By Fineline Cube 
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced it has received National Medical Products Administration (NMPA) approval to initiate a clinical study evaluating HLX43 combined with HLX07 plus HanSiZhuang (serplulimab) for the treatment of advanced solid tumors.
Regulatory Milestone & Combination Strategy
| Item | Detail |
|---|---|
| Company | Shanghai Henlius Biotech, Inc. (2696.HK) |
| Approval | NMPA clinical trial authorization |
| Combination | HLX43 + HLX07 + HanSiZhuang (serplulimab) |
| Indication | Advanced solid tumors |
| Mechanisms | PD-L1 ADC + anti-EGFR mAb + PD-1 mAb |
| Strategic Rationale | Triple targeting of PD-L1, EGFR, and PD-1 pathways |
| HLX43 Status | PD-L1 ADC with DNA topoisomerase I inhibitor; global monotherapy/combination trials ongoing |
| HLX07 Status | In-house anti-EGFR mAb; favorable safety in early trials |
| HanSiZhuang Status | Approved in China for 4 cancer indications; gastric cancer NDA in priority review |
Drug Profile & Combination Mechanism
- HLX43: PD‑L1‑targeting antibody‑drug conjugate (ADC) conjugated with a novel DNA topoisomerase I inhibitor small molecule toxin; licensed technology combined with Henlius’ self‑developed PD‑L1 antibody backbone
- HLX07: In‑house developed anti‑EGFR monoclonal antibody (mAb) demonstrating favorable safety and tolerability in early‑stage clinical trials
- HanSiZhuang (Serplutimab): Self‑developed PD‑1 mAb approved in China for first‑line treatment of squamous NSCLC, ES‑SCLC, esophageal SCC, and non‑squamous NSCLC; NDA for gastric cancer neoadjuvant/adjuvant therapy entered NMPA priority review in December 2025
- Synergistic Approach: Triple combination targets PD‑L1 (ADC‑mediated cytotoxicity), EGFR (tumor growth signaling), and PD‑1 (immune checkpoint) simultaneously, addressing multiple resistance mechanisms in advanced solid tumors
Market Impact & Commercial Outlook
- Advanced Solid Tumor Market: China market valued at ¥80 billion (~US$11 billion) in 2025, growing at 12% CAGR
- Competitive Landscape: Triple combos gaining traction; Henlius’ integrated ADC + mAb approach differentiates from standard chemo‑immunotherapy regimens
- Strategic Value: Builds on HanSiZhuang’s established market presence; positions Henlius as leader in next‑generation immuno‑oncology combinations
- Revenue Potential: Analysts project ¥2–3 billion (US$280–420 million) peak annual sales potential if approved across multiple solid tumor indications
- Global Ambition: HLX43’s global trial program may enable ex‑China licensing opportunities, complementing domestic combination strategy
- Next Steps: Phase I trial initiation expected Q2 2026; dose‑escalation data anticipated H2 2027
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and commercial expectations for the HLX43/HLX07/HanSiZhuang combination. Actual results may differ due to clinical trial risks, competitive dynamics, and NMPA review processes.-Fineline Info & Tech