Shanghai, China – June 18, 2025 — Biomissile (Anji) Pharmaceuticals and Fudan University today announced the publication of Phase 2 clinical trial results for BM219, a novel inhaled bispecific single-domain antibody for mild-to-moderate COVID-19. The double-blind, placebo-controlled trial demonstrated that BM219 is safe, well tolerated, and effective in reducing symptom duration and viral load.
BM219 is a novel bispecific nanobody derived from Biomissile’s proprietary multi-specific antibodies (UDAB-MTM) platform technology. It targets two conserved, non-overlapping epitopes on the SARS-CoV-2 spike protein, enabling broad neutralization across variants. Nebulized delivery ensures high lung concentrations (200–300× serum levels) with minimal systemic exposure. In the epidemic strain JN.1 subgroup, the 60 mg BID regimen showed the fastest clinical recovery—over five days faster than placebo, while the 120 mg BID regimen achieved the largest viral load reduction (−1.18 log₁₀ copies/ml).
“The success of this trial highlights Biomissile’s strength in our translating cutting-edge academic discoveries into clinical-stage therapeutics and validates our platform technologies,” said Dr. Chao Tu, CEO of Biomissile. “We’re proud to have advanced BM219 from concept to a successful Phase 2 asset, enabling a practical, scalable solution to address immune-evasive COVID-19 variants.”
“BM219 was engineered to achieve synergistic binding through bispecific targeting of structurally distinct RBD epitopes, including a deeply buried conserved site,” said Dr. Tianlei Ying, professor at Fudan University. “This rational design underpins its broad neutralization profile and resilience against viral escape mutations.”
A Phase 3 trial is being prepared to further assess efficacy in a broader population.
BD: bd@biomissile.com
HR: hr@biomissile.com
Website: www.biomissile.com