The Golden Track of 9-Valent HPV Vaccine Bound to Be Eventful: On April 10, WANTAI BioPharm announced that the Phase III primary clinical trial of the 9-valent HPV vaccine, co-developed with Xiamen University, had been unblinded. Preliminary analysis showed that the main results met expectations. It is not far from submission for marketing approval.This means that WANTAI BioPharm will have a strong chip to compete with MSD's Gardasil 9. The hidden line of this competition is between WANTAI BioPharm andGardail9The Battle of ZHIFEI Biological Agent.The Battle for the 9-Valent HPV Vaccine Has Begun.
WANTAI BioPharm Breakthrough
According to the PharmCube database, there are five HPV vaccines approved for marketing in China: MSD's Gardasil (4-valent, 2014) and Gardasil 9 (9-valent, 2018), GSK's Cervarix (2-valent, 2016), WANTAI BioPharm’s Cecolin (2-valent, 2019), and Shanghai Zerun Biotech Co., Ltd.'s Walrin (2-valent, 2022). Among them,Gardail9It is the only approved 9-valent HPV vaccine in China and globally.Compared with the 2-valent vaccine, the 9-valent vaccine provides protection against five additional high-risk HPV types and two low-risk types, offering better prevention of cervical cancer and thus gaining more popularity. The 9-valent HPV vaccine has significantly encroached on the market space of the 2-valent vaccine.The performance of WANTAI BioPharm provides a glimpse into the situation. In 2023, WANTAI BioPharm reported revenue of 5.511 billion yuan, a year-on-year decrease of 50.73%. WANTAI BioPharm explained that one of the main factors was the impact of the expanded age range for the 9-valent HPV vaccine and market competition, which led to lower-than-expected sales of its 2-valent HPV vaccine.The competition for the bivalent HPV vaccine has intensified, even escalating into a price war. In August 2023, WANTAI BioPharm's bivalent HPV vaccine won the bid in Guangdong Province’s vaccine procurement at a single-dose price of 116 yuan, marking a reduction of nearly 65%. This year, WANTAI BioPharm's bivalent HPV vaccine has set a new low for the procurement price of domestically produced bivalent HPV vaccines in China, with the Jiangsu Government Procurement website showing the winning bid at a single-dose price of 86 yuan.A price war is no different from cutting flesh to survive, and even if prices fall further, there will eventually be a bottom line. The superior strategy is to open up a new battleground and break into the incremental market. Now, WANTAI BioPharm already has the ticket to enter the 9-valent HPV vaccine market, and the competitive landscape of the future may be reshuffled.
Of course, Gardasil 9 has the first-mover advantage. Even at the fastest approval pace, there is still a minimum 7-year gap between the launch of WANTAI BioPharm’s 9-valent HPV vaccine and Gardasil 9. Therefore, WANTAI BioPharm must race against time.In subsequent plans, WANTAI BioPharm has made thorough preparations. Its 9-valent HPV vaccine is undergoing several Phase III clinical trials, including head-to-head comparisons with Gardasil 9, age expansion studies, and two-dose vaccination schedules, all of which are within its strategic scope.WANTAI BioPharm has not missed out on the layout of emerging markets. It has signed a Memorandum of Understanding with multiple institutions in Thailand for localized cooperative production of the 9-valent HPV vaccine, and market access work is proceeding in an orderly manner. WANTAI BioPharm and PATH (Program for Appropriate Technology in Health) are also simultaneously advancing an international clinical collaboration on the 9-valent HPV vaccine, planning to conduct related research in Africa and Southeast Asia.In addition, WANTAI BioPharm has also initiated preclinical research work on the third-generation HPV vaccine.
