By Fineline Cube Duality Biologics (HKG: 9606) announced that its ADAM9‑targeting ADC candidate DB‑1317 has received Investigational New Drug (IND) approval from China’s CDE of NMPA for a monotherapy trial in patients with advanced or metastatic solid tumors, advancing the first‑in‑class therapy into human studies.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Duality Biologics (9606.HK) |
| Drug | DB‑1317 (ADAM9‑targeting ADC) |
| Platform | Proprietary DITAC platform |
| Application | IND (Investigational New Drug) |
| Agency | CDE of NMPA (China) |
| Indication | Advanced or metastatic solid tumors |
| Study Design | Monotherapy Phase I trial |
| Approval Date | 14 Jan 2026 |
| Rights | Global rights retained by Duality |
Drug Profile & Mechanism of Action
- Target: ADAM9 (A Disintegrin and Metalloproteinase 9) – highly expressed in gastric, colorectal, pancreatic, NSCLC, and other solid tumors, with low expression in normal tissue
- Platform: DITAC (Duality‑Integrated Toxin‑Antibody Conjugate) – proprietary ADC technology enabling stable linker chemistry and bystander effect
- Mechanism: DB‑1317 binds ADAM9 on tumor cells, internalizes, and releases a cytotoxic payload, inducing targeted cell death while sparing healthy cells
- Differentiation: First ADAM9‑targeted ADC in clinical development; preclinical studies show promising anti‑tumor activity across multiple cancer models
Market Opportunity & Competitive Landscape
| Parameter | China | Global |
|---|---|---|
| ADAM9‑Positive Solid Tumors | 480,000 | 2.1 million |
| Advanced/Metastatic Cases | 192,000 | 840,000 |
| ADC Market (2030E) | ¥18 billion | $14 billion |
| DB‑1319 Peak Revenue (2032E) | ¥2.8 billion | $1.9 billion |
| Penetration Rate | 0 % | 0 % |
Key Competitors:
- ADAM9 Targeting:
- M1231 (Mersana Therapeutics) – ADC in Phase I (undisclosed target)
- No other ADAM9 ADCs in active clinical development
- TEAD Inhibitors (downstream of Hippo pathway): Signet Therapeutics (SIGX2649) in preclinical stage
- Differentiation: DB‑1317’s high ADAM9 specificity and DITAC platform offer potential for superior efficacy and safety
Strategic Positioning & Next Steps
- Manufacturing: Duality’s Guangzhou ADC facility (capacity 5,000 L) will produce DB‑1317 for clinical trials; commercial scale‑up planned for 2028
- Clinical Development: Phase I initiation expected Q2 2026 in China; US IND filing planned for H2 2026 leveraging China data
- Combination Potential: ADAM9 expression correlates with immunotherapy resistance; future studies may combine DB‑1317 with PD‑1 inhibitors
- Platform Validation: Deal validates DITAC platform for first‑in‑class targets, supporting pipeline expansion
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and commercial projections for DB‑1317. Actual results may differ due to clinical trial outcomes, competitive dynamics, and manufacturing challenges.-Fineline Info & Tech