4 on the morning of April 14, some media reported that the World Health Organization (who) recently announced on its official website that the organization held an immunization strategy expert group (SAGE) meeting from April 4 to 7
The evidence of single dose human papillomavirus (HPV) vaccination was reviewed. It was concluded that single dose HPV vaccination regimen could effectively prevent cervical cancer caused by persistent HPV infection, and the effect was equivalent to that of two or three dose regimen.
affected by the above news, HPV vaccine related concept stocks fell sharply, Chongqing Zhifei Biological Products Co.Ltd(300122) ( Chongqing Zhifei Biological Products Co.Ltd(300122) ) intraday share price collapsed, and Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) ( Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) ) intraday limit fell
Compared with the listed enterprises, the decline of HPV vaccine in research manufacturers is less obvious. Walvax Biotechnology Co.Ltd(300142) ( Walvax Biotechnology Co.Ltd(300142) ), which has just been approved for the listing of bivalent HPV vaccine, once fell to 7% in early trading, and the decline has narrowed to 3% as of the closing; Hong Kong stock Ruike Biology (02179. HK), which is expected to be listed as the first domestic nine price vaccine, once turned red in the session.
It is reported that the sage meeting minutes mentioned that for people with low immunity, three doses will be regarded as the best. In addition, a series of clinical, data support and registration change procedures need to be performed in order to change the grade of inoculants.
Some brokers believe that the above contents are protective suggestions for women in some poor countries with very low vaccine coverage, and have no impact on China's standard three shot vaccination procedures. Insiders also told the reporter of securities times · e company that the short-term impact is limited. After all, China's HPV vaccine gap is still large. At the same time, relevant leading companies also told reporters that their influence was limited.
relevant companies' emergency response
this morning, Chongqing Zhifei Biological Products Co.Ltd(300122) originally opened slightly higher by about 1 percentage point, the trend was stable before 10:19, and the share price remained above 130 yuan / share. However, with the spread of the above news, Chongqing Zhifei Biological Products Co.Ltd(300122) share price plunged rapidly, falling to about 110 yuan / share, down more than 18%, and the share price narrowed in the afternoon
It is reported that sage reviewed new evidence on the efficacy of a single dose HPV vaccine. Based on all available evidence, sage suggests that countries can choose a single dose vaccination plan or a two dose vaccination plan when developing HPV vaccination plans for girls aged 9 ~ 14, because the single dose vaccination and two doses vaccination have the same and efficient protective effect. In addition, young women aged 15 to 20 can also use a single or two dose vaccination plan, while women over 21 should use a two dose vaccination plan with an interval of six months.
The WHO sage meeting mentioned that for people with low immunity, more evidence is needed to prove that reducing the number of vaccines can still have a protective effect on them. Prior to further evidence, priority should be given to people aged 9 and over with low immunity and at least two doses of vaccine, but if feasible, three doses of vaccine will be considered the best option.
In response to the above report, Chongqing Zhifei Biological Products Co.Ltd(300122) relevant people told the reporter of securities times · e company that in order to expand the global coverage of HPV vaccination for women, who began to promote one shot HPV vaccination as early as 2018, which is not the first time. The immunization procedure of the vaccine needs a large number of clinical experimental data as support, and the State Food and Drug Administration will approve the listing. The company is also communicating with MSD and relevant departments in time to understand the situation.
Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) issued a statement and announced that up to now, the company has only obtained the vaccine registration license in China and has not obtained the vaccine registration license in overseas countries. At present, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) the bivalent HPV vaccine approved in China is 3 doses (women aged 9-14 can take 2 doses). Under the current national drug administration policy, a series of clinical, data support and registration change procedures need to be performed for the change of vaccination grade, which takes a certain time, and has no significant impact on the company's operating performance in the short term.
In addition, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) also reminded the risk that before the change of national policy, the company will continue to sell according to the currently approved doses, but it does not rule out that the WHO and the Chinese government will actively promote the immunization procedure of one dose or two doses in the future. If the existing manufacturers and new entrants obtain the registration license through clinical trials and registration changes, and promote the once or twice dose immunization program in China or abroad, it will have a great impact on the market supply and immunization of the whole cervical cancer vaccine.
how big is the impact of securities companies interpretation
How big is the actual impact? Many voices believe that it has little impact on the industrial chain in the short term.
BOC pharmaceutical analysts believe that "HPV injection" does not affect demand, but may bring more incremental opportunities. The analyst believes that the starting point of this meeting is the slow progress of global HPV vaccination and the overall low vaccination rate (especially in poor countries). Dr. Cravioto, sage's chairman, said sage's proposal was to enable more women to be vaccinated
The above analysts explained that the starting point of sage's proposal on HPV vaccine at this meeting is to allocate the limited production capacity to more women, so it will not have an impact on the demand for HPV vaccine, but only make recommendations on distribution. HPV vaccine is still one of the most scarce vaccines in the world. From another perspective, who attaches great importance to HPV vaccine, which further explains the necessity and scarcity of HPV vaccine.
In addition, the main goal of this proposal is poor countries, with the aim of rapidly increasing the HPV vaccination rate in poor countries. For China, Europe and the United States, as well as other developed countries, the marketing use of HPV vaccine must be verified by strict clinical trials. The adjustment of the marketing vaccination procedure needs to go through a strict demonstration and experimental process, and it is almost impossible to make adjustment in a short time.
In addition, Soochow medicine commented that antibodies can also be detected in women vaccinated with one shot of HPV vaccine, and the virus infection rate is lower than that of women not vaccinated, but the long-term protection efficiency has not been verified by phase III clinical trials, and the antibody titer in women vaccinated with one shot is significantly lower than that of three shots.
