Dalmelitinib Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Dalmelitinib 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.
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 Dalmelitinib 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 | Dalmelitinib (query alias: Dalmelitinib) |
|---|---|
| Modality / target | Small molecule drug; c-Met; c-Met inhibitors |
| Highest global status | NDA/BLA |
| Originator | Jiangsu Hansoh Pharmaceutical Group Co., Ltd. |
| Active developers | Jiangsu Hansoh Pharmaceutical Group Co., Ltd. |
The MCP disease footprint includes EGFR positive non-small cell lung cancer, metastatic non-small cell lung 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 |
|---|---|---|---|---|
| NCT06823245 | Phase 1 | Not yet recruiting | 32 | Peak Plasma Concentration (Cmax) of HS-10241 |
| CTR20243273 | Phase 1 | 已完成 | 20 | Not disclosed |
| CTR20242612 | Phase 1 | 已完成 | 18 | Not disclosed |
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
31P - HS-10241 combined with aumolertinib in EGFR-TKIs pretreated EGFR-mutant and MET-amplified advanced NSCLC: A phase Ib study
Phase 1; n=132; evaluation: Positive. Reported fields: ORR = 53.3 % ; ORR = 60.0 % ; ORR = 48.7 % ( 39.3 - 58.2)
Phase 1b study of HS-10241 combined with almonertinib in pre-treated advanced non-small cell lung cancer (NSCLC) harboring EGFR mutation.
Phase 1; n=45; evaluation: Positive. Reported fields: DLT = Only one dose-limiting toxicity (grade 2 Nausea with grade 2 vomiting leading to discontinuation≥14 days) was reported in the cohort with HS-10241 300 mg. Participant ; DLT = 1 Participant ; DLT = Only one dose-limiting toxicity (grade 2 Nausea with grade 2 vomiting leading to discontinuation≥14 days) was reported in the cohort with HS-10241 300 mg. Participant
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
Dalmelitinib addresses EGFR positive non-small cell lung cancer, metastatic non-small cell lung 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: 78 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
Transaction-scope note: No direct asset-specific transaction was returned. The table below shows target-level comparable: c-Met records as comparable precedents only.
| Date | Transaction | Phase at deal | Disclosed economics |
|---|---|---|---|
| 2026-04-17 | 贝达药业控股子公司Xcovery与美国Eversana公司达成恩沙替尼商业化合作 | Approved | Financial terms not disclosed |
| 2026-02-26 | Kairos Pharma, Ltd. Announces Signing of Term Sheet for Strategic Asset Acquisition of Two Clinical Oncology Assets from Celyn Therapeutics | Preclinical | Financial terms not disclosed |
| 2025-12-16 | 科伦博泰与宜联生物订立和解协议，就宜联生物管线中YL201、YL202、YL211、YL212、YL221及YL222收益达成分享协议 | Phase 3 | 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
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
Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.
Required pre-signing gates: reproduce key efficacy analyses; complete an indication-specific safety review; run a full patent-family and freedom-to-operate search; model risk-adjusted economics by territory; and reconcile all rights, sublicenses and encumbrances.
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Data provenance: PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP; accessed 23 July 2026. Counts and status fields may change as source records update.
