CTR20262400 Human Coagulation Factor IX (Yuanda Shuyang) Hemorrhage Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready landscape. This focused report examines CTR20262400—评价人凝血因子Ⅸ在经治疗儿童（＜12岁）中、重型血友病B患者中预防治疗的安全性、有效性的单臂、开放、多中心临床试验—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.

MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.

Why CTR20262400 is a hot trial to watch

Hemorrhage is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. CTR20262400 is notable because it evaluates Human Coagulation Factor IX (Yuanda Shuyang) in a Phase 3 design while 6个月预防治疗期的年化出血率*（Annualized Bleeding Rate, ABR） serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.

PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.

Trial landscape snapshot

Design and endpoint interpretation

The phase label is only the starting point. Allocation is 非随机化, masking is 开放, and the intervention model is 单臂试验. Planned enrollment of 24 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: 6个月预防治疗期的年化出血率*（Annualized Bleeding Rate, ABR） (6个月)
• Secondary: 6个月预防治疗期经治疗的年化出血率*（Annualized Bleeding Rate, ABR） (6个月)
• Secondary: 6个月预防治疗期的年化关节出血率*（Annual Joint Bleeding Rate, AJBR） (6个月)
• Secondary: 预防治疗期前后的血友病关节健康评估表（Haemophilia Joint Health Score, HJHS）评分的变化值 (6个月)
• Secondary: 预防治疗前后靶关节数#的变化值。 (6个月)

Benchmark readouts in the surrounding field

• A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients With Previously Treated AL Amyloidosis (Phase 2): Assess Efficacy by Confirmed Overall Hematologic Response = 77.1 percentage of paticipants (95% Confidence Interval, 59.9 - 89.6)
• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of RDX-002 on Postprandial Triglycerides in Patients Discontinuing the Glucagon-like Peptide-1 (GLP-1) Agonists, Semaglutide, or Tirzepatide for the Treatment of Obesity (Phase 2): Incremental Postprandial Triglycerides (TG)(Mean) = 43.81 percent change (Standard Deviation, 92.373); Incremental Postprandial Triglycerides (TG)(Mean) = -51.91 percent change (Standard Deviation, 72.293)
• A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women (Phase 2): Interval From First Dose to Evidence of Ovulation.(Mean) = 2.67 Number of days (Standard Deviation, 1.53); Interval From First Dose to Evidence of Ovulation.(Mean) = 4.0 Number of days (Standard Deviation, 0)

These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.

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Asset and sponsor context

Drug & Asset context: Human Coagulation Factor IX (Yuanda Shuyang) (Approved; factor IX)

Company & Deal Intelligence context: Grand Shuyang Life Sciences (Chengdu) Co., Ltd. — China — http://www.shuyang.com

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 decide 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.
• Sequencing evidence: comparative data after the most 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 probability of success before a headline data release.

Bottom line

CTR20262400 is a focused lens on Hemorrhage development. Its value will be determined by whether Human Coagulation Factor IX (Yuanda Shuyang) can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.

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