By Fineline Cube 
Beijing Gene Mink Biotechnology announced that its self-developed QM103 Cell Injection, a BCMA‑targeted CAR‑NK cell therapy, was granted tacit approval for clinical trials by China’s National Medical Products Administration (NMPA) (Acceptance No.: CXSL2500762), marking the first CAR‑NK product approved for trials in China for relapsed/refractory multiple myeloma (RRMM).
Regulatory Milestone & Product Profile
| Attribute | Details |
|---|---|
| Company | Beijing Gene Mink Biotechnology |
| Product | QM103 Cell Injection |
| Approval | NMPA tacit approval (IND) |
| Acceptance No. | CXSL2500762 |
| Indication | Relapsed/Refractory Multiple Myeloma (RRMM) |
| Significance | First BCMA‑targeted CAR‑NK therapy approved for clinical trials in China |
Technology Breakthrough & Manufacturing Innovation
QM103 is developed on Gene Mink’s proprietary platform addressing three critical CAR‑NK manufacturing bottlenecks:
- Expansion Challenge: Traditional NK cell expansion achieves only hundreds‑fold growth with insufficient purity
- Gene Mink Solution: Serum‑free, feeder‑cell‑free expansion system
- Performance:
- Tens of thousands‑fold NK cell expansion
- >98% NK cell purity
- Effective resolution of large‑scale CAR‑NK manufacturing constraints
Market Context & Competitive Landscape
| Market Parameter | Global Status | China Opportunity |
|---|---|---|
| CAR‑NK Products | No products formally launched globally | QM103 first to enter clinical trials |
| Industry Stage | Most development remains preclinical | Gene Mink leads manufacturing innovation |
| Multiple Myeloma Incidence | ~180,000 new cases globally (2024) | ~20,000 new cases in China annually |
| Current Standard | CAR‑T therapies (BCMA‑targeted) | High cost, complex logistics, toxicity concerns |
| CAR‑NK Advantages | Off‑the‑shelf, lower cost, reduced toxicity | Addresses key barriers to patient access |
Strategic Outlook & Next Steps
- Clinical Development: Phase 1 trial initiation expected Q1 2026
- Manufacturing Scale: Proprietary platform enables cost‑effective production for commercial scale
- First‑Mover Advantage: Positions Gene Mink as pioneer in China’s emerging cell therapy market
- Global Potential: China IND approval may support future US/EU development pathways via manufacturing data
- Investment Appeal: Platform technology applicable to other oncology and autoimmune indications
Forward‑Looking Statements
This brief contains forward‑looking statements regarding QM103 development timelines, clinical outcomes, and manufacturing scalability. Actual results may differ due to clinical, regulatory, and competitive uncertainties.-Fineline Info & Tech