How big is the pie?

The tragedy of the HPV vaccine is gradually breaking the ice
.

Today (March 24), the State Food and Drug Administration revealed that Watson Bio's bivalent HPV vaccine was officially approved, becoming the second domestic bivalent HPV vaccine approved for marketing
.

Previously, the domestic HPV vaccine market was mainly monopolized by multinational pharmaceutical companies Merck and GSK, and it was difficult for domestic pharmaceutical companies to get a share of it
.

At that time, domestic pharmaceutical companies successively laid out on the track, catching up
.
With the advantage of low price, the domestic bivalent HPV vaccine developed by Wantai Bio was approved for marketing at the end of 2019, becoming the first domestic HPV product in China, breaking the previous situation of "two heroes competing for hegemony"

Up to now, a total of 5 HPV vaccines have been approved for marketing in China, namely the bivalent vaccine of Wantai Bio, the bivalent vaccine of Watson Bio, the bivalent vaccine of GlaxoSmithKline (GSK) of the United Kingdom, and the quadrivalent vaccine of Merck & Co.
of the United States.
and the 9-valent vaccine
.

01

5 HPV vaccines approved for marketing in China

Four and nine prices still rely on imports

For a long time, the HPV vaccine has been regarded as the best in the world, and it is difficult to get a single shot
.
This is not unrelated to the relatively short period of domestic HPV vaccine popularization

It was not until July 2016 that GlaxoSmithKline's bivalent HPV vaccine was launched in China, which broke the deadlock that was completely blank in the domestic HPV vaccine market
.

Then, the multinational pharmaceutical company Merck's quadrivalent HPV vaccine and nine-valent HPV vaccine were also launched in China in 2017 and 2018, respectively
.

With the opening of the domestic HPV vaccination upsurge, there have been scenes of short supply in many places
.
Local pharmaceutical companies have also entered the market one after another, launching a race on the HPV vaccine track to speed up the development of HPV vaccines

It is worth mentioning that Zhifei Bio has won the exclusive agent of Merck's four-valent and nine-valent HPV vaccines in the mainland, and its performance has also escaped the tepid predicament and made a lot of money for a while
.

The domestic HPV vaccine has been slower, and it took more than a year before it was officially launched
.
At the end of 2019 (December 31, 2019), the State Food and Drug Administration issued an announcement stating that it approved the application for the registration of Wantai Biological's bivalent vaccine, with the trade name Cecolin

According to the batch issuance data of the Central Inspection Institute, the batch issuance of Wantai Bivalent HPV vaccine in 2020 is 2.
46 million, and the batch issuance in 2021 is expected to be about 10 million
.
The data shows that in 2021, Wantai Bio's bivalent HPV vaccine will account for 37% of the four approved HPV vaccines in China (excluding Watson Bio's bivalent HPV vaccine)

Previously (February 14), Wantai Bio released the 2021 annual performance report, achieving an operating income of 5.
75 billion yuan, a year-on-year increase of 144.
25%; net profit attributable to shareholders of listed companies was 2.
016 billion yuan, a year-on-year increase of 197.
83%
.
Net profit attributable to shareholders of listed companies after deducting non-recurring gains and losses was 1.

It is mentioned in the announcement that the bivalent HPV vaccine has made a great contribution to Wantai Bio's performance, and continued to maintain a boom in production and sales, with rapid growth in revenue and profit
.

At present, with the official approval of the recombinant human papillomavirus bivalent (type 16/18) vaccine of Yuxi Zerun Bio, a subsidiary of Watson Bio, the domestic bivalent vaccine market will be dominated by Watson Bio, Wantai Bio, GlaxoSmithKline is dominated by three pharmaceutical companies, while the quadrivalent and nine-valent HPV vaccines are still monopolized by the multinational pharmaceutical company Merck
.

In other words, HPV vaccines are still relatively dependent on imports, especially for quadrivalent and nine-valent HPV vaccines, there is still a lot of room for improvement in the domestic penetration rate
.

02

How big is the pie?

HPV vaccine domestic market exceeds 100 billion yuan gap to be filled

How big is the HPV vaccine in the domestic market?

Public information shows that among female malignant tumors, the incidence of cervical cancer is second only to breast cancer, and most cervical cancers are caused by HPV infection
.
There are more than 300 subtypes of HPV, and more than 200 can infect humans

Currently, HPV vaccination is one of the main means of preventing cervical cancer
.
There are three types of HPV vaccines currently on the market worldwide: bivalent, quadrivalent and 9-valent

According to the Frost & Sullivan report, the market size of HPV vaccines in China will increase to 13.
5 billion yuan in 2020, and is expected to reach 69 billion yuan by 2030, with a compound annual growth rate of 17.
7% from 2020 to 2030
.

Among them, the HPV nine-valent vaccine market may have the largest market share in the HPV vaccine market in 2030; the HPV bivalent vaccine market is expected to grow rapidly, given that HPV bivalent vaccines are generally more affordable and available to larger companies with limited affordability Population vaccination
.

Screenshot source: Ruike Biological Prospectus

According to the calculation of Debon Securities, the domestic HPV vaccine stock market space may exceed 220 billion yuan, and the 4-valent and 9-valent vaccine market space may exceed 180 billion yuan.
HPV vaccines can maintain rapid growth for at least 5-10 years
.

It is reported that the number of women aged 9-45 in China is about 381 million, and the current penetration rate of HPV vaccination among women of the appropriate age is only about 7%
.
The domestic HPV vaccine market size is far from reaching its peak
.

In addition, with the approval of domestic HPV vaccine male indications in the future, domestic HPV vaccine sales may usher in another round of explosive growth
.

