The mRNA Pivot Year: Can Star Companies Sustain Momentum as China's Market Transforms?

Last week, CanSino Biologics announced its support for AstraZeneca’s mRNA vaccine project, driving a sharp surge in its stock price. The partnership allows CanSino to utilize its excess production capacity, while AstraZeneca’s pursuit of mRNA technology, combined with its strengths in oncology, has sparked market speculation about the potential of mRNA-based cancer vaccines.

This is a microcosm of the mRNA sector in the post-pandemic era. Over the past two years, mRNA technology has gained widespread acclaim for its application in COVID-19 vaccines, sparking a surge of domestic mRNA startups in China. However, as the pandemic recedes, the mRNA field has entered a phase of consolidation: companies are either being acquired, pivoting their business strategies, or exiting the sector altogether.

“There is a large number of mRNA innovative drug companies in China, resulting in intense competition. Only those with excellent technology platforms and comprehensive capabilities are likely to emerge as leaders,” pointed out an industry insider.

In the vaccine race of the past few years, mRNA has proven its value. However, very few companies have been able to capitalize on this “Kondratiev wave moment.” COVID-19-related pipelines and manufacturing facilities have come to an end along with the pandemic. Moving forward, the increasingly mature mRNA technology will be applied to other therapeutic areas, including cell and gene therapy, antibody drugs, and protein replacement therapies.

The two most closely watched companies in the global mRNA sector, Moderna and BioNTech, must also contend with the downturn from their pandemic-era peaks and identify new growth trajectories: both vaccine manufacturers aim to secure approvals for additional vaccines.

In Moderna's subsequent pipeline,The RSV vaccine has submitted a rolling Biologics License Application (BLA) in the United States in July and filed a full Marketing Authorization Application (MAA) in Europe, among other regions. The tumor neoantigen mRNA vaccine, developed in collaboration with Merck & Co., has initiated Phase III clinical trials for melanoma.

BioNTech initially built its foundation on cancer vaccines, and its oncology-related pipeline has once again become a corporate priority. This includes BNT113, a candidate developed based on BioNTech’s off-the-shelf mRNA cancer immunotherapy platform FixVac; BNT316, co-developed with OncoC4 for non-small cell lung cancer (NSCLC); and BNT122, developed in collaboration with Genentech as an adjuvant therapy for pancreatic cancer.BioNTech expects its oncology products to make their debut in 2026.

In China, the suspension of trial operations at SteadyMed’s Tianci facility has drawn significant attention. The plant was originally intended for the production of COVID-19 mRNA vaccines, but there is currently “no demand for COVID-19 vaccine production.” During the same period, SteadyMed registered an investigator-initiated trial (IIT) to evaluate a tumor neoantigen mRNA vaccine for the treatment of advanced malignant tumors, in collaboration with Peking University Cancer Hospital.

The New Era of mRNA Is Unfolding,How is the momentum of star companies, and what changes are taking place in the domestic market?

The COVID-19 pandemic provided a real-world testing ground for various vaccine platforms. mRNA vaccines rapidly underwent human clinical trials, further validating their safety and highlighting the remarkable development speed of mRNA technology: Moderna’s COVID-19 mRNA vaccine took only 42 days from project initiation to Phase I clinical trials.

“We have successfully validated one candidate and are close to achieving the same for another,” said Chen Bofan, Vice President of Regenerative Medicine.

Regen Biopharma is one of the earliest startups in China to enter the mRNA field. Its accumulated patents for mRNA drug development cover product development across the entire industrial chain of mRNA vaccines and innovative therapeutics, establishing a vertically integrated platform capability.

Amid skepticism that mRNA technology was merely a fleeting trend buoyed by the “tailwinds” of the COVID-19 pandemic, mRNA companies quickly demonstrated their robust capabilities once again with RSV vaccines.According to statistics, the global market size for RSV therapeutics is projected to grow from $1.8 billion in 2020 to $12.8 billion by 2030. The industry has been engaged in R&D of RSV vaccines for over 60 years, with GSK’s RSV vaccine Arexvy and Pfizer’s RSV vaccine Abrysvo for older adults finally gaining approval and reaching the market in 2023.

Moderna’s candidate vaccine, mRNA-1345, was granted Fast Track designation by the FDA in 2021 as it prepared to enter Phase II/III clinical trials, and by July of this year, the company had submitted marketing applications for its RSV vaccine in multiple countries. Phase III clinical trials demonstrated that the vaccine exhibited an efficacy of 83.7% against RSV-associated lower respiratory tract disease defined by two or more symptoms, and an efficacy of 82.4% against RSV-associated lower respiratory tract disease defined by three or more symptoms.mRNA technology has achieved remarkable results in the highly challenging field of RSV vaccines.

mRNA-1345 utilizes the same lipid nanoparticles (LNPs) as Moderna’s COVID-19 vaccine. The success of this RSV vaccine demonstrates that the experience accumulated during the development of the COVID-19 vaccine has been effectively leveraged, further confirming the high reusability and platform-based nature of mRNA technology.mRNA has finally paved its way to becoming a viable drug in the conventional vaccine field, enabling it to compete with other technologies for a multi-billion-dollar market.

Tumor immunotherapy holds even broader prospects; no technology platform or innovative therapy can bypass this massive market.Moreover, the principles of mRNA technology and tumor immunotherapy are inherently highly compatible:The goal of tumor immunotherapy is to activate the host's anti-tumor immunity and alter the tumor-suppressive microenvironment. In addition to activating B cell-mediated antibody immunity, mRNA vaccines can also stimulate T cell responses. Rather than saying that various mRNA companies are pivoting toward tumor immunotherapy, it is more accurate to describe them as building on their prior successes to press their advantage.

