Legend Biotech
传奇生物
Executive Summary
Legend Biotech is a Nanjing-based CAR-T cell therapy company (NASDAQ: LEGN) with strong pipeline assets and established US presence through NASDAQ listing. The company appears deal-ready with proven regulatory capabilities and no current BIOSECURE designation, making it an attractive partner for US pharma BD teams. Limited recent event data suggests stable operations with standard SEC compliance for a US-listed Chinese biotech.
Structure: Legend Biotech operates as a US-listed Chinese biotech with standard VIE structure typical for Chinese companies accessing US capital markets, as indicated by VIE disclosures in their 10-K filings. The corporate structure likely involves Cayman holding company layers with Chinese operating entities, requiring careful due diligence review of VIE arrangements and cross-border regulatory compliance.
Key People
| Name | Title | Education | Flags |
|---|---|---|---|
Xiaohu Fan 范晓虎 | Co-founder & CTO, Legend Biotech | PhD, Rutgers University |
Ownership & Shareholder Structure
Legend Biotech → Johnson & Johnson
J&J-Legend Carvykti (cilta-cel). First China CAR-T with FDA approval.
GenScript Biotech → Legend Biotech
GenScript Biotech is the majority shareholder of Legend Biotech, holding ~58% stake. Legend Biotech developed Carvykti (cilta-cel) in partnership with J&J.
Corporate Events
Legend Biotech 10-K Annual Report
10-K annual report filed with SEC. Contains corporate structure, VIE disclosures, and risk factors.
FDA approves Carvykti (cilta-cel)
Carvykti became the first China-originated CAR-T therapy with FDA approval. For relapsed/refractory multiple myeloma. Now generating $1B+ annual revenue. Developed jointly by Legend Biotech and J&J (Janssen).
Clinical Trials(38 total)
13
Phase 1
5
EARLY_Phase 1
2
NA
| NCT ID | Interventions | Phase | Status | Enrollment |
|---|---|---|---|---|
| NCT07331272 | LUCAR-G79D T cells | Ph.1 | RECRUITING | 38 |
| NCT07399444 | LVIVO-TaVec400 product | EARLY_Ph.1 | NOT YET RECRUITING | 38 |
| NCT07294625 | LVIVO-TaVec200 product | EARLY_Ph.1 | RECRUITING | 36 |
| NCT07095075 | LUCAR-DKS1 NK cells | EARLY_Ph.1 | RECRUITING | 36 |
| NCT07100067 | LCAR- F33S cells intravenous infusion | NA | RECRUITING | 35 |
| NCT07049081 | LUCAR-G79 T cells | Ph.1 | RECRUITING | 42 |
| NCT06866080 | LCAR-AIO T cells | EARLY_Ph.1 | WITHDRAWN | 0 |
| NCT06869278 | LCAR-AIO T cells | Ph.1 | RECRUITING | 37 |
| NCT07002112 | LVIVO-TaVec100 product | Ph.1 | RECRUITING | 30 |
| NCT06653556 | LCAR-AIO T cells | EARLY_Ph.1 | RECRUITING | 34 |
| NCT06472479 | LCAR-M61S cells preparation, LCAR-M61D cells preparation | NA | NOT YET RECRUITING | 66 |
| NCT06494371 | LCAR-HL30 cells | Ph.1 | RECRUITING | 32 |
| NCT06395870 | LUCAR-G39D cells product | Ph.1 | RECRUITING | 33 |
| NCT06295549 | LUCAR-G39P cells product | Ph.1 | TERMINATED | 11 |
| NCT06313957 | LUCAR-20SP cells | Ph.1 | RECRUITING | 42 |
| NCT06197178 | LCAR-G08 cells | Ph.1 | TERMINATED | 17 |
| NCT05680922 | LB2102 | Ph.1 | RECRUITING | 41 |
| NCT05539430 | LB1908 | Ph.1 | ACTIVE NOT RECRUITING | 56 |
| NCT05654779 | LCAR-AMDR Cells Product | Ph.1 | TERMINATED | 4 |
| NCT05376345 | LCAR-BCDR cells product | Ph.1 | TERMINATED | 24 |
Showing 20 of 38 trials
Drug Molecules (ChEMBL)
CILTACABTAGENE AUTOLEUCEL
Phase 4Top Publications (by citations)
Ciltacabtagene Autoleucel, an Anti-B-cell Maturation Antigen Chimeric Antigen Receptor T-Cell Therapy, for Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 2-Year Follow-Up.