In the past two years, a wave of free HPV vaccination has emerged in many parts of the country
.
At the same time, this has also become one of the key topics during the two sessions this year.
In the future, it may show a trend of accelerating progress and be vigorously promoted on a larger scale
.

In the face of such a vast market space, domestic HPV vaccine-related companies have also made great efforts and are gearing up to prepare
.
Despite the repeated setbacks in the research and development of HPV vaccines, there are still many pharmaceutical companies that have rushed forward, racing against time to invest in research and development, and are also making frequent moves in the capital market
.

03

Domestic pharmaceutical companies have deployed

Will the HPV vaccine market rapidly "PD-1"?

In addition to the multinational pharmaceutical companies GSK and Merck, a number of domestic players have gathered on the domestic HPV research and development track, including Wantai Bio, Recreation Guard, Bowei Bio, and Ruike Bio
.

Note: incomplete statistics

For example, in addition to the currently listed GSK, Wantai Bio, and Watson Bio products for bivalent vaccines, Ruike Bio is also deployed here
.

The nine-price track is more "crowded"
.
According to incomplete statistics, at present, in addition to the Merck 9-valent vaccine that has been approved for marketing, other 9-valent vaccines such as Bowei Bio, Wantai Bio, and Ruike Bio are all in the phase III clinical stage and are undergoing intensive clinical trials
.

In addition, among a large number of HPV vaccine companies, Recreation Guard nine-valent vaccine has also expanded clinical research on male-related indications
.
Its research and development for female indications is already in the phase III clinical stage, while the progress for male-related indications is a little later, but it is also in the phase I clinical stage
.

In addition to the 2-, 4-, and 9-valent vaccines that have attracted many domestic pharmaceutical companies, the 11- and 14-valent HPV types that cover more HPV types have also begun to attract more players
.
For example, the Sinopharm Zhongsheng 11-valent vaccine is currently in phase II clinical trials, and the Shenzhou Cell 14-valent vaccine has also entered the clinical stage
.

Relevant companies are making efforts in the HPV vaccine research and development process, but are not willing to lag behind in the capital market
.
Since the beginning of this year, Ruike Bio and Recreation Guard have entered the Hong Kong Stock Exchange and the Beijing Stock Exchange respectively, grabbing the name of "the first domestically produced nine-valent HPV vaccine"
.
However, at present, in terms of progress, Rico Bio is going faster
.

01

At present, Ruike Bio has completed the Hong Kong Stock Exchange's IPO, priced at HK $ 24.
80 per share, and the first-hand entry fee is HK $ 12,524.
97.
It is expected to become the first HPV stock on the Hong Kong Stock Exchange
.

Screenshot source: Ruike Bio official website

According to the prospectus, Ruike Bio holds 5 HPV vaccine pipelines
.
They are two bivalent HPV vaccine pipelines, one quadrivalent HPV vaccine pipeline, and two nine-valent HPV vaccine pipelines
.
At present, its aluminum-adjuvanted HPV nine-valent vaccine REC603 has entered the phase III clinical trial stage, which is the product closest to commercialization, and is expected to submit a BLA application in 2025
.

However, Ruike Bio has no commercial products for the time being, and is currently in a state of loss for a long time, and the loss is increasing year by year
.

02

Coincidentally, Recreation Guard also recently released a prospectus
.
On February 15, the HPV vaccine research and development company Recreation Guard announced that the company plans to apply for listing on the Beijing Stock Exchange
.

According to public information, Recreation Guard was established in 2008.
It is a biopharmaceutical research and development enterprise focusing on recombinant protein based on structural design.
At present, it has deeply and comprehensively deployed the research and development of various innovative vaccine varieties.
Its core products include recombinant trivalent, nine-valent and Fifteen-valent HPV vaccine and recombinant bivalent new crown vaccine, recombinant multivalent norovirus vaccine, recombinant respiratory syncytial virus vaccine and recombinant herpes zoster vaccine,
etc.

Screenshot source: Recreation Guard official website

It is worth mentioning that in the product pipeline of Recreation Guard, the recombinant trivalent and nine-valent HPV vaccines have entered Phase 3 clinical trials, and their progress ranks among the top three
.

In addition to the above-mentioned companies, there are also a number of companies that have "opened up a new way" to lay out the HPV vaccine track
.

Bowo Bio, a holding subsidiary of Rurenfu Medicine, signed a contract with the National Institutes of Health (NIH) to obtain the global exclusive product development rights, market rights and patent use rights for the development technology of a new generation of human papillomavirus (HPV) vaccine.
still in the clinical stage
.

In addition, Dongfang Lue, a subsidiary of Dezhan Health, and its US partner Inovio have jointly developed a DNA therapy drug VGX-3100 combined with the device CELLECTRAM5PSP to treat HPV-16/18-related cervical high-grade squamous intraepithelial lesions (HSIL)
.

Undoubtedly, more and more domestic pharmaceutical companies are eyeing the "fat meat" of the HPV track
.

With the development and rise of domestic vaccines, the trend of domestic vaccines replacing imports has become more and more obvious
.
At the same time, vaccine prices are also expected to fall
.
Taking China as an example, the total cost of GSK's bivalent HPV vaccine is 1,740 yuan, while the total cost of Wantai Bio's bivalent HPV vaccine for 9-14 year olds is 658 yuan, and the 15-45 year olds' total cost is 658 yuan.
The total cost is 987 yuan, which is far lower than the unit price of imported similar products
.

Nowadays, new players are pouring into the HPV vaccine track one after another, and there is a sense of PD-1 competition in the past, but as for the final differentiated layout, how can the late entrants differentiate their layout and how many opportunities are left? The HPV vaccine market is getting more and more hot, will it be "PD-1" quickly?