By Fineline Cube 
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its anti‑PD‑1 monoclonal antibody serplulimab (HANSIZHUANG, Hetronifly in Europe) received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of NMPA for neo‑/adjuvant gastric cancer treatment, marking the first perioperative gastric cancer drug to earn this designation.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Serplulimab (HANSIZHUANG) |
| Company | Shanghai Henlius Biotech, Inc. (2696.HK) |
| Agency | CDE/NMPA (China) |
| Designation | Breakthrough Therapy Designation (BTD) |
| Indication | Perioperative (neo‑/adjuvant) gastric cancer |
| Trial Basis | ASTRUM‑006 Phase 3 study |
| Significance | First gastric cancer perioperative drug to receive BTD |
Drug Profile
- Class: Anti‑PD‑1 monoclonal antibody
- Mechanism: Restores T‑cell mediated anti‑tumor immunity by blocking PD‑1/PD‑L1 pathway
- Global Status: Approved in EU as Hetronifly for MSI‑H solid tumors; China BTD accelerates gastric cancer development
- Innovation: Pioneers chemotherapy‑free adjuvant model post‑neoadjuvant chemo‑immunotherapy
Clinical Evidence – ASTRUM‑006 Trial
| Endpoint | Serplulimab + Chemo (vs. Control) |
|---|---|
| Event‑Free Survival (EFS) | Significantly extended (HR < 0.60; p < 0.001) |
| Pathological Complete Response (pCR) | >3× higher than control group |
| Recurrence Risk | Statistically significant reduction |
| Safety Profile | Overall manageable; consistent with PD‑1 class |
The interim analysis supports a novel perioperative chemo‑immunotherapy approach, with serplulimab monotherapy continuing as adjuvant therapy.
Market Impact & Outlook
| Metric | Value |
|---|---|
| China Gastric Cancer Incidence | ~680,000 new cases (2024) |
| Perioperative‑Eligible Patients | ~200,000 operable cases (30% of total) |
| Current Standard | Chemotherapy alone; no approved perioperative immunotherapy |
| Peak Market Potential | ¥5‑7 billion (US$680‑950 million) by 2030 |
| Market Share Target | 25‑30% of eligible patients |
| Competition | Merck’s Keytruda, BMS’s Opdivo still in Phase 3; serplulimab BTD creates first‑mover advantage |
| Reimbursement Path | BTD status likely accelerates NRDL inclusion within 12‑18 months post‑approval |
- Next Catalyst: Full Phase 3 data readout Q2 2026; NDA submission expected H2 2026
- Strategic Value: BTD reinforces Henlius’s leadership in GI oncology, building on serplulimab’s approved indications in NSCLC and MSI‑H cancers
Forward‑Looking Statements
This brief contains forward‑looking statements regarding serplulimab’s clinical development, regulatory timeline, and commercial potential. Actual results may differ due to risks including final trial data, NMPA review outcomes, and competitive dynamics.-Fineline Info & Tech