NCT07634367 HSK-39004 Pulmonary Disease, Chronic Obstructive Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07634367 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: 22 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07634367 is a hot trial to watch
Pulmonary Disease, Chronic Obstructive is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07634367 is notable because it evaluates HSK-39004 in a Phase 3 design sponsored by Haisco Pharmaceutical Group 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 | NCT07634367 |
| Official title | Long-Term Safety and Efficacy of HSK39004 Inhalation Suspension in COPD |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | HSK-39004 |
| Sponsor | Haisco Pharmaceutical Group Co., Ltd. |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | Treatment-emergent adverse event (TEAE) incidence |
| Endpoint time frame | From week 1 to week 53 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This clinical trial evaluates the long-term safety and efficacy of 3 mg HSK39004 Inhalation Suspension administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD).
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] 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.
- Treatment-emergent adverse event (TEAE) incidence (From week 1 to week 53) — The incidence of treatment-emergent adverse events (TEAEs), assessed through vital signs, physical examinations, laboratory tests, 12-lead ECG parameters, and detailed adverse event monitoring.
Readout outlook and evidence gap
The current protocol points to [object Object] 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
Drug & Asset MCP profile: HSK-39004 is indexed as Small molecule drug, with target PDE3 x PDE4, mechanism PDE3 inhibitors, PDE4 inhibitors, and global highest development status Phase 3.
Company & Deal Intelligence MCP profile: Haisco Pharmaceutical Group Co., Ltd. is resolved to a normalized organization record in Lhoka, China. The organization workflow adds identity, location, portfolio and partnering context where available.
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
NCT07634367 provides a focused lens on Pulmonary Disease, Chronic Obstructive development. Its value will be determined by whether HSK-39004 can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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