By Fineline Cube 
Juventas Cell Therapy Ltd. announced that inaticabtagene autoleucel (CNCT 19), China’s first self‑developed CD19‑targeting CAR‑T cell therapy, received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for relapsed or refractory large B‑cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, marking the product’s second major indication following its November 2023 approval for adult r/r B‑cell acute lymphoblastic leukemia (r/r B‑ALL).
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | inaticabtagene autoleucel (CNCT 19) |
| Company | Juventas Cell Therapy Ltd. |
| Agency | NMPA (China) |
| Approval Type | New Drug Application (NDA) |
| Indication | r/r LBCL after ≥2 prior systemic therapies |
| First Approval | r/r B‑ALL (adult) – November 2023 |
| Technology Origin | Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital |
| Key Innovation | Globally unique CD19 scFv (HI19a) structure; complete independent IP rights |
Drug Profile
- Mechanism: Autologous CD19‑targeted CAR‑T cells engineered with proprietary HI19a single‑chain variable fragment
- Manufacturing: Internationally leading processes; closed‑system automation reducing vein‑to‑vein time to 14‑16 days
- Differentiation: First fully China‑owned CD19 CAR‑T with complete IP independence; addresses both leukemia and lymphoma within a single platform
- Clinical Validation: Successive approvals validate platform’s versatility and manufacturing consistency
Market Context & Outlook
| Metric | Value |
|---|---|
| China LBCL Incidence | ~85,000 new cases annually (2024) |
| r/r LBCL Eligible for CAR‑T | ~25% (21,000 patients) |
| China CAR‑T Market Size | ¥6.5 billion (US$890 million) |
| Growth CAGR | 35% (2024‑2030) |
| Peak Sales Forecast (CNCT 19) | ¥2.8‑3.5 billion (~US$380‑480 million) by 2031 |
| Market Share Target | 25‑30% of CD19 CAR‑T segment |
- Competition: Competes with Fosun Kite’s Yescarta (imported) and BMS’s Breyanzi (pending China approval); Juventas’s local manufacturing and lower cost (¥300,000‑350,000 vs. ¥1.2 million for Yescarta) provide pricing advantage
- Strategic Value: Dual indication approval positions Juventas as leader in hematologic CAR‑T; potential for NRDL inclusion in 2026
- Next Catalysts: Pediatric r/r B‑ALL Phase II data Q2 2026; potential global partnership discussions for ex‑China rights
Forward‑Looking Statements
This brief contains forward‑looking statements regarding inaticabtagene autoleucel’s commercial launch, market penetration, and pipeline expansion. Actual results may differ materially due to risks including competitive dynamics, manufacturing scalability, and reimbursement negotiations.-Fineline Info & Tech