By Fineline Cube 
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the National Medical Products Administration (NMPA) has approved a clinical trial for SYS 6055, the first in vivo CAR‑T therapy approved for trials in China, for the treatment of relapsed/refractory aggressive B‑cell lymphoma.
Regulatory Milestone & Technology Innovation
| Item | Detail |
|---|---|
| Company | CSPC Pharmaceutical Group Ltd (HKEX: 01093) |
| Drug | SYS 6055 |
| Approval | NMPA clinical trial authorization |
| Indication | Relapsed/refractory aggressive B‑cell lymphoma |
| Technology | In vivo chimeric antigen receptor (CAR)‑T therapy |
| Mechanism | Lentiviral vector generates CD19‑targeted CAR‑T cells within the body |
| Innovation | First in vivo CAR‑T therapy approved for trials in China |
| Key Advantages | Cost, accessibility, and timeliness vs. traditional ex vivo CAR‑T |
Drug Profile & Preclinical Data
- Mechanism of Action: Utilizes a lentiviral vector to directly generate CD19‑targeted CAR‑T cells in vivo, enabling specific recognition and elimination of malignant B cells
- Preclinical Validation: Demonstrated ability to specifically generate CAR‑T cells in vivo, with significant tumor suppression effects and a favorable safety profile
- Competitive Edge: Compared with traditional CAR‑T products requiring complex ex vivo manufacturing, SYS 6055 offers potential advantages in cost reduction, broader patient accessibility, and faster treatment initiation
- Market Position: First‑in‑class in China for in vivo CAR‑T approach, addressing critical gaps in B‑cell lymphoma treatment
Market Impact & Commercial Outlook
- B‑Cell Lymphoma Burden: ~100,000 new aggressive B‑cell lymphoma cases annually in China; 30‑40% become relapsed/refractory to frontline therapy
- CAR‑T Market Growth: China’s CAR‑T cell therapy market projected to reach ¥15 billion (~US$2 billion) by 2030, driven by expanding indications and patient access
- Cost Advantage: In vivo manufacturing could reduce treatment costs by 50‑70% versus traditional CAR‑T, expanding addressable patient population beyond current reimbursement limits
- Revenue Potential: Analysts estimate ¥800 million–1.5 billion (US$110–210 million) peak annual sales potential if approved, based on premium pricing and first‑mover advantage
- Strategic Value: Positions CSPC as pioneer in next‑generation cell therapy; validates proprietary lentiviral platform for future pipeline expansion
- Next Steps: Phase I trial initiation expected Q2 2026; early efficacy and safety data anticipated H1 2027
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, market potential, and regulatory pathways for SYS 6055. Actual results may differ due to clinical trial outcomes, competitive dynamics, and NMPA review processes.-Fineline Info & Tech