By Fineline Cube 
Chongqing Precision Biotech Co., Ltd. announced that its pCAR‑19B cell‑based product has received National Medical Products Administration (NMPA) marketing authorisation. pCAR‑19B is the first Class 1 biological new drug in China to treat refractory or relapsed B‑cell acute lymphoblastic leukaemia (r/r B‑ALL) in children and adolescents.
Product Profile
| Attribute | Details |
|---|---|
| Product name | pCAR‑19B |
| Therapeutic class | Autologous CAR‑T cell therapy |
| Target antigen | Humanised CD19 scFv (single‑chain variable fragment) |
| Indication | r/r B‑ALL in patients ≤ 18 years |
| Regulatory status | NMPA marketing approval (National Class 1) |
| Unique selling point | Only humanised CD19 CAR‑T on the Chinese market for paediatric/adolescent use |
| Developer | Chongqing Precision Biotech Co., Ltd. (Precision Biotech) |
| International collaborations | Perez Scremini Foundation (USA) & University of Navarra (Spain) |
Clinical & Market Significance
- First‑in‑class: pCAR‑19B follows the global trend set by tisagenlecleucel and axicabtagene ciloleucel, but it is the first humanised CD19 CAR‑T approved for the pediatric B‑ALL segment in China.
- Unmet need: Approximately 4,000 Chinese children are diagnosed with B‑ALL each year; about 15 % experience relapse or refractory disease, representing a high‑value, high‑unmet‑need market.
- Pricing outlook: Early‑stage pricing guidance suggests a ¥1.8–¥2.2 million per treatment course, comparable to imported CAR‑T products, but with a domestic supply chain advantage.
Expansion Strategy
| Goal | Timeline | Target Region |
|---|---|---|
| Establish regional branches | 2026‑2028 | Europe, United States, Japan |
| Launch additional Class 1 cell‑based drugs | ≥ 3 products | Global |
| License‑out & technical services | Ongoing | International biotech partners |
The company plans to leverage its Perez Scremini Foundation and University of Navarra collaborations to accelerate global IND filings, technology transfer, and licensing agreements for future CAR‑T candidates.
Financial & Partnership Outlook
- Up‑front & milestone potential: Precision Biotech expects RMB 1.5–2.0 bn in upfront payments and development milestones from prospective licensees over the next five years.
- Royalty stream: Projected tiered royalties of 12 %–20 % on net sales for any licensed CAR‑T products entering overseas markets.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, commercial launch, pricing, and partnership activities. Actual results may differ due to clinical outcomes, regulatory review, market acceptance, and execution of international agreements.-Fineline Info & Tech