The latest progress of the domestic nine-valent HPV vaccine has been disclosed, and it is one step closer to mass production and marketing.
On April 10, Wantai Biotech (603392. SH) announced that the V8 phase V8 main clinical trial of the "recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 nine-valent vaccine (Escherichia coli)" developed in cooperation with Xiamen University has been unblinded and preliminary analysis results of the main data have been obtained.
The study used a multicenter, randomized, double-blind, bivalent HPV vaccine-controlled design with a total of 12 visits (V1-V12 visits). By the end of the V8 visit specimen testing, the number of persistent infection endpoint events in December had been accumulated in the main analysis data set of the trial, and the results of the preliminary analysis of the primary data by the third-party statistical company showed that the main results were in line with expectations.
The announcement pointed out that the data obtained from the unblinding of the phase III clinical trial of the nine-valent HPV vaccine are only part of the main results up to the V8 visit, and a comprehensive and in-depth analysis needs to be carried out in accordance with the provisions of the protocol and statistical analysis plan, and the clinical trial summary report will be completed.
It should be noted that the data on the protective efficacy of HPV vaccine development have always been based on histopathology such as cervical squamous cells (CIN2+) and adenocarcinoma or cervical cancer.
Wantai Biotech also said that the phase III clinical trial of its nine-valent HPV vaccine still needs to continue to monitor histopathological endpoints such as CIN2+ according to the protocol design, until the number of histopathological endpoints scheduled by the protocol is accumulated or all 12 visits are completed.
Regarding the progress of the approval of the nine-valent HPV vaccine, which is very concerned by the market, Wantai Bio said that the company is simultaneously carrying out the writing of new drug registration application materials, and will actively carry out communication with the drug regulatory department on the declaration matters.
The latest progress of Wantai Bio's nine-valent HPV vaccine has been disclosed, sweeping away the haze caused by the company's poor performance in 2023 and the public opinion turmoil of the actual controller. On April 11, Wantai Biotech opened at 74.16 yuan, with a total market value of 94.05 billion yuan.
The participants who are about to eat the market cake on the table came with good news, Merck Sharp & Dohme's HPV vaccine agent Zhifei Biotech (300122.SZ) opened low on Thursday, and fell more than 7% intraday.
The domestic nine-valent seedlings are about to hit the line, and some people are happy and some are worried
Up to now, a total of 5 HPV vaccines have been approved for marketing in China, including three bivalent HPV vaccines, one quadrivalent HPV vaccine, and one 9-valent HPV vaccine.
Specifically, Merck & Co., Ltd. approved the quadrivalent and PV vaccine Gardail4 in 2014, Gardail9 (Jiadail9) approved in 2018, GSK's bivalent HPV vaccine Cervarix approved in 2016, Wantai Biotech's bivalent HPV vaccine Xinkonin approved in 2019, and Walvax's bivalent HPV vaccine Wozehui approved in 2022.
Among them, Merck's Jiadaxiu 9 is the only approved nine-valent HPV vaccine in the world, and its domestic agent is Zhifei Biotech. With the shortening of the approval process of Wantai Biotech's nine-valent HPV vaccine, Zhifei Biotech took the lead in the pressure.
The 9-valent HPV vaccine is of extraordinary importance to Zhifei Biotech, and it is related to the lifeline of growth.
In the first half of 2023, Zhifei's revenue will be 24.445 billion yuan, of which the revenue of agent products will be 23.583 billion yuan, accounting for 96.47%, and the largest contribution among the agent products is Merck's nine-valent HPV vaccine.
The picture comes from the semi-annual report of Zhifei Biotech
Regardless of the fact that Wantai Biotech's nine-valent HPV vaccine will be the first to compete with Zhifei Biotech for the market after it is approved, even if it has not yet been approved, any news disclosure related to progress will cause Zhifei Biotech to suffer negative sentiment in the secondary market, causing the stock price to fall.
On December 14 last year, Wantai Biotech disclosed that the on-site work of the V8 phase III main clinical trial of its nine-valent HPV vaccine has been completed, and specimen testing is underway. The next day, Zhifei Biotech fell nearly 9%, and so far, it has fallen by 36.26%.
Previously, Southwest Securities predicted that domestic HPV vaccines were generally expected to be launched after 2025. In other words, at least throughout 2024, if there is any news about the progress of the approval of the domestic nine-valent HPV vaccine, the stock price of Zhifei Biotech will be disturbed by bearish sentiment.
For Zhifei Biology, the news that can be called "negative" is not only from Wantai Biology.
