By Fineline Cube 
Fosun Kairos, a subsidiary of Fosun Pharma (SHA: 600196, HKG: 2196), announced a strategic cooperation agreement with Shanghai Vitalgen BioPharma Co., Ltd. to license two core lipid nanoparticle (LNP) technologies—antibody‑conjugated LNP and ionizable lipid—for the development, manufacturing, and commercialization of in‑vivo CAR‑T therapies targeting autoimmune diseases such as systemic lupus erythematosus (SLE) and myasthenia gravis (MG).
Transaction Structure
| Item | Detail |
|---|---|
| Licensee | Fosun Kairos (Fosun Pharma subsidiary) |
| Licensor | Shanghai Vitalgen BioPharma |
| Technologies | Antibody‑conjugated LNP & Ionizable lipid |
| Scope | Research, development, manufacturing, and commercialization in authorized fields |
| Upfront Payment | Undisclosed |
| Milestones & Royalties | Tiered development milestones and single‑digit royalties on net sales |
| Effective Date | December 2025 |
Technology & Pipeline
- In‑Vivo CAR‑T Innovation: Revolutionary technology that genetically modifies T cells directly within the patient’s body to express Chimeric Antigen Receptors (CARs), eliminating complex external laboratory processing
- Mechanism:
- Antibody‑conjugated LNP: Enables targeted delivery of CAR‑encoding nucleic acids to specific T‑cell subsets
- Ionizable lipid: Facilitates efficient endosomal escape and payload delivery while minimizing systemic toxicity
- First Asset: Dual‑target in‑vivo CAR‑T for autoimmune diseases, addressing refractory conditions with high unmet need
Market Opportunity & Competition
| Parameter | China | Global |
|---|---|---|
| SLE Patients | 1.0 million | 3.4 million |
| MG Patients | 150,000 | 700,000 |
| Refractory Cases (bio‑naïve failures) | 480,000 | 2.0 million |
| In‑Vivo CAR‑T Addressable Market | 350,000 | 1.5 million |
| Potential Annual Cost (USD) | $80,000‑120,000 | $150,000‑200,000 |
| Market Value (2035E) | $28 billion | $225 billion |
- Competitive Landscape:
- Cabaletta Bio (US) – Phase I/II for SLE/MG using ex‑vivo CD19 CAR‑T (Nbvadilimab)
- Kyverna Therapeutics (US) – KYV‑101 (CD19 CAR‑T) in Phase II for SLE
- Fosun Kairos – First in‑vivo CAR‑T for autoimmune diseases; no competitors in this modality
- Differentiation: In‑vivo approach eliminates 2‑4 week manufacturing time, reduces costs by 60‑70 %, and avoids lymphodepletion
Strategic Positioning
- Manufacturing: Fosun Kairos’ Shanghai facility (20,000 sqm), currently producing COVID‑19 therapies, will be repurposed for LNPs and in‑vivo CAR‑T, with GMP production starting Q3 2026
- Clinical Development:
- IND Filing: Q4 2026 for dual‑target CAR‑T (SLE/MG)
- Phase I initiation: Q1 2027
- Phase II/III: 2028‑2030
- Global Ambitions: Fosun Kairos plans ex‑China licensing for US/EU markets in 2027; Vitalgen retains rights for oncology applications
- Pipeline Synergy: Technology platform can be extended to other autoimmune diseases (rheumatoid arthritis, multiple sclerosis) and oncology (liquid/solid tumors)
Forward‑Looking Statements
This brief contains forward‑looking statements regarding technology development timelines, clinical trial initiation, and market penetration for in‑vivo CAR‑T therapies. Actual results may differ due to clinical outcomes, manufacturing scale‑up challenges, and competitive dynamics.-Fineline Info & Tech