1. 2025 Financial Snapshot • Revenue reached RMB 356.09 million, a 20.10% decline year-on-year, attributable to temporary account freezes linked to the Qingdao litigation that disrupted Envafolimab supply. • Gross profit fell 19.80% to RMB 327.91 million, yet gross margin inched up to 92.10% (2024: 91.80%) on lower sales-related taxes. • Research & development expenses dropped 13.60% to RMB 156.10 million, reflecting lower outsourcing and payroll costs. • Selling & marketing expenses decreased 21.50% to RMB 185.25 million, broadly in line with reduced sales volume. • Total comprehensive loss narrowed 7.30% to RMB 184.89 million; on an adjusted (non-IFRS) basis, loss was RMB 160.08 million versus RMB 166.71 million in 2024. • Year-end cash, bank balances and short-term investments stood at RMB 524.99 million, down from RMB 864.32 million a year earlier, mainly after loan repayments and a RMB 98 million settlement tied to Qingdao Hainuo.
2. Commercial Performance – Envafolimab (恩維達®) • Sole revenue contributor with 2025 China sales of RMB 356.10 million, 20.10% lower year-on-year. • Maintains industry-leading profile as China’s only subcutaneous PD-L1 inhibitor; now cited in 20 domestic guidelines/consensus documents. • Eleven Envafolimab studies were presented at ASCO 2025, spanning lung, gastrointestinal, biliary, pancreatic and sarcoma indications.
3. R&D and Pipeline Progress • Radionuclide Drug Conjugates: Lead candidate 3D1015 (¹⁷⁷Lu-PSMA) entered investigator-initiated trial, showing superior pre-clinical tumor suppression versus Pluvicto. • AI LNP-mRNA Platform: First in-house therapeutic vaccine 3D124 advanced pre-clinically; proprietary ionizable lipid filed for PCT patent. • In vivo CAR Platform: Two targeted LNP programs (CAR-T 3D128, CAR-NK 3D129) in evaluation phase. • Ongoing multi-regional Phase III REGAL trial of WT1 vaccine 3D189 for AML has completed enrolment; independent monitoring board supports continuation.
4. Regulatory & Corporate Updates (Post-balance-sheet) • January 2026: NMPA accepted NDA for Envafolimab + GEMOX as first-line therapy for unresectable/metastatic biliary tract cancer. • February 2026: Supplemental filing accepted to convert Envafolimab’s conditional approval to regular approval in China. • January 2026: Lu Xiaohao appointed Chief Financial Officer, focusing on global capital markets.
5. Outlook & Strategy Management targets stable revenue and completion of key R&D milestones while transitioning from precision oncology to metastasis- and recurrence-prevention platforms (RDC, LNP-mRNA, in vivo CAR). Global commercial expansion continues, supported by the Glenmark licensing deal and advancing ex-China out-licensing discussions.
6. Dividend No final dividend declared for FY 2025.