The second domestic HPV vaccine was approved.
On March 24, the drug approval certificate issued by the State Food and drug administration included the information to be received, including the bivalent human papillomavirus (HPV) vaccine (Pichia pastoris) of Zerun Biotechnology Co., Ltd., a holding subsidiary of Walvax Biotechnology Co.Ltd(300142) ( Walvax Biotechnology Co.Ltd(300142) ), which means that the bivalent HPV vaccine developed by Walvax Biotechnology Co.Ltd(300142) itself has finally been approved for listing.
This is also the second domestic bivalent HPV vaccine approved for marketing in China after the bivalent HPV vaccine of Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) ( Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) ). So far, five HPV vaccines have been approved in China. In addition to two domestic products, the other three are imported, including GlaxoSmithKline’s bivalent HPV vaccine, MSD’s tetravalent HPV vaccine and jiuvalent HPV vaccine.
It can be predicted that with the approval of the new vaccine, the HPV vaccine field with a market prospect of more than 100 billion will also usher in a new competition pattern.
prevention of cervical cancer, more vaccine options
Cervical cancer is a high incidence of cancer in women, and more than 90% of cervical cancer is due to continuous infection with high-risk human papillomavirus (HPV). The advent of HPV vaccine makes cervical cancer the only cancer that can be prevented by vaccine in the world. Therefore, HPV vaccine is often called cervical cancer vaccine.
Bivalent, tetravalent and jiuvalent in the name of HPV vaccine are the different types of viruses that the vaccine prevents. For example, bivalent mainly prevents high-risk HPV16 and 18 viruses. Although the titer is low, 70% of cervical cancer is caused by these two types of virus infection. Therefore, bivalent HPV vaccine is still of great preventive significance.
a research report in Huaxi Securities Co.Ltd(002926) 3 pointed out that although HPV vaccine has been listed in China for many years, due to the huge stock population and the limited supply of HPV vaccine, the demand of HPV vaccine market in China is still in short supply. At the same time, the government provided free HPV vaccine for school-age girls, which further stimulated the market demand. At present, the penetration rate of HPV vaccination among school-age women in China is only about 7%. According to the penetration rate of 30% / 45% / 60%, China still needs 280 / 4.5 / 620 million HPV vaccines, which is far from reaching the peak.
As more and more HPV vaccines are approved, there is more room for people who are willing to be vaccinated to choose HPV vaccines, and the current situation of “one shot is difficult to obtain” may be improved. With the increase of production capacity and market competition, there may be room for further decline in prices.
What does bivalent HPV vaccine mean to Walvax Biotechnology Co.Ltd(300142)
With bivalent HPV vaccine, Walvax Biotechnology Co.Ltd(300142) broke into a 100 billion market.
Guolian Securities Co.Ltd(601456) 3 A Research Report on March 20 believes that the effectiveness of HPV vaccine has been verified by many countries. Due to production capacity constraints, the world has been in short supply for a long time. With the listing of domestic vaccines, the production capacity is gradually released, which is expected to usher in a 100 billion market.
Guolian Securities Co.Ltd(601456) analysis: in the future, with the promotion of vaccination awareness and policies, the vaccination rate of 9-15 years old / 16-45 years old will reach about 70% and 25% – 30% respectively. It is estimated that the total demand of HPV vaccine in China will be 268 million, and the cumulative demand of only female market is expected to exceed 100 billion yuan. In the future, with the approval of male indications, the Chinese market is expected to usher in another peak.
According to the data on the official website, Walvax Biotechnology Co.Ltd(300142) established in 2001, is a high-tech biopharmaceutical enterprise specializing in human vaccines and other biotechnology drugs, integrating R & D, production and sales. It was listed on the Shenzhen Stock Exchange in 2010.
According to the 2021 annual report, Walvax Biotechnology Co.Ltd(300142) mainly produces and sells independent vaccine products, including 13 valent pneumococcal polysaccharide conjugate vaccine (vial and pre encapsulated), 23 valent pneumococcal polysaccharide vaccine (vial and pre encapsulated), Haemophilus influenzae type b conjugate vaccine (vial and pre encapsulated), meningococcal polysaccharide conjugate vaccine group A and C, meningococcal polysaccharide vaccine group acyw135 Group A, group C meningococcal polysaccharide vaccine and adsorbed acellular DPT combined vaccine have a total of 7 products (10 specifications).
