Wantai Biological's First Domestic 9-Valent HPV Vaccine Nears Market Approval Following Positive Phase III Trial Results

Source: Beijing Business Today

On April 11, influenced by the message that the company's Phase III clinical trial of the nine-valent HPV vaccine had been unblinded with results meeting expectations,WANTAI BioPharmThe opening price surged by the daily limit, reaching 74.16 yuan per share, with a 10% increase. The unblinding results this time met expectations, meaning that the company’s nine-valent HPV vaccine is one step closer to applying for market approval and obtaining authorization. Currently, manufacturers of domestically produced nine-valent HPV vaccines have entered the final sprint stage, according toWalvaxIt was disclosed in March this year that the company's nine-valent HPV vaccine is currently in Phase III clinical trials. The overall data from the head-to-head clinical trials with similar vaccines is still under statistical analysis. Domestic manufacturers are competing to be the first to obtain approval for a domestically produced nine-valent HPV vaccine in China. However, with the imported nine-valent HPV vaccine having already expanded its age range and reduced the number of doses required, regardless of who secures the "first approval," the first domestically produced nine-valent HPV vaccine in China will still face significant challenges.

　　WANTAI BioPharm Unblinding

The first domestically produced nine-valent HPV vaccine in China enters the sprint stage.

According to the announcement, the on-site work for the V8 visit (with a total of 12 visits set) of the Phase III primary clinical trial of the nine-valent HPV vaccine, co-developed by Xiamen Wantai Biological Technology Co., Ltd., a wholly-owned subsidiary of WANTAI BioPharm, and Xiamen University, has been completed. Specimen testing is currently underway. Recently, the company received the preliminary analysis results of the main data from a third-party statistical company, and the main results met expectations.

The unblinding of the trial this time and the results meeting expectations means that WANTAI BioPharm's nine-valent HPV vaccine is a step closer to applying for market approval and obtaining authorization. However, WANTAI BioPharm also mentioned in the announcement that the unblinding data obtained from this clinical trial only includes some of the main results as of the V8 visit. Subsequently, a comprehensive and in-depth analysis must be carried out according to the protocol and statistical analysis plan, and the clinical trial summary report must be completed.

According to incomplete statistics, the manufacturers of domestically produced nine-valent HPV vaccines with relatively rapid R&D progress include WANTAI BioPharm, Walvax, and Bowei BioPharm.KangLeWeiShiRecoBio, whose relevant vaccine products have all entered the Phase III clinical stage.

Walvax Biotechnology Co., Ltd. told Beijing Business Today that the Phase III clinical trial comparing the immunogenicity of Walvax's nine-valent HPV vaccine with similar vaccines is in the data statistical analysis and clinical research report writing stage. Subsequent R&D work will be promoted in an orderly manner according to regulatory requirements and the company’s business plan. For specific progress, please refer to the information disclosed by the company subsequently.

As early as late December 2023, rumors spread that WANTAI BioPharm's nine-valent HPV vaccine would be launched ahead of schedule, sparking a stock market frenzy. In its announcement, WANTAI BioPharm revealed that the company is simultaneously working on drafting the new drug registration application materials and will actively communicate with the drug regulatory authorities regarding the submission. After submitting the new drug registration application, the company must pass technical reviews by national authorities, on-site inspections of clinical trial data, research site inspections, and production site inspections before obtaining the drug registration certificate.

Investor in the pharmaceutical industry, Li Xu, told reporters from the Beijing Business Today that the results currently received for WANTAI BioPharm's nine-valent HPV vaccine are preliminary analyses. It may be necessary to follow up for a period of time before submitting an application for market approval. However, in terms of progress, WANTAI BioPharm is currently the fastest advancing nine-valent HPV vaccine developer in China.

　　MSD Holds the Lead

For a long time, there was only one approved nine-valent HPV vaccine available in China, which firmly dominated the high-priced HPV vaccine market. In April 2018, the National Medical Products Administration conditionally approved the listing of the nine-valent HPV vaccine developed by the multinational pharmaceutical company MSD for the prevention of cervical cancer, with an applicable population of females aged 16-26.

Despite the different "prices," due to the varying approved vaccination age ranges, each HPV vaccine has formed a certain level of differentiated competition. As domestic manufacturers of the nine-valent HPV vaccine increase their efforts in development and continue to make progress, MSD is also working to expand its user base among consumers with purchasing power.

In August 2022, MSD's nine-valent HPV vaccine was approved by the National Medical Products Administration, expanding its target population from females aged 16-26 to females aged 9-45. In January 2024, MSD announced that the two-dose vaccination schedule for its nine-valent HPV vaccine had been approved, applicable to females aged 9-14. At a cost of 1,323 yuan per dose (including a 25-yuan service fee for Category II vaccines), females aged 9-14 will need to spend 2,646 yuan to receive the imported nine-valent HPV vaccine.

The first domestically produced nine-valent HPV vaccine in China may capture a portion of the market through its price advantage. Although imported nine-valent HPV vaccines are expensive, the demand for higher-valency HPV vaccines among eligible women continues to grow, as seen from the batch release volumes. In the first half of 2023, MSD's nine-valent HPV vaccine had a batch release volume of 14,678,176 doses, representing a year-on-year increase of 57.85%.

Founder of medical strategic consulting firm Latitude Health, Zhao Heng, told Beijing Business Today reporters that despite the expansion of indications such as age range for the imported nine-valent HPV vaccine, the first domestically produced nine-valent HPV vaccine still has a certain market space. By leveraging price advantages, the first Chinese-made nine-valent HPV vaccine can cover part of the下沉market.

　　After the 9-valent

No second product has been approved for marketing yet, but the competition in the nine-valent HPV vaccine market is already fierce. Zhao Heng believes that the current market competition for nine-valent HPV vaccines is becoming extremely intense, and the second or third domestically produced nine-valent HPV vaccine to hit the market will inevitably face a price war.

Higher-priced HPV vaccines with indications for males have become a breakthrough direction for domestic manufacturers. On March 29, Kangle Guardian andChengda BioPharmJointly announced the official launch of the Phase I clinical trial for the "Recombinant 15-valent Human Papillomavirus Vaccine (E. coli)" developed in collaboration.

It is reported that the 15-valent HPV vaccine can prevent 15 types of viruses. Compared with the 9-valent HPV vaccine, which can prevent 90% of cervical cancer, theoretically, the 15-valent HPV vaccine can increase the prevention range of cervical cancer to over 96%.

Kangle Weishi is also the first HPV vaccine manufacturer in China to initiate clinical trials for male indications. The company expects to submit a BLA application for its nine-valent HPV vaccine (male indication) in 2027.

In addition, the Phase I clinical trial of Bowei Bio's nine-valent HPV vaccine for male indications officially launched in September 2022. WANTAI BioPharm stated that the clinical trial of its nine-valent HPV vaccine for the male population is in the planning stage, and the company will formulate the clinical development strategy for this product based on market demand.

However, in Zhao Heng's view, currently all manufacturers are moving towards higher-priced vaccines and expanding into male indications, but due to low penetration rates, it is difficult to expand the male market.

Regarding the progress of HPV vaccine development and other issues, a Beijing Business Today reporter contacted WANTAI BioPharm but had not received any response as of press time.

Reporter Yao Zhen from Beijing Business Today

Editor: He Songlin