World's First Mpox mRNA Vaccine Receives Dual Clinical Trial Approvals in China and the U.S.

A Chinese biotechnology company has achieved a global first in the race to develop next-generation vaccines against mpox, securing regulatory clearance to begin clinical trials in both China and the United States — a dual approval that underscores the growing capabilities of China's mRNA platform technology.

Ab&B Bio-Tech Co., Ltd., together with its Shanghai-based subsidiary Yihui Biotechnology (Shanghai) Co., Ltd., received approval from China's Center for Drug Evaluation (CDE) under the National Medical Products Administration for an investigational new drug application for its mpox mRNA vaccine. The approval makes it the world's first mpox mRNA vaccine to obtain clinical trial authorization in both China and the U.S., according to the company.

The milestone represents more than a regulatory win. It signals that Ab&B Bio-Tech's proprietary mRNA technology platform has reached a level of maturity that positions the company to contribute to global public health responses — a significant development as nations continue to seek more effective tools against emerging infectious diseases.

The vaccine employs an innovative quadrivalent antigen design, combining four antigens — A27, L1, A33, and B5 — in a tandem configuration on a single mRNA strand. This architecture enables each of the four antigens to be expressed independently from one mRNA molecule, a design the company says offers advantages in both manufacturing efficiency and immune response breadth.

In preclinical studies, the vaccine demonstrated strong immunogenicity in both Sprague-Dawley rats and rhesus macaque models, generating high levels of binding antibodies, neutralizing antibodies, and cellular immune responses. The company also reported favorable safety profiles and robust in vivo protective effects in mpox challenge tests. On the manufacturing side, the product features high yield and highly controllable quality — characteristics the company says give it a commercialization advantage.

The mpox mRNA vaccine is the latest innovation to emerge from Ab&B Bio-Tech's mRNA technology platform. To date, the platform has produced two innovative vaccines that have received dual clinical trial approval in both China and the United States. The company credits this sustained output to a research and development team led by Ph.D. holders from both domestic and overseas institutions.

The platform's core strengths lie in its development agility and scalable production potential. As a "digital" platform, once a target genetic sequence is obtained, the company can rapidly design and synthesize candidates, enabling fast iteration cycles. On the safety front, mRNA does not enter the cell nucleus and carries no risk of genomic integration. In terms of efficacy, through sequence optimization and advanced delivery systems, the platform can simultaneously activate both robust humoral and cellular immune responses.

Looking ahead, Ab&B Bio-Tech has completed its technical foundation for single-pathogen mRNA vaccine development in the infectious disease space. The company plans to rapidly expand into multi-pathogen combination vaccine development as well as innovative cancer therapies based on mRNA technology. The company is also actively integrating artificial intelligence into its mRNA platform to enhance research efficiency and quality.

The dual approval comes at a time when global health authorities continue to monitor mpox outbreaks, particularly in regions where the virus has established endemic transmission. A safe and effective mRNA-based vaccine could offer a new generation of solutions for pandemic preparedness and response.