Walvax Biotechnology Co.Ltd(300142) main products sales in 2021
From the financial data, the revenue in 2021 was 3.463 billion yuan, a year-on-year increase of 17.82%, and the net profit attributable to the parent company was 428 million yuan, a year-on-year decrease of 57.36%. It is noteworthy that the main revenue of Walvax Biotechnology Co.Ltd(300142) contributed to its 13 valent pneumonia conjugate vaccine, with a revenue of 2.746 billion yuan, a year-on-year increase of 65.59%, accounting for nearly 80% of the total revenue. Now the approved bivalent HPV vaccine is expected to become the next important product to improve its performance.
It is noteworthy that the bivalent HPV vaccine approved this time comes from Yuxi Zerun Biotechnology Co., Ltd. According to tianyancha, the company is 100% controlled by Shanghai Zerun Biotechnology Co., Ltd. (hereinafter referred to as “Shanghai Zerun”). At the end of 2020, Walvax Biotechnology Co.Ltd(300142) announced the transfer of 32.60% equity of Shanghai Zerun with RMB 1.14 billion. After the completion of the transaction, Shanghai Zerun will no longer be its holding subsidiary. At that time, the announcement was considered that Watson gave up high-quality assets of HPV vaccine, causing investor dissatisfaction.
At the end of 2021, Walvax Biotechnology Co.Ltd(300142) also announced that it planned to increase the capital of its holding subsidiary, Shanghai Zerun, by 100 million yuan. This capital increase will introduce new investors and accelerate the clinical research and industrialized listing process of Shanghai Zerun HPV series vaccines. After the capital increase, Shanghai Zerun is still the holding subsidiary of the company, and the proportion of equity directly held by the company in Shanghai Zerun has changed from 586610% to 566161%.
As of the closing on March 24, Walvax Biotechnology Co.Ltd(300142) reported 58.97 yuan, up 1.05%, with a market value of 94.44 billion yuan.
layout is more cost-effective, and the competition in the field of HPV vaccine is fierce
There are many entrants and potential competitors in the 100 billion market of HPV vaccine.
Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , which is also a domestic HPV vaccine manufacturer, the annual report data of 2021 shows that the cumulative batch issuance of bivalent HPV vaccine in the whole year exceeded 10 million. In terms of production capacity, the annual production capacity of bivalent HPV vaccine was increased to 30 million by adding a pre potting syringe production line and expanding the scale of Xilin bottles twice.
It is noteworthy that Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) is promoting the listing of nine valent HPV vaccine. The annual report shows that the phase III clinical trial of the vaccine is progressing smoothly. The main clinical trial has completed the enrollment and vaccination, and the visit is under way. The head-to-head clinical trial with the nine valent HPV vaccine of MSD has completed the on-site work, and the young bridging clinical trial has also started and completed the enrollment work.
In addition to Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) laying out the nine price HPV vaccine, two companies that are impacting the IPO are competing for the title of “the first share of domestic nine price HPV vaccine”, namely Kangle guard and Ruike biology. From their product pipelines, we can see that they are promoting HPV vaccine with higher price and efficiency.
Kangle guard was founded in 2008 and officially listed on the new third board in 2015. In the introduction on the official website, Kangle guard claimed to be the first echelon of domestic HPV vaccine development. HPV vaccines in pipeline products include recombinant trivalent, jiuvalent and 15valent HPV vaccines, of which recombinant trivalent and jiuvalent HPV vaccines have entered phase III clinical practice and are ahead of schedule.
Ruic bio was founded in 2011, the product line includes HPV series vaccine, recombinant COVID-19 vaccine, recombinant herpes zoster vaccine, recombinant quadruvalent influenza vaccine, recombinant adult tuberculosis vaccine. Among them, the company’s core product REC603, a recombinant HPV nine valent vaccine, is in the phase of III clinical trial.
It is worth mentioning that Chongqing Zhifei Biological Products Co.Ltd(300122) ( Chongqing Zhifei Biological Products Co.Ltd(300122) ), another listed company in China, although it does not produce HPV vaccine, it has gained a lot by relying on the four price and nine price HPV vaccines of MSD. According to the third quarterly report of 2021, Chongqing Zhifei Biological Products Co.Ltd(300122) revenue reached 21.829 billion yuan, up 97.55% year on year; The net profit attributable to the parent company was 8.404 billion yuan, a year-on-year increase of 239.05%; Deduction of non net profit was 8.418 billion yuan, a year-on-year increase of 239.06% Chongqing Zhifei Biological Products Co.Ltd(300122) will disclose the 2021 annual report on April 28.
