Recently, there have been rumors on the Internet that "Wantai Bio's nine-valent HPV vaccine will be launched in advance". In this regard, the securities department said that the company's nine-valent HPV vaccine is of great concern to everyone, and there are many reports and rumors on the Internet, and the company does not comment and reply, and the specific situation is subject to the company's recent announcement. Although there was no positive response, the share price of Wantai Biotech performed really well, and the stock price rose by nearly 60% in 8 trading days!
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First, about the HPV vaccine
HPV (human papillomavirus) is a common virus, and more than 100 types of HPV have been isolated, of which at least 14 can cause cervical cancer or other malignancies. According to Merck's announcement, about 98% of cervical cancers in China are caused by high-risk HPV. 9-valent HPV can protect against 9 subtypes of HPV virus, so it has attracted widespread attention.
According to statistics, since China first approved the HPV vaccine in 2017, the HPV vaccine market size has grown rapidly to 13.5 billion yuan in 2020, and the HPV vaccine market size is expected to grow to 69 billion yuan in 2030.
Second, the current situation of bivalent and quadrivalent HPV vaccines in China
At present, there are a total of 5 HPV vaccines on the market in China, with Merck accounting for 90% of the market share, and is currently represented by the listed company Zhifei Biotech. Among them, 2 domestic vaccines are Wantai Biotech's bivalent vaccine and Walvax Biologics' bivalent vaccine, and there are 3 imported vaccines, namely GlaxoSmithKline's bivalent vaccine, Merck's quadrivalent and nine-valent vaccines.
From the price point of view, the original bivalent vaccine of Wantai Biotech was the cheapest. According to statistics, the domestic bid price of Wantai Biotech's "Xinkonin" is 329 yuan/piece, GlaxoSmithKline's bivalent vaccine is 580 yuan/piece, Merck's quadrivalent vaccine is 798 yuan/piece, and the nine-valent vaccine is 1298 yuan/piece.
However, in May 2022, in the bidding for HPV vaccines in Jiangsu Province, Walvax Biotech won the bid at a price of 246 yuan/vial, while Wantai Bio's HPV vaccine only won the bid of 9,600 pieces/vial, and the winning bid price was still 329 yuan/vial. In July this year, Wantai Biotech won the bid for the HPV vaccine procurement project in Guangdong Province at a price of 116 yuan/piece.
Judging from the batch release of HPV vaccine in China, although Merck has the highest price, the batch release is still quite large. In the first half of 2023, Merck issued 6,266,651 quadrivalent HPV vaccines, a year-on-year increase of 28.5%, and 14,678,176 nine-valent HPV vaccines, a year-on-year increase of 57.85%.
Third, the arms race of domestic 9-valent HPV vaccine has begun
1. In the first half of the year, Zhifei Biotech "made a fortune with a muffled voice"
Globally, the nine-valent HPV vaccine is only produced and marketed by Merck & Co., Ltd. in the United States, and Zhifei, as the exclusive agent of Merck's quadrivalent and nine-valent HPV vaccines in China, naturally follows the meat. According to the data, in the first half of 2023, a total of 20,944,827 imported HPV vaccines were issued by Zhifei Biotech, which exceeded the annual batch issuance of 19 million HPV vaccines of the two HPV vaccines in 2021, while the batch issuance volume in 2022 was 29,505,700, that is, the batch release volume in the first half of this year has reached 70% of the batch issuance volume in the whole year of last year. Judging from the latest data, Zhifei's revenue in the third quarter increased rapidly year-on-year, mainly due to the rapid increase in HPV vaccines, among which, the growth momentum of 9-valent HPV vaccines was strong, driving the company's performance to improve.
At the same time, as there is currently no commercial domestic 9-valent HPV vaccine product in China, the 9-valent HPV vaccine has been in short supply for a long time. As a result, Zhifei was able to "make a fortune".
2. After 2025, there will be a number of 9-valent HPV vaccines on the market, and competition will intensify
This time, Wantai Biotech took the lead in announcing the R&D progress, which may indicate that the situation of Zhifei Biotech's dominance will be broken, and the market pattern of tens of billions of HPV vaccines will undergo major changes, and the domestic vaccine leaders are expected to join the ranks of sharing the cake.
At present, there are five local companies that have made rapid progress in the research and development of nine-valent HPV vaccines, including Wantai Biotech, Walvax Biotech, Bowei Biotech, Kangle Guard, and Ruike Biotech, and their related vaccine products have entered the phase III clinical stage.
On December 7, Walvax Biotech said in an investor survey that the company's phase III clinical trial of the nine-valent HPV vaccine is progressing as planned and is currently in the stage of serological testing. According to the Technical Guidelines for Clinical Trials of Human Papillomavirus Vaccine (Trial), the company's bivalent HPV vaccine has been launched, which is conducive to the research and development and marketing application of 9-valent HPV vaccine products.
According to the design of Wantai Biologics, a total of 12 visits were designed for the phase III main clinical trial of the company's nine-valent HPV vaccine, but the application for the vaccine does not need to be completed in full, as long as the previous visits have accumulated enough infection records, it can be declared. Since Wantai Biotech already has a bivalent HPV vaccine on sale, some investors believe that Wantai Bio is expected to be unblinded and then apply for listing after the V8 data is perfected.
Under the overall market situation of short supply and demand in China, the HPV vaccine market is far from saturated, with a market penetration rate of only 6.1%, and there is still a lot of room for growth.
Fourth, the nine-valent vaccine-related listed companies are sorted out:
Wantai Bio: The on-site work of the V8 phase III main clinical trial of the company's nine-valent HPV vaccine has been completed, and specimen testing is underway. (Leader at this stage)
Zhifei Biotech: The main varieties of Merck products have also achieved good sales results. Among them, the number of batches of 9-valent HPV vaccine has increased significantly, and as of the end of June 2023, the number of batches issued has increased by 57.85% year-on-year. (Acting faucet)
Walvax Biotech: The company is actively promoting the work of phase III clinical research of nine-valent HPV vaccine, and the company is currently organizing relevant departments to study and judge the "Technical Guidelines for Clinical Trials of Human Papillomavirus Vaccine (Trial)", and the specific clinical trial plan The company needs to communicate with the regulatory authorities to determine, and the company will make follow-up arrangements for related work in combination with the requirements of the regulatory authorities, and the follow-up progress is subject to the company's announcement.
Kangle Guard: The company has a total of 10 recombinant human vaccine research projects, of which the trivalent HPV vaccine, 9-valent HPV vaccine (female indication) and 9-valent HPV vaccine (male indication) have all entered phase III clinical trials
Recbio: The company's vaccine portfolio has 12 vaccines, including the company's core product REC603, a recombinant HPV nine-valent vaccine, which is currently in phase III clinical trials
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