"The first stock of HPV vaccine on the Hong Kong Stock Exchange" exploded!

Ruike Bio, known as "the first HPV vaccine stock in Hong Kong", entered the last day of the new launch.
The deadline was March 23.
A total of HK$509.
688 million was publicly offered for margin subscription.
Ruike Bio has been oversubscribed by 5.
6 times
.
Such performance can be described as "hot"

Echoing the "first stock of HPV vaccine in Hong Kong stocks" is Wantai Bio, which is listed on the A-share market
.
On April 29, 2020, Wantai Bio, which focuses on HPV vaccine, was listed on the Shanghai Stock Exchange at an issue price of 8.
75 yuan per share.

Driven by the policy, China's HPV vaccine market has broad prospects, and it has also raised investors' expectations for Ruike Bio
.
So, can Ruike Bio, which has not yet launched a product, get the green light in the capital market?

Facing the blue ocean market, domestic HPV vaccine companies are on the rise, and several nine-valent pipelines have advanced to Phase III clinical trials.
They will share the domestic storage market with Zhifei Biological as the agent of Merck's imported varieties

When the heroes are fighting for the deer, it is not yet known who will rise and fall
.

Founded in 2012, Ruike Biotech is currently a clinical-stage biotechnology company that has established a vaccine portfolio consisting of 12 vaccine candidates, including HPV vaccine, new crown vaccine, adult tuberculosis vaccine, hand, foot and mouth disease vaccine, influenza vaccine,
etc.
Among them, with regard to HPV vaccines, Ruike Bio has 2 bivalent HPV vaccine pipelines, 1 quadrivalent HPV vaccine pipeline, and 2 nine-valent HPV vaccine pipelines

With the enrichment of vaccine product research and development pipelines, Ruike Bio's demand for research and development funds has gradually expanded, and multiple rounds of financing have been carried out for this purpose
.
According to the prospectus, as of September 30, 2021, Ruike Bio has obtained B+ and C rounds of financing of 1.
165 billion yuan; in 2020, it has obtained B-round financing of 686 million yuan; in 2019, it has obtained A round of financing of 500 million yuan

It is worth mentioning that, as of now, since Ruike Bio has no products approved for commercial sale, its main products have not generated any sales revenue
.
The prospectus shows that in 2019, 2020 and the first three quarters of 2021 (hereinafter referred to as the "reporting period"), Ruike Bio achieved revenue of 12.
932 million yuan, 9.
551 million yuan, and 25.
569 million yuan respectively

At the same time, the company lost 138 million yuan, 179 million yuan, and 520 million yuan in each period during the reporting period, and the cumulative loss over two years was as high as 837 million yuan; of which R&D costs were 63.
265 million yuan, 131 million yuan, and 372 million yuan respectively

It is reported that the increase in the loss of Recco Bio is mainly due to the start of the research and development of the new coronary pneumonia candidate vaccine ReCOV in response to the new crown epidemic in early 2020, and the phase III trial of the nine-valent HPV vaccine REC603 and the phase I trial of ReCOV in 2021.
Shares resulted in an increase in share-based compensation

"We estimate that the net loss for the year ended December 31, 2021 will increase significantly compared to the year ended December 31, 2020, especially as our R&D expenditure will increase by more than 200%
.
R&D activities have increased, and we expect net losses to continue to increase in 2022,
" said RicoBio
.
Part of the proceeds from the listing in Hong Kong will be used to continue optimizing, developing and commercializing the HPV vaccine pipeline
.

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; at the same time, the Chinese HPV vaccine market also shows a high concentration and insufficient supply
.

According to the Frost & Sullivan report, since Gardasil was approved in China in 2017 and Gardasil 9 in 2018, the total batches of Gardasil and Gardasil 9 in China in 2020 were about 16.
9 million and 9.
6 million respectively; For the general population, the HPV vaccination rate in China is generally low, less than 1%
.
Even taking into account the expected increase in HPV vaccination rates, it is estimated that by 2025, there will still be about 234 million women aged 9-45 years who have not received the HPV vaccine in China, assuming 3 doses per person, an additional 702 million doses may be required
.

