By Fineline Cube Shanghai Pharmaceuticals Holding Co., Ltd (SPH, HKG: 2607, SHA: 601607) announced that its B023 cell injection, an allogeneic invariant natural killer T (iNKT) cell therapy, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for locally advanced or metastatic solid tumors that are inoperable, have failed standard therapy, and lack effective treatment options.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Shanghai Pharmaceuticals Holding Co., Ltd (601607.SH) |
| Drug | B023 cell injection (iNKT cell therapy) |
| Application | Investigational New Drug (IND) |
| Agency | NMPA (China) |
| Indication | Locally advanced or metastatic solid tumors (inoperable, post‑standard therapy failure) |
| Core Technology | Allogeneic invariant natural killer T (iNKT) cells |
| Approval Date | 16 Jan 2026 |
| Innovation | First iNKT‑based universal (“off‑the‑shelf”) cell therapy for solid tumors in China |
Drug Profile & Mechanism of Action
- Cell Type: Invariant NKT (iNKT) cells – non‑classical T cells expressing invariant TCR (Vα24‑Jα18/Vβ11)
- Mechanism: Recognizes lipid antigens presented by CD1d (non‑polymorphic MHC‑class I‑like molecule) on tumor cells
Key Advantages:
- Universal (Off‑the‑Shelf): CD1d non‑polymorphism enables allogeneic administration without graft‑vs‑host disease (GvHD)
- Dual Function: Direct cytotoxicity via CD1d‑targeting + immunomodulation via cytokine secretion (IFN‑γ, IL‑4)
- Manufacturing: Scalable cGMP iNKT expansion from healthy donor peripheral blood
- Safety: Lower risk of cytokine release syndrome vs. CAR‑T due to innate‑like regulation
Market Opportunity & Competitive Landscape
| Parameter | China Solid Tumor Market | iNKT Cell Therapy Market |
|---|---|---|
| Advanced/Metastatic Solid Tumor Patients (2026E) | 1.8 million | – |
| Failed Standard Therapy | 540,000 | – |
| Cell Therapy Addressable | 180,000 | – |
| iNKT Therapy Penetration | 0% | 0% |
| Market Value (2030E) | ¥45 billion | ¥8.5 billion |
| B023 Peak Revenue (2032E) | ¥2.8 billion | – |
Key Competitors:
- CAR‑T: No approved CAR‑T for solid tumors; high toxicity (CRS, neurotoxicity)
- TIL Therapy: Iovance (US) – autologous, manufacturing complexity; limited China presence
- iNKT Platforms: Agenus (US, pre‑clinical), NKT Therapeutics (US, Phase I) – no competitors in late‑stage development
- Differentiation: B023’s off‑the‑shelf allogeneic approach avoids GvHD, reduces cost by 60‑70% vs. autologous CAR‑T
Strategic Positioning & Next Steps
- Manufacturing: Shanghai Pharma’s Shanghai biologics facility (capacity 20,000 L) will produce B023 for clinical trials; scale‑up to 50,000 L by 2028
- Clinical Development: Phase I/II dose‑escalation in NSCLC, gastric, and triple‑negative breast cancer planned Q2 2026; conditional approval pathway via BTD possible
- Regulatory Path: First iNKT cell therapy in China; eligible for priority review and accelerated approval
- Commercialization: Shanghai Pharma’s 12,000‑hospital network and 3,000‑person sales force can rapidly commercialize upon approval
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and commercial projections for B023. Actual results may differ due to clinical trial outcomes, competitive dynamics, and manufacturing scale‑up challenges.-Fineline Info & Tech