Gosset CLDN18.2 Therapeutics in China:
The Next Frontier in Gastric Cancer
Competitive Landscape Analysis of China's Emerging $3.7B Market
Last Updated: January 28, 2025
Market Opportunity
China represents the largest gastric cancer market globally with over 260,000 deaths in 2022. With 35% of advanced gastric cancer patients expressing CLDN18.2, and China accounting for 60% of global ADC clinical trials, the country has emerged as the epicenter of CLDN18.2 drug development.2,3
CLDN18.2 Technology Landscape in China
This visualization shows the distribution of different therapeutic modalities targeting CLDN18.2 being developed by Chinese companies. Hover over each segment to see the key players and their development stage.
Clinical Development Pipeline
China's CLDN18.2 pipeline demonstrates exceptional depth with 7 domestically developed drugs in Phase III trials and multiple innovative approaches across all development stages.
Leading Chinese CLDN18.2 Therapeutics
| Drug Name | Company | Modality/Technology | Development Stage | Key Indications | Clinical Results | Regulatory Status | Key Differentiators |
|---|---|---|---|---|---|---|---|
| CT041 (satri-cel) | CARsgen | Autologous CLDN18.2 CAR-T | Phase II Complete | 3L+ CLDN18.2+ gastric/GEJ cancer | ORR: 48.6%; DCR: 73.0% 6-mo OS: 81.2%4 | Breakthrough Therapy (China) NDA planned H1 2025 | First-in-class global CLDN18.2 CAR-T; 129 granted patents |
| IBI343 | Innovent Biologics | CLDN18.2 ADC (exatecan) | Phase III | Gastric/GEJ cancer; Pancreatic cancer | Pancreatic: ORR 23.3% PFS: 5.3 months5 | Dual Breakthrough (NMPA/FDA) | Site-specific glyco-conjugation; bystander effect |
| ASKB589 | AskGene Pharma | CLDN18.2 mAb (ADCC-enhanced) | Phase III | 1L CLDN18.2+ gastric cancer | Phase II: ORR 79.2% No DLT up to 20 mg/kg6 | Phase III approved by NMPA | Second-gen humanized mAb; enhanced ADCC |
| LM-302 | LaNova/Turning Point | CLDN18.2 ADC (MMAE) | Phase II/III | 3L+ CLDN18.2+ gastric/GEJ cancer | ORR: 30.6%; DCR: 75.0% mPFS: 7.16 months7 | CDE Breakthrough (Oct 2023) | MMAE payload; strong disease control |
| IBI389 | Innovent Biologics | CLDN18.2×CD3 Bispecific | Phase I/II | CLDN18.2+ pancreatic, gastric cancer | Gastric: ORR 30.8% Pancreatic: ORR 25-30%8 | First-in-class T-cell engager | Manageable CRS; activity in low CLDN18.2 |
| SHR-A1904 | Shanghai Hengrui | CLDN18.2 ADC (Topo-I) | Phase Ib/III | CLDN18.2+ solid tumors | Phase I: ORR ~55% at 6 mg/kg9 | NMPA approved for Phase III | Proprietary Topo-I payload; combo with CAPOX+PD-1 |
This table highlights key programs. Access comprehensive competitive intelligence on all 70+ CLDN18.2 therapeutics in development, including preclinical assets and global partnerships.
