By Fineline Cube Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that subsidiary Shanghai Henlius Biotech, Inc. (HKG: 2696) received NMPA approval to initiate a clinical trial evaluating HLX07 in combination with Serplulimab for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC). The study expands Henlius’s anti-EGFR + PD-1 combination strategy in solid tumors, leveraging Serplulimab’s established multi-regional commercial footprint.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Approval Type | Clinical trial authorization (IND) |
| Product | HLX07 (anti-EGFR biologic) + Serplulimab (PD-1 inhibitor) |
| Developer | Shanghai Henlius Biotech, Inc. (HKG: 2696), Fosun Pharma subsidiary |
| Indication | Advanced squamous non-small cell lung cancer (sqNSCLC) |
| Study Design | Combination therapy trial |
| Approval Date | 16 Mar 2026 |
Product Profiles
HLX07 (Anti-EGFR Biologic):
| Attribute | Specification |
|---|---|
| Target | EGFR (epidermal growth factor receptor) |
| Format | Innovative anti-EGFR biologic |
| Development Status | Phase II ongoing for CSCC and sqNSCLC as monotherapy |
| Mechanism | EGFR pathway inhibition for squamous cell carcinomas |
Serplulimab (PD-1 Inhibitor):
| Attribute | Specification |
|---|---|
| Target | PD-1 (programmed cell death protein 1) |
| Format | Innovative PD-1 monoclonal antibody |
| Marketing Authorization | Approved in Mainland China, EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, India |
| Commercial Status | Multi-regional revenue contributor for Henlius |
Clinical Development Strategy
| Program | Status | Indication |
|---|---|---|
| HLX07 Monotherapy | Phase II | Advanced cutaneous squamous cell carcinoma (CSCC) |
| HLX07 Monotherapy | Phase II | Squamous non-small cell lung cancer (sqNSCLC) |
| HLX07 + Serplulimab | NMPA-approved (new) | Advanced sqNSCLC (combination) |
Combination Rationale:
- Dual Checkpoint Blockade: EGFR inhibition enhances tumor immunogenicity; PD-1 blockade sustains anti-tumor T-cell response
- Synergistic Potential: Preclinical data suggests enhanced efficacy in EGFR-expressing squamous tumors vs. monotherapy
- Commercial Leverage: Serplulimab’s established reimbursement and hospital access accelerates combination trial enrollment
Market Context & Competitive Position
| Factor | Implication |
|---|---|
| sqNSCLC Market | ~30% of NSCLC cases in China (~250,000 annual new cases); limited targeted therapy options vs. adenocarcinoma |
| EGFR Inhibitor Landscape | Cetuximab (Eli Lilly) approved for head/neck; no anti-EGFR biologics specifically approved for sqNSCLC in China |
| PD-1 Competition | Serplulimab differentiated by EU/UK approvals (rare for China-origin PD-1); supports global combination study potential |
| Revenue Synergy | Successful combination positions Henlius for label expansion and fixed-dose combination development |
- Development Pathway: Phase I/II dose-finding expected Q2 2026; potential for accelerated review if breakthrough efficacy demonstrated in PD-L1 high population
- Global Strategy: Serplulimab’s EU approval enables parallel EMA filing for HLX07 combination if China data positive
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical trial initiation, combination efficacy, and regulatory pathways for HLX07 plus Serplulimab. Actual results may differ due to dose-limiting toxicities, competitive dynamics in the PD-1/EGFR combination space, and reimbursement negotiations.-Fineline Info & Tech