Our reporter Xie Lan

　　Trainee reporter Li Rushi

　　According to the batch issuance data disclosed by the China National Institute for Food and Drug Control (hereinafter referred to as the "CIQ"), as of July 13, a total of 153 domestic bivalent HPV vaccines have been approved and issued.

Among them, Wantai Bio has been issued in 147 batches (163 in the whole year of 2021); Watson Bio's bivalent HPV vaccine was launched in May this year and has been issued in 6 batches.

In addition, Zhifei Biological Agency's imported nine-valent HPV vaccine has been issued in 40 batches (41 times in total in 2021).

Since the beginning of this year, the number of HPV vaccine batches has increased significantly.

　　Deng Zhidong, general manager of Hainan Boao Medical Technology Co., Ltd., told the "Securities Daily" reporter: "Policy promotion, the improvement of residents' health awareness, and the continuous acceleration of HPV vaccine research and development have become important factors driving the rapid growth of the HPV vaccine market." The half-year performance forecast also reflects the contribution of the HPV vaccine to performance.

　　Domestic bivalent HPV vaccine

　　Booming supply and demand

　　From the supply side, the number of batches of bivalent HPV vaccines has grown significantly.

According to the Huaan Securities Research Report, the number of batches of bivalent HPV vaccines in the first half of this year increased by more than 200% year-on-year.

It is worth noting that the domestic bivalent HPV vaccines of Wantai Bio and Watson Bio have been approved for marketing, with a total of 153 approvals and issuances.

　　As of July this year, the number of batches of the bivalent HPV vaccine produced by Wantai Bio has approached the total number of last year.

At the same time, Wantai Bio released a performance pre-increase announcement on July 12, saying that it is expected to achieve a net profit of 2.5 billion to 2.750 billion yuan in the first half of this year, a year-on-year increase of 246% to 281%.

The company's bivalent cervical cancer vaccine continued to maintain a boom in production and sales, with rapid growth in revenue and profit.

　　On June 28, the bivalent HPV vaccine (hereinafter referred to as "Wozhui") produced by Watson Bio was officially launched in Yunnan Province.

On the same day, five districts in Kunming (Chenggong District, Wuhua District, Xishan District, Panlong District, Guandu District), as well as Yuxi City, Qujing City, and Maitreya City successively launched the first batch of domestic bivalent cervical cancer vaccine vaccinations in Yunnan Province. .

　　Jiang Runsheng, President of Watson Bio, said: "Wozhui can produce up to 30 million doses per year, which will contribute to the elimination of cervical cancer in my country and the world. At present, the vaccine has been used in Guangdong, Guangxi, Shandong, Yunnan, Anhui, Heilongjiang, Shanxi and Jiangxi. Other places to achieve recruitment standards." Watson Bio said that the company's bivalent HPV vaccine may enter a period of high volume in the second half of this year and in 2023, becoming a new profit growth point for the company.

　　According to the data from the China Inspection and Quarantine Institute, Watson Bio obtained the first batch of bivalent HPV vaccine (batches from May 16 to 22, 2022) in May this year, and rapidly increased to 6 batches within 2 months.

　　From the demand side, “Although the batch issuance volume is not equal to the actual vaccine sales volume, from the HPV vaccine reservation situation, the demand for vaccination is indeed increasing. At present, my country is committed to improving the HPV vaccine for women before the age of 15 years old. Vaccination coverage rate. During the summer vacation, the number of HPV vaccination appointments will increase significantly." Deng Zhidong said.

　　According to the analysis of Guolian Securities Research Report, Neutral estimates that the total demand in the stock market is 268 million pieces.

Assuming that women aged 9 to 15 are vaccinated with bivalent HPV vaccine, two doses per person, based on a penetration rate of 70%, 68 million doses are required; women aged 16 to 26 and 26 to 45 years old are 40% and 20% respectively According to the penetration rate calculation, there are three needles per person, and the estimated demand is 200 million.

At present, domestic HPV vaccine production capacity cannot meet this demand.

　　Since the nine-valent HPV vaccine is mainly aimed at women between the ages of 16 and 26, the age limit for vaccination is strict, and the domestic supply is limited, some women tend to choose the bivalent HPV vaccine, which is also the reason for the increase in the demand for the bivalent HPV vaccine. one.

　　Ding Zhengrong, chief expert of the Yunnan Provincial Immunization Program, said: "Existing evidence shows that from the perspective of public health, the efficacy of bivalent, quadrivalent and 9valent vaccines in immunogenicity, prevention of HPV16/18-related cervical cancer and The effects are basically the same. Under the current tight supply of HPV vaccines, local vaccines should be vaccinated as soon as possible to avoid missing the best vaccination time due to waiting for higher-priced vaccines.”

　　Domestic nine-valent HPV vaccine

　　R&D in progress

　　From the price point of view, the price of the bivalent HPV vaccine produced by Watson Bio and Wantai Bio is 356 yuan/injection, and a total of three injections are required; the price of the nine-valent HPV vaccine (import) is 1325 yuan/injection, and a total of three injections are required. Needle.

However, there is only Merck & Co. of the United States as the world's nine-valent HPV vaccine manufacturer, which has resulted in a high vaccine price and a shortage of supply, which also means that new entrants can obtain greater profit margins.

　　The number of batches of Merck's nine-valent HPV vaccine, represented by Zhifei Biological, has also increased significantly.

In the first quarter of this year, the number of batches of nine-valent HPV vaccines issued by the company reached 4.83 million, an increase of nearly 280%.

Driven by the strong market demand for the nine-valent HPV vaccine, the relevant research and development process of vaccine companies has accelerated.

　　The relevant person in charge of Watson Bio told the "Securities Daily" reporter: "The nine-valent HPV vaccine of the subsidiary Shanghai Zerun is currently undergoing preparations for Phase III clinical trials."

　　Wantai Biology stated on the interactive platform on July 7 that the clinical trial of the nine-valent HPV vaccine has completed three injections and is undergoing follow-up.

It is estimated that the entire phase III clinical trial cycle is about 66 months to 78 months.

　　In addition to the two A-share listed companies, the nine-valent HPV vaccine of the New Third Board-listed company Recreation Guard, the Hong Kong Stock Exchange-listed company Ruike Bio, and Shanghai Bowei Biotechnology Co., Ltd. have also entered the clinical phase III stage.

Among them, the HPV vaccine production workshop of Recreation Guard has been located in Yunnan Central New Area, and its 2021 annual report shows that the company's nine-valent HPV vaccine will complete the enrollment of phase III clinical trial subjects in September 2021, and it is planned to be 2 to 4 years. Completion of Phase III clinical trials of the vaccine.

　　Ruike Bio's 2021 annual report shows that the company has completed the recruitment of subjects for the nine-valent HPV vaccine product, and completed the three-injection administration as planned in the first half of this year, and will submit a marketing authorization application to the State Food and Drug Administration in 2025.

　　The first domestic nine-valent HPV vaccine "R&D war" is underway, or it may enter the harvest period after 2026.

(Securities Daily)