengyan's failure experience online, Zhang Qi made a nine -valent HPV vaccine appointment through a lottery.
Nine -valent HPV vaccine should not be required. (Photo confession in the respondent)
"After experiencing a lot of money to buy a house and a license plate, I did not expect that one day I had to shake the number to vaccine." Zhang Qi told reporters that he had been shaking the number since January 2020, and has not been signed for more than two years. "Because I don't want to spend 2,000 yuan more to get the vaccine, I have no other way except praying for myself."
Due to the collapse of the nine -valent HPV vaccine appointment system, the vaccine shortage in the short term is difficult to alleviate. In order to ensure that women with age have more fair vaccination opportunities, in November 2018, Shenzhen Nine Valentine HPV vaccines began to vaccinate. Subsequently, Hangzhou, Wuhan, Guiyang, Xi'an and other cities have also adopted the model of vaccination to distribute the supply of nine -valent HPV vaccines.
The vaccination is applied to the vaccination. The vaccination needs to complete the real -name registration (one WeChat can only be bound to one ID card) once a month, and the winner needs to complete the vaccine appointment within two days. If the vaccination is completed after completing the appointment, if the vaccination cannot be vaccinated on time, it needs to be canceled one day in advance, otherwise it will enter the "blacklist" and not participate in the shaking number within three months.
In this opportunity, Zhang Qi was obviously not the one who was lucky to be cared about. From the initial 1305 number source signed to the No. 7 HPV vaccine number of the 7th 2022th HPV vaccine announced by the Shenzhen CDC, 49,129 young ladies successfully signed, and there was no Zhang Qi. "If the lottery does not win, with three months as the cycle, you need to re -confirm whether to continue participating in the lottery before the next cycle, so I have been waiting for the lottery."
In 2020, the top ten cancer types of women's cancer cases in China. (Picture source: CA: a Cancer Journal for Clinicians)
The nine -price HPV vaccine fever is not blindly followed. According to the latest global cancer burden data released by the World Health Organization International Cancer Research Agency (IARC) recently, in 2020, the global female cervical cancer cases are 600,000, and the new cases of cervical cancer are 109,700. 3.5%, accounting for 5.2%of the total number of female tumors in China, with a rough incidence of 15.6/100,000. At present, whether it is onset or death, China is second only to India, which is the world's second largest cervical cancer disease country.
On the second day of the Mid -Autumn Festival holiday, Zhang Qi, who had eaten lunch, received a text message from the Health and Health Committee from the Shenzhen Municipal Health and Health Commission: "You have signed it and obtained the qualifications for vaccine appointments." According to the text message, Zhang Qi needs to be on September 11th 22th. Before point, enter the WeChat public account shake system of the Shenzhen Health Commission, and make an appointment for the source of this month. "According to the age of injection vaccine that can be executed now, I have been very old for two months, and I have vaccinated the quadrangal HPV vaccine at the beginning of the month." Zhang Qi told reporters that when the policy of the nine -valent HPV vaccine was expanded, I also wanted Go to make up. "But at that time, there should be more people in the lottery, and it was even more difficult to get about nine valence (HPV vaccine)."
Nine -valent HPV vaccine is still unknown after the age of expansion. (Photo confession in the respondent)
Being a vaccine on the body is the best vaccine
According to WHO, the incidence of cervical cancer in the world is relatively high, and the overall incidence of cervical cancer in China accounts for 18%of the global cervical cancer incidence. Andre Cavi Li, a senior scientist of the World Health Organization International Cancer Research Agency, said in his speech that HPV infections that have always existed may become cancerous. It is best to take HPV vaccines for girls before 15 years old to avoid infection.
"According to previous surveys, the two ages with a higher incidence of women in my country are around 25 years old and 40-45 years old." In Dr. Bao, what age group should be vaccinated in what age group, and it is necessary to follow women in various countries. The actual living conditions are judged. "There were many age -aged vaccinations under the age of 18 because they could not grab the nine -valent HPV vaccine, but they needed to vaccinate the vaccine in time. In fact, women with more active sexual life, no protection measures in sexual life or women with multiple personality partners , my country will also promote the HPV vaccine under the age of 14 for free, so students and parents do not need to worry too much. "
In fact, regardless of the two -price, four -valent, or nine -valent HPV vaccine, it is the key to vaccination as soon as possible within the scope of ability. As the world's first vaccine to prevent tumors, HPV vaccines are the first time that humans have tried to eliminate cancer through vaccines. "Actually, many experts have previously explained that the binary HPV vaccine can already resist 70%of cervical cancer. On the basis of the second price, the quadrimal HPV vaccine can also prevent 90%of genital warts. Compared with, the three vaccines are basically equal to the effectiveness and effect of cervical cancer related cervical cancer in HPV16/18. "
Dr. Bao bluntly said: "If you have a delay to make a nine -valent HPV vaccine, it is recommended to give priority to the second or fourth valence. Only the vaccine on your body is the best vaccine."
