Moderna’s “mRNA Personalized Vaccine” Achieves Initial Success as Chinese Innovative Drugs Queue Up

The success of Moderna’s Phase III clinical trial provides the first key proof-of-concept for the feasibility of mRNA technology in oncology treatment, drawing market attention to Chinese healthcare companies actively positioning themselves in this sector.

According to Zhuifeng Trading Desk, a report released by Citigroup Research on August 20 stated that the success of Moderna’s Phase III trial demonstrates that mRNA vaccines can produce clinically meaningful results in oncology. However, several challenges remain to be addressed before broader application in cancer treatment, including validating clinical efficacy in indications beyond melanoma, neoantigen screening, lipid nanoparticle (LNP) delivery, and personalized manufacturing. In the report, Citigroup expressed optimism about Chinese mRNA-related companies that possess mature platforms, production infrastructure, and the ability to combine vaccines with their own tumor immunotherapy drugs.

This assessment has direct market reference significance for the Chinese innovative drug sector. Currently, Hengrui Pharma, CSPC PHARMA, AKESO, EVEREST MED, and CanSinoBIO have all established positions in the field of mRNA cancer vaccines, each at different clinical stages, with significant differences in progress and technical pathways.

Moderna’s Phase III Success: Significant Proof-of-Concept, Yet Challenges Remain

The success of Moderna’s recent Phase III trial marks the first time an mRNA personalized cancer vaccine has demonstrated its oncological therapeutic value in a large-scale clinical trial, regarded as a major milestone for this technological route.

However, research indicates that this success is currently limited to the melanoma indication, and whether it can be replicated in other cancer types remains a core uncertainty. Furthermore, precise screening of neoantigens, optimization of LNP delivery efficiency, and the execution capability for personalized small-batch production are key bottlenecks restricting the large-scale clinical implementation of this technology.

The development process for personalized mRNA cancer vaccines is highly complex—from sequencing patient tumor samples, identifying neoantigens, and constructing mRNA, to LNP encapsulation and individualized quality release. Each step imposes strict requirements on platform integration capabilities and production turnaround efficiency.

Chinese Players: Clear Differentiation in Platform Maturity and Clinical Progress

Among the Chinese mRNA companies covered by Citigroup, Hengrui Pharma and CSPC PHARMA are considered to have outstanding comprehensive strength.

Hengrui Pharma has positioned itself in personalized neoantigen therapy through its 47%-owned subsidiary, Ruihongdi. Ruihongdi’s RGL-270 is a personalized neoantigen mRNA vaccine that has currently entered Phase II clinical trials, making it one of the projects with the most advanced clinical progress in China. In a 16-patient open-label investigator-initiated trial (IIT) involving patients after pancreatic cancer resection, RGL-270 combined with adebrelimab reported a 100% 18-month recurrence-free survival rate and a 100% vaccine-specific immune response rate, with a median follow-up time of 18 months. This dataset has a small sample size and lacks a control design, so the conclusions require confirmation through larger-scale studies. Additionally, an independent Phase II study of RGL-270 combined with adebrelimab as adjuvant therapy for high-risk resected non-small cell lung cancer is also underway.

CSPC PHARMA’s SYS6026 is a therapeutic mRNA vaccine delivered via LNP, targeting HPV16/18 E6 and E7 antigens for HPV-associated high-grade squamous intraepithelial lesions of the cervix, currently in Phase II clinical trials. Unlike RGL-270, SYS6026 is a standardized viral antigen vaccine rather than a patient-specific neoantigen product. Its ongoing trial employs a multicenter, randomized, double-blind, placebo-controlled design, offering a clearer path for efficacy validation.

Early-Stage Companies: Pipeline Potential Promising, But Data Accumulation Takes Time

AKESO, EVEREST MED, and CanSinoBIO are also positioned in the mRNA cancer vaccine field but are overall at earlier stages.

AKESO’s AK154 is a Phase I personalized neoantigen mRNA vaccine for adjuvant treatment after pancreatic cancer resection, evaluating its efficacy as a monotherapy and in combination with cadonilimab (a PD-1/CTLA-4 bispecific antibody) or ivonescimab (a PD-1/VEGF bispecific antibody). Human data for this project has not yet been disclosed. Citigroup pointed out that AKESO’s proprietary bispecific antibody combinations give it the most differentiated internal combination strategy among Chinese developers, making the option value of its pipeline worthy of attention.

EVEREST MED’s EVM16 is a Phase I personalized neoantigen mRNA vaccine targeting advanced solid tumors. First-in-human data from nine patients showed that eight exhibited neoantigen-specific T-cell responses, with no dose-limiting toxicities, and all treatment-related adverse events were Grade 2 or lower. EVEREST MED is also developing EVM14—an off-the-shelf tumor-associated antigen mRNA vaccine—allowing it to cover both personalized and standardized technical routes. CanSinoBIO is leveraging its mRNA processes and proprietary LNP delivery capabilities to develop therapeutic mRNA cancer vaccines, including an early-stage glioblastoma project, but its disclosed oncology pipeline remains currently in preclinical or earlier stages.

The Citigroup report also outlined the value chain composition of personalized mRNA cancer vaccines from an industrial chain perspective. Gene sequencing of tumor and normal samples is the starting point of the entire process, creating upstream demand for sequencing platforms and bioinformatics service providers such as MGI Tech and Novogene. Screened neoantigens are then encoded into optimized mRNA constructs, with the LNP delivery system determining intracellular expression efficiency, immune activation intensity, and tolerability.

Unlike traditional mass-produced vaccines, personalized products require rapid small-batch production and patient-level quality release, making CMC execution capabilities and treatment turnaround time key constraining factors. Platform value must ultimately be validated through clinical immunogenicity, recurrence outcomes, and combination data with checkpoint inhibitors. This logic favors developers who simultaneously master both vaccine platforms and complementary tumor immunity assets.