By Fineline Cube Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that China’s National Medical Products Administration (NMPA) has approved clinical studies for ZGGS18 and ZG005 in combination with chemotherapy for advanced solid tumors, advancing two Category 1 biologics with novel mechanisms into human trials.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Suzhou Zelgen Biopharmaceuticals (688266.SH) |
| Assets | ZGGS18 (VEGF/TGF‑β trap) and ZG005 (PD‑1/TIGIT bispecific) |
| Application | Clinical Trial Application (CTA) |
| Agency | NMPA (China) |
| Indication | Advanced solid tumors (combination with chemotherapy) |
| Approval Date | 14 Jan 2026 |
| Study Design | Phase I/II dose‑escalation and expansion |
| Innovation | First dual‑functional VEGF/TGF‑β trap; PD‑1/TIGIT bispecific for solid tumors |
Drug Profile & Mechanism of Action
ZGGS18 (VEGF/TGF‑β Dual‑Functional Fusion Protein):
- Binds VEGF to inhibit tumor angiogenesis
- Traps TGF‑β to suppress immunosuppressive tumor microenvironment and reduce metastasis
- Synergistic effect: Addresses both vascularization and immune evasion pathways
ZG005 (PD‑1/TIGIT Bispecific Antibody):
- Blocks PD‑1/PD‑L1 immune checkpoint
- Inhibits TIGIT, a secondary checkpoint that limits NK and T‑cell function
- Dual checkpoint blockade enhances anti‑tumor immunity in solid tumors
Market Opportunity & Competitive Landscape
| Parameter | China | Global |
|---|---|---|
| Advanced Solid Tumor Patients (2026E) | 1.8 million | 7.5 million |
| VEGF/TGF‑β Targetable Population | 720,000 | 3.0 million |
| PD‑1/TIGIT Eligible Patients | 900,000 | 3.8 million |
| Market Value (2030E) | ¥45 billion | $32 billion |
| ZGGS18/ZG005 Peak Revenue (2032E) | ¥6.2 billion | $4.1 billion |
Competitors:
- VEGF/TGF‑β: Bintrafusp alfa (GSK/Merck KGaA) – failed Phase III; ZGGS18’s fusion protein design may offer improved safety
- PD‑1/TIGIT: Tiragolumab (Roche) – failed lung cancer trials; Vibostolimab (Merck) – Phase II; ZG005’s bispecific format could overcome prior failures
Strategic Positioning
- Manufacturing: Zelgen’s Suzhou facility (capacity 10,000 L) will produce both assets for clinical trials; commercial scale‑up planned for 2028
- Clinical Speed: NMPA’s Category 1 biologic fast‑track enables Phase I initiation in Q2 2026 and potential conditional approval by 2029
- Combination Strategy: Co‑development of ZGGS18 and ZG005 allows for potential triple‑combination regimen (VEGF/TGF‑β + PD‑1/TIGIT + chemotherapy)
- Pipeline Value: Validates Zelgen’s bispecific and fusion protein platforms for next‑generation oncology assets
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and competitive positioning for ZGGS18 and ZG005. Actual results may differ due to clinical trial outcomes, competitive dynamics, and market access challenges.-Fineline Info & Tech