Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the NMPA accepted its New Drug Application (NDA) for HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly) as neoadjuvant/adjuvant treatment for PD‑L1 positive, operable gastric cancer, granting Priority Review status. The filing is supported by the pivotal ASTRUM‑006 Phase 3 trial, which demonstrated significant improvements in Event‑Free Survival (EFS) and pathological complete response (pCR) rates vs. chemotherapy alone.
Regulatory Milestone
Item
Details
Submission Date
12 Dec 2025
Agency
NMPA (China)
Product
HANSIZHUANG (serplulimab)
Indication
PD‑L1 positive, operable gastric cancer (neoadjuvant + adjuvant)
Review Status
Priority Review granted
Trial Basis
ASTRUM‑006 Phase 3 study met primary EFS endpoint and pCR superiority
Safety Profile
Manageable and consistent with prior serplulimab data
Drug Profile & Commercial Reach
Attribute
Serplulimab
Global Launch Status
Mechanism
Anti‑PD‑1 monoclonal antibody
Approved in 40+ countries
Approved Indications
sqNSCLC, ES‑SCLC, ESCC, nsNSCLC
China, UK, Germany, Singapore, India
New Indication
Adjuvant/neoadjuvant gastric cancer
Filing under Priority Review
Market Opportunity
450,000+ new gastric cancer cases annually in China
PD‑L1 positive subset ~40‑50% of operable patients
ASTRUM-006 Efficacy Data
Endpoint
Serplulimab + Chemotherapy
Placebo + Chemotherapy
Statistical Significance
Event‑Free Survival (EFS)
Primary endpoint met
Control arm
Superiority demonstrated
Pathological Complete Response (pCR)
Significantly higher
Baseline comparator
Clinically meaningful improvement
Recurrence Risk Reduction
Substantial risk reduction
—
p < 0.05 (pre‑specified)
Forward‑Looking Statements This brief contains forward‑looking statements regarding serplulimab’s NDA review timeline, market penetration in gastric cancer, and potential NRDL negotiations. Actual results may differ due to regulatory feedback, competitive dynamics, or pricing pressures.-Fineline Info & Tech
By Fineline Cube 