This week, the nine-valent HPV vaccine of Wantai Biological was launched in Shanghai.

The curtain has risen on the competition between Wantai Biological and Merck in the field of nine-valent HPV vaccines. The HPV vaccine is of great significance in preventing diseases such as cervical cancer and saving tens of thousands of lives. At present, only these two enterprises have launched the nine-valent vaccine in China. Previously, Merck had monopolized this market for seven years, taking away the most profitable portion of it.

Now, Merck's agent, Zhifei Biological, has accumulated too much inventory. Wantai Bio has leveraged the price-sensitive market with lower prices. But now the commercial returns of vaccine enterprises are becoming increasingly unclear, especially for those whose products are still in the clinical stage. The problem facing some enterprises is whether the ongoing clinical trials of bivalent and nonavalent HPV vaccines should be halted.
The nine-valent vaccine is in competition

On the morning of December 8th, the domestic nine-valent HPV vaccine was officially launched at Shanghai Medical University Hospital. This vaccine was developed by Wantai Biological and is the world's second nine-valent HPV vaccine. This vaccine is priced at 499 yuan. Women aged 9 to 17 only need two doses throughout the course, while those aged 18 to 45 need three doses.
Cervical cancer in women is usually caused by HPV infection, which is divided into various subtypes. The nine-valent vaccine means it can prevent diseases such as cervical cancer caused by infections of nine types of HPV.

The world's first nine-valent HPV vaccine is from Merck & Co. and was approved for marketing in China in 2018. Before Wantai's nine-valent vaccine was introduced to hospitals, domestic institutions such as Shanghai Medical University Hospital administered Merck's nine-valent vaccine, Gardasil, to consumers.

When Merck's vaccine was first launched in China, it was in high demand for a considerable period of time. For instance, two years ago, the number of people vaccinated at Shanghai Medical University Hospital could reach 2,000 per month. Some women, in an effort to get protection as soon as possible, are not reluctant to travel to Hong Kong to receive the Merck vaccine.

Previously, those who rushed to get the HPV vaccine were either very concerned about their health or had money and were not sensitive to the price. The market for this group of people is the part of imported vaccines that they can get, similar to the tip of a strawberry, the sweetest part. Wang Hao, a relevant person in charge of a vaccine research and development enterprise, told Yicai Global.

Over the past seven years, Merck has monopolized the nine-valent HPV vaccine market in China. At present, the vaccination rates in the four first-tier cities of Beijing, Shanghai, Guangzhou and Shenzhen are already not low, but the number of people vaccinated each month has dropped significantly from the peak. For instance, the number of people vaccinated each month at Shanghai Medical University Hospital has dropped from 2,000 to around 200.
Now that Wantai's nine-valent vaccine has entered the market, how much room is left for it?

The core differences between the Wantai 9-valent vaccine and the Merck 9-valent vaccine are: first, the production technology; second, the vaccination procedure; and third, the price. Zhang Jinyi, a resident physician in the Department of Preventive Health Care at Shanghai Medical University Hospital, told Yicai Global.

Wantai adopts the prokaryotic expression virus-like particle technology of Escherichia coli, which has a lower production cost and more stable production capacity. During the early clinical trial stage, five clinical trials of the domestically produced 9-valent product have been conducted in China, involving approximately 11,000 Chinese women. Most of the observed adverse events were mild to moderate and could resolve on their own in the short term. The imported Merck nine-valent vaccine has been on the global market for a longer time and has accumulated more long-term real-world protection data. Merck's two-dose vaccine is limited to women aged 9 to 14, while the domestic two-dose vaccine is suitable for women aged 9 to 17.

Zhang Jinyi said that at the special needs outpatient department of Shanghai Medical University Hospital, the current price of the full set (three doses) of the Wantai 9-valent vaccine is only about 40% of that of the full set of Merck. She believes that after the launch of the Wantai 9-valent vaccine, the lower price will encourage more women to get vaccinated. For instance, Merck's current participation in various HPV vaccination benefit projects across the country has significantly boosted the number of appointments for vaccination.

