Nanjing Leads Biolabs (9887) H2 2025 earnings summary

Executive summary

• 2025 revenue was RMB177.3m, entirely from LBL-047 license payments; reported loss narrowed to RMB211.4m.

• R&D costs rose to RMB289.1m as clinical and preclinical programs advanced.

• Year-end cash and highly liquid financial assets reached RMB1,548.1m; LBL-024’s China BLA filing is targeted for Q3 2026.

Financial highlights

• Revenue was RMB177.3m in 2025 versus nil in 2024, from upfront and near-term LBL-047 license payments from Dianthus.

• R&D costs increased 55.7% to RMB289.1m from RMB185.7m, mainly supporting LBL-024 BLA preparation, clinical development and preclinical advancement.

• Reported loss was RMB211.4m versus RMB301.2m; loss before tax was RMB195.9m and income tax expense was RMB15.5m.

• Adjusted loss was RMB180.0m in 2025.

• Administrative expenses fell to RMB82.7m from RMB87.7m.

Outlook and guidance

• LBL-024 pre-BLA submission to NMPA is planned for Q2 2026, followed by a Q3 2026 BLA filing for 3L+ EP-NEC; China approval is estimated for mid-2027.

• 2026 LBL-024 data updates are planned at ESMO and WCLC; NSCLC enrollment completion is targeted for Q2 2026, with a Phase III confirmatory-trial first patient before year-end.

• IND filings for LBL-054, LBL-061, LBL-076 and LBL-066 are expected in Q4 2026 or Q1 2027; five other candidates target PCC nomination in H1 2026.

• Plans call for 3–5 preclinical assets to enter IND-enabling development annually; 2030 targets are 3 commercialized and 4–8 late-clinical-stage products.

• BD revenue and out-licensing transactions are expected to continue supporting development and cash flow.