①Today, Beijing Wantai Biological Pharmacy Enterprise's application for the listing permit of the 9-valent HPV vaccine has obtained the acceptance notice from the Drug Evaluation Center of the National Medical Products Administration; ②In the afternoon, the stock price of Beijing Wantai Biological Pharmacy Enterprise rose by the limit, but quickly fell back. As of today's close, the increase was 3.9%; ③In addition, Beijing Wantai Biological Pharmacy Enterprise still faces fierce competition from competitors in the 9-valent HPV vaccine field.
On August 26, Chailian News Agency reported (Reporter He Fan) that today, the listing application of Beijing Wantai Biological Pharmacy Enterprise's 9-valent HPV vaccine has been accepted, as shown on the CDE website. Influenced by this news, the stock price of Beijing Wantai Biological Pharmacy Enterprise rose by the limit in the afternoon, but quickly fell back. As of the close, the increase was 3.9%, at 72.71 yuan/share. The company told the Chailian News Agency reporter that the company is actively promoting related commercialization matters.
Industry experts told Chailian News Agency that the acceptance of the listing application means that the product is one step closer to market. As China's first 9-valent HPV vaccine, it is expected to be approved in half a year. In addition, Beijing Wantai Biological Pharmacy Enterprise still faces fierce competition from competitors in the 9-valent HPV vaccine field.
On the news side, as of noon today, the National Medical Products Administration's Drug Evaluation Center (CDE) website shows that the listing application of Beijing Wantai Biological Pharmacy Enterprise's 9-valent HPV vaccine has been accepted. The specific name of the product is the 9-valent human papillomavirus vaccine (Escherichia coli).
After the close, the company announced that the listing application of the 9-valent HPV vaccine developed by its wholly-owned subsidiary, Beijing Wantai Canghai, in collaboration with Xiamen University, has been accepted by the Drug Evaluation Center of the National Medical Products Administration. According to the "Drug Registration Management Measures", the National Medical Products Administration will conduct technical evaluation of the safety, efficacy, and quality controllability of the vaccine, and at the same time carry out on-site inspection of production facilities and pre-market inspection of compliance with drug production quality management standards. The 9-valent HPV vaccine needs to go through a relatively long period from acceptance to approval and listing, and will not have a significant impact on the company's financial condition and business performance in the short term.
Beijing Wantai Biological Pharmacy Enterprise told Chailian News Agency that it has planned 6 production lines for the 9-valent HPV vaccine, with an annual production capacity of 60 million doses. At present, two production lines have been completed. The company is also simultaneously pushing forward related matters for pre-market sales and hopes to quickly respond once the vaccine is approved. Because the 9-valent HPV vaccine is of great concern and competition is fierce, it is also good news for eligible women. The specific pricing will be announced after the vaccine is launched.
Industry expert Li Changcheng told Chailian News Agency that the acceptance of the listing application for Beijing Wantai Biological Pharmacy Enterprise's 9-valent HPV vaccine means that it is one step closer to approval and listing, indicating that the product's data and files are qualified. As for the formal approval and listing time, because it is the first approval for China's 9-valent HPV vaccine, it may involve on-site testing of production processes and other steps, and may take about 6 months.
In addition to Beijing Wantai Biological Pharmacy Enterprise, several domestic manufacturers are accelerating in the 9-valent HPV vaccine field. According to data from Pharmacompass, KangLeWeiShi (833575.BJ), BoWei Biological, Walvax Biotechnology (300142.SZ), and Ruikang Biology (02179.HK) are all in the phase III clinical trial stage. In addition to female indications, the phase III clinical trial of KangLeWeiShi's 9-valent HPV vaccine for male indications has completed subject enrollment and most subjects' first dose visit after 7 months.