China's mRNA Vaccine Race: A Two-Horse Contest Between Abogen Biosciences and Aim Vaccine

Recently, IND approvals have been granted for multiple COVID-19 vaccines, with mRNA COVID-19 vaccines being the most eye-catching.

According to incomplete statistics, in the fiercely competitive mRNA technology sector, companies such as Walvax & Abogen Biosciences, Aim Vaccine, Stemirna Therapeutics, Sinopharm–CNBG–Funova, BlueQuail Bio, WisdomeBio, CanSino Biologics, and CSPC Pharmaceutical Group—both newcomers and established players—are accelerating their race by stepping on the gas.

Looking at the golden track of domestically produced mRNA vaccines, the final race has begun. Who will emerge as the fastest and most enduring contender?

Based on the current R&D progress and outcomes across various companies, Abogen Biosciences and Aimei Vaccine have taken the lead in domestic clinical development, with the first-tier competitive landscape gradually becoming clear.

Among the first three companies in China to obtain clinical trial approvals for mRNA COVID-19 vaccines, Abogen Biosciences and Aim Vaccine have entered pivotal clinical trials, with product marketing applications expected by the end of this year or early next year.

In terms of speed, the two companies are progressing hand in hand. Currently, Abogen’s ARCoV has completed participant enrollment for its overseas Phase III clinical trial, and the relevant R&D units are awaiting data unblinding and analysis. Aimei Vaccine’s LVRNA009 has entered Phase II/III clinical trials and has submitted an application for sequential vaccination.

Based on the results of existing Phase I clinical trials, Abogen Biosciences’ ARCoV demonstrates outstanding stability, remaining stable for extended periods (at least six months) at standard household refrigerator temperatures. However, in terms of safety, ARCoV is associated with a higher rate of adverse reactions; the incidence of fever and lymphopenia exceeds that reported across all clinical trials of the Pfizer/BioNTech and Moderna mRNA vaccines. Other media outlets have cited industry experts suggesting that if the Phase I data persist into Phase II and Phase III trials, the prospects for this vaccine would be bleak. However, based on the company’s subsequent public statements, Phase III data may prove more favorable than earlier results.

In contrast, Phase I clinical data for AiMi Vaccine’s LVRNA009 have received positive acclaim from the industry. In the Phase I clinical trial, live-virus neutralizing antibody assays demonstrated favorable safety and immunogenicity profiles, with the geometric mean titer (GMT) in the mid-dose cohort approaching 1,600. All adverse events were Grade 1 or 2, with no Grade 3 or higher adverse events reported. Furthermore, the Phase I clinical trial indicated that the vaccine effectively activates T-cell responses.

Notably, Livzon Vaccine has made full preparations for the industrialization of this product. According to Frost & Sullivan, Livzon’s mRNA vaccine pilot-scale production workshop is among the first in China to meet GMP standards, and the company’s mRNA vaccine manufacturing facility under construction is designed with an annual production capacity of 400 million doses.

The advantages of the mRNA technology platform and its remarkable efficacy in combating the global COVID-19 pandemic have spurred Chinese vaccine manufacturers to accelerate their efforts. This technology has not only generated substantial financial gains for leading vaccine companies, but more importantly, it has instilled confidence and hope in humanity’s ultimate victory over various intractable diseases.

Taking COVID-19 as an example, according to Pfizer’s financial reports, the company’s total revenue for 2021 amounted to $81.3 billion, with mRNA COVID-19 vaccine sales contributing $36.8 billion. For 2022, Pfizer projected $54 billion in revenue from its COVID-19-related businesses.

Latest research data from the School of Public Health at The University of Hong Kong indicate that, in terms of effectiveness against Omicron infection across various vaccination combinations, the regimen consisting of two doses of the BioNTech mRNA COVID-19 vaccine followed by one dose of an inactivated vaccine (heterologous boosting) showed an effectiveness slightly above 80% at 14 days post-vaccination, which declined to just over 40% after six months. In contrast, three doses of the BioNTech mRNA COVID-19 vaccine demonstrated an effectiveness exceeding 90%, and although it decreased somewhat after six months, it remained around 80%. This fully underscores the advantages of mRNA vaccines in preventing SARS-CoV-2 infection.

Focusing on the two leading contenders in China’s mRNA COVID-19 vaccine race—Abogen Biosciences and Aim Vaccine—their respective strategic layouts in the mRNA technology sector are also becoming increasingly clear.

Abogen Biosciences publicly disclosed that it will accelerate the clinical development of its series of COVID-19 vaccine products, expand the pipeline of other vaccine products, enrich its existing portfolio in the field of oncology therapeutics, and extend into additional therapeutic areas.

Public information indicates that AiMi Vaccine has a clearer strategic roadmap. Specifically regarding its COVID-19 vaccine, AiMi Vaccine plans to conduct clinical trials to expand the eligible subject age group to include individuals under 18 years of age. Furthermore, the company is developing mRNA vaccines against rabies virus and respiratory syncytial virus (RSV), aiming to gradually replace existing traditional vaccine products on the market.

AIM Vaccine recognizes that mRNA technology, as a next-generation therapeutic modality, holds potential far beyond vaccine development. Leveraging this technological platform, the company will develop mRNA-based drugs and therapeutic regimens for multiple indications, including oncology, replacement of monoclonal antibodies and protein therapeutics, immune deficiency-related disorders, heart failure, rare diseases, assisted reproductive procedures, and medical aesthetics.

The Future Is Here. In response to the changing domestic epidemic situation, the approval process for clinical trial applications of mRNA COVID-19 vaccines has accelerated. Some analysts believe this reflects, to a certain extent, the regulatory authorities’ supportive stance toward mRNA vaccines. As mRNA technology rose to prominence during the COVID-19 pandemic, its significance can be best captured by the assessment of Jean-Marie Lehn, Nobel Laureate in Chemistry: “The development of mRNA vaccines represents the most significant breakthrough in combating the pandemic. More importantly, beyond its contribution to vaccinology, this technology has ushered in an ‘mRNA era’ with broad applications in disease prevention and treatment.”