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On October 27, the opening stock price of vaccine giant Zhifei Biologics fell rapidly, falling by more than 17%
at one point.
As of midday, Zhifei Biotech's share price closed at 82.
49 yuan per share, down 14.
61%.
What happened?
What happened?On October 26, the State Food and Drug Administration issued the "Clinical Technical Guidelines for Human Papillomavirus Vaccines (Draft for Comments)", which is based on the background of the research and development of domestic human papillomavirus (HPV) vaccines in full swing and the approval of multiple HPV vaccines for clinical trials, aiming to improve and solve the problems of long research and development cycle and high research and development costs of HPV vaccines, and to guide vaccine companies to standardize research and development and accelerate the launch
of related products.
From the perspective of market investors, the notice may imply the meaning
of "encouraging domestic substitution, encouraging more manufacturers to accelerate the listing process and consolidate supply".
At present, the HPV vaccines approved in China are divided into 2-valent, 4-valent and 9-valent, of which 2 domestic enterprise products of bivalent HPV vaccines have been approved, namely Wantai Biologics (2019) and Watson Biologics (2022), and the substitution effect on imported vaccines since its listing is very obvious, increasing from 16% of the market share in 2020 to 65%
in 2021.
On the other hand, the 4-valent and 9-valent vaccines are firmly occupied by the importer Merck (exclusively approved), and the operating income of Zhifei Biologics (Merck 9-valent HPV domestic exclusive agent) agent products (HPV vaccine-related) will be 20.
93 billion yuan in 2021, a year-on-year increase of 49.
9%.
At present, the 4-valent HPV vaccine is in clinical phase III of the company, Shanghai Bowei Biotechnology, and the 9-valent HPV vaccine in clinical phase III companies include Wantai Biotechnology, Bowei Biotechnology, Healthguard, Rico Biotechnology and Watson Biologics (Zerun Biotechnology).
From the perspective of the time of the clinical phase III clinical status of 9-valent HPV, Shanghai Bowei was the earliest (May 2020), followed by Wantai Biotech (August 2020), Healthguard was enrolled in phase III in December 2020, and Watson Biologics (Zerun) is currently in the enrollment stage
.
Shanghai Bowei obviously has a certain time difference advantage over Healthguard and Zerun Biologics, and the new launch of the "Clinical Technical Guidelines for Human Papillomavirus Vaccines (Draft for Comments)" (hereinafter referred to as the "Draft for Comments") may change
.
.
The Draft points out (a few key points):
● Iterative vaccines can be accelerated to a certain extent: Compared with first-generation vaccines, compared with first-generation vaccines, in addition to increasing the coverage of HPV types, clinical trials of iterative vaccines such as production equipment/facilities, production processes, process control, and quality standards that are the same or highly similar to first-generation vaccines in principle can be simplified or accelerated to a certain extent, but if there are major pharmaceutical changes compared with first-generation vaccines, they need to be analyzed
separately 。 (Note: The first generation of vaccines is generally divided into type combinations HPV6/11, HPV16/18, HPV31/33/45/52/58.
)
and other new types
.
）
●
If the protective efficacy test of the previous generation vaccine uses a recognized histopathological endpoint, the iterative vaccine that meets the requirements after evaluation can accept the 12-month PI (roughly understood here as the clearance rate of patients enrolled in continuous HPV virus for 12 months) in advance to shorten the approval time
.
In fact, the market has not been detailed about
the approximate time required for the phase III trial of the nine-valent HPV vaccine.
In 2018, Merck's nine-valent HPV vaccine was launched in China according to the "use of overseas clinical data for clinically urgent drugs" and directly used for registration
in China.
According to the public information of Wantai Biotech, the Phase III clinical trial of Wantai 2-valent vaccine took only three and a half years to obtain high-quality interim effectiveness analysis results, and thus successfully marketed
.
According to 21 New Health interviewing industry insiders: At present, most of the manufacturers in phase III clinical trials are that HPV continuous infection will first lead to low-grade squamous intraepithelial lesions, then advanced to high-grade squamous intraepithelial lesions, and finally may evolve into cervical cancer
.
Because this cycle is too long (more than 10 years), CIN2+ disease becomes a surrogate standard
.
Because the incidence of CIN2+ itself is particularly low, this also leads to "enrollment size" and "clinical site incidence", which will affect the time to
collect enough cases.
Now, iterative vaccines can accept early application for marketing with 12-month PI at the end of virological termination, which means that the time
for domestic manufacturers of the 9-valent HPV vaccine under development will be greatly shortened.
However, according to the content of the guidance, this is not beneficial to all "barefoot" enterprises under research, for the regulatory level, more may prefer the 2-valent HPV vaccine has confirmed the effectiveness and safety of the technology platform, in order to provide fast-track convenience in the 9-valent vaccine under development covering more virus types, such as Wantai Biologics, Watson Biologics
.
In addition, the management of Wantai Biotech also mentioned in the survey: "Phase III will be faster than other domestic manufacturers, because of the experience accumulated by doing bivalent HPV vaccine, and there are sales channels that can contact the clinical end
.
" ”
As far as the current market competition pattern is concerned, the regulator's intention to accelerate the listing of the varieties of enterprises under research is definitely not a good thing for Merck/Zhifei Biologics emotionally, which means that the logic of exclusive business will soon be broken
.
.
Merck/Zhifei Biologics may also feel the oncoming pressure, and have accelerated the coverage of HPV vaccines and the convenience of vaccination trials in China, including the use of two-dose vaccination procedures, the age of vaccination is expanded, and the coverage is covered by the male population
.
Although the current domestic HPV vaccination penetration rate is still not high, and HPV vaccines have been in short supply for a long time, Zhifei can still tell the view
that "in the future, many companies will jointly develop the market to improve penetration and accelerate sales".
But the essential difference is that Zhifei is only the agent of Merck, while self-developed manufacturers such as Wantai Biotechnology and Watson Biotechnology may not be subject to others in terms of capacity allocation, for example, Wantai has prepared 60 million doses of production capacity
.
How will the 9-price HPV market pattern evolve in the future? Worth looking forward to
.
.
