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"Science and Technology Innovation Board Daily" August 6th (Special Correspondent Gao Qing Reporter Xu Hong) The domestically produced nine-valent HPV vaccine, which has long been favored, has not yet been released, and its prospects are shrouded in a cloud.

Recently, Merck released its financial report for the first half of 2024, showing that its HPV vaccine product Gardasil (GARDASIL/GARDASIL 9) had sales of $2.478 billion in the second quarter, a year-on-year increase of only 1%. This is undoubtedly a figure that surprised the market, almost stagnant growth.

"Merck's decline is not an isolated case. The entire Chinese HPV vaccine market is in a decline." In response, Robert M. Davis, Chairman and CEO of Merck, said in a subsequent conference call.

But this obviously cannot eliminate market concerns: If the market for the nine-valent HPV vaccine continues to develop according to the current trend and the quantity can no longer be "increased", how should those vaccine companies that are still queuing up for listing, and the domestically produced nine-valent HPV vaccine "rising stars" that are waiting in the pipeline to be shipped out, face this embarrassing market situation?

When the Tide Goes Out

So far, there are different types of HPV vaccines available in the market, such as bivalent, quadrivalent, and nonavalent vaccines for consumers to choose from. However, some studies believe that in the future, the Chinese HPV vaccine market will still be dominated by nine-valent vaccines. Among domestic companies, the vast majority have already focused their research and development on nine-valent vaccines or even higher-valent HPV vaccines.

Vaccine expert Tao Lina told the reporter of "Science and Technology Innovation Board Daily" that for a long time in the past, the domestic nine-valent HPV vaccine has been a "net celebrity vaccine" and has been in short supply. As a result, some women who have both the ability to pay and the willingness to be vaccinated have to go to Hong Kong, Singapore and other places for vaccination, or find scalpers to buy it at a higher price.

but,In recent years, Merck has been increasing its supply to the domestic market., especially in 2023, the nine-valent HPV vaccine has seen significant growth in volume. In Tao Lina's view, "the number of consumers for the nine-valent HPV vaccine was originally relatively limited, and now that it is basically covered, the growth rate has naturally slowed down."

This change can also be seen intuitively from some market performance. The annual summer vacation has always been the peak period for HPV vaccination, but compared with the previous "hard to get a shot", during this summer vacation, "no appointment required" and "inoculation upon arrival" have become the norm, and even in some community hospitals and health service stations, the nine-valent HPV vaccine shows "sufficient surplus".

After checking policies in many places, the reporter found that many provinces, municipalities and autonomous regions across the country, including Hunan, Shaanxi, Chongqing, Guangdong, Beijing, Zhejiang, Shanghai, Henan and Inner Mongolia, have recently launched a variety of summer nine-valent HPV vaccination special sessions and green channel free appointment activities. This is very different from people’s previous impression that the nine-valent vaccine is "difficult to get."

Afterwards, the reporter visited a community health service center in Huangpu District, Shanghai. According to the regulations of the service center, this afternoon was the concentrated vaccination time for HPV vaccine.

Ding Jing (pseudonym), who has completed the vaccination and is currently under observation, told the reporter of Science and Technology Innovation Board Daily that he is a "beneficiary" of Merck's nine-valent HPV vaccine expansion and has completed the first shot of the vaccine. "It is indeed easier to make an appointment for vaccination now.In the past, you might have to wait in line for a long time, but now you can get a call without waiting.。”

At the same time, a staff member of the center also confirmed to reporters thatSince the second half of last year, the supply of nine-valent HPV has been sufficient."In the past, we prepared vaccines for 100 people, which is 300 doses, and we might not be able to get so many. But now there is basically no such problem."

It is reported that at this service center, appointments for HPV vaccination can be made every Tuesday and Thursday morning, and Wednesday afternoon.Compared to last year when we had to release 60 or 70 appointments a day, we are now releasing 40 appointments a day, but generally only about 10 people make an appointment."But you can also get vaccinated on Saturday, but you still need to grab a number for Saturday," the staff told reporters.

It is worth mentioning that the reporter visited two community health service centers in the afternoon, one in Huangpu District and the other in Jing'an District in the center of Shanghai, and learned that the two service centersNo bivalent HPV vaccine is providedIn this regard, the staff said that they stocked the goods according to the needs of the surrounding residents.

