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Also known as prefilled liquid etanercept(Yisaipu)
prefilled liquid etanercept · 1 trial · 1 indication
Axial SpondyloArthritis international Society (ASAS) ASAS20 was defined as an improvement of at least 20% in at least three of the following four domains: 1) patient global assessment VAS, 2) nocturnal back pain and total back pain VAS, 3) Bath AS Function Index (BASFI) VAS, and 4) inflammation (mean of intensity and duration of morning stiffness components from the an improvement at least one unit relative to baseline VAS score; no worsening in the remaining fourth domain.
| Arm | Type | Description |
|---|---|---|
| group I | EXPERIMENTAL | twice weekly 25 mg prefilled liquid etanercept |
| group II | EXPERIMENTAL | once weekly 50 mg prefilled liquid etanercept |
| group III | ACTIVE_COMPARATOR | 25 mg twice weekly lyophilized etanercept powder |
| Name | Type | Description |
|---|---|---|
| prefilled liquid etanercept(Yisaipu) | DRUG | - |
| lyophilized etanercept powder(Yisaipu) | DRUG | - |
Inclusion Criteria: * age 18-65，male or female * Sign the informed consent * Fulfill the 1966 AS New York criteria for axial spondyloarthritis(SpA) * Active disease phase of SpA, defined as BASDAI≥4 or night back pain≥4 at screening * Inadequate response to NSAID≥4 week * Application of NSAID with ...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| XBiotech, Inc. | XBIT | 1 | PHASE2 | vilamakitug |
| Novartis AG Sponsored ADR | NVS | 2 | - | Secukinumab |
| AbbVie, Inc. | ABBV | 1 | - | Upadacitinib |
| Pfizer Inc. | PFE | 1 | - | tofacitinib |
Prefilled liquid etanercept is being developed for the treatment of active ankylosing spondylitis, an inflammatory condition affecting the spine and sacroiliac joints. It is a prefilled liquid formulation studied in adults 18 years and older. The program is in Phase 3 development and is not yet approved.
Prefilled liquid etanercept is being developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is advancing the prefilled liquid formulation of etanercept (Yisaipu) for ankylosing spondylitis. Development has reached the Phase 3 stage.
Prefilled liquid etanercept is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The program has not been approved by the FDA, so prefilled liquid etanercept remains investigational for ankylosing spondylitis.
Prefilled liquid etanercept has been studied in one Phase 3 trial, NCT04345458, titled Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis. The trial enrolled 640 participants in China, was randomized, double-blind, and active-controlled, and is now completed.
Yes. Prefilled liquid etanercept is also known as prefilled liquid etanercept(Yisaipu). Yisaipu is the alternative name used for this prefilled liquid etanercept product. Both names refer to the same Phase 3 asset being developed by Sunshine Biopharma Inc. for active ankylosing spondylitis.
The Phase 3 trial of prefilled liquid etanercept, NCT04345458, enrolled 640 participants. It was a randomized, double-blind, active-controlled study conducted in China in adults with active ankylosing spondylitis. The trial is completed, and the program remains in clinical development.