Industry Frontiers

Emerging in the field of infectious disease prevention and treatment, mRNA assets are now showing great potential in various fields such as cancer treatment. mRNA assets are undergoing unprecedented value reassessment, attracting the attention of global pharmaceutical companies and researchers, and becoming a key force driving the transformation of the pharmaceutical industry.

1、 MRNA tumor vaccine: leading a new direction in cancer treatment

In recent years, the development trend of mRNA tumor vaccines has been particularly remarkable, as if it has brought a revolutionary dawn for cancer treatment. Moderna's layout in this field can be regarded as an industry model, and the progress of its mRNA tumor vaccine V940 has greatly boosted market confidence. The 3-year data of V940 combined with K-drug treatment for resected melanoma, announced at the ASCO Annual Meeting in 2024, is stunning.

Data shows that V940 reduces the risk of recurrence or death in high-risk stage III/IV melanoma patients by 49%, and the risk of distant metastasis or death by 62%. There is also a clinically significant continuous improvement in survival without distant metastasis. This achievement means that V940 has the potential to significantly prolong the survival cycle of melanoma patients based on existing treatment methods, and even potentially rewrite the treatment landscape of melanoma.

Based on this, Moderna is confident in V940 and expects it to be launched in 2027, becoming the first mRNA tumor vaccine to be launched. This undoubtedly injects a shot in the arm into the commercialization process of mRNA tumor vaccines.

At the same time, domestic pharmaceutical companies are also catching up in the field of mRNA tumor vaccines, with Yunding Xinyao being one of the top performers. The rise of this enterprise in the mRNA field is like a dark horse, bringing many surprises to the market. On March 6, 2025, Yunding Xinyao announced that its first independently developed mRNA personalized tumor therapeutic vaccine EVM16 had completed the first patient administration, and phase 1b clinical data is expected to be released by the end of the year.

Once this news was announced, the stock price of Yunding Xinyao rose by as much as 20.12% in a single day, reaching a new high in nearly 4 years, fully demonstrating the high expectations of the market for it. Looking back at the development history of Yunding Xinyao, as early as 2021, the company proactively laid out mRNA technology and verified its platform capabilities through a series of solid research and development work.

In 2022, the phase II trial of the initial immunization of its mRNA COVID-19 vaccine PTX-COVID19-B achieved positive top line results, and achieved statistically non inferior effect with BioNTech's Comirnaty in terms of the geometric mean titer ratio of neutralizing antibodies, with good overall tolerance and similar safety. These preliminary achievements have laid a solid foundation for Yunding Xinyao in the field of tumor vaccine research and development.

The EVM16 from Yunding Xinyao has shown outstanding performance in preclinical studies. In normal mice, it can stimulate strong immunogenicity and demonstrate excellent effectiveness in homologous tumor models. In experiments conducted in rhesus monkeys, EVM16 exhibited significant characteristics of fast onset, strong and long-lasting effects. If the booster shot is administered on the 161st day, the vaccine can also stimulate a strong and persistent T cell response in rhesus monkeys, which is highly consistent with the efficacy of Moderna and BioNTech's tumor vaccines, indirectly confirming the enormous potential of EVM16 in subsequent human clinical trials.

Moreover, the combination of EVM16 and alpha PD-1 antibody exhibits a synergistic effect in T cell activation, which may lead to unexpected therapeutic effects in practical clinical applications. Therefore, the news of the first patient enrolled in the EVM16 IIT study has attracted widespread attention in the market, marking the successful entry of Yunding Xinyao's tumor neoantigen AI algorithm system and mRNA technology platform into the human trial stage, and the acceleration of value realization.

In addition to Yunding Xinyao, many domestic pharmaceutical companies have also invested in the research and development of mRNA tumor vaccines. On January 24, 2024, the clinical application for the new drug ARC01 (A002), a tumor vaccine developed by Nanjing Oro Biotechnology, a subsidiary of Yuanda Pharmaceutical, for the treatment of human papillomavirus type 16 (HPV-16) positive advanced unresectable or recurrent/metastatic solid tumors, was approved by the National Medical Products Administration.

In 2023, ABO2011 injection from Aibo Biotechnology and XH101 injection from Xinhe Biotechnology have also received approval or acceptance for clinical trials. Multinational pharmaceutical companies such as BioNTech, Moderna, CureVac, etc. are also actively expanding their presence, with dozens of clinical trials conducted worldwide

Related to mRNA tumor vaccines. The active participation of these pharmaceutical companies has promoted the development of tumor neoantigen vaccines and also indicates that mRNA tumor vaccines are expected to play an important role in future cancer treatment.