Facing the blue ocean market of tens of billions of 9-valent HPV vaccines, domestic companies have risen, and 4 9-valent pipelines have been advanced to Phase III clinical trials
.
Shanghai Bowei Bio launched Phase III clinical trials in April 2020, and is the first domestic nine-valent HPV vaccine to enter Phase III clinical trials in China
.
The nine-valent vaccines of Wantai Bio, Recreation Guard and Ruike Bio also started Phase III clinical trials in September 2020, December 2020, and June 2021, respectively
.

At the same time, intensified domestic competition leads to the risk of a sharp drop in product prices and a decline in market share 
.
With the accelerated popularization of HPV vaccine, it is expected that in 2025, the products of domestic HPV vaccine research and development enterprises will be put on the market.
Ruike Bio will compete with companies including Wantai Bio, Bowei Bio, and Recreation Guard.
It is currently uncertain who will lead the way.

.
Whether it can occupy the first-mover advantage of the first domestic nine-valent HPV vaccine is very important for Ruike Bio
.

In the eyes of industry insiders, the research and development of HPV vaccine is relatively difficult, so related companies will invest more in research and development, which will affect the company's profitability to a certain extent
.
As more and more capital pours into the HPV vaccine track, the capitalization trend of HPV vaccine companies is obvious, and the market growth potential is huge; at the same time, the pace of domestic substitution of HPV vaccines for imports will be further accelerated
.

Cervical cancer is one of the most common gynecological malignancies in the world.
In 2020, the number of global morbidity and deaths will reach 604,000 and 342,000 respectively, of which China contributes about 15% to 20%, and the burden of cervical cancer is heavy
.

At present, the nine-valent HPV vaccine approved for marketing in China is suitable for women aged 16 to 26.
The manufacturer of the vaccine is the multinational pharmaceutical company Merck, and the agent is the Chinese company Zhifei Biological
.
According to the prospectus of Ruike Bio, in 2020, the HPV vaccine market in China is highly concentrated.
According to the output value, Merck currently occupies 91% of the HPV vaccine market share
.

There are two main advantages of the 9-valent HPV vaccine REC603 of Rikco Bio: Merck's 9-valent HPV vaccine is in short supply, and Rik-Bio hopes that REC603 will become a domestic alternative to MSD's 9-valent HPV vaccine; in addition, Merck's 9-valent HPV vaccine is suitable for vaccination The population is 16-26 year old females, and the REC603 of Ruike Biotech is suitable for a wider age group and is expected to cover the 9-45 year old group
.

The above-mentioned industry insiders said that behind the shortage of nine-valent HPV vaccine is the only one manufacturer in the world.
Under the overall supply pattern with a large demand base and limited production capacity by Merck, the domestic nine-valent HPV vaccine will have a considerable space for development
.
With the launch of the domestic nine-valent HPV vaccine, consumers will also have more choices
.

According to the research and development analysis of Huaxi Securities, the advantage of domestic vaccines is that the price is lower
.
For example, as a late entrant in the market, Wantai Bio's bivalent HPV vaccine Xin Ke Ning is priced at 329 yuan per injection, 658 yuan for the whole course of vaccination for 9-14 years old, and 987 yuan for the whole course of over 14 years old
.
Comparing the price of imported vaccines, GSK's bivalent vaccine is 580 yuan/piece, and the whole process costs 1,740 yuan; Merck's quadrivalent and 9-valent vaccines are 798 yuan/piece and 1298 yuan/piece respectively, and three injections cost 2394 yuan and 3894 yuan.

.

In addition to price, from the perspective of market competition, the HPV vaccines of Merck and GlaxoSmithKline will focus on covering first- and second-tier cities with stronger affordability, while there are huge blank markets in third- and fourth-tier cities where domestic vaccines focus on sales
.
For vaccinators in third- and fourth-tier cities, imported vaccines are not only expensive, but the supply cannot meet demand
.
For those who have a strong demand for vaccination, it is necessary to go to first- and second-tier cities for vaccination, which greatly increases the cost of vaccination
.

The competitiveness of domestic vaccines in the sinking market is obviously better than that of vaccines produced by Merck.
In addition to lower prices, the country is also continuously promoting the production and nationwide implementation of domestic vaccines, so that domestic vaccines can achieve better coverage
.
However, the pressure of peer competition exists objectively
.
On the one hand, due to external squeeze, the first-mover advantage of foreign brands is more obvious, and the market influence of Merck and GSK will inevitably continue; Not to be underestimated either
.

Text editor: Yu Rujin

Format editor: Yu Chenglin