By Fineline Cube 
Antengene Corporation Limited (HKG: 6996) announced that China’s National Medical Products Administration (NMPA) has approved the Clinical Trial Application (IND) for its Phase Ib/II CLINCH-2 study, evaluating ATG-022 in combination with Merck’s Keytruda (pembrolizumab) ± chemotherapy for gastric cancer.
Regulatory Milestone & Study Design
| Attribute | Details |
|---|---|
| Company | Antengene Corporation Limited (6996.HK) |
| Product | ATG-022 (ADC targeting CLDN18.2) |
| Approval | NMPA IND approval |
| Study | Phase Ib/II CLINCH-2 |
| Population | CLDN18.2+, HER2-, PD-L1+ (CPS≥1) unresectable/metastatic GC/GEJC |
| Treatment Arms | ATG-022 + pembrolizumab (A+P); ATG-022 + pembrolizumab + CAPOX (A+P+C) |
Drug Profile: ATG-022 ADC Technology
Target & Engineering:
- Target: CLDN18.2 (Claudin 18.2), highly expressed in gastric cancer
- Affinity: Sub‑nanomolar affinity for enhanced tumor binding
- Internalization: Enhanced internalization characteristics for efficient payload delivery
- Linker‑Payload: VC‑MMAE (valine‑citrulline‑monomethyl auristatin E)
- DAR: Drug‑to‑Antibody Ratio of 4
- Coverage: Designed to treat patients with high, low, and ultra‑low CLDN18.2 expression
Mechanism:
- Selectively delivers cytotoxic payload to CLDN18.2‑expressing tumor cells
- Combination with pembrolizumab aims to enhance anti‑tumor immunity while targeting tumor directly
Strategic Context & Market Opportunity
- Gastric Cancer Burden: China accounts for ~40% of global gastric cancer cases; ~450,000 new cases annually
- CLDN18.2 Landscape: Emerging target with validated efficacy (Astellas’ zolbetuximab approved 2024); ATG-022 offers ADC advantage over monoclonal antibody
- Combination Rationale: PD‑1 inhibitor + targeted therapy addresses both immune evasion and tumor growth pathways
- Competitive Edge: First CLDN18.2 ADC to enter Phase II with Keytruda combination in China
- Development Timeline: Phase Ib dose escalation expected to complete H2 2026; Phase II expansion cohorts to read out 2027
Forward‑Looking Statements
This brief contains forward‑looking statements regarding ATG-022 development timelines, clinical outcomes, and strategic partnerships. Actual results may differ due to clinical, regulatory, and competitive uncertainties.-Fineline Info & Tech