Drugs / HBM9378
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05790694 | Sep 2022 → Oct 2023 | asthma | Harbour BioMed (Guangzhou) Co. Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-09-08 | Harbour BioMed (Guangzhou) Co. Ltd. | Results HBM9378/WIN378, an Ultra-Long-Acting Antibody Targeting TSLP, Achieves Positive Phase 2 Results in Asthma and Initiates Phase 3 Study harbourbiomed.com ↗
HBM9378/WIN378 produced significant and sustained effects on FEV1 (up to 174 mL mean increase, placebo-adjusted mean increases up to +256 mL, p=0.033), FeNO and blood eosinophils, key biomarkers that correlate with asthma exacerbations. |
| 2026-03-23 | Harbour BioMed (Guangzhou) Co. Ltd. | Results Harbour BioMed Reports the Online Publication of Phase I Results for HBM9378 (SKB378/WIN378), a TSLP-Targeting Antibody harbourbiomed.com ↗
Data showed that the incidence of treatment-emergent adverse events (TEAEs) was comparable between the HBM9378 dose groups and the placebo group, with no trend for increasing safety risks with dose escalation. |
| 2025-02-05 | Harbour BioMed (Guangzhou) Co. Ltd. | Regulatory Harbour BioMed Receives NMPA IND Clearance for HBM9378/SKB378 in the Treatment of Chronic Obstructive Pulmonary Disease harbourbiomed.com ↗ |
| 2024-11-08 | Harbour BioMed (Guangzhou) Co. Ltd. | Regulatory Harbour BioMed Announces Submission of IND Application for HBM9378/SKB378 in the Treatment of Chronic Obstructive Pulmonary Disease harbourbiomed.com ↗
today announced the submission of an Investigational New Drug (IND) application to the Centre for Drug Evaluation of the National Medical Products Administration of China for HBM9378/SKB378 |
| 2022-02-21 | Harbour BioMed (Guangzhou) Co. Ltd. | Regulatory Harbour BioMed Announces IND Approval for Next-Gen Anti-TSLP Fully Human Monoclonal Antibody in Asthma harbourbiomed.com ↗
The IND approval of HBM9378 is an achievement of the strategic collaboration between the parties. |
All press releases naming this drug 12 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HBM9378 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05790694 ↗ |
| Known as | SKB378 | “PURPOSE: HBM9378 (SKB378/WIN378) is a novel monoclonal antibody targeting thymic” PMID 41873335 ↗ Mar 2026 |
| Known as | WIN378 | “PURPOSE: HBM9378 (SKB378/WIN378) is a novel monoclonal antibody targeting thymic” PMID 41873335 ↗ Mar 2026 |
| Modality | Monoclonal antibody | “Human IgG1 Monoclonal Antibody Against TSLP” PMID 41873335 ↗ Mar 2026 |
| Route | Subcutaneous | “single subcutaneous injection” NCT05790694 ↗ |
| Target | TSLP | “Human IgG1 Monoclonal Antibody Against TSLP” PMID 41873335 ↗ Mar 2026 |