Recently, the good news of domestic HPV vaccine continues Liaoning Chengda Biotechnology Co.Ltd(688739) ( Liaoning Chengda Biotechnology Co.Ltd(688739) . SH) the recombinant fifteen valent human papillomavirus vaccine developed in cooperation with Kangle guard officially launched clinical trials. On March 24, the bivalent human papillomavirus vaccine under Walvax Biotechnology Co.Ltd(300142) ( Walvax Biotechnology Co.Ltd(300142) . SZ) was approved for marketing, becoming the second Chinese enterprise to be approved for bivalent HPV products after Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) ( Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) . SH).
There are many entrants, and the market pattern of HPV vaccine in China is changing synchronously. The accelerated R & D of Chinese vaccine enterprises has redistributed the HPV market originally dominated by multinational enterprises such as MSD and GSK. Under the background that the penetration rate of HPV vaccine in China is not high and there is still a large gap in the vaccine market, policy, technology, production capacity, price and market education will become the key to meet the nearly 100 billion HPV market.
"battle" started
In November 2020, the World Health Organization released the global strategy for accelerating the elimination of cervical cancer, which proposed that 90% of girls should complete HPV vaccination before the age of 15 by 2030. In addition, the demand for male HPV vaccine is also growing. According to the frost Sullivan report, China's HPV vaccine market is expected to reach 69 billion yuan by 2030.
Cervical cancer is a common malignant tumor that seriously threatens women's health. In the "Guangdong expert consensus on the application of HPV vaccine to eliminate cervical cancer" in September 2021, it was mentioned that at present, the immunization coverage rate of HPV vaccine in China is low, the vaccination rate of teenagers is less than 3%, and the vaccination rate of the whole population is less than 6%.
The huge market gap makes vaccine manufacturers see the prospect of HPV vaccine race track. At present, there are five HPV vaccines in China. In addition to the newly approved Walvax Biotechnology Co.Ltd(300142) bivalent HPV vaccine, there are also the tetravalent and jiuvalent vaccines of MSD, the bivalent vaccine of GSK, and the bivalent vaccine of Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) .
The listing of bivalent HPV vaccine is bound to intensify the competition of bivalent vaccine Walvax Biotechnology Co.Ltd(300142) , Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) in research projects contain nine valent HPV vaccine. In addition, more than 10 HPV vaccine clinical trials are in progress in China, including Chengdu Biological four price, MSD nine price, Yidao biological nine price, Sinopharm Zhongsheng eleven price, Sinocelltech Group Limited(688520) fourteen price and Liaoning Chengda Biotechnology Co.Ltd(688739) fifteen price HPV vaccine products.
For the first domestic bivalent vaccine on the market, the continuous large-scale production and marketing has brought huge profits to the enterprise. In December 2019, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) bivalent HPV vaccine was approved for marketing, becoming the first HPV vaccine in China and the fourth HPV vaccine in the world. The vaccine brought revenue growth to the company after its listing Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) released the annual report of 2021, which shows that in 2021, the revenue reached 5.75 billion yuan, a year-on-year increase of 144.25%, and the net profit attributable to the parent company was 2.021 billion yuan, a year-on-year increase of 198.59% Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) said that the high performance growth was mainly due to the increase in net profit brought by the increase in the income of bivalent cervical cancer vaccines, reagents and active raw materials.
In 2021, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) vaccine segment achieved revenue of RMB 3.363 billion, with a year-on-year increase of 288.49%, gross profit margin of 92.55%, and revenue proportion increased to 58%, mainly due to the continuous and rapid volume of bivalent HPV vaccine.
The "battle for the HPV market" has begun, and several vaccine manufacturers have announced IPOs On February 15, 2022, the new third board company Kangle guard (833575. NQ) announced that it plans to publicly issue shares to unspecified qualified investors and list them on the Beijing stock exchange. The number of shares to be issued is no more than 44.53 million, the reserve price is 77.68 yuan / share, and the issuing object is expected to be no less than 100.
The core products of Kangle guard R & D pipeline include recombinant trivalent, jiuvalent and 15valent HPV vaccine, recombinant bivalent covid-19 vaccine, recombinant polyvalent norovirus vaccine, recombinant respiratory syncytial virus vaccine and recombinant herpes zoster vaccine. Kangle guard pointed out that its recombinant trivalent and jiuvalent HPV vaccine has entered phase III clinical practice, and it is planned to complete phase III clinical work of trivalent and jiuvalent HPV vaccine in 2-4 years.
