Competition for domestic HPV vaccines: more than ten projects entered the clinic, Wantai Biotech outperformed
The price is less than 1,000 yuan, nearly half the price of imported vaccines, and vaccination can be scheduled next month . The first domestic cervical cancer vaccine will be available with all kinds of auras.It is understood that the domestically approved bivalent human papillomavirus (HPV) vaccine was produced by Xiamen Wantai Canghaihai Biotechnology Co., Ltd. (hereinafter referred to as Xiamen Wantai), and 93,643 vaccines were obtained on April 22The “Certificate for the Issuance of Biological Products” by the State Drug Administration means that the domestically produced cervical cancer vaccine can officially enter the market.Behind the scenes, Wantai Biotechnology emerged. As the vaccine manufacturer, it began to be listed in 2016 until March 2020. The Securities Regulatory Commission approved the initial application of Wantai Biotechnology in accordance with legal procedures.Obviously, there are still many domestic companies involved in the research and development of cervical cancer vaccines. There are more than 10 research projects in clinical trials that have begun, including many listed companies.The low price of domestic vaccines is the selling point. The price of imported nines rises more than 2,000 yuan per needle. According to the official website of Xiamen Wantai Company, the company is the third company in the world to obtain a cervical cancer vaccine marketing license.”Afterwards, immediately organize the production and batch declaration of products.With the approval of the batch issuance certificate, it signifies that the product can be officially listed for sale.The bivalent cervical cancer vaccine produced by Xiamen Wantai Xinxining?It is suitable for women aged 9-45 years old, implanted with 3 needles at 15-45 years old, and given 2 needles at 9-14 years old. It is the first cervical cancer vaccine product approved in China at the age of 9-14 years by 2 needles.According to media reports, from May, most community hospitals in Hubei, Xinjiang, Jilin, Yunnan, Jiangsu, Shandong and other provinces, cities, and autonomous regions can be booked and replaced in succession.The HPV vaccine is the world’s first vaccine that uses cancer as a supplement to the instructions. It has been marketed internationally and domestically as a two-, four-, and nine-valent vaccine.In the domestic market, there has been a shortage of cervical cancer vaccines.The upcoming Xiamen Wantai received the approved bivalent cervical cancer vaccine, and submitted the application for marketing as early as November 2017. It entered the priority evaluation process of the State Food and Drug Administration in July 2018 and was awarded on December 30, 2019.The State Drug Administration approved the listing.On April 26, the sauna and Yewang contacted a local maternal and child health hospital in Xinjiang. The staff told reporters that the 2020 cervical cancer vaccine for the hospital has been fully booked by the end of March.But at present, we have not accepted the notice that the domestic cervical cancer vaccine will arrive.It is worth mentioning that the low price is a major selling point for this domestic cervical cancer vaccine.Under the name of imported vaccines, the domestically made divalent cervical cancer vaccine is priced at 329 yuan / needle, 658 yuan for 9-14 years old, and 987 yuan for older adults.According to a research report released by Southwest Securities in 2018, three HPV vaccines have been listed on the domestic market, namely the bivalent cervical cancer vaccine produced by GSK (GSK). The winning price at that time was 580 yuan.The four-valent HPV vaccine is produced by Merck and the winning price is 798 yuan; the nine-valent HPV vaccine is produced by Merck and the terminal price is even more than 1,000 yuan per injection.The reporter noted that due to the scarcity of 9-valent cervical cancer vaccines, the prices in some private clinics have doubled.On April 26, Sauna and Yewang saw in a message issued by a private clinic in Beijing that the price of a nine-valent vaccine was 2230 yuan per needle.The emergence of Wantai Biotech: The total market value of Yangshengtang Holdings exceeded 3.7 billion. The first batch of over 90,000 domestic cervical cancers was issued and the producer Wantai Biotech emerged, and it will also be successfully listed in the near future.The data shows that the manufacturer of the vaccine, Xiamen Wantai, is a wholly-owned subsidiary of Beijing Wantai Biopharmaceutical Co., Ltd.As early as June 2016, Wantai Biotechnology submitted materials to apply for IPO.As of the end of May 2019, Wantai Bio has issued a total of 4 prospectuses.According to the announcement issued by Wantai Bio, the company has completed its initial public offering, and the issue price is used as an example.75 yuan.According to the calculation of the total capital of 433.6 million shares after the issuance of Wantai Biotechnology, its total market value is about 37.900 million yuan.In this initial public offering, Wantai Biotech is expected to raise funds3.1.7 billion yuan, of which 1.US $ 500 million plans to invest in cervical cancer vaccine quality system improvement and internationalization projects.The data