The first batch of enlightened pharmaceutical companies

The first batch of enlightened pharmaceutical companies have already taken the lead in enjoying the dividends of the RSV drug era.

As the first year of commercialization for RSV drugs, 2023 saw two RSV vaccines and one preventive antibody drug collectively achieve $3 billion in sales.

As the curtain slowly rises on market competition, more pharmaceutical companies continue to gain enlightenment.

Domestic Players No Longer 'Silent'

For the Chinese market, the RSV drug 赛道 can be described as a 'blue ocean within a blue ocean.'

Currently, among the three globally approved RSV drugs, only Sanofi/AstraZeneca's Beyfortus (nirsevimab) was launched in China this January, while GSK's Arexvy is still in Phase I clinical trials and is expected to achieve commercialization by 2026.

Although the domestic market is still in its infancy, the potential is enormous. According to CIC data, by 2030, China's RSV drug market size is expected to grow to $1.5 billion, with a compound annual growth rate of 75.8%, far exceeding the global growth rate (21.4%). Among this, RSV drugs targeting children are expected to account for 89.4% of China's total RSV drug market.

This has undoubtedly attracted many domestic companies to 布局， including Advaccine, Clover Biopharmaceuticals, Walvax Biotechnology, AIM Vaccine, and Zhifei Biological, with most adopting proven technical routes such as recombinant protein and mRNA.

Image source: AVIC Securities research report

The fastest progress is Advaccine's recombinant protein subunit vaccine ADV110 (BARS13), which has shown good safety, tolerability, and immunogenicity in Phase II clinical trials for elderly aged 60-80 and Phase I trials for adults aged 18-45.

Clover Biopharmaceuticals' bivalent recombinant protein RSV candidate vaccine SCB-1019, developed based on its proprietary Trimer-Tag (protein trimerization) vaccine technology platform, has yielded positive preliminary data in Phase I trials for adults aged 18-59.

Others in early clinical stages include recombinant protein vaccines by CanSino Biologics and Kangtai Biological, as well as recombinant subunit vaccines by Baike Biotechnology.

In terms of mRNA vaccines, AIM Vaccine, Walvax Biotechnology/BlueLake Biotech, CSPC Pharmaceutical Group, and JiaChen WestSea have all entered the field, currently in early clinical stages.

Notably, Zhifei Biological signed an agreement with GSK last October for the exclusive sales of the shingles vaccine Shingrix in China, while also reaching a preliminary cooperation 意向 for the latter's RSV vaccine Arexvy.

Additionally, some domestic companies have chosen to 布局 RSV preventive drugs.

For example, Ark Biosciences' RSV antiviral drug AK0529 has submitted a marketing application to the NMPA for treating RSV infections in infants and adults, potentially becoming the world's first approved clinical drug for RSV infections; Zhixiang Jintai's recombinant RSV monoclonal antibody GR2102, approved for clinical trials this February, is intended for preventing RSV infections.

Global Competition for the 'Big Cake'

According to incomplete statistics, there are nearly 70 RSV preventive pipelines globally, involving technical routes such as live attenuated vaccines, subunit vaccines, mRNA vaccines, and recombinant vector candidate vaccines targeting different viral proteins, with participants including giants like Johnson & Johnson and Merck.

Among them, Moderna's mRNA-1345 has the fastest progress, showing significant efficacy for the elderly over 60 and has applied for marketing authorization in the EU, Switzerland, Australia, and the U.S., while also conducting clinical trials for pediatric populations.

Particularly noteworthy is that AstraZeneca, which already has RSV preventive drugs, has 顺势 entered the RSV vaccine 赛道： at the end of 2023, it acquired Icosavax for $1.1 billion, whose core product IVX-A12 is a potential first-in-class VLP 组合 candidate vaccine targeting RSV and human metapneumovirus (hMPV), granted FDA Fast Track designation for adults over 60, complementing Synagis and Beyfortus to cover more populations, with Phase III trials 即将开展。

Beyond technological innovation, some companies are developing vaccine 联合疗法。 For example, GSK recently initiated a Phase III clinical trial for 联合免疫 of its RSV recombinant protein vaccine + COVID-19 mRNA vaccine; Moderna is also developing a triple mRNA vaccine for flu/COVID-19/RSV, mRNA-1230, currently in preclinical stages.

There are also numerous RSV preventive drug pipelines, including Merck's clesrovimab, Zhuhai Trinomab's TNM001, and Sanofi's gontivimab, all in Phase II or later stages.

The progress of these pipelines clearly indicates that the RSV drug market will enter a 白热化 stage in the coming years.

Global RSV antibody pipelines are abundant

Image source: Kaiyuan Securities research report

Since RSV can infect a wide population, expanding the applicable age range has become key to driving RSV vaccine growth. This is similar to HPV vaccines.

