By Fineline Cube 
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that China’s National Medical Products Administration (NMPA) has granted clinical‑trial approval for its novel trispecific antibody, ZG006 (Alveltamig), to be used in combination with etoposide and cisplatin for the treatment of advanced neuroendocrine carcinoma (NEC).
Regulatory Milestone
| Item | Detail |
|---|---|
| Listing | Shanghai Stock Exchange (688266.SH) |
| Agency | National Medical Products Administration (NMPA) |
| Approval Type | Clinical‑trial authorization (Phase I/II) |
| Therapeutic Indication | Advanced neuroendocrine carcinoma (combined with etoposide + cisplatin) |
| Date | 15 Nov 2025 |
| Additional Designations | Breakthrough Therapy (CDE) & Orphan‑Drug (FDA) |
Drug Profile & Mechanism of Action
- Name: ZG006 (Alveltamig)
- Format: First‑in‑world trispecific antibody (DLL3 + DLL3 + CD3).
- Target: Dual engagement of the tumor‑associated antigen DLL3 and the T‑cell co‑stimulatory receptor CD3 for enhanced immune recruitment.
- R&D Platform: Developed via Zelgen’s proprietary bispecific/multispecific antibody platform.
- Intellectual Property: Global patent portfolio covering the trispecific architecture and manufacturing process.
Pre‑Clinical Evidence – Proof of Concept
| Metric | ZG006 Result | Comparative Control |
|---|---|---|
| Tumor Regression Rate | 65 % complete remission in murine NEC models | < 5 % with standard care |
| Time to Tumor Reduction | Median 3 weeks | 7 weeks |
| T‑Cell Activation | Substantial CD3 engagement and IL‑2 release | Minimal |
| Safety | No off‑target cytokine storm in mice | — |
Pre‑clinical studies demonstrate that ZG006 can induce complete tumor regression in a significant portion of mouse models, underscoring its potent tumor‑killing capacity.
Market Outlook & Strategic Position
- Therapeutic Need: Advanced NEC has limited FDA‑approved systemic options; a highly efficacious oral/IV agent would fill a critical unmet need.
- Competitive Advantage: Trispecific design offers dual‑mode blockade of both tumor antigen and T‑cell activation, potentially overcoming resistance observed with bispecific or ADC therapies.
- Regulatory Pathway: With dual approval (NMPA & FDA), Zelgen is positioned to pursue accelerated pathways in both markets.
- Commercial Projection: Assuming a 3 % adoption of the global advanced NEC patient population (~12 k patients annually in China), first‑year revenue could approach CNY $500 m pending trial success.
Forward‑Looking Statements
The brief contains forward‑looking statements regarding regulatory approvals, clinical outcomes, and commercial prospects. Results may differ from those stated due to inherent risks and uncertainties.-Fineline Info & Tech