Repotrectinib Drug Asset Due Diligence Report 2026

This Repotrectinib 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: 15 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.

Approved

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 Repotrectinib can convert its Small molecule drug profile and ROS1 x TrkA x TrkB x TrkC biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Repotrectinib (query alias: repotrectinib)
Modality / target	Small molecule drug; ROS1 x TrkA x TrkB x TrkC; ROS1 inhibitors, TrkA antagonists, TrkB inhibitors
Highest global status	Approved
Originator	Turning Point Therapeutics, Inc.
Active developers	Turning Point Therapeutics, Inc., Zai Lab (Shanghai) Co., Ltd., Bristol Myers Squibb Co.

The MCP disease footprint includes NTRK fusion-positive solid tumors, Reactive oxygen species 1 positive non-small cell lung cancer, Advanced Malignant Solid Neoplasm. 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
NCT06552234	Phase 2	Recruiting	30	Objective response rate (ORR) according to RECIST v1.1.
NCT06493409	Phase 1	Completed	32	Maximum observed plasma concentration (Cmax)
NCT07223671	Phase 1	Completed	30	Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of AUC (0-T) of Probe Substrate With Repotrectinib

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.

Reproduce the asset-to-trial workflow with PatSnap MCP

3. Clinical readouts: what is known

2027TiP - Reporos trial-GFPC 04-2023: Open-label phase II efficacy study of repotrectinib in frail patients with ROS1-rearranged metastatic NSCLC

Phase 2; n=30; evaluation: Positive. Reported fields: AE(Grade ≥3) = neutropenia (42.9%) and hypertension (17.6%)

2013P - Repotrectinib in adult and pediatric patients with NTRK+ advanced solid tumors: Updated results from the TRIDENT-1 and CARE trials

Phase 2; n=172; evaluation: Positive. Reported fields: -; DoR = 9.6 month ( 7.4 - 13.0); DoR = NE

Repotrectinib in Patients With ROS1 Fusion-Positive (ROS1+) NSCLC: Long-Term Follow-Up From the Phase 1/2 TRIDENT-1 Trial

Phase 1/2; n=502; evaluation: Positive. Reported fields: cORR(RECIST v1.1) = 41 % (95%CI, 28 - 55); cORR(RECIST v1.1) = 79 % (95%CI, 68 - 88); -

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

Repotrectinib addresses NTRK fusion-positive solid tumors, Reactive oxygen species 1 positive non-small cell lung cancer, Advanced Malignant Solid Neoplasm. 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: 4 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
2026-01-08	赛生药业与再鼎医药达成合作获得瑞普替尼中国大陆独家推广权	Approved	Financial terms not disclosed
2022-06-24	Turning Point Therapeutics and MD Anderson Announce Strategic Alliance to Advance Precision Cancer Therapies	Phase 1/2	Financial terms not disclosed
2022-06-03	Bristol Myers Squibb to Acquire Turning Point Therapeutics, a Leading Precision Oncology Company	Phase 3	US$4,100.0M stated total

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

No asset-specific patent-application milestone appeared in the returned milestone slice. That absence is not a freedom-to-operate conclusion; a dedicated family, claim, ownership, expiry, and legal-status search remains mandatory before signing.

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