Merck's 九价 HPV vaccine became a blockbuster precisely due to its age-expansion strategy, extending the target population from females aged 16-26 to 9-45, significantly increasing the 潜在 consumer base and doubling the market space.

Beyond the elderly, the applicable 人群 for RSV vaccines continues to expand. At the end of January this year, the EU accepted GSK's application to expand Arexvy's 适用人群 to adults aged 50-59, expected to be approved in the second half of this year. Unfortunately, Arexvy's clinical trials for infants and pregnant women were unsuccessful.

Meanwhile, Pfizer's Abrysvo is also expanding its 适用人群: in August last year, it received FDA approval for a new indication for pregnant women at 32-36 weeks of gestation to protect newborns from RSV infection. Moreover, Abrysvo's Phase III study for people aged 18-59 has succeeded，即将申请上市， while Phase III trials for high-risk children and adolescents aged 2-17 are underway.

Clearly, both GSK and Pfizer are striving to 攻克儿童人群， especially infants under 5. After all, this age group is the most 核心易感人群 for RSV, with better market prospects. According to CIC data, RSV drugs for children are expected to grow to $11.7 billion by 2030, accounting for 91.1% of the global RSV drug market.

Accordingly, many pharmaceutical companies have 布局儿童 RSV vaccines, including Sanofi's nasal spray live attenuated vaccine LID/ΔM2-2/1030s (Phase III, expected to submit for marketing approval in 2026) and BlueLake Biotech's BLB-201 (Phase II).

Notably, Sanofi's LID/ΔM2-2/1030s can protect newborns during the second RSV 流行季 (April-September of the following year), while its jointly developed Beyfortus with AstraZeneca can protect newborns during the first RSV 流行季 (October-March of the same year), achieving comprehensive 布局。

Image source: MinSheng Securities research report

A $10 Billion 赛道

As a newly emerged star 赛道， RSV vaccines have large market demand and strong growth potential, dubbed the 'next HPV vaccine.'

Respiratory syncytial virus (RSV) infections are widespread and highly seasonal, peaking in late autumn and early winter, posing a threat to all age groups, especially high-risk populations such as infants, immunocompromised adults, and the elderly. According to WHO statistics, RSV causes approximately 64 million child infections and 360,000 adult hospitalizations globally each year.

Treatment for RSV infections mainly 分为 active immunization (RSV vaccines) and passive immunization (RSV preventive drugs).

In 1998, the world's first RSV preventive drug, Synagis (palivizumab) by MedImmune (later acquired by AstraZeneca), was approved by the FDA for preventing RSV-induced lower respiratory tract diseases in premature infants.

However, due to its high cost, limited patient coverage (approved only for premature infants in the U.S.), and monthly injection requirements, Synagis only became a 'blockbuster drug' 10 years after its launch.

In recent years, RSV preventive drugs have achieved major breakthroughs: Beyfortus (nirsevimab), jointly developed by AstraZeneca and Sanofi, was approved by the EU and FDA in 2022 and 2023, respectively, for preventing RSV-induced lower respiratory tract diseases in infants.

Image source: Ping An Securities research report

In contrast, the development of RSV vaccines has been more 坎坷， taking over 60 years to finally see 曙光。

In May 2023, GSK's Arexvy and Pfizer's bivalent RSV vaccine Abrysvo were successively approved by the FDA for preventing RSV-induced lower respiratory tract diseases in people aged 60 and above.

Thus, 2023 became the first year of commercialization for RSV drugs, with impressive sales. Arexvy achieved $1.566 billion in sales in just 7 months, Abrysvo reached $890 million in 6 months, and Beyfortus generated $598 million in revenue.

GSK predicts that Arexvy's peak sales will exceed £3 billion, highlighting the enormous potential of the RSV vaccine market.

Due to widespread infections, significant disease burden, and a still-blue ocean market, the RSV drug market has the potential to reach tens of billions of dollars. According to CIC research data, the global RSV drug market size is expected to grow to $12.8 billion by 2030.

$CLOVER BIO-B(02197.HK) $WALVAX(300142.SZ) $ZHIFEI-BIOL(300122.SZ)

References:

1. Financial reports, announcements, and official social media of various companies

2. "Pfizer, GSK, Sanofi... The $10 Billion RSV 赛道 Is a Battleground! Market Wars, Patent Wars—What Are the Opportunities for Domestic Pharma?", Pharmaceutical Economics News, 2024-02-08

3. "$1.1 Billion AZ Joins the Fray, Launching a 'Three-Kingdom' Battle with Pfizer and GSK? Who Is the Top Domestic Player in the RSV 赛道？", E 药经理人， 2023-12-16

4. Research reports from Ping An Securities, MinSheng Securities, Kaiyuan Securities, and AVIC Securities