Price is indeed a factor that many people need to consider. Zhang Jinyi said that, for instance, women aged 15 to 17 used to need three doses of vaccines, but now domestic vaccines only require two doses. The price she needs to pay has dropped from the original 4,000 yuan to around 1,000 yuan now, saving her 3,000 yuan. Many parents who originally thought it was too expensive might consider it. So I think the launch of domestic vaccines is quite good. On the one hand, it has promoted the price reduction of imported vaccines. On the other hand, it can increase the vaccination rate of cervical cancer vaccines among the population and effectively reduce the incidence of cervical cancer in our country.

According to Wang Hao's observation, the vaccination rate among women aged 9 to 45 in Shanghai is approximately between 39% and 40%, and "there are still about 5 million eligible women in the existing market."
Since its approval this year, Wantai Biological's nine-valent vaccine has been distributed to most provinces across the country. Overall, however, it is currently in the stage of ramping up its shipment volume, and the Merck vaccine will remain the main force in the market for the time being.
Where will the enterprises under research go

There are already concerns about oversupply in the HPV vaccine market in China.

In the first quarter of 2025, Merck's nine-valent HPV vaccine was approved for release in 15 batches, a year-on-year decline of 38%. During the same period, Merck's quadrivalent HPV vaccine was not released in batches.

The Merck 9-valent vaccine is represented by the domestic enterprise Zhifei Biological. As the Wantai 9-valent vaccine was launched on the market, it participated in various local public welfare projects and achieved price reductions.

Wang Hao believes that Merck's participation in the preferential reduction of its nine-valent vaccine is mainly not to counter Wantai Biological, but to clear its inventory as soon as possible.

"At present, Zhifei should still have an inventory of about 10 to 20 billion yuan. They are under tremendous pressure." " Wang Hao said.

It is not only Zhifei Biological and Wantai Biological, which hold the nine-valent vaccine, that are under pressure. Vaccine manufacturer Walvax Bio has launched a 2-valent HPV vaccine on the market.

In August 2022, the age range for Merck's 9-valent vaccine was expanded from the original 16 to 26 years old to 9 to 45 years old. This dealt a heavy blow to enterprises like Watson Bio.

In 2024, Walvax Bio's sales revenue declined compared to the same period of the previous year, and its net profit attributable to shareholders of the listed company was 142 million yuan, a year-on-year drop of 60%. One core reason is that the overall winning bid price of the company's bivalent HPV vaccine has dropped, and the willingness to self-pay for vaccination has decreased. As a result, the sales of this product in the self-paid market have continued to be under pressure.

In its interim report for 2025, Walvax Bio disclosed that the competitive environment of the HPV vaccine market has changed. Walvax Bio entrusted Shanghai Lixin to conduct impairment tests on the intangible assets and development expenditures related to HPV vaccines held by the company, and to make impairment provisions for the company's inventories, receivables, intangible assets and other assets. Among them, a provision for impairment of intangible assets of 76.29 million yuan was made for the bivalent HPV vaccine.
The future of the nine-valent HPV vaccine, which is being developed by several enterprises, remains uncertain.

As of the end of June 2025, Walvax Bio's nine-valent HPV vaccine is in the Phase III clinical trial stage. Recombinant Biologics' nine-valent HPV candidate vaccine is currently in the Phase III clinical trial stage. Wang Hao estimates that even the most optimistic Kanglue Weishi will take two to three years for its nine-valent vaccine to be available on the market.

Rico has established production capacity and completed the construction of an HPV vaccine production base in Taizhou City, Jiangsu Province, which meets the pre-certification standards of the World Health Organization. The designed production capacity is 20 million doses of the nine-valent HPV vaccine per year. The HPV vaccine base is currently in the trial production stage.

However, according to the performance commitment previously made by Recombinant Biologics, its HPV vaccine should be approved for marketing by December 31, 2026, and no later than June 30, 2027. This means that it will still be at least a year before its vaccine is available on the market.

The nine-valent vaccine still has room for growth in the market. But it's definitely impossible to return to the situation where a needle was hard to come by and everyone was frantically scrambling for it. Wang Hao said.

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