Drugs / tanfanercept
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT04092907 | Mar → Jul 2019 | dry eye syndrome | Harbour BioMed (Guangzhou) Co. Ltd. | Completed | Missed primary |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT06400589 | May 2024 → Aug 2025 | dry eye syndrome | HanAll BioPharma Co., Ltd. | Suspended | No outcome recorded |
| Phase 3 | NCT05109702 | Nov 2021 → May 2022 | dry eye syndrome | HanAll BioPharma Co., Ltd. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2023-05-19 | HanAll BioPharma Co., Ltd. | Results HanAll Biopharma Announces Results from Phase III randomized, double-masked active treatment-controlled VELOS-3 Trial Evaluating Tanfanercept 0.25% for Treatment of Dry Eye Disease hanall.com ↗
However, tanfanercept did demonstrate a highly statistically significant improvement on one of the secondary outcome measures, Schirmer testing of tear volume. |
| 2022-10-11 | HanAll BioPharma Co., Ltd. | Results HanAll Biopharma’s Licensed Partner in China Provides Updates on Phase 3 Trial in Dry Eye Disease in China hanall.com ↗
The Independent Data Monitoring Committee (IDMC), upon review of the efficacy trend observed to date during the second interim analysis, recommended to Harbour BioMed (HBM) that further enrollment be ceased. |
| 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. |
| 2021-07-22 | HanAll BioPharma Co., Ltd. | Regulatory HanAll Biopharma Submits IND for Second Phase 3 (VELOS-3) of HL036 in Dry Eye Disease hanall.com ↗ |
| 2021-02-08 | HanAll BioPharma Co., Ltd. | Regulatory HanAll Biopharma Completes Meeting with FDA for next Phase 3 Trials in Dye Eye Disease hanall.com ↗
FDA stated through the written response that “conducting sign trial(VELOS-3) and symptom trial (VELOS-4) separately for different patient groups“ and “setting the center corneal staining score (CCSS) and the eye dryness score(EDS) as primary endpoints for VELOS-3 and VELOS-4 respectively“ are both acceptable. |
| 2020-11-19 | HanAll BioPharma Co., Ltd. | Results HanAll Biopharma HL036 Clinical Trial Results Selected as Best Poster at AAO 2020 hanall.com ↗
As a result of the Sign clinical trial, the significant improvement effect of HL036 could not be verified through the ICSS(inferior corneal staining score), which was set as the primary endpoint, because it was displayed as p=0.187. |
| 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. |
| 2018-10-29 | HanAll BioPharma Co., Ltd. | Results HanAll Biopharma Announces the Results of HL036’s Phase 2 Clinical Trial at the Ophthalmology Innovation Summit (OIS) in the U.S. hanall.com ↗
At this event, we announced the safety and excellent efficacy of HL036 on inhibition of corneal damage and alleviation of dry eye symptom that were confirmed in the phase 2 clinical trial conducted in the U.S. |
| 2018-06-25 | HanAll BioPharma Co., Ltd. | Regulatory HanAll Biopharma’s HL036 was Approved of its International Nonproprietary Name (INN) by the World Health Organization(WHO) hanall.com ↗
The INN of HL036, approved by WHO, is Tanfanercept, a name associated with TNF (tumor necrosis factor), the target of the new drug candidate. |
All press releases naming this drug 19 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tanfanercept | “PURPOSE: This study evaluated the clinical safety and efficacy of tanfanercept (HBM9036) ophthalmic solution as a novel treatment for dry eye disease (DED) in a controlled...” PMID 35192105 ↗ Feb 2022 |
| Known as | HBM9036 | “PURPOSE: This study evaluated the clinical safety and efficacy of tanfanercept (HBM9036) ophthalmic solution as a novel treatment for dry eye disease (DED) in a controlled...” PMID 35192105 ↗ Feb 2022 |
| Known as | HL-036337 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594387 ↗ |
| Known as | HL036 | “A Phase 3, Multicenter, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% and 1.0%...” NCT06400589 ↗ |
| Action | Inhibit | “TNF-α inhibitor tanfanercept (HBM9036)” PMID 35192105 ↗ Feb 2022 |
| Modality | Protein / enzyme biologic | — CHEMBL4594387 ↗ |
| Route | Other | “HBM9036 0.25% Ophthalmic Solution” NCT04092907 ↗ |
| Target | TNF | “TNF-α inhibitor tanfanercept (HBM9036)” PMID 35192105 ↗ Feb 2022 |