An official document from the who has exacerbated the concern that the HPV vaccine market may “shrink”. Affected by this, on the 14th, three vaccine stocks Chongqing Zhifei Biological Products Co.Ltd(300122) ( Chongqing Zhifei Biological Products Co.Ltd(300122) . SZ), Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) ( Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) . SH), Walvax Biotechnology Co.Ltd(300142) ( Walvax Biotechnology Co.Ltd(300142) . SZ) collectively fell, falling 14.19%, 9.46% and 3.08% respectively as of the close.
On the news, on April 11 local time, the World Health Organization (who) announced on its official website that for the prevention of cervical cancer caused by human papillomavirus (HPV), the effect of one dose of HPV vaccine is equivalent to that of two doses of HPV vaccine. This may change the rules of the game to prevent cervical cancer.
Up to now, HPV vaccines approved for marketing in China include: Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) bivalent HPV vaccine Xinkening, Walvax Biotechnology Co.Ltd(300142) bivalent HPV vaccine wozehui, bivalent HPV vaccine produced by GlaxoSmithKline, tetravalent HPV and jiuvalent HPV vaccine produced by MSD company, and the latter two are exclusively represented by Chongqing Zhifei Biological Products Co.Ltd(300122) .
The reporter of science and Innovation Board daily noted that the above vaccines need to be vaccinated at least 2-3 times.
After the news was released, Chongqing Zhifei Biological Products Co.Ltd(300122) said that the claim that three doses of HPV vaccine can only be given one dose has no clinical data support, and the company will actively respond;
Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) said that under the current national drug administration policy, a series of clinical, data support and registration change procedures need to be performed in case of secondary change of inoculants, which takes a certain time, and has no significant impact on the company’s operating performance in the short term.
will the hpv vaccine market shrink significantly
At present, in China’s vaccine market, HPV vaccine is a widely favored “explosive product”, and the market growth rate in recent years is far ahead of other large varieties of vaccines.
According to the vaccine signing and wholesale data of the Central People’s Procuratorate and local inspection institutes, the total batch issuance of HPV vaccine in China in 2021 was 225 batches, second only to the tetravalent influenza vaccine (318 batches). Among them, the number of signing and wholesale of bivalent HPV vaccine increased by 269% year-on-year, while that of bivalent HPV vaccine increased by 83% year-on-year, both of which were higher than the 75% year-on-year growth rate of tetravalent influenza vaccine.
If we change to one shot on the premise of the same protective effect, this growth rate may decline.
According to the estimation of Huaxi Securities Co.Ltd(002926) Cui Wenliang, the penetration rate of HPV vaccination among school-age women in China is only about 7%. According to the penetration rate of 30% / 45% / 60%, China still needs 280 / 450 / 620 million HPV vaccines; If only one dose of HPV vaccine is given, the amount of vaccine required to cover the same population will be reduced by at least half.
This may mean that the HPV vaccine market will “shrink” significantly. At the same time, the competition among enterprises will be more intense in order to compete for more market share.
This has raised concerns in the market. In intraday trading on the 14th, Chongqing Zhifei Biological Products Co.Ltd(300122) fell by more than 18%, while Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) fell by the limit for a time. As of the closing, the market value of Chongqing Zhifei Biological Products Co.Ltd(300122) , Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Walvax Biotechnology Co.Ltd(300142) , fell by 14.19%, 9.46% and 3.08% respectively. Compared with the closing on the 13th, the market value evaporated by more than 30 billion yuan, 16.3 billion yuan and 2.5 billion yuan respectively.
follow up or further validation of clinical data
So, how many doses of HPV vaccine do you need? Why does the who think that the effect of one dose of vaccination is equivalent to that of two doses?
In this regard, Dr. Xiong Changyun, vice president of Emmy vaccine production preparation department and head of mRNA production, explained to the reporter of science and Innovation Board daily that the dosage of vaccination is related to the duration of neutralizing antibody in the body.
“Generally speaking, vaccines stimulate the human body to produce humoral immunity and cellular immunity. The former produces neutralizing antibodies and will gradually weaken over time; the latter produces memory B cells for a long time.” Xiong Changyun explained that some vaccines only produce humoral immunity. Due to the weakening of neutralizing antibody titer, they need to be vaccinated again every other time; In some vaccines, the neutralizing antibodies stimulated by the human body last for a very long time, and memory B cells exist for life. Then, one dose is enough.
He also said, exactly how many injections need clinical experimental data and effect tracking and reassessment after the product is launched
But the who’s recommendations are not “groundless”. According to who, it reviewed the evidence of several clinical trials and observational studies and model analysis (including ken-she trial in Kenya, Doris trial in Tanzania, IARC trial in India, HPV vaccine trial in Costa Rica, etc.), which showed that HPV-16 / 18 antibody could also be detected in women after only one dose of HPV vaccine, and the protection efficiency against HPV-16 / 18 infection was similar to that of multi dose vaccination.
manufacturer’s attitude: no comment
HPV vaccine manufacturers are noncommittal about who’s recommendations.
Moshadong made a strong statement that the immunization procedures of four valent and nine valent HPV vaccines listed in China are three doses, and the program is an indication approved based on clinical research data in China. The effectiveness of single vaccination, single vaccination and other unapproved vaccination procedures by Chinese regulatory agencies remains to be confirmed.
“The vaccination plan of the vaccine should be based on strict scientific demonstration. The tetravalent and nine valent HPV vaccines of methadone have accumulated a large number of clinical trials and real-world data in terms of protective efficacy, protective effect, safety and durability of protective effect.” Moshadong said.
The reporter of the science and technology innovation board daily learned from Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) that when carrying out clinical trials, enterprises choose the scheme of multi dose vaccination. “The company’s products are vaccine products approved and registered by the State Food and drug administration under the demonstration of a large number of clinical studies and data. There are three doses for women aged 9-45 (two doses for women aged 9-14), and three doses for competitive products methadone and GSK.” Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) scale.
Soochow Securities Co.Ltd(601555) believes that the who’s proposal is to expand the global coverage of HPV vaccination for women and strive to improve the HPV vaccination rate in the world, especially in low-income countries. It is more of a “public welfare proposal”. Therefore, it is expected that it will have no impact on the standard vaccination procedure of three shot HPV vaccine in China in the short term.
“Although one dose vaccination can provide better protection against HPV-16 / 18 infection, the current evidence is difficult to completely replace two or three doses of vaccination. There is still a lack of more evidence on the protection efficiency of other types of HPV infection other than HPV-16 / 18. Therefore, three doses of vaccination is always the best way to protect and proved by sufficient clinical evidence.” Soochow Securities Co.Ltd(601555) .
Will this suggestion of who affect the market space of domestic bivalent vaccine for overseas sales in the future? As of press time, the reporter of “science and Innovation Board daily” has not received a reply from the enterprise.
Who also said that stakeholders would be consulted on these important policy changes before revising the position paper on HPV vaccination.