At present, the two-valent HPV vaccine that can be vaccinated in my country is divided into domestic vaccines with 354 yuan/branch and imported vaccines of 605 yuan/branch. HPV16, 18. The price difference is nearly doubled. Is the expensive vaccine better than cheaper?
"In fact, for the same vaccine, the domestic production is not lost to imports. If the vaccinator wants to choose the second -price HPV vaccine, the domestic vaccine cannot guarantee that its effectiveness must be better than the import, but there must be no problem in safety." Affirmation, strict approval from the my country Pharmaceutical Bureau on the market before the vaccine was listed. "Take the expansion of age 4 years after the listing of the imported HPV nine-valent vaccine. The vaccine must complete clinical research on East Asian people as required and prove through research data. After women have the same protection effect as those 16-26 years old, they can expand their applicable age to 9-45 years, but the listing standards for the vaccine abroad will be much easier. "
It is urgent to be completed by the product description replacement and vaccine appointment online platform data update. Dr. Bao said that the 9 -valent HPV vaccine still needs to wait for a period of time to facing the female group after the age expansion. "Optimistic estimation, in the first quarter of 2023, the expanded women can start inoculation."
As of September 11, tens of thousands of users have reserved a 9-45-year-old and nine-valent HPV vaccine on the promotion app. When the cover reporter called Beijing Jiahe Women's and Children's Hospital for inquiries, the staff said that the current vaccination of the nine -valent HPV vaccine can only make real -name appointments. Further notice. "We will also take the vaccination notice as soon as the customers who make a successful vaccine. The fastest vaccination time is expected to be early next year."
Data source "Wantai Biological-R & D platform has obvious advantages, HPV vaccine volume can be expected -220701 (p. 31)"
Men want to vaccinate HPV vaccine? Really necessary!
"To eliminate cervical cancer, it is impossible to rely on women, and men are also critical." Bao Renjie said that because the main transmission pathway of HPV is sexual communication, the infection rate of male genital HPVs is higher than women worldwide, which means that men As a high -incidence group of HPV infection, it is also necessary to do a good job of prevention.
It is worth noting that in Australia, men aged 9-19 are also groups that must be vaccinated by HPV vaccines. In Europe, America and other countries, men can choose whether to vaccinate HPV vaccines. Vaccine costs. At present, in Hong Kong and Macau in China, men's men can take HPV vaccination at their own expense. Fu Xi, chief physician of the obstetrics and gynecology department of the Third Hospital of Guangzhou Medical University, said that there is no problem with men who want to inject HVP vaccines, but they must inject four or nine -valent HPV vaccines in order to effectively prevent related cancer and inject binary HPV The vaccine cannot work.
In the face of more and more men in China expressed their demands for inoculation of HPV vaccines online, Dr. Bai told reporters that the clinical trials of the nine -valent HPV vaccine for male groups were also ongoing.
According to the information of drug clinical trial registration and information publicity platform, on March 7, the immunogenicity of Chinese men among Chinese men among the 9 to 19 years of Chinese men among Chinese men aged 9 to 19 by Merida East R & D (China) Co., Ltd. The Phase III clinical trials of Safety "and the nine -valent papilloma virus (HPV) vaccine (V503) immune procedures for Chinese men aged 9 to 14, and evaluated V503 among Chinese men 9 to 19 years old. Three -dose immune procedures of openness and safety of immune procedures are undergoing 78 months of experiments.
As early as October 2021, Meridodon R & D (China) Co., Ltd. has announced the "evaluation of nine-valent papilloma virus vaccine in 20-45 years of protection, immunogenicity, and safety. Drug clinical trials of information (registration number: CTR20212488). The latest data show that 400 men have participated in the experiment.
"In the third phase of the experiment, the most important thing about phase III clinical trials is the last step to determine whether the vaccine can be listed." Dr. Bao bluntly said that if the experiment is successful, the men in need can also be vaccinated, especially the need for vaccines, especially Boys with multiple personality partners.
