Expand to 45 years old!The "one stitch is difficult to find" the nine -valent HPV vaccine expansion, and the five domestic nine -valent HPV vaccines have entered the third phase of the clinical clinical

China Times (chinatimes.net.cn) reporter Sun Mengyuan Yu Na Beijing report

The nine -valent HPV vaccine of "one shot" announced the expansion.

On August 30, the "Merck China" WeChat public account released a news that its nine -valent papilloma virus vaccine (hereinafter referred to as the "nine -valent HPV vaccine") has been approved by the National Drug Administration of China. The approval marks the expansion of women in China to 9-45 years old in China. Earlier, the vaccine's applicable population was 16-26 years old.

As soon as the news came out, it quickly caused high attention from the outside world. Deng Zhidong, general manager of Hainan Boao Medical Technology Co., Ltd., said in an interview with the China Times reporter that after the nine -valent HPV vaccine expands, the market demand will also increase significantly. In short -term supply, the appointment will also be even more intense.

In this context, domestic pharmaceutical companies are constantly increasing R & D rate. At present, five domestic nine -priced HPV vaccines have entered the third phase of clinical clinical stages.

status quo

Cervical cancer is one of the common gynecological malignant tumors. According to data released by the International Cancer Research Agency, about 570,000 women have new cervical cancer each year and about 310,000 women die in cervical cancer. There are nearly 110,000 new cases of cervical cancer each year and nearly 50,000 death cases. According to Merck's announcement, about 98%of China's cervical cancer is caused by high -risk HPV.

Nevertheless, my country's HPV vaccine is not high, and the market gap is huge. The Guilian Securities Research Report pointed out that the World Health Organization (WHO) proposed that the HPV vaccination rate of women 9-15 years old will reach 90%by 2030, and the current penetration rate of my country's stock market will be less than 6%. Policies are promoted that the total demand for the stock market is expected to be 275 million. According to the Figarian report, the size of China's HPV vaccine market increased to 13.1 billion yuan in 2020, and it is expected to reach 69 billion yuan by 2030.

Deng Zhidong believes that the previous HPV vaccine supplier has fewer HPV vaccine, limited production and supply capacity, expensive imported vaccine prices, lack of understanding of cervical cancer, HPV vaccine -related knowledge, and no inoculation of appropriate vaccine in the applicable age range. The factors are related.

"To improve this situation, first of all, we must continue to implement free vaccination policies for women's age; second, strengthen domestic high -priced vaccine research and development alternative and large -scale mass production, and increase market supply; finally The enthusiasm for vaccination. "Deng Zhidong told the reporter of Huaxia Times.

Age expansion

On August 30, Merck announced that the new indication of the nine-valent papilloma virus vaccine has been approved by the China National Drug Administration. Female -year -old women.

The Merida East Nine Valentine HPV vaccine is my country's first approval nine -valent HPV vaccine. In April 2018, the State Drug Administration has the conditions to approve the nine-valent HPV vaccine for cervical cancer to prevent the listing of women aged 16-26.

As a global vaccine giant, the Meridas HPV vaccine -Gardasil/Gardasil9 (Jiada Xiu®) (4/9 Valentine's papilloma virus vaccine (brewing and yeast) performance is extraordinary. According to financial report data, Merhadon HPV vaccine in 2021 is high. 5.673 billion US dollars, a year -on -year increase of 44%. The Chinese market has made important contributions.

对于备受关注的产能问题，默沙东全球高级副总裁、默沙东中国总裁田安娜（Anna Van Acker）公开回应称，默沙东将继续与政府、学会、商业伙伴和社会各方紧密合作，通过扩大全球产能、 Increase the supply of the Chinese market, continuously improve the accessibility of the HPV vaccine, and support the development of China's public health.

It is worth noting that approved aging does not mean formal listing. "Huaxia Times" reporter in Shanghai Medical University Hospital's HPV appointment platform for consultation for more than 26 years of age can be vaccinated with a nine-valent HPV vaccine. Customer service said: "The latest news of Merhadon Company is approved by the age of nine prices (9-45 years old), but illness control and control There is no official news in the center. We are also waiting for the specific notification. The time is uncertain. It is recommended to directly vaccinate the four -price vaccine. Early vaccination and early protection. The younger the age, the better the immune effect. Don't miss the best vaccination time. "

After the nine -valent HPV vaccine is expanded, the secondary and quadrimal vaccines still have a large market. Deng Zhidong told the reporter of the Huaxia Times that the nine -valent HPV vaccine is tight, and it can consider the domestic binary HPV vaccine. The results of clinical trials show that the protection rate of domestic two -valent vaccine prevention HPV16 and HPV18 -related pre -cancer lesions reached 100%, preventing HPV16 and HPV18 sustainable infection protection rates of 97.7%. At the same time, domestic binary HPV vaccines also have advantages in price, and they are more inclusive. Women who have played two -price and quadrilateral HPV have generally not needed to make nine -valent HPV vaccines.

Vaccine expert Tao Lina also suggested that the sooner the HPV vaccine vaccination time, the better. Women of appropriate age can be used to supply a more sufficient binary HPV vaccine. After the nine -valent HPV vaccine supply is tight, it can be supplemented by high prices depending on the situation. Vaccine.

accelerate

At present, there are five domestic HPV vaccines in China and have been approved to be listed, including "Jiada Xiu", "Jiada Xiu", Nine -Valentine vaccine "Jiada Xiu 9", Grammort's two -valent vaccine "Herry Shi", Wantai Biological Second The binary vaccine of the price of "Xin Kening" and the Watson creature "Wozawa".

Despite the continuous expansion of production capacity of vaccine companies, the supply of vaccine is still tight, and the nine -valent vaccine is "difficult to find."

The contradiction between supply and demand for high -priced HPV vaccines is prominent, and domestic pharmaceutical companies have made every effort to accelerate research and development. According to incomplete statistics, as of the end of February 2022, there were about 16 domestic HPV research projects. Nine -valent HPV vaccine has made five local enterprises progressing rapidly, Wantai Biology, Watson Biology, Boyi Bio, Kangle Guardian, and Ruico Bio, all have entered the clinical phase of the III phase; higher -priced vaccine also has Shenzhou The 14 -valent HPV vaccine of the cells, the 15 -valent HPV vaccine for adults, and the 11 -valent HPV vaccine of China Pharmaceutical Group.

Wantai Biological said in the semi -annual report of 2022 that the company's nine -valent HPV vaccine is in the data statistical analysis stage. The clinical trials of the head -to -head clinical trials of the Merida East Nine Valentine HPV vaccine have completed the clinical trial site and specimen testing. The age bridge will be completed in clinical trials. At the same time, the construction of commercial production workshops has been completed, and industrialization amplification production research has been conducted.

Watson Biological said on August 14th in the investor interactive platform that the subsidiary Shanghai Zerun Nine -valent HPV vaccine has been in the clinical research stage and is currently carrying out the relevant preparations before the stage of phase III clinical research subjects.

Zhongtai Securities believes that since 2020, Xiamen, Ordos, Jinan and other places have issued policies to promote free vaccination for women's HPV vaccines, which will help further increase the awareness and vaccination rate of HPV vaccines. It is expected that domestic HPV in the next few years is expected Vaccine is expected to usher in acceleration.

Xuexue Editor: Editor of Yan Yuan: Chen Yanpeng

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