By Fineline Cube 
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) announced that China’s National Medical Products Administration (NMPA) has granted approval for the JT118 injection to enter clinical trials aimed at preventing monkeypox virus infection.
What Is JT118?
- Two‑in‑One Design – JT118 combines tandem‑fused antigens A35 (extracellular enveloped virus) and M1 (intracellular mature virus) into a single recombinant protein.
- Targeted Immunity – The vaccine is engineered specifically for monkeypox virus prevention, eliciting both humoral and cellular immune responses.
Preclinical Success
| Study | Outcome |
|---|---|
| Binding Antibodies | High‑titer responses against monkeypox antigens |
| Neutralizing Antibodies | Potent neutralization of vaccinia and monkeypox viruses |
| Cell‑Mediated Immunity | Robust T‑cell activation in small and large animal models |
| Protective Efficacy | Significant protection against viral challenge in animal studies |
| Safety Profile | Favorable tolerability with no serious adverse events reported |
These data demonstrate that JT118 confers comprehensive protection with a strong safety margin, positioning it as a promising candidate for global monkeypox prevention.
Regulatory Milestone
The NMPA approval marks an important step toward expanding the therapeutic arsenal against orthopoxviruses. The licensing enables Junshi Biosciences to initiate Phase I/II studies to assess safety, immunogenicity, and efficacy in humans.
Market Implications
- Strategic Positioning – As the first recombinant protein vaccine specifically targeting monkeypox, JT118 could capture a niche in both domestic and international markets.
- Public Health Impact – With rising monkeypox cases worldwide, an effective vaccine could mitigate outbreaks and reduce transmission.
- Collaborative Opportunities – Junshi Biosciences may seek partnerships with global health agencies and pharmaceutical companies to accelerate development and distribution.-Fineline Info & Tech