Product Center
The world's first! The monkeypox mRNA vaccine has obtained dual clinical trial approvals from both China and the United States.
- Categories:Company news
- Author:
- Origin:
- Time of issue:2026-07-02
- Views:
(Summary description)Recently, the IND application for a Class 1 new drug, the "Monkeypox mRNA vaccine," jointly submitted by Ab&B Bio-Tech CO.,LTD.JS (Ab&B Bio) and its subsidiary Yither Biotech CO., Ltd (Yither Bio), was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration.
The world's first! The monkeypox mRNA vaccine has obtained dual clinical trial approvals from both China and the United States.
(Summary description)Recently, the IND application for a Class 1 new drug, the "Monkeypox mRNA vaccine," jointly submitted by Ab&B Bio-Tech CO.,LTD.JS (Ab&B Bio) and its subsidiary Yither Biotech CO., Ltd (Yither Bio), was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration.
- Categories:Company news
- Author:
- Origin:
- Time of issue:2026-07-02 09:29
- Views:
Recently, the IND application for a Class 1 new drug, the "Monkeypox mRNA vaccine," jointly submitted by Ab&B Bio-Tech CO.,LTD.JS (Ab&B Bio) and its subsidiary Yither Biotech CO., Ltd (Yither Bio), was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. This makes it the world's first monkeypox mRNA vaccine to simultaneously obtain clinical trial approvals in both China and the United States. This milestone not only further validates the company's R&D capabilities but also strongly affirms the strength of Zhonghui Biotech's mRNA technology platform, demonstrating the company's solid capacity to contribute to global public health prevention and control efforts in China.
Regarding the monkeypox mRNA vaccine
This monkeypox mRNA vaccine employs an innovative quadrivalent antigen (A27, L1, A33, B5) tandem design with proprietary intellectual property rights, enabling independent expression of all four antigens on a single mRNA strand. In nonclinical studies, the vaccine demonstrated excellent immunogenicity (high levels of binding antibodies, neutralizing antibodies, and cellular immunity) and favorable safety profiles in both SD rats and rhesus macaque models, along with robust protective efficacy in monkeypox challenge trials. Regarding manufacturing processes, the product features high production capacity and stringent quality control, offering advantages for commercialization. It is poised to provide a safer and more effective next-generation solution for global monkeypox prevention and control efforts.
Regarding the mRNA technology platform
The monkeypox mRNA vaccine represents another innovative achievement of the company's mRNA technology platform. To date, two innovative vaccines developed using this platform have obtained dual clinical trial approvals in both China and the United States. The sustained delivery of such innovations is attributed to the mRNA technology platform established by the company's doctoral teams worldwide. The platform's core strengths lie in its rapid development capabilities and scalable production potential; as a "digital" platform, it enables swift design and synthesis once the target sequence is identified, facilitating rapid iteration. In terms of safety, mRNA does not enter the cell nucleus, eliminating the risk of genomic integration. Regarding efficacy, through sequence optimization and advanced delivery systems, it can simultaneously induce robust humoral and cellular immunity.
To date, the company has established comprehensive technical expertise in developing single-pathogen mRNA vaccines for infectious diseases and will rapidly expand its capabilities to include multi-pathogen combination vaccine development as well as innovative mRNA-based cancer therapies. Additionally, the company is actively leveraging AI technologies to enhance its mRNA technology platform, thereby improving research efficiency and quality.
Relevant information
-
The world's first! The monkeypox mRNA vaccine has obtained dual clinical trial approvals from both China and the United States.Recently, the IND application for a Class 1 new drug, the "Monkeypox mRNA vaccine," jointly submitted by Ab&B Bio-Tech CO.,LTD.JS (Ab&B Bio) and its subsidiary Yither Biotech CO., Ltd (Yither Bio), was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. - Phase I/II Clinical Trial of the Re engineered Respiratory Syncytial Virus Vaccine (CHO Cells)(Adjuvant)Officially Launched 05-13
- The mRNA technology platform has achieved another milestone, with global innovation efforts accelerating. 05-08
- Our innovative vaccine research team won the 20th "Jiangsu Youth May Fourth Medal Collective" award 04-27
- The Ab&B Bio Promotion Business Conference and 10th Anniversary Celebration were successfully held 04-25
Got a project? Contact us today !
At Ab&B Bio, our mission is to care for life and protect health by developing globally innovative vaccines.
Contact
E-mail:haixin.zhang@yitherbiotech.com
Add:No. 32, Xinglin Road, Medical High-tech Zone, Taizhou City
Quick view
Follow us