Martin T, Usmani SZ, Berdeja JG, Agha M, Cohen AD, Hari P, Avigan D, Deol A, Htut M, Lesokhin A, Munshi NC, O'Donnell E, Stewart AK, Schecter JM, Goldberg JD, Jackson CC, Yeh TM, Banerjee A, Allred A, Zudaire E, Deraedt W, Olyslager Y, Zhou C, Pacaud L, Madduri D, Jakubowiak A, Lin Y, Jagannath S.
Unanswered questions following reports of secondary malignancies after CAR-T cell therapy.
Levine BL, Pasquini MC, Connolly JE, Porter DL, Gustafson MP, Boelens JJ, Horwitz EM, Grupp SA, Maus MV, Locke FL, Ciceri F, Ruggeri A, Snowden J, Heslop HE, Mackall CL, June CH, Sureda AM, Perales MA.
Challenges and new technologies in adoptive cell therapy.
Zhang P, Zhang G, Wan X.
Current updates on generations, approvals, and clinical trials of CAR T-cell therapy.
Asmamaw Dejenie T, Tiruneh G/Medhin M, Dessie Terefe G, Tadele Admasu F, Wale Tesega W, Chekol Abebe E.
CAR T therapies in multiple myeloma: unleashing the future.
Sheykhhasan M, Sheykhhasan M, Ahmadieh-Yazdi A, Vicidomini R, Poondla N, Tanzadehpanah H, Dirbaziyan A, Mahaki H, Manoochehri H, Kalhor N, Dama P.
Discovery of nanobodies: a comprehensive review of their applications and potential over the past five years.
Alexander E, Leong KW.
The state of cell and gene therapy in 2023.
Chancellor D, Barrett D, Nguyen-Jatkoe L, Millington S, Eckhardt F.
Systematic Review on CAR-T Cell Clinical Trials Up to 2022: Academic Center Input.
Wang V, Gauthier M, Decot V, Reppel L, Bensoussan D.
Ciltacabtagene autoleucel: The second anti-BCMA CAR T-cell therapeutic armamentarium of relapsed or refractory multiple myeloma.
Chekol Abebe E, Yibeltal Shiferaw M, Tadele Admasu F, Asmamaw Dejenie T.
CAR-T cell therapy for cancer: current challenges and future directions.
Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, Diaz-Beya M, Juan M, Urbano-Ispizua Á, Esteve J, Velasco-Hernandez T, Menéndez P.
BIOSECURE Risk
Company has clear BIOSECURE status with no current designation, reducing immediate regulatory risk for US partnerships
Key Exposures:
- •Chinese entity subject to potential future BIOSECURE designation
- •VIE structure may complicate regulatory review
- •Manufacturing operations in China could face supply chain restrictions
Mitigation: Unclear - limited data on specific BIOSECURE mitigation strategies beyond maintaining compliant status
BD Intelligence
Therapeutic Areas:
Recent Deals: No recent deal activity data available in provided events
Approach: Approach as established partner given NASDAQ listing and regulatory compliance history, but conduct thorough VIE structure review and BIOSECURE risk assessment during due diligence
Red Flags
- ⚠Limited transparency on key management team
- ⚠Duplicate 10-K filing entries suggest potential data quality issues
- ⚠No recent pipeline or business development updates available
Quick Facts
- Key People
- 1
- Subsidiaries
- 0
- CDMO/CRO Subs
- 0
- Genomics Subs
- 0
- Direct BIOSECURE
- 0
- Corp Events
- 2
- Gov-Connected
- 0
- Clinical Trials
- 38
- Publications
- 10
- Drug Molecules
- 1
- Relationships
- 2
Sources & Methodology
Clinical trials data: ClinicalTrials.gov API v2 (38 trials linked to this entity)
SEC BIOSECURE filings: EDGAR EFTS full-text search (850+ filings from 230 companies)
Publications: Europe PMC API (10 publications indexed)
Drug molecules: ChEMBL database (European Bioinformatics Institute)
Financial data: East Money (东方财富) datacenter API / CNINFO (巨潮资讯网)
Corporate structure: Company official filings, HKEX/SSE/SZSE disclosures
Executive profiles: Company official biographies, SEC filings, LinkedIn (where verified)
Data is collected from public sources and updated weekly. Corporate intelligence is verified by a native Mandarin-speaking analyst against Chinese-language primary sources including Tianyancha (天眼查), GSXT (国家企业信用信息公示系统), and CNINFO (巨潮资讯网). This is not financial or legal advice.