TNM001 / Guangzhou Trinomab Biotechnology - LARVOL DELTA

Prioritization to foster equitable access to RSV preventive monoclonal antibodies and antivirals for children (RSVVW 2026) - "PADO-RSV reaffirmed nirsevimab and clesrovimab as cornerstones of RSV prevention and placed them on the PADO Priority List, while highlighting the need to align product presentations with programmatic requirements for global use, including autodisable features and temperature monitoring. Similar considerations apply to pipeline products, such as TNM001 (PADO Watch List), which needs to align with existing immunization platforms to enable large-scale delivery, with equity metrics integrated into core development planning. PADO also identified a small but progressing pipeline of antivirals: ziresovir emerged as the most advanced candidate based on Phase III data in infants and, despite resistance signals and trial limitations, was added to the Priority List in an age-appropriate formulation, while other Phase II candidates were added to the Watch List. PADO emphasized a strong preference for oral therapies suitable for outpatient and primary care use and underscored the..."

Clinical • Respiratory Syncytial Virus Infections

Genetic variability of respiratory syncytial virus and its impact on monoclonal antibody binding sites: a national cross-sectional study during the 2023-2024 season. (PubMed, Int Immunopharmacol) - "This study provides a critical genomic snapshot of RSV in Italy prior to the introduction of vaccines and mAbs. Continuous surveillance is essential for monitoring viral evolution and supporting the long-term effectiveness of future immunization strategies."

Clinical • Journal • Observational data • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants (clinicaltrials.gov) - P3 | N=201 | Not yet recruiting | Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.

New P3 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study of TNM001 in Chinese Healthy Preterm and Term Infants (clinicaltrials.gov) - P1/2 | N=31 | Completed | Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Jun 2023 | Trial primary completion date: Dec 2023 ➔ Jun 2023

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants (clinicaltrials.gov) - P2b | N=2250 | Not yet recruiting | Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.

New P2b trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study of TNM001 in Chinese Healthy Preterm and Term Infants (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Trinomab Biotech Co., Ltd.

New P1/2 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections