Report scope. This 2026 Drug Asset Due Diligence Report evaluates Multiple antigen specific cell therapy(Hengrui Yuanzheng Bio-Technology Co., Ltd.) as a potential licensing, partnership, acquisition, or option asset. The review separates verified evidence from open diligence questions across clinical development, intellectual property, market positioning, and transaction precedent.
Executive recommendation: CONDITIONAL GO
Multiple antigen specific cell therapy(Hengrui Yuanzheng Bio-Technology Co., Ltd.) is a Therapeutic vaccine associated with its disclosed target and a global highest development stage of Phase 2. The lead disclosed indication is Desmoplastic Small Round Cell Tumor. The current evidence supports a CONDITIONAL GO posture, subject to confirmation of study-level data, ownership, patent coverage, manufacturing readiness, and regional rights.
Decision memo
- Asset: Multiple antigen specific cell therapy(Hengrui Yuanzheng Bio-Technology Co., Ltd.)
- Target: its disclosed target
- Lead indication: Desmoplastic Small Round Cell Tumor
- Highest phase: Phase 2
- Matched trials: 11
- Matched result records: 7
- Matched asset deals: 0
1. Asset identity and development status
The first diligence task is entity resolution. Teams should reconcile development codes, nonproprietary names, salts, formulations, combinations, sponsors, and predecessor owners before relying on portfolio counts. For Multiple antigen specific cell therapy(Hengrui Yuanzheng Bio-Technology Co., Ltd.), the MCP profile identifies its disclosed target as the primary target context and Desmoplastic Small Round Cell Tumor as the lead indication. Global phase labels are useful orientation points, but investment decisions require country- and indication-level status verification.
Confirm the exact molecule, formulation, route, dose, biomarker definition, and current sponsor. Review discontinuations separately from active development so that an historical high phase is not mistaken for a live program.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT06277154 | Phase 2 | Recruiting | Not disclosed | Not disclosed |
| NCT05877651 | Phase 1 | Completed | Not disclosed | Not disclosed |
| CTR20221634 | Phase 2 | （） | 120 | Not disclosed |
| NCT04074564 | Early Phase 1 | Unknown status | Not disclosed | Not disclosed |
| NCT03393416 | Phase 1 | Unknown status | Not disclosed | Not disclosed |
| NCT03205930 | Phase 1/2 | Unknown status | Not disclosed | Not disclosed |
| NCT03067493 | Phase 2 | Unknown status | Not disclosed | Not disclosed |
| NCT03034304 | Phase 1 | Terminated | Not disclosed | Not disclosed |
| NCT02858232 | Phase 1/2 | Unknown status | Not disclosed | Not disclosed |
| NCT02844881 | Phase 1/2 | Unknown status | Not disclosed | Not disclosed |
| NCT02026362 | Phase 1/2 | Suspended | Not disclosed | Not disclosed |
The clinical program should be audited for randomization, comparator relevance, dose selection, endpoint hierarchy, multiplicity, analysis population, geographic mix, and readout timing. Early-stage programs require attention to pharmacokinetics, pharmacodynamics, adverse events, dose-limiting toxicities, and the rationale for the expansion dose.
3. Clinical readouts: what is known
Updated results on multiple antigens stimulating cellular therapy (MASCT-I) in metastatic urothelial carcinoma: A randomized, open-label, phase I trial.
Study: NCT03034304 (MASCT-I, ASCO2024). Phase: Phase 1. Enrollment: 39. Published: 2024-05-24.
mOS = 16.9 Month | DoR = 48 Month
A pilot study of multi-antigen stimulated cell therapy-I plus camrelizumab and apatinib in patients with advanced bone and soft-tissue sarcomas
Study: NCT04074564 (Pubmed | BMC Med). Phase: Phase 1. Enrollment: 19. Published: 2023-11-29.
Adverse Event: grade 3 or 4 treatment-related adverse events = 11 (57.9%) experienced grade 3 or 4 treatment-related adverse events
Multiple antigen stimulating cellular therapy (MASCT)-I for metastatic urothelial carcinoma (mUC): A multicenter, phase I study (MASCT-I-1001).
Study: NCT03034304 (MASCT-I-1001, ASCO2023). Phase: Phase 1. Enrollment: 39. Published: 2023-05-26.
SAE = 2 Pts
Combination Neoantigen-Based Dendritic Cell Vaccination and Adoptive T-Cell Transfer Induces Antitumor Responses Against Recurrence of Hepatocellular Carcinoma
Study: NCT03067493 (Pubmed | NEWS). Phase: Phase 2. Enrollment: 10. Published: 2022-06-03.
RFS(2-year) = 71.4 %
A phase I study to evaluate the safety of multiantigen stimulated tumor specific cell therapy (MASCT-I) in subjects with advanced gastric cancer.
Study: NCT03393416 (ASCO_GI2021). Phase: Phase 1. Enrollment: 15. Published: 2021-01-22.
Hepatic function abnormal = Abnormal liver function may be related to Camrelizumab
Safety and efficacy of PD-1 blockade-activated multiple antigen-specific cellular therapy alone or in combination with apatinib in patients with advanced solid tumors: a pooled analysis of two prospective trials
Study: NCT02844881 (Pubmed | Cancer Immunol Immunother). Phase: Phase 1/2. Enrollment: 70. Published: 2019-09-01.
TRAE = 56.3 % | TRAE = 65.8 %
Safety and efficacy of PD-1 blockade-activated multiple antigen specific cellular therapy alone or in combination with apatinib in patients with advanced solid tumors: A pooled analysis of two prospective trials.
Study: NCT02858232 | NCT02844881 (ASCO2019). Phase: Phase 1/2. Enrollment: Not disclosed. Published: 2019-05-26.
PFS = 4.5 Month | PFS = 6.0 Month
For every reported endpoint, obtain the protocol, statistical analysis plan, patient disposition, baseline characteristics, subgroup definitions, exposure duration, and full safety tables. Conference abstracts and registry summaries can support screening, but they should not replace source data review in a binding transaction.
4. Market and competitive position
The commercial case depends on differentiated efficacy, tolerability, convenience, biomarker reach, treatment setting, and access. A target-level market may be attractive while an individual asset remains undifferentiated. Benchmark Multiple antigen specific cell therapy(Hengrui Yuanzheng Bio-Technology Co., Ltd.) against approved therapies and clinical competitors in Desmoplastic Small Round Cell Tumor, including likely standards of care at the expected launch date.
Build a scenario model around addressable patients, diagnosis and biomarker rates, line of therapy, duration, net price, uptake, displacement, combination costs, and probability-adjusted timelines. Test slower enrollment, delayed readout, narrower labels, safety restrictions, and competitor launches.
5. Transaction precedent and economics
| Date | Transaction | Status | Type | Disclosed value |
|---|---|---|---|---|
| No exact asset-specific transaction was returned. Use target-level precedents only as comparables and do not present them as asset transactions. | ||||
Transaction records should be normalized for territory, asset scope, phase at signing, option mechanics, development obligations, cost sharing, royalties, milestones, and change-of-control terms. Undisclosed economics must not be converted into invented benchmarks.
6. IP and freedom-to-operate screen
Complete a family-level patent review covering composition of matter, sequence or construct claims, polymorph and salt claims, formulation, dosing, combinations, biomarkers, manufacturing, and method of use. Verify priority, ownership, assignments, prosecution status, term adjustments, extensions, oppositions, and regional coverage. Freedom to operate is a separate legal analysis and should include competitor claims and platform dependencies.
The diligence room should reconcile inventorship, employee and contractor assignments, university or platform licenses, sublicensing restrictions, government rights, and obligations triggered by development milestones or commercialization.
7. Principal risks and diligence gates
- Identity risk: resolve all aliases, formulations, combinations, and owners.
- Clinical risk: confirm source data, protocol deviations, endpoint definitions, and safety follow-up.
- Regulatory risk: review agency correspondence, meeting minutes, holds, commitments, and indication-specific pathways.
- IP risk: validate enforceable coverage, remaining life, ownership, and freedom to operate.
- CMC risk: assess process control, analytical methods, comparability, scale-up, supply, and cost of goods.
- Commercial risk: pressure-test differentiation, market access, competitive timing, and realistic adoption.
- Transaction risk: map rights, encumbrances, royalties, options, consent requirements, and change-of-control provisions.
8. Final go/no-go memorandum
CONDITIONAL GO
Proceed only through staged diligence. Before exclusivity or a binding offer, require a verified asset identity package, complete clinical data room, regulatory correspondence, patent-family schedule, freedom-to-operate opinion, CMC package, ownership chain, regional rights map, and risk-adjusted valuation. Any material mismatch between public records and source documents should pause the process until reconciled.
Method note: This report uses PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP data retrieved on 2026-10-14. It is a screening and diligence framework, not medical, legal, regulatory, or investment advice.