shows that the controlling shareholder of Wantai Biological is Yangshengtang, and the actual controller is Zhong Zui.Before this issuance of stocks, Zhong Dizhi directly held 78.8 million shares of Wantai Biotechnology, accounting for 20% of the company’s total share capital before the issue.2053%, and indirectly holds 63 companies through Yangshengtang.3526% of pre-issue shares.From 2017 to 2019, Wantai Bio’s operating income was 9, respectively.4.9 billion yuan, 9.800 million, 11.8.3 billion, with a net profit of 1.500 million, 2.900 million, 2.1 ppm; the reported amount, the R & D expenses of Wantai Biological Ingestion are 1 respectively.5.8 billion yuan, 1.3.8 billion and 1.6.6 billion yuan.Behind the large amount of research and development, Wantai Bio’s 9-valent cervical cancer vaccine is still in clinical stage.According to the Wantai Biological Prospectus, as the world ‘s second, China ‘s first domestically applied nine-valent cervical cancer vaccine, the company has applied for clinical trials in 2015, obtained clinical trial approvals in 2017, and completed Phase I clinical trials in 2019And conduct a phase II clinical trial.Wantai Bio said that the vaccine is produced based on the E. coli prokaryotic expression system, which has the advantages of low production cost, high output, and affordable prices. It has gradually become a substitute for imported products and is also highly competitive in the international market.The actual company is competing. The clinical trials of domestically produced HPV vaccines are indeed numerous.On April 27, Sauna and Yewang saw 36 clinical trials related to the human papillomavirus vaccine (ie cervical cancer vaccine) on the drug clinical trial registration and information disclosure platform.Most of the completed clinical trials are phase I clinical trials, including phase I clinical trials of the recombinant trivalent human papillomavirus vaccine of Xiamen University and Xiamen Wantai, which were announced earlier in June 2015.In terms of time, the latest development stayed on April 8, 2020-Shanghai Bowei Biotechnology Co., Ltd. applied for a phase III clinical trial of a recombinant human papillomavirus nine-valent vaccine.It is understood that this double-blind, randomized, parallel grouped phase III clinical trial plans to enroll 8,000 women aged 20-45 in China to receive the treatment of HPV nine-valent and four-valent vaccines.In addition, Phase II clinical trials of the recombinant 9-valent human papillomavirus vaccine, which was first publicly announced by Beijing Krolz Bio on January 13, 2020, have also begun.The Phase I clinical trial of the safety and preliminary immunogenicity of the 11-valent recombinant HPV vaccine jointly conducted by Sinopharm Zhongsheng Biotechnology Research Institute Co., Ltd., Beijing Institute of Biological Products, and Chengdu Institute of Biological Products was first conducted in September 2019Public announcement, has begun clinical trials.In March 2019, the Shanghai Institute of Biological Products has also been conducting a phase II clinical trial of the tetravalent human papillomavirus vaccine.Jiangsu Ruike Biotechnology Co., Ltd. and Beijing Ambient Biotechnology Co., Ltd. jointly conducted a phase I clinical trial of a recombinant human papillomavirus nine-valent vaccine and a bivalent phase I clinical trial; Shanghai Zerun Biotechnology Co., Ltd., Shanghai BoOnly Biological Technology Co., Ltd. started phase I clinical trials of a recombinant human papillomavirus nine-valent vaccine.There are many listed companies participating in the research and development of HPV vaccines.The above-mentioned Sinopharm Zhongsheng Biotechnology Research Institute Co., Ltd. is a subsidiary of China Pharmaceutical Group, a Hong Kong-listed company, and Shanghai Zerun Biotechnology Co., Ltd. is a subsidiary of Yunnan Watson Biotechnology, a listed company.According to the first quarter report of 2020 issued by Watson Biotechnology, the HPV vaccine (bivalent) clinical study invested in the “Shanghai Zerun R & D Project” at the end of the reporting period has completed the disclosure of phase III clinical trials and entered the statistical analysis of clinical trials and clinical researchSummary stage; HPV vaccine (nine-price) has obtained clinical approval and reached the pre-order status.Air Force listed company Chengda Biology also announced that it has signed an agreement with Beijing Kangle Biotech Co., Ltd. to develop a fifteen-valent HPV vaccine.Shuanglu Pharmaceutical also said in 2017 that the company has declared a quadrivalent recombination (E. coli) 16/18/52/58 human papillomavirus type virus particle vaccine (new type I biological product).In addition, Shenzhou Cell, the company to be listed, also revealed in the prospectus that the company’s independent research and development of the fourteen-valent HPV vaccine has obtained clinical trial approvals and preparations for phase I / II clinical research.According to the data disclosed by Shenzhou Cell in the prospectus, as of March 9, 2020, 4 HPV vaccine products have been gradually approved for listing, 2 are in phase III clinical trials, and 5 projects are in phase II clinical trials.Six phase I clinical trials are underway.Sauna, Ye Wang Li Yunqi editor Wang Jinyu proofreading Wei Zhuo