By Fineline Cube 
Johnson & Johnson (J&J, NYSE: JNJ) announced that Darzalex Faspro (daratumumab and hyaluronidase-fihj) has received National Medical Products Administration (NMPA) approval for an expanded indication in newly diagnosed multiple myeloma (MM). The CD38-directed antibody is now indicated in combination with bortezomib, lenalidomide, and dexamethasone for adult patients eligible for autologous stem cell transplantation, marking its 11th MM indication globally.
Regulatory Milestone & Drug Profile
| Item | Detail |
|---|---|
| Company | Johnson & Johnson (Janssen) |
| Drug | Darzalex Faspro (daratumumab + hyaluronidase-fihj) |
| Mechanism | CD38-directed monoclonal antibody |
| New Indication | Newly diagnosed MM (transplant-eligible) in combination with VRd |
| Combination | Bortezomib, lenalidomide, dexamethasone (VRd) |
| Approval | NMPA expanded indication |
| Global Approvals | 11 MM indications (5 first-line) |
| First US Approval | May 2020 |
| Technology | Halozyme ENHANZE® drug delivery (subcutaneous) |
| Strategic Significance | Only subcutaneous anti-CD38 mAb approved for MM |
Licensing History & Market Position
- Origin: August 2012 global agreement between Janssen and Genmab A/S, granting J&J exclusive license to develop, manufacture, and commercialize daratumumab
- Market Leadership: Daratumumab has become a cornerstone therapy for multiple myeloma since launch
- Formulation Advantage: Subcutaneous delivery via ENHANZE® technology (recombinant human hyaluronidase PH20) offers 15‑minute administration vs. hours for IV, improving patient convenience
Market Impact & Commercial Outlook
- China MM Market: Transplant‑eligible patients represent 40% of newly diagnosed cases; market valued at ¥12 billion (~US$1.7 billion) in 2025
- Competitive Advantage: As only subcutaneous anti‑CD38 mAb, Darzalex Faspro differentiates from Sarclisa (Sanofi) and Empliciti (BMS)
- Revenue Potential: Analysts project ¥2–3 billion (US$280–420 million) incremental annual sales in China from transplant‑eligible indication by 2028
- Strategic Value: Expands J&J’s MM franchise; supports continued leadership in plasma cell disorders
- Next Steps: Commercial launch expected Q2 2026; physician education on subcutaneous administration benefits to target transplant centers
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, market penetration, and revenue projections for Darzalex Faspro. Actual results may differ due to competitive dynamics, pricing negotiations, and market adoption rates.-Fineline Info & Tech