“Tumor immunotherapy is certainly a new growth engine for mRNA companies. However, the challenges lie not only in the mRNA technology itself, but also”Bioinformatics of Tumors“mRNA works by expressing target proteins (tumor antigens) in vivo; a prerequisite for its efficacy is knowing which proteins need to be expressed. If the accuracy of tumor antigen prediction is insufficient, even the high inherent compatibility between mRNA technology and cancer immunotherapy may not yield ideal outcomes,” pointed out Chen Bofan, highlighting the challenges in advancing the application of mRNA in cancer immunotherapy.

“Additionally,Cost IssuesFor example, BioNTech’s personalized pancreatic cancer vaccine must complete the entire process—from sample analysis and drug manufacturing to reinfusion—within a matter of weeks. Previous estimates have placed the cost of this process at tens of thousands of euros, implying that the final commercial product would carry an exorbitant price tag, making it affordable only to a very small fraction of patients even after market launch. Reducing costs is therefore a critical challenge that the industry must explore and address. Regeneron Biopharma is also actively pursuing solutions in this area, leveraging strategies such as patent portfolio development, raw material supply chain management, process optimization, and technological iteration, with the aim of delivering commercially viable and truly accessible therapies to benefit human health.

Compared with the currently hot bispecific antibodies and ADC technologies, which are closer to commercialization, mRNA technology in China is still in its early stages. Investors have been particularly cautious this year, demanding clear product differentiation and a well-defined path to industrialization. In the face of more mature technologies, mRNA lacks prominent competitiveness. Recently, Chen Zhisheng, CEO of WuXi Biologics, bluntly stated, “Many companies are pursuing R&D in the mRNA space, but it is difficult to deliver actual products... At present, mRNA remains all talk and little action.”The Competition Between mRNA Products and Traditional Products Still Has a Long Way to Go。”

Yet all transformations begin with small-scale exploration, much like the prolonged developmental journey of antibody-drug conjugates (ADCs). mRNA technology, having weathered the pandemic, boasts broad prospects for industrialization. A review published in Nature Reviews in September 2021 predicted that by 2035, the global market size for preventive mRNA vaccines will reach $12–15 billion; the market for personalized cancer vaccines will amount to approximately $7–10 billion; and the market for protein replacement therapies and other applications will be around $4–5 billion. This corresponds to a total addressable market of approximately $23–30 billion for mRNA technologies in both therapeutic and preventive fields, with a compound annual growth rate (CAGR) of 68% from 2025 to 2035.

CRDMO companies are the most sensitive to changes in market demand.Dr. Wang Xiao, Co-founder and CEO of WuXi Biologics’ partner company (or as appropriate: KaiTuo Bio), shared her insights with VCBeat New Medicine: “mRNA has evolved into a broadly applicable emerging technology platform, rather than merely a tool targeting specific diseases. From late last year to the present, we have observed an expansion into more indications—major categories include infectious disease vaccines and oncology; additionally, some companies are developing therapeutics for chronic and rare diseases, while numerous innovative efforts combining mRNA technology with gene editing and cell therapy are also underway.”

WuXi Biologics provides one-stop CRDMO services specifically for biopharmaceutical companies in the DNA and RNA fields, pioneering an integrated industrial chain from plasmids to RNA, LNPs, and fill-finish processes. According to Dr. Wang Xiao, WuXi Biologics has seen continuous growth in its customer base and order volume this year. It currently serves over 100 clients and has begun international expansion, with successful track records in delivering overseas orders.

““Another significant change in the market is the scale of production. Currently, facilities sized appropriately for the Investigational New Drug (IND) application stage are experiencing high utilization rates. Our collaborators include not only mRNA biotechnology companies, but also vaccine manufacturers and comprehensive pharmaceutical enterprises that are strategically deploying mRNA technologies, as well as animal vaccine companies entering the field.”Dr. Wang Xiao believes that,““mRNA technology applications are flourishing. What matters most is for the entire industry to remain focused, lay a solid foundation, strengthen collaboration, and systematically overcome technical barriers, thereby fulfilling the widespread expectations for this emerging field.”

However, domestic mRNA companies, or those expanding into the mRNA field, still face multiple challenges in R&D and future commercialization.

First,Patent Portfolio, there is a significant gap between China and other countries. Leading overseas mRNA companies, such as Moderna and BioNTech, hold more than 2,000 patents in the mRNA field, while CureVac holds several hundred. Chen Bofan pointed out: “Domestic mRNA enterprises must directly address patent issues during their industrialization process. As innovative drug R&D companies, they must build their own patent portfolios to better compete internationally in the future.”

Second,Technical Interdisciplinary CapabilityBreakthroughs in individual technical capabilities are insufficient to meet the demands of mRNA drug development. For instance, personalized mRNA cancer vaccines require extensive expertise across multiple disciplines, including clinical practice, immunology, algorithm development, chemical delivery systems, and formulation processes, thereby presenting high technical barriers.

Third,Business Control, The vaccine development race during the COVID-19 pandemic has demonstrated that companies standing out need precise control over every detail across the entire process; any lag or error in any link carries the risk of total failure. On one hand, in an environment where rationality is returning, companies may need to streamline their operations and concentrate on advancing the clinical progress of key pipelines; on the other hand, they should actively seek external collaborations to secure support for mRNA technologies across all stages, including R&D, translation, production, and commercialization.

mRNA-based drugs feature short development cycles, strong platform scalability, no risk of genomic integration, and a high safety profile. As numerous multinational corporations (MNCs) enter the field and deepen their involvement, mRNA-based therapies are poised to reach new heights. Entrepreneurs in China who are deeply committed to the mRNA sector are riding this wave and have the opportunity to grow into the next generation of innovative pharmaceutical companies.