"Zhang Xueyou Cancels Concert Due to RSV Infection" Trending on Hot Search.On the same day, GSK's RSV vaccine Arexvy received FDA approval, expanding its eligible population to include adults aged 50 to 59 who are at high risk for RSV.Not long ago, Moderna's RSV mRNA vaccine mRESVIA (mRNA-1345) was approved by the FDA for marketing, becoming the world's first RSV mRNA vaccine.As this series of events unfolded, the RSV vaccine market became highly volatile.So, can China's RSV vaccines carve out a place in this huge market?
A $10 billion track,Next HPV Vaccine?In the blink of an eye, "God of Song" Jacky Cheung is already 63 years old. As netizens say, "Once a person gets old, various diseases tend to come knocking." Among them, RSV infection (Respiratory Syncytial Virus) is one of the common illnesses in the elderly.RSV is a widely prevalent respiratory pathogenic virus that can infect people of all ages, especially high-risk groups (such as children, the elderly, and those with weakened immune systems), who are more vulnerable to its effects.Although there are currently no specific drugs for RSV available globally, several RSV preventive drugs (including antibody drugs and vaccines) have been introduced. Among them, the marketed RSV antibody drugs include AstraZeneca'sSynagis(Palivizumab), co-developed by Sanofi/AstraZenecaBeyfortus(Nirsevimab).Three RSV vaccines have been approved by the FDA for marketing globally，They are GlaxoSmithKline (GSK)Arexvy, Pfizer'sAbrysvoand Moderna's RSV mRNA vaccinemRESVIA(mRNA-1345). Among them, Arexvy and Abrysvo were successively launched in May 2023, while mRESVIA was launched in May 2024, becoming the first conventional mRNA vaccine to be marketed following the mRNA COVID-19 vaccine.
In view of the wide range of people infected with RSV, the blue ocean stage of the market, and the huge market potential,RSV vaccine is called "the next HPV vaccine" in the industry.In 2023, GSK's Arexvy achieved sales of 1.238 billion pounds (approximately 1.57 billion US dollars), becoming a "blockbuster drug" just nine months after its launch. GSK expects the future sales peak of this vaccine to exceed 3 billion pounds; Pfizer's Abrysvo also achieved sales revenue of 890 million US dollars and is highly likely to become the next member of the billion-dollar club.The combined sales of two RSV vaccines reached nearly $2.5 billion, a figure that not only demonstrates strong market demand but also far exceeds market expectations. Meanwhile, these vaccines are continuously expanding their eligible populations: Arexvy now covers adults aged 60 and above as well as those aged 50-59, while Abrysvo is available for adults aged 60 and above and pregnant women at 32-36 weeks of gestation.In the field of RSV antibody drugsAstraZeneca's Synagis (Palivizumab) was approved by the FDA in 1998 for the prevention of lower respiratory tract RSV infections in high-risk infants. Despite its relatively narrow patient coverage, the drug has been considered a "blockbuster" since 2008, with stable sales in the range of $900 million to $1.5 billion over the past decade.Beyfortus (Nirsevimab), a long-acting monoclonal antibody jointly developed by Sanofi and AstraZeneca, was approved by the FDA for marketing in July 2023. As the world's first and only RSV preventive drug widely applicable to newborns and infants, Beyfortus achieved sales of 547 million euros (approximately 598 million US dollars) in less than half a year after its launch and is expected to join the billion-dollar sales club this year.Clearly, the RSV prevention drug market has shown enormous development potential.It is predicted that the global RSV drug market (covering vaccines and drugs) will reach 12.8 billion US dollars by 2030, while the potential scale of China's RSV vaccine market is expected to reach 13.4 to 22.3 billion RMB.
"The Great Rivers and Streams" of RSV VaccinesThe development in the RSV vaccine field is in full swing.The development of vaccines involves multiple technological approaches, each with its own characteristics and advantages in terms of immunogenicity, protective efficacy, safety, durability, and vaccination regimens.As of now, two technical routes of RSV vaccines have been approved for marketing: GSK's Arexvy and Pfizer's Abrysvo both belong to the recombinant protein subunit technical route, while Moderna's mRESVIA (mRNA-1345) falls under the mRNA technical route.