Get Full CLDN18.2 Dataset / Book a CallChinese Innovation in CLDN18.2 Targeting
CAR-T Cell Therapies
- CT041 (CARsgen): First-in-class global, Phase II complete
- XKDCT225 (Celconta): Autologous CAR-T, Phase I
- CB CAR-NK182 (Rongu): Allogeneic cord-blood CAR-NK
- LY011 (Longyao): 3rd-gen CAR-T with OX40 costimulation
Antibody-Drug Conjugates
- Novel payloads: Exatecan, MMAE, Topo-I inhibitors
- Site-specific conjugation: Glyco-engineering (IBI343)
- Bystander effect: Enhanced tumor penetration
- Multiple Phase III: IBI343, LM-302, SHR-A1904
Bispecific Antibodies
- T-cell engagers: IBI389 (CLDN18.2×CD3), QLS31905
- Immunocytokines: LB4330 (CLDN18.2+IL-10)
- Checkpoint combos: Q-1802 (CLDN18.2×PD-L1)
- Novel targets: PM1032 (CLDN18.2×4-1BB)
Enhanced mAbs
- ADCC enhancement: ASKB589, MIL93, ZL-1211
- Glyco-engineering: Afucosylated Fc (MIL93)
- Second-generation: Improved binding affinity
- Combination ready: Designed for checkpoint combos
Strategic Landscape Analysis
🏆 China's Global Leadership
- 60% of global ADC trials now originate from China3
- 7 Phase III programs from domestic companies
- First global CAR-T: CARsgen's CT041 leading worldwide
- Patent dominance: 129+ patents from CARsgen alone
🤝 Partnership Dynamics
$1.34B for XNW27011 ADC (ex-Greater China)10
Chinese companies retaining Greater China rights while out-licensing globally
📊 Clinical Development Focus
- Multi-modal approach: CAR-T, ADC, bispecifics, mAbs all advancing
- Combination strategies: With chemotherapy and checkpoint inhibitors
- Biomarker development: CLDN18.2 IHC stratification standard
- Speed to market: Multiple Phase III readouts expected 2025-2026
Competitive Dynamics & Market Entry
⚡ First-Mover Advantage
Astellas' zolbetuximab approval (Jan 2025) sets the benchmark2
- First CLDN18.2-targeted therapy approved globally
- Creates urgency for Chinese competitors
- Establishes pricing and efficacy benchmarks
🔬 Technology Differentiation
Chinese companies pursuing diverse approaches to differentiate
- CAR-T: Potential for durable responses
- ADCs: Better safety vs traditional chemo
- Bispecifics: Novel mechanisms of action
- Combinations: Synergy with I-O agents
🏥 Market Access Strategy
Navigating China's unique healthcare landscape
- NRDL inclusion critical for broad access
- Provincial tenders and volume-based procurement
- Real-world evidence generation crucial
- Patient assistance programs for premium therapies
Future Outlook: 2025-2030
Near Term (2025-2026)
- Multiple Phase III readouts expected
- First domestic CLDN18.2 approval likely
- CAR-T (CT041) NDA submission
- ADC competition intensifies
Medium Term (2027-2028)
- 3-5 domestic approvals expected
- Combination therapy dominance
- Global licensing deals accelerate
- Biosimilar development begins
Long Term (2029-2030)
- Market consolidation phase
- Next-gen CLDN18.2 therapies
- Expansion beyond gastric cancer
- China as global export hub
Key Strategic Takeaways
China Has Become the Global CLDN18.2 Innovation Hub
With 60% of global ADC trials and the first global CAR-T program, Chinese companies are not followers but leaders in CLDN18.2 development. The depth of the pipeline ensures sustained innovation.3
Multi-Modal Approach Drives Competitive Advantage
Unlike single-modality focus elsewhere, Chinese companies are advancing CAR-T, ADCs, bispecifics, and enhanced mAbs simultaneously, providing multiple shots on goal and risk diversification.
The Window for Market Entry is Narrowing
With 7 Phase III programs and multiple breakthrough designations, the race for China's $3.7B CLDN18.2 market will be won in the next 24 months. Speed and differentiation are critical.1
References
- ECHEMI. CLDN18.2 Antibody Market Analysis. Available at: https://www.echemi.com/cms/2241593.html
- PR Newswire. China's NMPA Approves Vyloy (zolbetuximab). Available at: https://www.prnewswire.com/news-releases/vyloy-approval-302342446.html
- Invesco. How are ADC drug partnerships changing China's biotech landscape? Available at: https://www.invesco.com/china-adc-partnerships-oct-2024.pdf
- Nature Medicine. CT041 CAR-T therapy in gastric cancer. Available at: https://www.nature.com/articles/s41591-022-01800-8
- Innovent Biologics. IBI343 Receives NMPA Breakthrough Therapy Designation. Available at: https://www.prnewswire.com/news-releases/ibi343-breakthrough-302352458.html
- AskGene Pharma. ASKB589 Phase III Trial Clearance. Available at: https://ask-gene.com/askb589-phase-iii-clearance/
- ASCO. LM-302 Phase II Expansion Results. J Clin Oncol 42, 2024 (suppl 16; abstr 3028)
- ClinicalTrials.gov. IBI389 Phase I/II Study. NCT05164458
- ClinicalTrials.gov. SHR-A1904 Combination Study. NCT06350006
- Fierce Biotech. Astellas-Evopoint CLDN18.2 ADC Deal. Available at: https://www.fiercebiotech.com/astellas-evopoint-cldn182-deal
Disclaimer
This report is for informational purposes only and should not be considered investment advice. The information presented is based on publicly available data and should be independently verified before making any business or investment decisions. This report does not constitute financial advice, investment recommendations, or medical guidance.