By Fineline Cube 
Abbisko Cayman Limited (HKG: 2256) announced that its Investigational New Drug (IND) application for ABSK141, an oral, highly potent and selective small molecule KRAS G12D inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced solid tumors harboring the KRAS G12D mutation.
Regulatory Clearance & Development Status
| Attribute | Details |
|---|---|
| Company | Abbisko Cayman Limited (2256.HK) |
| Product | ABSK141 |
| Regulatory Milestone | FDA IND approval |
| Indication | Advanced solid tumors with KRAS G12D mutation |
| Drug Class | Oral small molecule KRAS G12D inhibitor |
| Next Step | Phase 1 clinical study initiation planned for Q1 2026 |
Drug Profile & Mechanism of Action
- Innovation: Novel oral small molecule KRAS G12D inhibitor independently designed and developed by Abbisko
- Selectivity: Highly selective binding to mutant KRAS G12D protein, sparing wild-type KRAS
- Mechanism: Blocks downstream signaling pathways and inhibits tumor cell proliferation
- Key Advantages: High potency, high selectivity, and potential best-in-class oral bioavailability
Preclinical Validation
| Study Parameter | Results |
|---|---|
| Oral Bioavailability | Demonstrated potential best-in-class oral bioavailability across multiple animal species |
| Anti-Tumor Efficacy | Significant tumor regression in human tumor cell line derived xenograft (CDX) models |
| Key Tumor Types | Pancreatic Ductal Adenocarcinoma (PDAC) and Colorectal Cancer (CRC) |
| Pharmacokinetics | Favorable drug exposure and half-life supporting once-daily dosing |
Market Opportunity & Strategic Outlook
- KRAS G12D Prevalence: Represents approximately 30% of all KRAS mutations, with high incidence in pancreatic (45%) and colorectal (12%) cancers
- Unmet Medical Need: No FDA-approved KRAS G12D targeted therapies currently exist, representing a significant commercial opportunity
- Competitive Landscape: Abbisko joins a select group of biotech companies advancing KRAS G12D inhibitors into clinical development
- Pipeline Validation: FDA IND approval underscores Abbisko’s discovery engine capabilities and strengthens its oncology franchise
- Global Development: US trial initiation will be followed by potential expansion to China and other markets
Forward‑Looking Statements
This brief contains forward‑looking statements regarding ABSK141 development timelines, clinical outcomes, and market potential. Actual results may differ due to clinical, regulatory, and competitive uncertainties.-Fineline Info & Tech