CTR20262597 SR-604 Hemophilia B Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines CTR20262597 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 21 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why CTR20262597 is a hot trial to watch
Hemophilia B is being segmented by mechanism, treatment setting, geography and endpoint architecture. CTR20262597 is notable because it evaluates SR-604 in a Phase 2 design sponsored by Shanghai RAAS Blood Products Co., Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | CTR20262597 |
| Official title | SR604注射液治疗先天性凝血因子VII缺乏症的安全性疗效探索性II期试验 |
| Phase / status | Phase 2 / 进行中 （尚未招募） |
| Intervention | SR-604 |
| Sponsor | Shanghai RAAS Blood Products Co., Ltd. |
| Geography | China |
| Enrollment | 12 |
| Primary endpoint | |
| Endpoint time frame | 首次用药至出组访视 |
| Primary completion / readout proxy | Not reported |
Protocol design and endpoint interpretation
The indexed record describes a Phase 2 study of SR-604 in Hemophilia B.
Allocation is 随机化, masking is 开放, and the intervention model is 单臂试验. Planned enrollment of 12 participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Primary endpoint (首次用药至出组访视) — 治疗28周，经治疗的总年化出血率（Annualized Bleeding Rate, ABR）。 可采用以下公式进行计算：治疗28周内经治疗的总出血次数/28周出血暴露时间×365.25。
Readout outlook and evidence gap
The current protocol points to Not reported as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Trial-sourced asset: SR-604. The Drug & Asset MCP enrichment step is designed to add normalized targets, modality and global development status when an exact asset match is available.
Trial-sourced sponsor: Shanghai RAAS Blood Products Co., Ltd.. Company & Deal Intelligence MCP is the companion workflow for resolving organization identity, corporate profile and partnering context.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
CTR20262597 provides a focused lens on Hemophilia B development. Its value will be determined by whether SR-604 can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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