MSD Holds the Lead
In 2023, MSD surpassed AstraZeneca to become the multinational pharmaceutical company with the best performance in China, largely due to the strong boost from its blockbuster product, Gardasil 9. The global sales of Gardasil/Gardasil 9 reached $8.886 billion, with an impressive growth rate of 29%. MSD specifically highlighted the robust demand in the China region as a key contributing factor.The intense competition in the 9-valent HPV vaccine market today was likely anticipated by Merck & Co., Inc., a company with over a century of experience in the industry — whether it was WANTAI BioPharm or another player, a challenge was inevitable. Therefore, some time ago, MSD began a series of strategic defenses.Step 1, Age Expansion. In August 2022, Gardasil 9 was approved by the National Medical Products Administration (NMPA) of China for a new indication, expanding its target population from females aged 16-26 to those aged 9-45. The halving of WANTAI BioPharm's revenue in 2023 fully demonstrates the effectiveness of this strategy.Step 2: Addition of a Two-Dose Vaccination Schedule. In January 2024, Gardasil 9 received another approval from the NMPA for the addition of a two-dose vaccination schedule for females aged 9-14. On one hand, the two-dose schedule simplifies the process, offering greater convenience to patients and potentially further increasing the vaccine's coverage rate.On the other hand, this is also a means of "indirect price reduction." The vaccination cost for MSD's Gardasil 9 in major public hospitals in China is 1,331 yuan per dose. Compared with three doses, the two-dose regimen is undoubtedly a more economical choice for recipients, which will help MSD accelerate its penetration into the HPV vaccine market in China.Step 3: Expand the male market. In the United States, Gardasil 9 has long been approved for use in males. In China, MSD has also laid out relevant clinical trials, with two Phase III studies—CTR20212488 and CTR20220441—targeting Chinese males aged 20 to 45 and 9 to 19, respectively. In September last year, a new indication for Gardasil 9 was submitted for marketing approval in China, possibly for use in males.Step 4, Continuous Iteration and Upgrade. In March this year, MSD announced plans to initiate a clinical study on a multivalent HPV vaccine aimed at providing protection against a broader range of HPV types. Meanwhile, MSD also proposed exploring the efficacy and safety of a single-dose regimen of Gardasil 9 compared to the three-dose regimen.This shows that, in the HPV vaccine sector, MSD still has ambitions to go further.
Future Battle: WANTAI BioPharm vs. ZHIFLY BioPharm
One point that cannot be ignored is that in the Chinese market, MSD has little time left. It not only has to face the fierce offensive from WANTAI BioPharm, but also the key patent for Gardasil 9 in China will expire in 2025.In order to gain more time and capture a larger market share, MSD chose a strategy more suited to the Chinese market — in 2018, the same year it received approval, it entrusted the market promotion of its 9-valent vaccine product to ZF Bio, a leading domestic vaccine company. In January 2023, the two parties renewed their cooperation on five vaccine products, including the HPV vaccine and the pentavalent rotavirus vaccine, with the base procurement amount for the HPV vaccine reaching 98 billion yuan.Unlike other drugs, vaccine products require a broader distribution network in China and need to go through a series of channels to reach end users, placing higher demands on a company's ability to expand sales to lower-tier markets.Following MSD, some other multinational corporations (MNCs) have also entrusted their vaccine products to local companies for agency cooperation. Among them, GSK has chosen ZHIFEI Biological. In October 2023, ZHIFEI Biological and GSK entered into an exclusive cooperation agreement regarding the recombinant shingles vaccine Shingrix. The initial term of this agreement is three years, with the possibility of a three-year extension after the initial period ends.Relying on its powerful sales strength, ZF Bio has successively won the favor of MSD and GSK, two major vaccine giants. In its 2022 annual report, ZF Bio stated that it had successfully built the largest direct-sale marketing network in terms of personnel scale and deepest terminal coverage within the industry. That year, the number of market personnel reached 3,359.
In the future, in the 9-valent HPV vaccine market, WANTAI BioPharm will also face a head-to-head battle with the formidable sales force of Zhifei Biological Products. By comparison, WANTAI BioPharm disclosed in its 2023 financial report that it has 796 sales personnel.However, sales capability is not the sole determinant of market competition. WANTAI BioPharm stated in its annual report that, compared with the 9-valent HPV vaccines produced by overseas-listed eukaryotic expression systems, its 9-valent HPV vaccine has a low production cost advantage. It can be inferred that WANTAI BioPharm’s 9-valent HPV vaccine may offer a more competitive price advantage.As for how much room is left in China’s 9-valent HPV vaccine market, Robert M. Davis, head of MSD, shared his view during the release of the company's 2023 earnings report: "The HPV vaccine market in China is huge, and it is estimated that there are currently about 120 to 130 million urban women who meet the conditions for vaccination." However, capturing the remaining market share has become more challenging.9PriceHPVThe battle of vaccines may also have an impactWANTAI BioPharm andZhiFei BioThe development trend of things.Currently, the share price of WANTAI BioPharm is 67.42 yuan per share, with a total market value of 85.503 billion yuan.The share price of ZHIFEI Biological is 43.83.Yuan/Stock, Total Market ValueRMB 105.192 billion.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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