Preventing tumor recurrence and metastasis remains one of the most formidable challenges in the ongoing advancement of modern medicine. On January 21st, Beijing time, the latest clinical data from Merck & Co. and Moderna offered a new potential solution: five-year follow-up data from a Phase II clinical trial for the combination of their mRNA-4157 (V940) and the PD-1 inhibitor Keytruda in treating melanoma showed that in high-risk stage III/IV melanoma patients after complete resection, the combination therapy significantly reduced the risk of recurrence or death by 49%, with the efficacy remaining stable over the long-term follow-up. Influenced by this news, Moderna's U.S. stock price continued to climb. The industry widely regards this as the first long-term survival benefit evidence for mRNA technology in the non-infectious disease field, providing a significant boost to the global field of cancer immunotherapy.
Existing cancer treatments have not been able to adequately address the issues of recurrence and metastasis. This research data suggests that mRNA technology might play a role in preventing tumor recurrence and metastasis.
Simultaneously, it was learned from domestic biopharmaceutical companies, including Everest Medicines Ltd. ("Everest Medicines"), that the pace of domestic companies' strategic deployment and advancement in mRNA technology is also accelerating noticeably. The advantages of mRNA technology are gradually becoming apparent. Public information indicates that mRNA technology works by introducing mRNA encoding specific antigen proteins into human cells, which then directly produce the antigen proteins within the body, thereby inducing a specific immune response. Compared to traditional vaccines or drugs, its research and development pathway and production logic are significantly different.
mRNA technology is considered the third-generation drug development platform, following small molecules and large-molecule antibodies. Its greatest characteristics are the short drug development cycle and high versatility. Currently, the safety and efficacy of mRNA technology have been relatively well validated, and its long-term market potential is gradually emerging.
In the field of cancer treatment, mRNA technology may potentially prevent tumor recurrence and metastasis. Cancer vaccines developed based on mRNA technology, after entering human cells, can stimulate the generation of immune cells. These immune cells can attack tumor cells and create specific immune memory; if tumor cells attempt a 'comeback,' they are immediately identified and eliminated by the immune cells. We have observed such effects in animal experiments.
It was also learned that mRNA technology makes drug development somewhat akin to programming DNA, potentially revolutionizing the drug development model. Beyond oncology, mRNA technology holds broad application prospects in various difficult-to-treat disease areas, including autoimmune diseases, metabolic diseases, and infectious diseases. According to predictions from institutions like Precedence Research and Rongzhong Consulting, the global market size for mRNA drugs is approximately $18 billion in 2024 and is expected to grow to over $43 billion in the next 10 years, accounting for 10%-15% of the total pharmaceutical market.
Domestic companies are accelerating their strategic deployments. Against the backdrop of the rapid global development of the mRNA industry, several domestic companies are also actively positioning themselves in this field, gradually forming differentiated technological pathways. It was learned from Everest Medicines that its self-developed mRNA personalized therapeutic cancer vaccine, EVM16, has now initiated its first-in-human clinical trial in China and completed patient dosing. Its investigator-initiated trial (IIT) has completed low- and medium-dose cohort escalation, with preliminary data showing positive results. Everest Medicines expects to read out complete early-stage clinical data within the next 6 to 12 months.
According to a relevant person in charge at Everest Medicines, this mRNA vaccine was developed based on the company's self-developed EVER-NEO-1 "Miao Suan" AI algorithm system for tumor neoantigens. In March 2025, EVM16 completed the first patient dosing at Peking University Cancer Hospital. Their algorithm system can not only identify most reported tumor neoantigens but has also discovered several previously unreported neoantigens. In multiple independent validation studies, the "Miao Suan" algorithm demonstrated predictive capability comparable to internationally leading algorithms.
The nano-delivery system is a core technological bottleneck and key breakthrough point in mRNA drug研发, significantly impacting its druggability and efficacy, and is a critical link in achieving clinical translation. Jitech Technology (Beijing) Co., Ltd. ("Jitech Tech") is a domestic startup focused on AI-driven nano-delivery. It was learned from the company that by the end of 2025, its self-developed mRNA-encoded bispecific antibody (TCE, T-cell engager) drug candidate MTS-105 for hepatocellular carcinoma treatment, which utilizes its proprietary liver-high-specificity LNP delivery system, received Orphan Drug Designation in the United States. It is expected to potentially become the world's first mRNA-encoded TCE therapy for solid tumors and has now entered the clinical development stage.
JiaChenXiHai (Westlake Therapeutics) possesses multiple technology platforms including mRNA, self-amplifying RNA (saRNA), and circular RNA (circRNA), and has also formed significant differentiated advantages in delivery technology. Their unique ready-to-use delivery vector addresses the bottleneck of the stringent storage conditions required for mRNA vaccines, greatly improving vaccine accessibility. Additionally, JiaChenXiHai's targeted delivery vectors are expanding the application of mRNA in the direction of in vivo CAR-T, entering the vast blue ocean market of autoimmune diseases.
Based on an incomplete review, listed companies such as CSPC Pharmaceutical Group Limited, CanSino Biologics Inc., and Youcare Pharmaceutical Group Co., Ltd. have also disclosed information indicating strategic deployments in mRNA technology platforms.