The chief doctor of a third class hospital told reporters that he also believed that the above news had a limited impact on the actual demand. On the one hand, the supply of HPV vaccine in China is in short supply. Even if each female of school age is only vaccinated with one shot of HPV, the current supply is insufficient; On the other hand, the above news does not deny that the effect of three injections is better than one. From this point of view, people with conditions will still choose three injections, just like "we all know that bivalent vaccine can resist more than 80% of HPV virus, but we still tend to give priority to nine valent vaccine".
for ordinary women, three needle vaccination is always the best way to protect women and has been proved by sufficient clinical evidence. Soochow Securities believes that the latest news is that the who's recommendations with public welfare nature are protective suggestions for women in some poor countries with very low vaccine coverage, and have no impact on the standard vaccination procedures of our country's three shot vaccine
In addition, doctors in relevant fields told the reporter of securities times · e company that this guidance will not be of great practical significance. HPV is not implemented with strong will, but depends on personal will. Qualified vaccinators must choose high-standard products. For example, bivalent HPV vaccine has been able to protect against more than 80% of HPV virus, but most people with conditions are still willing to choose the bivalent vaccine.
MSD: vaccination plan should be strictly and scientifically demonstrated
In view of the above situation, the reporter of securities times · e company learned from MSD China that at present, the immunization procedure of four valent and nine valent HPV vaccines listed in China is three doses, and the program is an indication approved based on clinical research data in China.
MSD China said that the vaccination plan should be based on strict scientific demonstration. MSD's four valent and nine valent HPV vaccines 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, and were successively approved by China's State Drug Administration (former State Food and Drug Administration) in 2017 and 2018
MSD China further pointed out that the effectiveness and safety of two dose vaccination, single dose vaccination or other immunization procedures not approved by regulatory authorities for Chinese people need to be further confirmed. MSD China recommends that health professionals and consumers be vaccinated according to the HPV vaccine instructions approved by the regulatory authorities.
Moshadong said that the company is committed to protecting the health of Chinese women through HPV vaccine and helping Chinese school-age women reduce the risk of HPV related cervical cancer and other related diseases. At present, methadone's four - and nine valent HPV vaccines have been approved in some markets outside China for two doses of immunization procedures for adolescents.
in recent years, MSD has invested more than US $1 billion to increase the production capacity of existing HPV vaccine production facilities and build new production facilities. From 2017 to 2020, the global HPV vaccine supply of MSD has nearly doubled. It is expected that the global HPV vaccine supply of MSD will double from 2020 to 2023
With the increase of global production capacity, the supply of HPV vaccine from MSD to China is also increasing year by year. In the first quarter of 2022, the batch issuance of tetravalent HPV vaccine in MSD increased by nearly 70% year-on-year, and the batch issuance of nine valent HPV vaccine increased by nearly 280% year-on-year. Moshadong said that it will continue to increase the supply to the Chinese market to meet the growing demand of more women for HPV vaccine and contribute to the development of public health in China.
hpv vaccine supply gap
According to the report of the World Health Organization, cervical cancer is one of the common gynecological malignancies and the second highest incidence of cancer among women aged 15 to 44 in the world. HPV is directly related to cervical cancer. HPV vaccine is the first vaccine used to prevent cancer in the world. Human beings try to eliminate a kind of cancer through vaccine for the first time. At present, there are three main types of HPV vaccines commercialized in the world, namely HPV bivalent vaccine, HPV tetravalent vaccine and HPV jiuvalent vaccine.
at present, the products listed in the Chinese market are mainly nine valent and four valent vaccines imported from MSD, and some domestic four valent and two valent vaccines. The current recommended number of injections is three. At present, China's HPV vaccine market is dominated by four types of vaccines, including cinchonine (bivalent) of Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392)
The phenomenon of "exclusive sale of HPV vaccine" began in November 2017, which is worthy of attention. Subsequently, the nine price HPV vaccine has been in a state of "difficult to obtain one shot" since it came into the market. All parts of the country need to make an appointment. At present, the two price and four price HPV vaccines are also in short supply.
There is still a large gap in the supply of HPV vaccine in China. According to frost Sullivan's prediction, the overall vaccination rate of HPV vaccine in China is low (less than 1%); If the expected increase in HPV vaccination rate is included, it is expected that 234 million women aged 9 to 45 will not be vaccinated by 2050.
Faced with a market in short supply, many Chinese enterprises have joined the ranks of developing HPV vaccines.
On March 15, Liaoning Chengda Biotechnology Co.Ltd(688739) announced that the fifteen valent HPV vaccine developed in cooperation with Kangle guards had received the notice of approval for drug clinical trial approved and issued by the State Drug Administration, approving the fifteen valent HPV vaccine to carry out clinical trial Walvax Biotechnology Co.Ltd(300142) 3 on March 28, it was announced that Zerun biology, an indirect holding subsidiary of the company, recently received the drug registration certificate of bivalent human papillomavirus vaccine (Pichia pastoris) approved and issued by the State Food and drug administration.
According to Huaan Securities Co.Ltd(600909) Research Report, in the field of nine valent vaccine, in addition to Kangle guard and Ruike biology, Bowei biology and Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) have also entered the phase III clinical stage. In the field of tetravalent vaccine, there are three clinical products. At present, the fastest progress is Bowei biology and China biology, both of which have entered phase III. In the field of bivalent vaccine, Walvax Biotechnology Co.Ltd(300142) has made the fastest progress and has entered the stage of listing application.
