Deulorlatinib Drug Asset Due Diligence Report 2026

This Deulorlatinib 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: 24 July 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 3

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Deulorlatinib can convert its Small molecule drug profile and ALK x ROS1 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Deulorlatinib (query alias: Deulorlatinib)
Modality / target	Small molecule drug; ALK x ROS1; ALK inhibitors, ROS1 inhibitors
Highest global status	Phase 3
Originator	Shenzhen TargetRx, Inc.
Active developers	Shenzhen TargetRx, Inc.

The MCP disease footprint includes Advanced Lung Non-Small Cell Carcinoma, ALK positive Non-Small Cell Lung Cancer. 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
CTR20242826	Phase 3	进行中（尚未招募）	70	Not disclosed
NCT06294561	Phase 1	Completed	34	Plasma Tmax
NCT06438367	Phase 1	Completed	6	Urine radioactivity

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

Efficacy and safety of deulorlatinib (TGRX-326) in patients with locally advanced or metastatic ALK+ non–small cell lung cancer: A multicenter, open-label, pivotal phase 2 trial.

Phase 2; n=158; evaluation: Positive. Reported fields: ORR = 55.8 % ( 39.9 - 70.9); ORR = 43.7 % ( 35.8 - 51.8); ORR = 62.5 % ( 24.5 - 91.5)

Safety, Efficacy, and Biomarker Analysis of Deulorlatinib (TGRX-326) in Anaplastic Lymphoma Kinase-Positive NSCLC: A Multicenter, Open-Label, Phase 1/1b Trial

Phase 1; n=198; evaluation: Positive. Reported fields: Adverse Event: TRAEs = The most common treatment-related adverse events (TRAEs) were hypercholesterolemia (79.3%), hypertriglyceridemia (77.3%), and weight gain (53.0%). 40.4% of patients had grade 3 or higher TRAEs. Meanwhile, TRAE-associated dose interruptions, reduction, and discontinuation occurred in 11.1%, 3.0%, and 1.5% of patients, respectively. ; Adverse Event: TRAEs = The most common treatment-related adverse events (TRAEs) were hypercholesterolemia (79.3%), hypertriglyceridemia (77.3%), and weight gain (53.0%). 40.4% of patients had grade 3 or higher TRAEs. Meanwhile, TRAE-associated dose interruptions, reduction, and discontinuation occurred in 11.1%, 3.0%, and 1.5% of patients, respectively. ; Adverse Event: TRAEs = The most common treatment-related adverse events (TRAEs) were hypercholesterolemia (79.3%), hypertriglyceridemia (77.3%), and weight gain (53.0%). 40.4% of patients had grade 3 or higher TRAEs. Meanwhile, TRAE-associated dose interruptions, reduction, and discontinuation occurred in 11.1%, 3.0%, and 1.5% of patients, respectively.

Deulorlatinib (TGRX-326)in Patients with ALK Fusion-Positive NSCLC: Update from the Phase 1 Trial

Phase 1; n=198; evaluation: Positive. Reported fields: TRAE = Common TRAEs were hypercholesterolemia (77.8%), hypertriglyceridemia (74.2%) and weight gain (46.0%). TRAE-associated dose interruptions, reduction and discontinuation occurred in 8.6%, 2.5% and 1.5% of patients, respectively. Treatment-related CNS effects occurred in 7.6% of patients, with 0.5% (n=1) requiring dose modification. % ; TRAE = Common TRAEs were hypercholesterolemia (77.8%), hypertriglyceridemia (74.2%) and weight gain (46.0%). TRAE-associated dose interruptions, reduction and discontinuation occurred in 8.6%, 2.5% and 1.5% of patients, respectively. Treatment-related CNS effects occurred in 7.6% of patients, with 0.5% (n=1) requiring dose modification. % ; TRAE = Common TRAEs were hypercholesterolemia (77.8%), hypertriglyceridemia (74.2%) and weight gain (46.0%). TRAE-associated dose interruptions, reduction and discontinuation occurred in 8.6%, 2.5% and 1.5% of patients, respectively. Treatment-related CNS effects occurred in 7.6% of patients, with 0.5% (n=1) requiring dose modification. %

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

Deulorlatinib addresses Advanced Lung Non-Small Cell Carcinoma, ALK positive Non-Small Cell Lung Cancer. Commercial attractiveness rests on addressable biomarker-positive 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 strongest market-validation signal in this screen is partner behavior: 1 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2024-09-02	2000万美元预付款：先声再明引进塔吉瑞第三代ALK抑制剂	Phase 1	US$20.0M upfront

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 “Method for treating ALK-positive or ROS1-positive non-small cell lung cancer”.

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. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Therapeutic index across KRAS/BRAF mutation subgroups
On-target toxicity and adaptive MAPK resistance
Lack of matched efficacy results in the current MCP result set

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

GO