HPV vaccine market space forecast. (Picture source: Ruico Biological Prospectus instructions)
When supply is in short billion markets, the "R & D war" is ongoing
In 2020, the World Health Organization proposed to accelerate the elimination of the global cervical cancer strategy. It is necessary to promise to vaccines HPV vaccines more than 9-14 years before 2030 for 194 countries, including China. If this goal, the Chinese vaccine market will still be in depression in the next ten years, and it will enhance the broad space.
As the exclusive agent of the Merhadon nine -valent HPV vaccine in China, the vaccine approval volume of the vaccine of Zhifei Biological Agency has also doubled. The publicly released semi -annual report in 2022 shows that the number of nine -valent HPV vaccines for its agency was 9.2988 million, a year -on -year increase of 379.34%. The staff of Merck (China) also revealed to the cover journalist that as of the end of June 2022, the quadrimal HPV vaccine and the nine -valent HPV vaccine had been vaccinated by more than 25 million Chinese -aged women.
At present, the nine -valent HPV vaccine producer has only one Merhadon in the world. The price of vaccines is high, and the problems of vaccine supply in short term are difficult to change in the short term. "(HPV vaccine) The market space is very large." Wang Yu, who was former deputy director of the AIDS Prevention and Control Center of the China Disease Control Center, told the cover journalist that market demand is stimulating to increase the production of vaccines in foreign countries. R & D.
Fortunately, the research and development of domestic nine -priced HPV vaccine is actively underway. In July of this year, Wantai Bio announced that the nine -valent HPV vaccine clinical trial has completed three needles and is currently followed up. It is reported that the entire phase III clinical trial cycle is about 66 months to 78 months. 60 million yuan/year.
Wantai Bio announced the construction of the nine -valent HPV vaccine in the semi -annual report of 2022. (Picture source: China Merchants Securities)
As the leader of domestic HPV vaccine companies, thanks to the two -valent HPV vaccine production and sales, Wantai Bio achieved a significant growth in performance. According to the semi -annual report disclosed by Wantai Bio in August 26, in the first half of 2022, Wantai Bio achieved revenue of 5.93 billion yuan, an increase of 202%year -on -year. The revenue of 875 million yuan, an increase of 400%.
As of the end of June this year, Wantai Bio R & D costs increased by 14.13%year -on -year, with R & D expenses of 233 million yuan. In the construction of the nine -valent cervical cancer vaccine base (Phase I) (Phase II) projects, the cumulative investment amount was 532 million yuan and 30.64 million yuan, respectively. The nine -valent HPV vaccine phase 3 clinical trials and industrialization amplification progress has made smooth progress. It has completed the construction of commercial production workshops and is undergoing industrialization amplification production research.
Wantai Bio announced the profitability of the semi -annual report of 2022. (Picture source: China Merchants Securities)
On September 9th, the reporter called Ms. Wu when Ms. Wu, Ms. Wu of the Wantai Biological Nine -Valing HPV vaccine project team, that the current research and development of the Nine -valent HPV vaccine is in a confidential stage, and it is inconvenient to disclose too much information.
At present, four companies including Wantai Biology, Kangle Guardian, and Ruico Bio are conducting phase III clinical trials of the Nine -valent HPV vaccine to varying degrees.
Among them, the HPV vaccine production workshop of Kangle Guard has landed in Yunnan. Its 2021 annual report shows that the company's nine -valent HPV vaccine has completed the stage III clinical trials in September 2021. Phase III clinical trial work. The five HPV vaccines of the two -valent, the four -valent of the new agent, and the nine -valent are the largest combination of Ruico's biological pipeline. In 2021, Ruico Bio has completed the recruitment of the nine -valent HPV vaccine products, and the three -needle administration was completed in the first half of 2022, and it will submit a listing license to the State Drug Administration in 2025.
The latest semi -annual report of Ruico Biological shows that its core product nine -valent HPV vaccine RPV vaccine REC603 main effectiveness test all the subjects entering and vaccination work have been completed, and they are in the follow -up stage; test.
Domestic nine -valent HPV vaccine "R & D war" is ongoing, or after 2026, it enters the harvest period. Although the launch of the nine -valent HPV vaccine needs to be waited, the prevention and treatment intervention of cervical cancer has been included in the national level of health planning. With the improvement of the research and development level of relevant enterprises and the expansion of production capacity, the current status of "one seedling" will be improved.
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