By Fineline Cube 
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that ZG006, the world’s first trispecific antibody targeting DLL3 (DLL3/DLL3/CD3), received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for single‑agent treatment of advanced neuroendocrine carcinoma (NEC) in DLL3‑positive patients who progressed after platinum‑based therapy.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | ZG006 (DLL3/DLL3/CD3 trispecific antibody) |
| Company | Suzhou Zelgen Biopharmaceuticals (688266.SH) |
| Agency | NMPA (China) |
| Designation | Breakthrough Therapy Designation (BTD) |
| Indication | Advanced DLL3‑positive NEC post platinum therapy |
| Global Status | FDA and NMPA approved for clinical trials |
| Innovation | First‑in‑class trispecific DLL3 format globally |
Drug Profile
- Mechanism: Trispecific antibody targeting DLL3 on tumor cells and CD3 on T‑cells, redirecting immune cells to kill NEC cells
- Preclinical Data: Demonstrated significant tumor suppression in mouse models, with complete regression in a substantial proportion, indicating potent tumor‑killing effects
- Differentiation: Unique DLL3/DLL3/CD3 format may overcome resistance and improve specificity vs. bispecific competitors
- Pipeline Status: Part of Zelgen’s First‑in‑Class pipeline in solid tumors
Market Context & Outlook
| Metric | Value |
|---|---|
| China NEC Incidence | ~12,000‑15,000 new cases annually |
| DLL3‑Positive Share | ~70‑80% of NEC patients (8,400‑12,000 eligible) |
| Current Standard | Platinum‑based chemo; no approved targeted therapies |
| Peak Sales Forecast (ZG006) | ¥2.0‑3.0 billion (~$280‑410 million) by 2032 |
| Market Share Target | 40‑50% of eligible DLL3‑positive patients |
| Competition | Amgen’s tarlatamab (DLL3 bispecific) in Phase 3 for SCLC; ZG006’s trispecific format offers potential differentiation |
- Next Catalyst: Phase I dose‑escalation data expected Q3 2026; BTD status accelerates NMPA review timeline
- Global Strategy: Dual FDA/NMPA approval enables simultaneous development; potential for global partnership similar to other Chinese biotechs
- Strategic Value: Reinforces Zelgen’s position as a leader in novel antibody engineering, building on its successful JAK inhibitor portfolio
Forward‑Looking Statements
This brief contains forward‑looking statements regarding ZG006’s clinical development, regulatory pathway, and market potential. Actual results may differ materially due to risks including clinical trial outcomes, competitive dynamics, and manufacturing scale‑up challenges.-Fineline Info & Tech