HPV vaccine jianghu "dark war": domestic imports who is the market winner?

The nine-valent HPV vaccine is expected to no longer be "hard to find". Merck China recently disclosed that it will significantly increase its vaccine supply in 2022.

At the same time, industry news shows that Merck's nine-valent vaccine is expected to be approved for new indications this year, further broadening the vaccination age from the original 16-26 years old to 9-15 years old.

Photo by Huang Jinhui

There is a shortage of the nine-valent HPV vaccine

According to merck's official website, by the end of 2021, Merck quadrivalent and nine-valent HPV vaccines have reached 16.5 million Chinese women of appropriate age.

However, since the nine-valent vaccine was launched, it has been in short supply. In the hot reviews about HPV vaccination, the anxiety of "not getting a nine-valent vaccine by appointment" is everywhere. It even spawned a nine-valent vaccine intermediary "scalper" to make high profits from it.

According to the latest 2021 research report of the International Agency for Research on Cancer (IARC), there will be about 110,000 new cases of cervical cancer in China in 2020, and the incidence of cervical cancer in women aged 15-44 ranks third, accounting for about 1/3 of Asia. Cervical cancer is currently the only cancer with a clear etiology, and almost all cervical cancers have been linked to HPV infection. Therefore, improving the coverage of HPV vaccines and timely screening for cervical cancer among relevant populations to effectively treat precancerous lesions is expected to achieve the goal of eliminating cervical cancer in the future.

According to the data of the China Commercial Industry Research Institute, according to the data of the China Institute of Food and Drug Control, since the HPV vaccine was listed in China, the cumulative batch issuance volume reached 27.3228 million, combined with the vaccination dose, the cumulative number of vaccinations was about 9.74 million people. Estimates show that there are still 320 million people in the domestic stock demand gap.

The nine-valent vaccine was approved for conditional import registration on April 28, 2018, and the batch issuance volume for that year was 1.216 million. By 2020, the number of nine-valent vaccine batches will reach 5.066 million. However, the industry believes that this number is only a "drop in the bucket" compared to Chinese women of school age.

Domestic vaccines have conquered the free vaccination market

For the Merck announcement to significantly increase the supply of vaccines, the industry believes that it is related to the free HPV vaccination program in many cities.

In September 2021, the pilot work of the Healthy China Action Innovation Model was launched, with 15 cities (districts) across the country as the first batch of pilot cities for the Healthy China Action Innovation Model, and 15 cities (districts) as candidate pilot cities. This pilot work will comprehensively promote the implementation of the comprehensive prevention and control strategy of cervical cancer in the pilot areas, realize the integration and overall implementation of primary, secondary and tertiary prevention, improve the efficiency of resource use, and strive to achieve in the permanent population of the pilot area: the HPV vaccination coverage rate of girls before the age of 15 has reached more than 90%, the proportion of women aged 35-45 receiving cervical cancer screening has reached more than 70%, and the standardized treatment rate of cervical cancer and precancerous patients has reached more than 90%. And finally take the lead in achieving the elimination goal of cervical cancer incidence of less than 4/100,000.

According to public information, at present, Chengdu in Sichuan, Xi'an in Shaanxi, Wuxi in Jiangsu, Jinan in Shandong, Ordos in Inner Mongolia, Shenzhen in Guangdong, Xiamen in Fujian, Zhengzhou in Henan and Chongqing in The pilot cities of the Healthy China Innovation Model have successively laid out cervical cancer prevention and treatment, and one of the important tasks is to promote the universal vaccination of HPV vaccine among local adolescent girls of appropriate age. In addition, jiangsu Lianyungang, Guangdong Guangzhou and Zhuhai among the candidate pilot cities have also launched free or subsidized HPV vaccination programs.

Many cities are vaccinating girls of appropriate age against HPV vaccines. For example, according to the "Guangdong Provincial Implementation Plan for Free HPV Vaccination for School-age Girls (2022-2024)", in September this year, girls under the age of 14 who have a school registration in Guangdong Province, who have entered the first grade of junior high school from September 2022 and have not been vaccinated with HPV, will receive free HPV vaccination. According to statistics, the free vaccination population is estimated to be about 1 million, and the vaccines used in the project are all domestic bivalent HPV vaccines, and the municipalities entrust the provincial CDC to sign a procurement contract with the transaction supplier after the procurement negotiation, and distribute the vaccine to the vaccination points in each jurisdiction step by step.

At present, there are three HPV vaccines that have been approved for marketing in the world: bivalent, quadrivalent and nine-valent. Bivalent vaccines target two high-risk types of HPV16 and 18 infections that can cause cervical cancer, quadrivalent vaccines cover two low-risk types of HPV6 and 11, and the nine-valent HPV vaccine is currently the vaccine with the most HPV coverage on the market.

At present, there are the earliest approved GlaxoSmithKline divalent HPV vaccine, Merck's quadrivalent and nine-valent vaccines, and Wantai Bio's domestic bivalent vaccine.

The previous information shows that most of the free HPV vaccines in various places purchase domestic bivalent vaccines. According to the third quarter report of Wantai Biotech in 2021, the operating income during the reporting period reached 3.596 billion yuan and the net profit was 1.188 billion yuan, and the revenue and net profit have exceeded the level of the whole year of 2020.

For which HPV vaccine to receive, the medical community has always advocated "early vaccination and early benefit" and "whoever is vaccinated benefits". The nine-valent vaccine was previously favored because it covered the most HPV types, but the supply could not meet the market demand, which also made some experts call for "no need to wait".

In addition, domestic high-priced HPV vaccines are also stepping up research and development. At present, the nine-valent HPV vaccine of 4 companies, including Connaught Guardian, Wantai Biology, Bowei Biology and Ruike Biology, has entered the phase 3 clinical stage. According to the analysis of the China Commercial Industry Research Institute, the continuous research and development of domestic HPV vaccines in the future is expected to break the international monopoly and open up a new vaccine development technology system.

[Reporter] Yan Huifang

【Author】 Yan Huifang

Healthy living circle