In the HPV vaccine market, the bivalent HPV vaccine faces greater survival pressure than the nine-valent vaccine. In August 2022, Merck's nine-valent HPV vaccine was expanded from women aged 16-26 to women aged 9 to 45. After that, not only did the sales of domestic bivalent vaccines drop sharply, but the price also intensified the "involution".

On August 2, a bivalent HPV vaccine procurement announcement from the Shandong Provincial Center for Disease Control and Prevention showed that Watson Bio's bivalent HPV vaccine "Wo Ze Hui" won the bid at a price of 27.50 yuan per dose. From more than 300 yuan per dose when it was first launched to less than 30 yuan now, the bivalent HPV vaccine has once again refreshed the price bottom line.

▌How big is the market?

Merck's nine-valent vaccine was launched in China in 2018, and has since entered a five-year period of rapid growth.

Relevant approval data show that from 2018 to 2023, the approval quantities of the nine-valent HPV vaccine were 1.216 million, 3.324 million, 5.066 million, 10.2061 million, 15.4772 million and 36.5508 million respectively, with the growth rate basically above 50%. In 2023, the number of approvals for the nine-valent vaccine increased by 136.16% year-on-year.

The rapidly growing Chinese HPV vaccine market has also brought rich rewards to Merck. According to the financial report, the sales of Merck's quadrivalent and nine-valent HPV vaccines have jumped from US$3.7 billion in 2019 to US$8.9 billion in 2023, heading straight for the US$10 billion mark.60%-70% of them come from the Chinese market。

8.9 billion US dollars is an extremely competitive figure even among the top 20 best-selling drugs in the world.

Robert M. Davis appeared very confident about the Chinese market during the conference call and repeatedly reiterated Merck's goal of achieving sales of HPV-related vaccines exceeding US$11 billion by 2030.

With such a big piece of cake, can domestic HPV vaccine manufacturers get a piece of it?

Judging from the renewal agreement previously signed by Merck and Zhifei Bio, the two parties do not seem to be so optimistic about the growth of the domestic HPV vaccine market. According to the agreement between the two parties, the basic purchase amount of HPV vaccines (including nine-valent and four-valent) from 2024 to 2026 will be 32.626 billion yuan, 26.033 billion yuan, and 17.892 billion yuan, respectively, showing a downward trend year by year.

Judging from the offline vaccination situation, the enthusiasm for the nine-valent HPV vaccine is gradually cooling down from "people waiting for vaccines" to "vaccines waiting for people".

This is not without warning. Although Zhifei Bio's 2024 semi-annual report has not yet been disclosed, it has caused a wave of market discussion in its 2023 annual report due to high receivables and high inventory. The annual report shows that Zhifei Bio's nine-valent HPV vaccine batch issuance volume was 36.5508 million doses that year, while the sales volume of all vaccines was only 27.4906 million doses, and there were 42.096 million doses left in inventory.

The market space left for domestically produced HPV nine-valent vaccines such as Wantai Bio, Watson Bio, and Kanglewei seems to be less optimistic.On the one hand, Merck has expanded its user base and "reduced prices in disguise" by expanding the age range and reducing the number of injections. On the other hand, Merck has made early arrangements for indications for male users, and may gain the upper hand in this field.

Tao Lina said that judging from the progress of various domestic vaccine manufacturers, Wantai Biotech's nine-valent HPV vaccine should be the first to be released. In his opinion, there is no problem with the scientific nature of the HPV vaccines being developed by various companies.However, from a commercial perspective, if the relevant products are launched too late, they may face a "red ocean" market.After all, 3-4 companies are enough in the domestic vaccine market.

As of now, in addition to Wantai Biological, the nine-valent HPV vaccines of companies such as Bowei Bio, Kangleweisheng, Ruiko Bio, and Watson Bio have entered the Phase III clinical trial stage. The 11-valent HPV vaccine developed by Chengdu and the 15-valent HPV vaccine developed by Chengda Bio are also ready to go.

Who will be the survivor in the increasingly fierce HPV market competition?

“If a domestic vaccine becomes available, will it be your choice?”

"I will consider the option, but I hope the company can publish clinical-related data in authoritative journals. I also hope that there will be some retrospective research results after the vaccine is launched on the market that can be used as a reference. When choosing a vaccine, what I value most is safety." In response to a reporter's question, Ding Jing said this, and her answer may also bring some inspiration to the industry.