There are dozens of domestic companies involved in the research and development of nine-valent HPV vaccine, among which Wantai Biotech and Walvax Biotech (300142. SZ), Bowei Biotech, Kangle Guardian (833575. BJ), Recbio five, and with the unblinding of the phase III main clinical trial data of Wantai Biology, the market's expectations for the nine-valent HPV vaccine of Kangle Guardian have risen.
In December 2023, Kangle Guardian said that the on-site work of the Phase III main clinical trial V8 visit of its 9-valent HPV vaccine has been completed, and the specimen testing work is underway, and it can be declared for marketing as an iterative vaccine.
This is very close to the timeline of the promotion of Wantai Bio's nine-valent HPV vaccine, and if Kangle Guardian also unblinds the V8 data, the market will soon receive good news about the domestic nine-valent HPV vaccine. On Thursday, Kangle Guardian rose more than 9% intraday.
During the disclosure of the overwhelming progress of the approval of the domestic nine-valent HPV vaccine, Zhifei Biotech seemed to be difficult to parry, and in addition, Merck's every move also affected the nerves of Zhifei Biotech investors.
Merck & Co., Ltd. "Plum Blossom Three" Study Single-Dose Vaccination Program, Zhifei Biotech Was "Judged"
In the face of the approaching domestic 9-valent HPV vaccine, Merck, which dominates the global market, is responding to the upcoming shock in another way.
In March, Merck announced plans to launch a clinical trial of a novel multivalent human papillomavirus (HPV) vaccine at the 2024 European Organization for the Study of Reproductive Infections and Oncology (EUROGIN) Congress, which aims to provide broader protection against HPV types. The first-in-human trial (Phase I) is expected to begin in the fourth quarter of 2024, with a broader HPV spectrum including those known to have a high impact in African and Asian populations, as well as in individuals of African and Asian descent.
At present, in China, the research and development of higher-priced HPV vaccines is also being promoted, including the 11-valent HPV vaccine in Chengdu, the 14-valent HPV vaccine of Shenzhou Cell, and the 15-valent HPV vaccine of Chengda Biologics/Kangle Guard. The high-priced HPV vaccines above the 9-valent have not yet been approved, and they are all in the early stage, and the impact on the market at this stage is limited.
Another move by Merck is more noteworthy.
Also at the EUROGIN conference, Merck announced plans to conduct additional clinical trials to evaluate the efficacy and safety of the single-dose Adequate-9 regimen compared to the approved three-dose regimen, to determine whether the single-dose Adedashu 9 regimen can provide long-term protection comparable to the approved regimen while meeting regulatory requirements. The clinical trial is expected to begin enrollment in the fourth quarter of 2024.
For Merck's yet-to-be-started single-dose vaccination regimen study, investors have asked Zhifei about the impact.
"Based on the urgent need of the majority of people of appropriate age to prevent diseases, the company and Merck have worked together to continuously improve the supply of vaccines, committed to reducing the global burden of cancer and disease related to HPV infection, refining and optimizing market services, and helping to achieve the Global Strategy to Accelerate the Elimination of Cervical Cancer," Zhifei Biotech replied in the investor communication minutes disclosed in March. ”
Since 2022, Merck has made many big moves, first expanding the age from women aged 16 to 26 to women aged 9 to 45, and then the second dose vaccination program for women aged 9 to 14 was approved. Consolidating its competitive advantage by reducing the number of vaccinations is Merck's "disguised price reduction" strategy, and it is understandable that Zhifei is the direct "victim" in this strategy.
Regarding the previous addition of the second dose vaccination program for 9-14 year olds in Jiada Xiu 9, investors also asked about the impact of Zhifei Biotech.
In this regard, the company said, "For women aged 9-14 years, the two-dose vaccination program of the 9-valent HPV vaccine simplifies the vaccination process and releases more vaccine resources, which will further promote the increase of the vaccination rate of young age women in mainland China, contribute to further reducing the burden of disease, and help accelerate the elimination of cervical cancer in China." The company will work hand in hand with Merck & Co., Ltd. to continuously improve people's awareness of infectious disease prevention and vaccination willingness, so that high-quality vaccine products can truly benefit more people in China. ”
In the competition for the nine-valent HPV vaccine market, Zhifei Biotech was the first to be injured, and in the face of Merck's "blockade", it is not easy for local players represented by Wantai Biotech to take food from their mouths, and a "vicious battle" is brewing.
(This article was first published in Titanium Media App Author丨Yang Yaru Editor丨Sun Cheng)