Juventas CAR-T LBCL Launch Marks Second Indication

Juventas CAR-T LBCL Launch Marks Second Indication

Juventas Cell Therapy Ltd announced the commercial launch of inaticabtagene autoleucel for relapsed or refractory large B-cell lymphoma (r/r LBCL) across multiple locations in China, marking the second indication for its self-developed CD19-targeted CAR-T therapy.

Regulatory & Commercial Milestone

AttributeDetails
CompanyJuventas Cell Therapy Ltd
ProductInaticabtagene autoleucel (CD19-targeted CAR-T)
Launch Date04 Dec 2025
New IndicationRelapsed or refractory large B-cell lymphoma (r/r LBCL)
Geographic CoverageMultiple locations across China

Development & Approval Timeline

DateMilestoneIndication
Nov 2023First NMPA approvalAdult r/r B-cell acute lymphoblastic leukemia (r/r B-ALL)
28 Nov 2025Second NMPA approvalr/r LBCL
04 Dec 2025Commercial launchr/r LBCL (multi-location rollout)

Product Profile & Mechanism

  • Technology: Self-developed CD19-targeted chimeric antigen receptor (CAR) T-cell therapy
  • Mechanism: Genetically engineered T-cells expressing CD19-binding CAR to eliminate malignant B-cells
  • Manufacturing: Autologous cell therapy produced in Juventas’ GMP facilities
  • Administration: Single intravenous infusion following lymphodepletion chemotherapy

Market Context & Competitive Landscape

Market ParameterValue/Insight
China LBCL Incidence~25,000 new cases annually; ~40% become r/r
CAR‑T Market Size (China)Projected ¥8 billion by 2028
CompetitionAxicabtagene ciloleucel (Fosun Kite), Tisagenlecleucel (Novartis)
Juventas DifferentiationFirst domestic CAR-T with dual hematologic malignancy approvals
PricingEstimated ¥1.2-1.5 million per treatment; potential for NRDL inclusion

Strategic Outlook & Commercial Implications

  • Multi-Location Launch: Demonstrates robust commercial infrastructure and supply chain readiness
  • Portfolio Expansion: Dual indications (B-ALL + LBCL) maximize manufacturing facility utilization
  • Market Penetration: LBCL indication addresses larger patient population vs. B-ALL
  • Revenue Impact: Analysts project ¥500-800 million peak sales from LBCL indication by 2028
  • Pipeline Value: Validates platform technology for potential future CAR-T candidates in solid tumors

Forward‑Looking Statements
This brief contains forward‑looking statements regarding Juventas’ commercial launch execution, market penetration, and revenue projections for inaticabtagene autoleucel. Actual results may differ due to manufacturing capacity, competitive dynamics, and reimbursement uncertainties.-Fineline Info & Tech