ZSP-1601 Drug Asset Due Diligence Report 2026

This ZSP-1601 Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 18 September 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Phase 2

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: CONDITIONAL GO

Decision memo

Advance with milestone-based economics while efficacy durability, safety differentiation, patent scope, and market positioning are validated.

The central underwriting question is whether ZSP-1601 can convert its Small molecule drug profile and PDEs biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	ZSP-1601 (query alias: ZSP-1601)
Modality / target	Small molecule drug; PDEs; Phosphodiesterases, 3',5'-cyclic nucleotide (PDEs) inhibitors
Highest global status	Phase 2
Originator	Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Active developers	Guangdong Zhongsheng Pharmaceutical Co., Ltd.

The MCP disease footprint includes Metabolic Dysfunction Associated Steatohepatitis. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT05692492	Phase 2	Active, not recruiting	180	Primary endpoint not disclosed in English source
NCT04140123	Phase 1/2	Completed	37	Primary endpoint not disclosed in English source
NCT03392779	Phase 1	Completed	94	Primary endpoint not disclosed in English source

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

Safety, pharmacokinetics and efficacy of the novel pan- phosphodiesterase inhibitor ZSP1601 in 36 NASH patients: a double-blinded, placebo-controlled, multiple-dose escalation phase Ib study

Phase 1; n=36; evaluation: Positive. Reported fields: ALT = 24.8 U/L ; ALT = 38.94 U/L

Safety, tolerability, and pharmacokinetics of the novel pan-phosphodiesterase inhibitor ZSP1601 in healthy subjects: a double-blinded, placebo-controlled first-in-human single-dose and multiple-dose escalation and food effect study

Phase 1; n=not disclosed; evaluation: Not stated in English source. Reported fields: Adverse Event: adverse events (AEs) = All adverse events (AEs) were assessed as mild or moderate, with headaches as the most common. The highest single doses (275 and 350 mg) yielded more AEs, yet the rates were similar with the placebo cohorts in the MAD study. ; Adverse Event: adverse events (AEs) = All adverse events (AEs) were assessed as mild or moderate, with headaches as the most common. The highest single doses (275 and 350 mg) yielded more AEs, yet the rates were similar with the placebo cohorts in the MAD study.

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

ZSP-1601 addresses Metabolic Dysfunction Associated Steatohepatitis. Commercial attractiveness rests on addressable patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The MCP screen returned 1 matched transaction record(s) under the scope “asset-specific.” Partner activity is a market-validation signal, but it does not establish net present value.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2016-06-16	Transaction title not available in English source	Not disclosed	Financial terms not disclosed

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “CRYSTAL FORM OF 4H-PYRAZOLO[1,5-[alpha]]BENZOIMIDAZOLE COMPOUND, PREPARATION METHOD THEREFOR AND INTERMEDIATE THEREOF”. The milestone feed surfaced a patent-application signal described as “Hydroxyl purine compounds and applications thereof”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights.

7. Principal risks and diligence gates

Therapeutic index and off-target toxicity
Resistance biology and biomarker-defined patient selection
Differentiation from established and emerging standards

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

CONDITIONAL GO