2、 MRNA layout of Chinese pharmaceutical companies: comprehensive layout, diversified development

The layout of Chinese pharmaceutical companies in the mRNA field presents comprehensive and diverse characteristics, and Yunding Xinyao is a typical representative of this. The company has established three major layouts: personalized vaccines, spot vaccines, and self generated CAR-T, which closely align with the development trend of mRNA technology in the field of cancer.

Personalized vaccines are currently a key development direction, and Yunding Xinyao's EVM16 has achieved phased results; Spot vaccines and self generated CAR-T represent future development trends. Despite the difficulty of research and development, Yunding Xinyao has also made remarkable progress in these two fields.

Taking the spot tumor vaccine EVM14 as an example, the vaccine has submitted an IND application to the US FDA in February this year and plans to submit an IND to the Drug Evaluation Center of the China National Medical Products Administration in the near future. Spot tumor vaccines have significant advantages as they target multiple tumor associated antigens, have a wide range of applications, can target multiple types of cancer, and are suitable for cancer patients at different stages. Meanwhile, due to the relatively low cost of mass production, which may even be lower than monoclonal antibody drugs, it has strong market competitiveness.

At present, the research and development of global spot mRNA tumor vaccines is still in the early stages, including overseas industry giants such as Moderna and BioNTech, which are still in the I/II research stage and making relatively slow progress; Only a few domestic enterprises such as Aibo Biotechnology have conducted relevant research, and they are all in the very early stage. If EVM14 can be successfully approved, it will become the first domestically produced spot mRNA tumor vaccine approved by the FDA, which is of great milestone significance for the development of Chinese mRNA technology worldwide.

EVM14 has demonstrated a powerful ability to effectively reduce tumor recurrence in preclinical studies. Most MC38-TAA5 tumor bearing mice showed complete tumor regression after treatment with the EVM14 vaccine. When re inoculated with MC38-TAA5 tumor cells or wild-type MC38 tumor cells, the tumors no longer grew. This phenomenon indicates that after treatment with EVM14, T cells in the patient's body can form immune memory. When encountering tumor cells again, they can quickly generate a strong immune response, effectively reducing the probability of recurrence and metastasis.

This means that although EVM14 is a therapeutic vaccine, it has functions similar to preventive vaccines, and is expected to benefit patients with "long-term cancer free survival". It has pioneering significance and enormous potential value in the field of tumor treatment. From clinical data, EVM14 has excellent preclinical data, and when combined with PD-1/CTLA-4, it significantly enhances anti-tumor activity in multiple mouse homologous tumor models, providing strong support for the exploration of combination therapy in clinical practice.

In terms of in vivo CAR-T technology, Yunding Xinyao also performed outstandingly, exceeding market expectations. The technology of directly generating CAR-T cells in the body can simplify the treatment process and has comprehensive advantages such as reducing costs and minimizing toxic side effects.

Although the fastest progress in this field globally is only in the Phase I research stage, with few domestic companies and no approved clinical trials, Yunding Xinyao has clearly defined its research and development strategy for generating CAR-T cells in vivo using mRNA technology. Key elements such as coupling methods and targeted molecules have been identified, and it is expected that the first preclinical candidate molecule will be born this year, which is expected to enter the global forefront in the In Vivo CAR-T field.

From the perspective of the company's development strategy, Yunding Xinyao plans to promote external authorization cooperation for independent research and development pipelines. Given the booming development trend in the mRNA field and the high attention and pursuit of Chinese assets by overseas pharmaceutical companies, Yunding Xinyao is expected to create a heavyweight BD project through authorized cooperation, becoming an important valuation anchor for global mRNA clinical assets. This will not only bring considerable economic benefits to the company, but also enhance the global influence of Chinese mRNA technology.

3、 AI empowers mRNA: ushering in a new era of technological innovation

Behind the booming development of mRNA technology, AI technology is playing an increasingly crucial role, and the deep integration of the two has brought new development opportunities and transformative power to the mRNA field. Taking mRNA sequence design as an example, due to the redundancy of the genetic code, each amino acid can be encoded by a massive number of codons. For example, the S protein of COVID-19 is composed of 1273 amino acids, and there are about 10 ^ 632 different mRNA sequences in theory.

The number of gene mutations in cancer cells can also be thousands, but in vaccine development, only a few mutations have practical significance. Vaccine design needs to balance multiple repetitive targets such as translation efficiency, reduction of adverse reactions, RNA synthesis efficiency, and stability, which makes traditional artificial design methods difficult to meet the needs.

The introduction of AI algorithms has completely changed this situation. It can quickly screen the best mRNA sequence from massive sequences and predict future mutation directions with unprecedented efficiency and accuracy, truly changing the logic of mRNA drug development.

