Hengrui's Phase 2 SHR-1905 nasal polyp trial completes, data still ahead
The China-based study closed after enrolling 114 patients, setting up a Phase 2 readout on nasal polyp scores that will inform Hengrui's already-recruiting Phase 3 program.
Executive Summary
- A Phase 2 trial testing Hengrui's SHR-1905 in chronic rhinosinusitis with nasal polyps has completed, closing out enrollment and finishing its primary completion window without a posted result yet.
- The trial's primary endpoint tests whether the drug shrinks nasal polyps over six months, the standard bar biologics in this indication have used to win approval.
- Hengrui is not waiting on this result to advance: a larger Phase 3 trial of the same drug in the same indication is already recruiting, making this readout a bridge study rather than a gating decision.
- The indication is populated by approved and late-stage biologics aimed at different targets, and SHR-1905's own molecular target has not been characterized in available records, so its differentiation rests on data still to come rather than a distinct mechanism story.
The completion
NCT05891483, a randomized, quadruple-masked Phase 2 trial of the injectable biologic SHR-1905, moved to Completed status on July 22, 2026, with a primary completion date of January 21, 2026. The trial enrolled 114 patients across four arms and tested the drug against a placebo comparator in patients with chronic rhinosinusitis with nasal polyps, a condition marked by recurring nasal blockages, facial pain, and loss of smell that current biologics target through pathways such as IL-4Rα, IL-5, and TSLP. The primary endpoint measures the change from baseline in nasal polyp score at week 24, the same efficacy bar every approved biologic in this indication has had to clear. NCT05891483Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal PolypsNCT05891483
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial can establish
The design, a randomized, quadruple-masked trial with a placebo arm and a validated symptom score, is built to produce a decision-grade efficacy read on nasal polyp shrinkage, not just a safety signal. Nine secondary endpoints track nasal congestion, sino-nasal symptom scores, and steroid rescue use through week 48, giving the eventual readout depth beyond the single primary measure. No results have posted to the registry yet, so the trial's contribution to date is confirmation that enrollment and follow-up are complete, not evidence of efficacy. NCT05891483Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal PolypsNCT05891483
Operational history
The trial's primary completion date moved once, from August 2025 to February 2026, alongside a routine enrollment increase from a 100-patient target to 114 actual patients recorded in June 2024, a change the trial's own operational model flags as within the typical range for this design. The registry briefly carried an Unknown status flag in late June 2026 before updating to Completed on July 22, 2026, consistent with a lag in routine registry housekeeping around trial closeout rather than a change in the trial's substance. NCT05891483Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal PolypsNCT05891483
Competitive context
Chronic rhinosinusitis with nasal polyps already has multiple approved biologics, including dupilumab, omalizumab, mepolizumab, and tezepelumab, each targeting a distinct pathway (IL-4Rα, IgE, IL-5, and TSLP respectively), alongside late-stage entrants such as GlaxoSmithKline's depemokimab and Sanofi's itepekimab. SHR-1905's own target has not been characterized in available records, so it cannot be placed on that same target map, and no isolation or first-in-class claim is supported. Hengrui is also running a 280-patient Phase 3 trial of SHR-1905 in the identical indication, which is already recruiting and lists a primary completion date in April 2028, positioning this Phase 2 result as a bridge into that larger program rather than a standalone gating readout. NCT05891483Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal PolypsNCT05891483
Sponsor context
Hengrui has completed 20 of 21 prior trials with one termination on record, a completion rate the trial's own landscape assessment cites as a sponsor-experience signal favoring execution. That track record does not speak to whether SHR-1905 will show a nasal-polyp-score benefit; it speaks only to whether the company tends to finish what it starts.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.