news

한어Русский языкEnglishFrançaisIndonesianSanskrit日本語DeutschPortuguêsΕλληνικάespañolItalianoSuomalainenLatina

Competition for domestic HPV vaccines is heating up. Wantai Biotech (603392) has just announced that the company's nine-valent HPV vaccine is planned to be included in the priority review process. Kangleweishi (833575) followed closely and announced the unblinding of the Phase III clinical trial of the trivalent HPV vaccine. If it is successfully launched on the market, it will also become the first domestic trivalent HPV vaccine product. Kangleweishi said that the positive progress made in the trivalent HPV vaccine is also expected to accelerate the launch of the company's nine-valent HPV vaccine under development. In the view of industry insiders, competition in the domestic HPV vaccine market will further intensify. In addition to Wantai Biotech and Kangleweishi, many companies such as Ruike Biotech and Shanghai Bowei are also conducting research and development of nine-valent HPV vaccines. It is worth looking forward to which company can "take the lead" and be the first to launch the domestic nine-valent HPV vaccine.

Wantai Bio is in the forefront

Wantai Biopharma's research and development of the nine-valent HPV vaccine is progressing relatively fast. The company's latest announcement shows that the "recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 nine-valent vaccine (Escherichia coli)" (i.e., "nine-valent HPV vaccine") developed by the company's wholly-owned subsidiary Xiamen Wantai Canghai Biotechnology Co., Ltd. in cooperation with Xiamen University has been included in the list of priority review varieties by the Center for Drug Evaluation of the National Medical Products Administration, with a public announcement period of 7 days.

Economist and new finance expert Yu Fenghui said that the priority review procedure is a mechanism to speed up the review process, which means that the approval process of related vaccines will be accelerated and the time to market is expected to be shortened. This progress means that the domestically produced nine-valent HPV vaccine is getting closer to market.

Wantai Biotech pointed out that there is uncertainty about whether the company's nine-valent HPV vaccine will be included in the priority review and approval process. If it cannot be included, the approval of the marketing registration application must be completed according to the normal review cycle. The nine-valent HPV vaccine will take a relatively long time from submitting a marketing authorization application to being approved for marketing, and will not have a significant impact on the company's financial status and operating performance in the short term.

Investors are paying close attention to the development progress of Wantai Biological's nine-valent HPV vaccine, as this product is seen as the driving force for Wantai Biological's future performance recovery.

The company's 2024 semi-annual performance forecast shows that during the reporting period, the company's attributable net profit is expected to be 240 million to 290 million yuan, a year-on-year decrease of 85.9% to 82.96%.

Wantai Bio said that during the reporting period, the main product of the vaccine segment, the bivalent HPV vaccine, continued to be affected by factors such as the expansion of the age of the nine-valent HPV vaccine, market competition, and inventory reduction, and sales revenue and profits fell compared with the same period last year. In response to company-related issues, a Beijing Business Daily reporter sent an interview letter to Wantai Bio, but as of press time, the reporter had not received a reply from the company.

The blinding of the trivalent HPV vaccine of Kangleweishi was unveiled

Just the day after Wantai Biological disclosed this latest progress, Kangliweisheng announced that the company's independently developed trivalent HPV vaccine Phase III clinical trial had completed the unblinding of the interim analysis, the main efficacy indicators and safety assessments.

Kang Le Wei Shi said that the interim analysis results of the company's trivalent HPV vaccine Phase III clinical trial were in line with expectations, marking a major progress in the clinical research of the trivalent HPV vaccine and laying the foundation for submitting a biologics marketing application (BLA).

A relevant person in charge of Kangleweishi told the Beijing Business Daily reporter that the trivalent HPV vaccine developed by the company is mainly used to prevent precancerous lesions and cervical cancer caused by persistent infection of HPV16/18/58. Compared with the currently available bivalent or quadrivalent HPV vaccines, the trivalent HPV vaccine will increase the protection of cervical cancer in women in East Asia from 70% to 78%.

The positive progress of the trivalent HPV vaccine is also expected to accelerate the launch of the nine-valent HPV vaccine under development by Kanglewei. According to the "Technical Guidelines for Clinical Trials of Human Papillomavirus Vaccines (Trial)" issued by the Center for Drug Evaluation of the National Medical Products Administration in July 2023, if the first-generation HPV vaccine independently developed by the company uses a recognized histopathological endpoint (CIN2+) to complete the protective efficacy test, and is evaluated to meet the requirements for listing, and the trial vaccine is confirmed to be an iterative vaccine after pharmaceutical evaluation, it can be accepted to apply for listing in advance based on the virological endpoint of 12-month persistent infection (PI12) to shorten the time it takes for iterative HPV vaccines to be approved for listing.

A relevant person in charge of Kangle Guard said that the company's trivalent HPV vaccine is expected to submit BLA this year, and the nine-valent HPV vaccine is expected to submit BLA in 2025.

It is worth mentioning that if the trivalent HPV vaccine of Kangle Guard is successfully launched, it will become the first commercial product of Kangle Guard. In this context, Kangle Guard has not yet achieved profitability. From 2021 to 2023, the operating income of Kangle Guard will be approximately RMB 274,800, RMB 1.901 million, and RMB 1.78 million respectively; the corresponding attributable net profits will be approximately RMB -380 million, RMB -293 million, and RMB -301 million respectively.

Intensified market competition

In addition to Wantai Biological and Kangleweisheng, Watson Biological, Shanghai Bowei, Ruiko Biological and Yida Biological are all developing nine-valent HPV vaccines.

Currently, Merck is still the only manufacturer in the field of nine-valent HPV vaccines. In recent years, Merck's nine-valent HPV vaccine has experienced an expansion of the age range and a reduction in the number of vaccination doses. On August 30, 2022, the new indication of Merck's nine-valent HPV vaccine was approved by the National Medical Products Administration, and the age range of the applicable population was expanded from 16-26 years old to 9-45 years old. On January 9 this year, Merck announced that its nine-valent HPV vaccine has been approved for a two-dose vaccination program for girls aged 9-14 in China.

According to industry insiders, as various companies have made new progress in the research and development of the nine-valent HPV vaccine, the nine-valent HPV vaccine will become the "main battlefield" of this industry in the future. If related companies want to maintain their advantages in market competition, it depends on who can take the lead in seizing the market for high-priced vaccines.

Zhao Heng, founder of Latitude Health, a medical strategic consulting company, said in an interview with Beijing Business Daily that once the nine-valent HPV vaccine is launched, a price war is inevitable, and because foreign manufacturers have a clear advantage in the nine-valent HPV vaccine market in the early stage, domestic companies will inevitably rely on price to win. The price of low-priced vaccines will continue to fall, and they may gradually withdraw from the market.

The relevant person in charge of Kangle Guard believes that low-priced and high-priced HPV vaccines will coexist for a long time in the future, and both are designed to meet different market demands.

In addition, Kangleweishi has set its sights on the international market. "Future competition will still be international and global. Although there are not many companies in China that are making HPV vaccines, their production capacity is huge, and the entire Chinese market may not be able to fully absorb them. In the future, these companies must go global, which is one of the future development directions for HPV vaccine research and development companies." said the above person in charge.

Yu Fenghui said that from the perspective of market demand, the HPV vaccine market has broad prospects. With the improvement of people's health awareness and the promotion of vaccination policies, the demand for HPV vaccines will continue to grow. However, competition will also become more intense. As market competition intensifies, relevant vaccine companies need to strengthen research and development, brand building and marketing to meet challenges and seize market opportunities.

Beijing Business Daily reporter Ding Ning