Why Moderna's mRESVIA Successfully Obtained FDA Approval for Market Launch, mainly due to the positive data support from the Phase III Conquer RSV study.The study showed that mRESVIA had a protective rate of up to 83.7% (95.88% CI 66.0%, 92.2%) against RSV-LRTD with two or more symptoms, and the protective efficacy for those with three or more symptoms reached 82.4%. Within the median follow-up period of 8.6 months, the vaccine demonstrated sustained protection against RSV-caused lower respiratory tract disease (LRTD).According to LSEG data, analysts' average forecast predicts that mRESVIA's sales will reach approximately $340 million in 2024 and are expected to grow to $830 million in 2025.Currently, the global RSV vaccine pipeline covers multiple technological approaches., including recombinant subunit, mRNA, viral vector, attenuated live vaccine, etc.Sanofi, which has already tasted success with its RSV vaccine, has continued to develop the live attenuated vaccine SP0125 (currently in Phase III clinical trials) and the RSV-hMPV-PIV trivalent mRNA vaccine SP0256 (currently in Phase II clinical trials).AstraZeneca Acquires Icosavax at a High Premium to Include the Latter's Vaccine Pipeline IVX-A12, Based on VLP Technology for the Prevention of RSV and Human Metapneumovirus (HMPV),The vaccine is currently in Phase II of clinical trials, having previously received Fast Track designation from the FDA for adults over 60.Moderna is also not to be outdone, having developed multiple RSV vaccines, including the flu/COVID/RSV trivalent mRNA vaccine mRNA-1230 and mRNA-1365 (RSV-hMPV combination vaccine), all of which have entered clinical stages.In addition, Daiichi Sankyo, which reached a $22 billion ADC pipeline collaboration with Merck, has also entered the RSV vaccine market, with its recombinant subunit vaccine VN-0200 already in Phase II clinical trials.
The Dawn of China-Produced RSV VaccinesThe frequent entry of overseas pharmaceutical giants into the market has made the prospects of the RSV vaccine market more imaginative.Chinese vaccine companies will naturally not miss out on this huge "market opportunity".Although most domestically produced RSV vaccines in China are still in the preclinical stage, more than 10 vaccine companies are already involved, including Advaccine, Walvax Biotechnology, Zhifei Biological Products, BCHT Biotechnology, CanSino Biologics, and Kangtai Biological Products.Among them,ADV110, Advinvax's recombinant protein RSV vaccine (AEO11 adjuvant), is the most advanced., and it is expected to complete Phase II clinical trials this year.According to the Phase I clinical data published by Advaccine in May 2023, the ADV110 vaccine demonstrated good safety, tolerability, and immunogenicity in healthy adults aged 18-45. Furthermore, the Phase II clinical data also showed that the ADV110 vaccine exhibited excellent safety and tolerability at different doses in healthy elderly individuals aged 60-80.In addition, the RSV mRNA vaccines from Deep Biologics, Starbright Pharmaceuticals, and Dami Bio (a subsidiary of Sirnaomics) have also entered the clinical stage.
Notably, none of the three globally approved RSV vaccines have been approved for marketing in China.However, ZF Bio had reached a preliminary agreement with GSK in October 2023 regarding the promotion and cooperation of GSK's RSV vaccine in mainland China.The "Exclusive Distribution and Co-Promotion Agreement" signed by both parties also elaborates on the cooperation for ZF Bio's agency promotion and sales of GSK's recombinant shingles vaccine Shingrix in mainland China.Shingrix is also one of GSK's blockbuster products, with sales reaching approximately $3.65 billion and $4.36 billion in 2022 and 2023, respectively, representing year-over-year growth of 58.8% and 17%.However, due to factors such as the high price of the vaccine and GSK's insufficient sales experience in the Chinese market, the sales performance of Shingrix in China has not been outstanding, with sales reaching 600 million yuan in 2021 and 1.2 billion yuan in 2022.Especially worth mentioning is,The Rise of Chinese-produced Shingles Vaccines Quickly Captures Market Share.Taking the example of Baik Biotech's shingles vaccine, its sales reached a staggering 882 million yuan in just 9 months, surpassing even the initial sales momentum of Shingrix.Moreover, ZF Bio has a strong vaccine sales capability, with a sales team of 3,990 people as of the end of 2023, and over 30,000 grassroots health service points established across more than 31 provinces in China. Its successful agency of Merck's HPV vaccine is a compelling testament to this.In view of this, GSK followed Merck's strategy and handed over the Chinese sales rights of Shingrix to ZF Bio, with both parties agreeing that the cumulative procurement amount in the next three years (2023-2026) will be no less than 20.64 billion yuan.
As the RSV vaccine market becomes increasingly dynamic, Chinese vaccine companies seem to be standing at a historic crossroads: overseas giants present a "tripod situation," while domestically produced vaccines hope to gain an advantageous position in the vaccine competition.For Chinese vaccine companies, this is a rare opportunity as the market is still in its blue ocean phase, but it is also a significant challenge. With little difference in clinical progress, it means that they will inevitably face fierce market competition in the future.Who can rise first to become the leader in the "next HPV vaccine" field?1. Financial reports, announcements, and official WeChat accounts of various companies2. Research reports from Ping An Securities, Guolian Securities, and CITIC Construction Investment Securities
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