By Fineline Cube 
Lepu Biopharma Co., Ltd. (HKG: 2157) announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) approval for its antibody‑drug conjugate (ADC) MRG007, an innovative CDH17‑directed therapy now entering first‑in‑human studies in the United States.
Deal & Development Overview
| Item | Detail |
|---|---|
| Company | Lepu Biopharma Co., Ltd. (2157.HK) |
| Product | MRG007 – CDH17‑targeted ADC |
| Regulatory Milestone | FDA IND approval (Nov 2025) |
| Current Trial Phase | Dose‑escalation (Phase 1) – first patient enrolled in China on 25 Jul 2025 |
| Licensing Partner | ArriVent – exclusive global rights outside Greater China |
| Agreement Date | 22 Jan 2025 – exclusive development, manufacturing, and commercialization license |
| Collaboration Model | Joint global clinical development; Lepu provides Chinese regulatory support and early‑stage data |
Scientific Rationale
- Target: CDH17 (Cadherin‑17) – over‑expressed in gastrointestinal malignancies, particularly gastric and colorectal cancers.
- ADC Architecture: Humanized anti‑CDH17 monoclonal antibody linked to a potent cytotoxic payload via a cleavable linker, designed for selective tumor cell killing while sparing normal tissue.
- Pre‑clinical Highlights: In xenograft models, MRG007 achieved >85 % tumor regression with a favorable safety margin compared with non‑targeted chemotherapy.
Clinical Development Timeline
| Milestone | Expected Date |
|---|---|
| IND filing (US) | 10 Nov 2025 (approved) |
| First US patient dosing | Q1 2026 |
| Dose‑escalation completion | Mid‑2027 |
| Phase 1b expansion (selected tumor types) | Late 2027 |
| Pivotal Phase 2/3 initiation | 2028 (contingent on Phase 1 data) |
| Potential US NDA submission | 2029‑2030 |
Market Potential & Financial Outlook
- Addressable Market: CDH17‑positive gastric and colorectal cancers represent an estimated $4.2 billion global market in 2025, with a high unmet‑need segment of patients refractory to standard chemotherapy and immunotherapy.
- Revenue Forecast (ArriVent): Assuming a 5 % market share post‑approval, projected U.S. sales of $150 M–$220 M by 2032.
- Strategic Fit: The IND clearance positions Lepu and ArriVent to be first‑to‑market with a CDH17‑directed ADC, differentiating from existing HER2 or EGFR ADC pipelines.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, clinical development, and commercial expectations for MRG007. Actual results may differ due to risks including clinical trial outcomes, regulatory approvals, manufacturing scale‑up, and competitive dynamics.-Fineline Info & Tech