Drugs / HBM9036
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04633213 | Feb 2021 → Aug 2022 | dry eye syndrome | Harbour BioMed (Guangzhou) Co. Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2022-01-13 | Harbour BioMed (Guangzhou) Co. Ltd. | Results Harbour BioMed Completes the First Interim Analysis of Phase III Clinical Trial of Tanfanercept harbourbiomed.com ↗
As a result of its observed efficacy trend and favorable safety, the study was recommended by the IDMC to be continued according to the current protocol. |
| 2020-11-16 | Harbour BioMed (Guangzhou) Co. Ltd. | Results Harbour BioMed Will Present Results From Its Phase II Clinical Trial with Tanfanercept (HBM9036) in Patients with Moderate-to-Severe Dry Eye Disease in China at the 25th Congress of Chinese Ophthalmological Society harbourbiomed.com ↗
In this proof-of-concept and comparability trial in China, Tanfanercept showed rapid onset of action, significant improvements in signs as measured by Corneal Staining Score, a measure of corneal damage. |
| 2019-10-11 | Harbour BioMed (Guangzhou) Co. Ltd. | Results Harbour BioMed Announces Completion of Phase 2 Study of HBM9036 in Patients with Moderate-to-Severe Dry Eye Disease in China harbourbiomed.com ↗
The study results were consistent with the previous Phase 2 trial (VELOS-1) that showed significant improvements in signs as measured by Corneal Staining Score, a measure of corneal damage. |
| 2018-10-01 | HanAll BioPharma Co., Ltd. | Regulatory HanAll’s HL036 eye drops for dry eye syndrome treatment was approved of phase 2 clinical trial IND in China hanall.com ↗
HL036(Chinese code: HBM9036), which HanAll BioPharma licensed out to a Chinese company, Harbour Biomed, was approved of phase 2 clinical trial IND in China by the National Medical Products Administration(NMPA) of China. |
| 2018-09-21 | Harbour BioMed (Guangzhou) Co. Ltd. | Regulatory Harbour BioMed Receives Approval to Start the Phase II Clinical Trial of Its Innovative Drug Candidate for The Treatment of Inflammatory Eye Disease harbourbiomed.com ↗
The National Medical Products Administration (NMPA) has recently granted Harbour BioMed to start phase II clinical trial with HBM9036, a global innovative biologic being developed for the treatment of dry eye disease. |
All press releases naming this drug 5 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HBM9036 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04633213 ↗ |
| Known as | HL036 | “HBM9036 (HL036) is a molecularly engineered TNFR1 fragment” NCT04633213 ↗ |
| Modality | Protein / enzyme biologic | “HBM9036 (HL036) is a molecularly engineered TNFR1 fragment” NCT04633213 ↗ |
| Route | Topical | “HBM9036, Ophthalmic Solution, twice a day, in the morning and evening” NCT04633213 ↗ |