GB05 / Shenzhen Kexing Pharma - LARVOL DELTA

Integrating in vitro aerosol characterization and cross-species PBPK modeling to predict human lung exposure of inhaled therapeutic proteins. (PubMed, Int J Pharm ) - "The PBPK model accurately predicted rhIFN-α1b exposure in the lungs and serum of healthy adults, with 85% of Cmax and AUC0-inf values falling within a 0.5-2.0-fold error range. This study provides a quantitative platform for clinical translation and dosing regimen evaluation of inhaled therapeutic proteins."

Journal • Preclinical • IFNA1

Aerosol inhalation of human IFN-α1b exhibits anti-RSV activity in mice and favorable pharmacokinetics/safety in cynomolgus monkeys. (PubMed, Front Microbiol) - "Aerosolized IFN-α1b demonstrates antiviral activity and favorable lung-targeted pharmacokinetics in preclinical models, supporting further investigation in clinical settings. It was associated with greater reduction in lung viral titers compared with ribavirin in this model while maintaining a favorable safety profile."

Journal • PK/PD data • Preclinical • Infectious Disease • Inflammation • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections • IFNA1

GB05, a safe and effective IFNα1b inhalation solution for treating respiratory syncytial virus infection. (PubMed, Int J Pharm) - "In summary, GB05 is the first reported IFN inhalation solution manufactured in compliance with regulatory standards, to our knowledge, exhibiting safety and efficacy due to effectively local delivery. GB05 will fill the gap in the treatment of HRSV infection."

Journal • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • IFNA1

Kexing Biopharm Obtained IND Approval for Its Self-developed GB05 from U.S. FDA (PRNewswire) - "Kexing Biopharm Co., Ltd...recently announced that the Investigational New Drug Application (IND) of GB05, Human Interferon α1b Inhalation Solution, a self-developed product by the Company's wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has been approved by the United States Food and Drug Administration (FDA), and this approval allows Shenzhen Kexing to initiate its proposed clinical trials in the US. The proposed indications are pediatric lower respiratory tract infections caused by respiratory syncytial virus (RSV), such as pneumonia and bronchiolitis. This significant breakthrough in antiviral drug development brings new hope to the treatment of RSV infections in children globally...Meanwhile, the IND applications of GB18 indicated for cancer cachexia (a nanobody targeting GDF-15) are about to be submitted in both China and the US within this year."

IND • New trial • Metabolic Disorders • Pneumonia • Respiratory Syncytial Virus Infections

KXZY-GB05-101: A Phase I Study in Healthy Participants (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: Kexing Biopharm Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion

Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections (clinicaltrials.gov) - P3 | N=322 | Recruiting | Sponsor: Kexing Biopharm Co., Ltd.

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

KXZY-GB05-101: A Phase I Study of Human Interferon Alfa 1b Inhalation Solution in Healthy Participants (clinicaltrials.gov) - P1 | N=35 | Active, not recruiting | Sponsor: Kexing Biopharm Co., Ltd.

New P1 trial