By Fineline Cube Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has approved a Phase Ib/II clinical study for HLX701, a SIRPα‑Fc fusion protein, in combination with cetuximab plus chemotherapy for advanced colorectal cancer (CRC), advancing Henlius’s CD47‑targeted immuno‑oncology pipeline into a key solid tumor indication.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Shanghai Henlius Biotech, Inc. (2696.HK) |
| Drug | HLX701 (SIRPα‑Fc fusion protein) |
| Application | Phase Ib/II Clinical Trial Application (CTA) |
| Agency | NMPA (China) |
| Indication | Advanced/metastatic CRC (inoperable, post‑standard therapy failure) |
| Regimen | HLX701 + cetuximab + chemotherapy |
| Approval Date | 16 Jan 2026 |
| Rights | Exclusive China (ex‑Taiwan), Southeast Asia, Middle East, North Africa (licensed from FBD Biologics, 2023) |
Drug Profile & Mechanism of Action
- Mechanism: SIRPα‑Fc fusion protein that binds CD47 on tumor cells, blocking the “don’t eat me” inhibitory signal
- Effect: Promotes macrophage‑mediated phagocytosis of tumor cells and enhances anti‑tumor activity
- Advantage: Fc domain enables ADCC (antibody‑dependent cellular cytotoxicity) and CDC (complement‑dependent cytotoxicity), potentially improving efficacy vs. pure CD47 blockers
- Combination Rationale:
- Cetuximab (EGFR inhibitor) sensitizes tumor cells to macrophage attack
- Chemotherapy induces immunogenic cell death, increasing CD47 expression and tumor antigen presentation
Market Opportunity & Competitive Landscape
| Parameter | China CRC Market | CD47 Inhibitor Landscape |
|---|---|---|
| Advanced CRC Patients (2026E) | 180,000 | – |
| Failed Standard Therapy | 54,000 | – |
| EGFR‑Expressing (Cetuximab‑Eligible) | 32,000 | – |
| HLX701 Addressable Market | 32,000 | – |
| Peak Market Share | 0% | 15% |
| Annual Cost (USD) | – | $45,000 |
| Peak Revenue (2032E) | – | $216 million (KRAS‑wildtype CRC segment) |
Key Competitors:
- Magrolimab (Gilead) – CD47 inhibitor, Phase III in AML/MDS, solid tumor trials ongoing
- Lemzoparlimab (I‑Mab) – CD47 inhibitor, Phase II, no CRC data yet
- Evorpacept (ALX Oncology) – SIRPα‑Fc fusion (similar to HLX701), Phase I/II in solid tumors
- HLX701 – First CD47‑targeted agent entering Phase II‑ready study in combination with cetuximab for CRC
Strategic Positioning & Next Steps
- Manufacturing: Henlius’s Shanghai biologics facility (capacity 10,000 L) will produce HLX701 clinical supply; scale‑up to 30,000 L planned for commercial launch
- Clinical Development: Phase Ib/II dose‑escalation and expansion planned Q2 2026; primary endpoint: ORR by RECIST 1.1; secondary: PFS, OS, safety
- Commercial Reach: 800‑person oncology sales force already detailing cetuximab biosimilar and PD‑1 inhibitor; cross‑selling HLX701 upon approval
- Global Strategy: Henlius plans US IND filing for HLX701 in 2027, leveraging China combination data; ex‑China licensing discussions underway for SEA and MENA markets
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and commercial projections for HLX701. Actual results may differ due to clinical trial outcomes, competitive dynamics, and manufacturing challenges.-Fineline Info & Tech