Yunding Xinyao can be regarded as an industry model in AI empowered mRNA technology. In the development process of its mRNA personalized tumor therapeutic vaccine EVM16, the company's independently developed "Clever Algorithm" system (EVER-NO-1) new antigen prediction algorithm played a core role. This algorithm collects tumor samples from patients and blood samples from healthy individuals, conducts comprehensive sequence analysis and comparison, and accurately identifies cancer specific mutations in patients.

Subsequently, using deep learning prediction algorithms, the mutation list was transformed into new antigens on the surface of cancer cells, and mRNA specific to the patient was designed. The "Miao Suan" system's new antigen prediction algorithm has strong global competitiveness, not only being able to identify the vast majority of reported tumor new antigens, but also successfully identifying multiple previously unreported tumor new antigens. In multiple independent validation studies, the algorithm has demonstrated comparable or superior ability to predict new antigens compared to industry-leading algorithms.

On a global scale, the mRNA field is sparking a fierce AI arms race. Moderna not only quickly launched its own generative artificial intelligence product mChat, but also actively carried out a series of work to promote the application of artificial intelligence in various aspects of mRNA drug development, including the creation of artificial intelligence generation models for new candidate proteins, artificial intelligence generation models around small molecules, and their applications in drug clinical research, drug vigilance, production and manufacturing, and even commercial fields. Moderna firmly believes that investing in the AI field will help build a more outstanding self and drive mRNA technology to new heights.

The national level has also attached great importance to and provided strong support for this competition. In January 2025, the United States announced the launch of the "Stargate Project", which plans to inject $500 billion to accelerate the research process of cancer treatment through AI and mRNA technology. The plan is led by SoftBank OpenAI、 Top tech giants such as Oracle have joined forces to promote a luxurious lineup.

Oracle founder Larry Ellison claims that with the help of AI technology, cancer in the human body can be detected in just 48 hours, and an exclusive vaccine can be produced within 48 hours. This commitment demonstrates the enormous potential of AI in the field of cancer treatment. OpenAI CEO Sam Ultraman also pointed out that with the continuous advancement of technology, we will witness a significant improvement in the speed of disease cure, and AI will also have a positive impact on the cost of high-quality healthcare.

MRNA technology has profound significance in the field of life sciences, and its economic value is also immeasurable. According to a report by Precedence Research, it is expected that the global mRNA therapy market will reach $42.64 billion by 2034, and the economic potential of the healthy population released by this technology is expected to grow several times.

It is precisely based on this broad prospect that many developed countries such as the UK and South Korea have invested huge amounts of money in mRNA technology to promote its development. For example, the UK launched a large-scale clinical trial program for cancer vaccines last year, led by the National Health Service (NHS) to establish a dedicated NHS Cancer Vaccine Launch Platform (CVLP). The plan is to enable approximately 10000 cancer patients to receive mRNA cancer vaccine treatment through the platform by 2030.

For Chinese innovative pharmaceutical companies, actively participating in the "AI+mRNA" arms race has important strategic significance and urgency. The successful experience of Yunding Xinyao shows us that domestic enterprises have the strength to compete with top tier enterprises on the international stage, and this competitiveness is expected to continue to consolidate in accordance with the "Moore's Law". The essence of AI competition lies in algorithms, and the accumulation of data can promote the continuous maturity of technology, accelerate iteration speed, and thus achieve the improvement of molecular output efficiency and quality at the clinical research level, forming a virtuous cycle.

Since 2021, Yunding Xinyao's proprietary mRNA sequence design algorithm has undergone three iterations, each of which has brought significant performance improvements, laying the foundation for further acceleration of subsequent iterations and forming a "data algorithm clinical validation" flywheel effect.

Looking ahead, we have reason to believe that Chinese companies will continue to create more surprises in the field of "AI+mRNA". Enterprises such as Yunding Xinyao can not only continue to deepen their cultivation in the mRNA field and achieve further technological breakthroughs, but also have the potential to expand their AI capabilities to more fields. As the unlimited potential of "AI+healthcare" is gradually released, the underlying logic of AI research and development of innovative drugs will be applied in more scenarios. Through strategic transformation and continuous technological investment, Chinese enterprises such as Yunding Xinyao have achieved a strategic upgrade from a focus on introduction to a dual wheel drive of "introduction+self-developed".

With the advantages of independent technology platforms and AI technology, these enterprises will continue to broaden their path of independent research and achieve disruptive results at a faster pace in the global "AI+mRNA" competition. They will provide new ideas and methods for overcoming the challenges of tumor treatment, especially reducing tumor recurrence and metastasis, create more "DeepSeek moments", lead the development trend of global mRNA technology, and make greater contributions to human health.

Original link: https://www.xianjichina.com/special/detail_570330.html

Source: Xianji.com

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