Savolitinib Drug Asset Due Diligence Report 2026

This Savolitinib 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: 23 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 Savolitinib can convert its Small molecule drug profile and c-Met biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Savolitinib (query alias: Savolitinib)
Modality / target	Small molecule drug; c-Met; c-Met inhibitors
Highest global status	Approved
Originator	Hutchison MediPharma Ltd.
Active developers	AstraZeneca PLC, Hutchison MediPharma Ltd., Hutchmed

The MCP disease footprint includes Gastroesophageal junction adenocarcinoma, Stomach Cancer, EGFR mutation MET 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
CTR20261803	Phase 3	进行中（招募中）	150	Not disclosed
NCT06692491	Phase 2	Not yet recruiting	200	Objective Response Rate (ORR)
NCT06563999	Phase 2	Recruiting	120	Resectability rate

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

A Phase I Study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS Tumors Harboring MET Aberrations

Phase 1; n=41; evaluation: not stated. Reported fields: -; -; -

A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas.

Phase 2; n=65; evaluation: Positive. Reported fields: ORR = 45.2 % ( 29.8 - 61.3); ORR = 32.3 % ( 21.2 - 45.1)

CALYPSO: Final Results of Savolitinib and Durvalumab Combination in Metastatic Papillary Renal Cancer

Phase 2; n=41; evaluation: Positive. Reported fields: mOS = 27.4 month ( 9.3 - 37.4); mOS = 18.3 month ( 7.3 - 30.7)

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

Savolitinib addresses Gastroesophageal junction adenocarcinoma, Stomach Cancer, EGFR mutation MET 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: 2 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
2023-02-28	Barts Cancer Institute and Vall d’Hebron Institute collaborate to investigate the effectiveness of savolitinib in combination with durvalumab for treating MET-driven metastatic papillary renal cell carcinoma (mPRC).	Approved	Financial terms not disclosed
2011-12-21	阿斯利康与和黄医药强联手打造全球创新癌症治疗方案 // HUTCHMED	Preclinical	US$20.0M upfront; US$120.0M milestones

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