Our reporters Zhang Yue and Cao Xueping report from Beijing
With the market's interest in Beijing Wantai Biopharmaceutical Co., Ltd. (603392. SH, hereinafter referred to as "Wantai Bio") nine-valent HPV vaccine approval progress, recently, Wantai Bio's share price has shown an upward trend, and the company issued an announcement on abnormal fluctuations in stock trading.
According to the announcement, the stock price of Wantai Biotech has increased by 60% for 8 consecutive trading days from December 15 to 26, 2023. On January 2, 2024, Wantai Biotech rose 2.82% again, and as of press time, Wantai Biotech has a market value of more than 90 billion yuan.
The R&D speed of Wantai Bio's 9-valent HPV vaccine is ahead of domestic vaccines, and it is not difficult to see from the investor interactive platform that the market is concerned about the progress of the approval of the 9-valent HPV vaccine. Recently, Wantai Biotech has repeatedly replied to questions about the nine-valent HPV vaccine. There are also some investors in the market who believe that the launch time of Wantai Biotech's nine-valent HPV vaccine is expected to be advanced.
On January 3, 2024, the staff of Wantai Biology told the reporter that the relevant content can refer to the company's announcement, and the company will announce it in a timely manner if there is any latest development.
It is expected to be approved ahead of schedule
In July 2023, the Center for Drug Evaluation of the State Food and Drug Administration issued a notice on the "Technical Guidelines for Clinical Trials of Human Papillomavirus Vaccines (Trial)" (hereinafter referred to as the "Guiding Principles"). According to the Guiding Principles, according to the existence of an HPV vaccine R&D platform, it can be roughly divided into first-generation vaccines and iterative vaccines. To encourage the development of HPV vaccines, iterative vaccines can simplify or accelerate clinical trials to a certain extent.
In addition, considering that the incidence of cervical cancer and other diseases caused by new types may be further reduced, and that PI (high-risk persistent infection) is the mechanism of pathogenesis and progression leading to histopathological changes, if the previous generation vaccine completes the protective efficacy trial with a recognized histopathological endpoint, the protective efficacy of the previous generation vaccine is assessed to meet the marketing requirements, and the trial vaccine is indeed an iterative vaccine after pharmaceutical evaluation, the virologic endpoint of 12 months is acceptable PI (PI12) was declared for marketing to shorten the time for iterative vaccines to be approved and marketed.
In November 2023, Wantai Biotech replied to investors that according to the design of the plan, V8 will be visited once every six months, and V9-V12 will be visited every 12 months. In accordance with the "Guiding Principles", the company's 9-valent HPV vaccine, as an iterative vaccine, can be conditionally applied for marketing for 12 months of persistent infection, and the new guidelines have a stricter definition of persistent infection.
According to Wantai Bio's reply on the investor interactive platform in December, the on-site work of the V8 visit of the phase III main clinical trial of the company's nine-valent HPV vaccine has been completed, and specimen testing is underway.
This is also believed by some market investors that the approval time of Wantai Bio's nine-valent HPV vaccine may be advanced.
On December 20, 2023, in response to the question of "how is the progress of the nine-valent HPV vaccine production line under construction by our company and whether it is expected to be put into production ahead of schedule", Wantai Biology said that the nine-valent HPV vaccine production line will build 6 drug substance production lines in two phases, with a design capacity of 60 million per year, and the construction of 2 drug substance production lines in the first phase has been completed.
R&D Race
The vaccines developed, produced and sold by Wantai Biotech mainly include hepatitis E vaccine, bivalent HPV vaccine and nasal spray vaccine, and the pipeline under development includes 9-valent HPV vaccine, 20-valent pneumonia vaccine, recombinant herpes zoster virus vaccine, etc. According to the 2023 semi-annual report, during the reporting period, the company's sales of bivalent HPV vaccines exceeded 10 million.
In terms of bivalent HPV vaccines, Wantai Biotech is also facing strong competition from Walvax Biotech (300142.SZ) in HPV vaccine procurement projects in many provinces. According to Wantai Bio's third quarterly report, the company's revenue in the first three quarters of 2023 has declined sharply compared with the same period last year. Revenue in the third quarter decreased by 70.4% year-on-year, mainly due to a significant decline in sales revenue of bivalent cervical cancer vaccine and new crown-related products.
At present, the 9-valent HPV vaccine manufacturer approved in the domestic market is Merck & Co., Ltd., which is represented by Zhifei Biotech (300122.SZ). In August 2022, with the approval of the State Food and Drug Administration, the applicable population of the 9-valent HPV vaccine was expanded from women aged 16-26 to women aged 9-45. According to Zhifei's 2023 semi-annual report, in the first half of 2023, 14.678 million copies of Merck's 9-valent HPV vaccine were issued, an increase of 57.85% from 9.299 million in the same period in 2022.
The nine-valent HPV vaccine is also considered by the market to bring new performance increments to Wantai Biotech. Huatai Securities' previous research report shows that the nine-valent vaccine is where the competition of the enterprise lies, and the current first echelon is Wantai Biological, Shanghai Zerun, Shanghai Bowei, and Kangle Guard, which is expected to be listed from 2025 to 2027, and the second echelon is Jiangsu Ruike and Zhonghui Yuantong. Some companies are accelerating the development of higher-priced vaccines to achieve higher coverage of virus typing.
Wantai Biotech also made a number of reminders on the approval time of the nine-valent HPV vaccine in a recent announcement. The current risks include, but are not limited to, the following points: first, there are many types of specimen testing at the V8 visit and the testing process is complex, and the quality control of the data needs to be carried out after the testing is completed, and the specific time needs to be determined according to the progress of each link; after the statistics of the specimen testing data of the V8 visit are completed, the persistent infection cases found are insufficient to meet the requirements of the number of clinical endpoint cases, and the cases need to be collected at the next visit; the above situation may lead to a delay in the end of the phase III clinical trial of the 9-valent HPV vaccine. Second, the commercial process verification is underway, due to the large number of product types and complex processes, the product quality characteristics and stability studies that need to be carried out are subject to high schedule risks, which may lead to the delay of the time for commercial production. Third, after the product is submitted for approval, according to the feedback from the State Food and Drug Administration, there may be unpredictable procedures for issuing and replying, resulting in a longer time for registration approval. All of these scenarios can lead to delays in bringing products to market.
(Editor: Cao Xueping Proofreader: Yan Jingning)