Nanjing Leads Biolabs (9887) investor relations material

Executive summary

• LBL-024’s NDA for previously treated advanced EP-NEC was accepted by the NMPA on August 21, 2026, after priority review inclusion in July; potential conditional approval and launch are targeted for H1 2027, subject to review.

• The pre-commercial pipeline spans 15 oncology and autoimmune candidates, including five clinical-stage assets.

• H1 revenue was RMB36.0m; IFRS loss was RMB221.9m and adjusted loss RMB171.1m.

Financial highlights

• Revenue was RMB36.0m versus nil in H1 2025, comprising RMB35.039m from the LBL-047 milestone and RMB0.930m from drug-material supply to Dianthus.

• IFRS loss was RMB221.9m versus RMB166.4m; adjusted loss was RMB171.1m versus RMB147.4m, excluding share-based compensation, net FX losses and one-off listing expenses.

• R&D costs rose 44.9% YoY to RMB191.0m; administrative expenses increased 15.5% to RMB41.4m.

• Other expenses included RMB47.9m of net FX losses; other income and gains were RMB29.8m, including bank interest and government grants.

• Operating cash outflow was RMB195.4m; cash and time deposits totaled RMB1,242.1m at June 30, down from RMB1,548.0m at year-end 2025.

Outlook and guidance

• Potential conditional approval and commercial sales for LBL-024 in previously treated EP-NEC are targeted for H1 2027, subject to timely review and no additional requests for data.

• First-line EP-NEC confirmatory Phase III enrollment is planned for H2 2026; LBL-024 NSCLC Phase III is targeted for 2027, and the BTC Phase III application for H1 2027.

• IND submissions for LBL-054, LBL-061, LBL-066 and LBL-076 target H2 2026 or H1 2027; LBL-058 and LBL-077 target H2 2027.

• Global partnering discussions for LBL-024 began in August 2026; LBL-034 partnering is ongoing, with a target of 1–2 high-impact transactions annually.