Ruike biology, another vaccine enterprise highly expected by the market, will become the first share of HPV vaccine in the Hong Kong stock exchange. On the morning of March 21, Ruike biology announced on the Hong Kong stock exchange that it plans to offer 30854500 shares worldwide at the price of HK $24.80 per share. It is expected to be listed on the main board of the stock exchange on March 31, 2022. According to the prospectus of Ruike biology, about 47.3% of the IPO will be used to continue to optimize, develop and commercialize the company's HPV vaccine pipeline.
At present, Rico has 12 innovative vaccine products, including HPV series vaccine, herpes zoster vaccine, recombinant COVID-19 vaccine, influenza vaccine, adult tuberculosis vaccine and other vaccine combinations. Its core product recombinant HPV nine valent vaccine rec603 is currently in phase III clinical trial stage. It is planned to complete three doses in the first half of 2022 and submit an application for biological product license (BLA) to the State Food and Drug Administration in 2025. In addition, Ruike biology has two bivalent HPV vaccines and the second generation of fourth and ninth valent HPV vaccines.
immunization planning and pricing strategy
The inclusion of HPV vaccination into the national immunization plan is an effective means to improve the immunization coverage of HPV vaccine. As of October 2020, 110 countries and regions have incorporated or partially incorporated HPV vaccine into the national immunization plan. The average whole course vaccination rate of countries included in the immunization plan is 53%, of which 22 countries have more than 75%.
The HPV vaccination rate in China is still very low. A survey of more than 4000 adult women from 30 provincial capitals in China shows that three years after the HPV vaccine was approved in China, only 3.1% of women aged 18-45 were vaccinated with HPV vaccine in the whole process. This is far from the full vaccination rate of countries included in immunization programmes.
At present, one of the reasons for the low vaccination rate in China is that the vaccine price has caused a certain economic burden to the people. Taking Guangdong Province as an example, GSK bivalent HPV vaccine was listed in China in 2016, and the bid winning price in Guangdong Province was 590 yuan / piece; Moshadong tetravalent HPV vaccine was listed in China in 2017, with a price of 810 yuan / bottle; Methadone nine price HPV vaccine was listed in China in 2018, with a price of 1310 yuan / bottle Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) domestic bivalent HPV vaccine was launched in 2019, with 339 yuan / bottle.
Previously, for pricing, Walvax Biotechnology Co.Ltd(300142) the information announcement of research activities disclosed in November 2021 showed that the company would fully consider the market price of the currently listed products, the company's product positioning, pricing strategy and coordination with the follow-up nine price HPV vaccine to determine the market price of the two price HPV vaccine.
Zhongtai Securities Co.Ltd(600918) once mentioned in the research report that HPV vaccine has the risk of intensified competition and price reduction. "China's HPV vaccine stock market is huge. At present, the penetration rate is low. In the future, with the continuous improvement of import and domestic approval and issuance, the market scale is expected to expand rapidly. However, objectively speaking, there are many manufacturers developing HPV vaccine in China, and leading manufacturers are expected to be approved and listed in succession within 2-5 years, with the risk of intensified competition and even price reduction."
According to the statistics of China Meheco Group Co.Ltd(600056) Industrial Information Center, in 2020, the global sales amount of methadone HPV vaccine was US $3.938 billion, ranking second among all vaccine products, second only to Pfizer's 13 valent pneumococcal conjugate vaccine. According to the batch issuance volume and bid winning price, HPV vaccine is also one of the vaccines with the highest sales in China in 2020.
With the listing of domestic bivalent HPV vaccine, the market share of domestic products has increased year by year in recent years China Meheco Group Co.Ltd(600056) industrial information center provided a set of data that showed that the number of HPV vaccines vaccinated in China doubled from 2018 to 2020, with 5372900 (bottles), 10875400 (bottles) and 15431700 (bottles) vaccinated respectively; In terms of batch issuance quantity, the batch issuance quantity of domestic Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) in 2020 is as high as 2456100 pieces / bottle, higher than 689700 pieces / bottle of GSK, with a market share of 15.92%. From January to April 2021, the market share of Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) increased to 19.95%.
"Since China announced its support for the who's global strategy to accelerate the elimination of cervical cancer in December 2020, pilot policies for free HPV vaccination have been introduced in many places across the country. It is expected that more products will be approved in succession and the market supply will be further guaranteed in the future." China Meheco Group Co.Ltd(600056) industry information center senior industry researcher Sheng Yangji told the first financial reporter that HPV vaccine has added active prevention means for cervical cancer to the clinic. The change of diagnosis and treatment view is not achieved overnight. Enterprises and medical institutions need to carry out market education together.
Some vaccine manufacturers told the first financial reporter that they hope to improve the convenience of HPV vaccination. For example, doctors can popularize science for patients after diagnosis and treatment to improve patients' awareness, and then they can be vaccinated directly in the hospital.
