Leads Biolabs (Nanjing Leads Biolabs Co., Ltd.) released its audited 2025 annual results.
Financial Highlights • Revenue: RMB177.26 million, versus zero in 2024, driven entirely by upfront and near-term milestone payments from the global licence of autoimmune asset LBL-047 to U.S.-listed Dianthus Therapeutics. • R&D expenses: RMB289.09 million, up 55.7%, reflecting higher CMC spending for core product LBL-024, faster clinical enrolment for LBL-024 and LBL-034, and expansion of pre-clinical programmes. • Administrative expenses: RMB82.70 million, down 5.7% due to lower one-off share-based compensation, partly offset by post-listing costs. • Net loss: RMB211.42 million, narrowing 29.8% from RMB301.22 million in 2024. • Cash and short-term deposits: RMB1.55 billion at year-end (2024: RMB538.69 million), reflecting IPO proceeds and out-licence payments. • Gearing ratio fell to 28.9% from 60.3%.
Clinical and Pipeline Progress • Core product LBL-024 (PD-L1/4-1BB bispecific, “Opamtistomig”): – Completed enrolment (n=96) for China registrational trial in ≥3L extrapulmonary neuroendocrine carcinoma (EP-NEC); pre-BLA filing targeted for Q2 2026, BLA submission for Q3 2026. – Granted FDA Fast Track and EU Orphan Drug Designations for EP-NEC in January 2026. – Phase I/IIa monotherapy in 2L/3L+ EP-NEC showed ORR 33.3% and median OS 11.9 months (data cut-off 3 June 2025). – Combination Phase Ib/II with EP/EC chemotherapy in 1L EP-NEC delivered ORR 75.0%; 15 mg/kg cohort achieved ORR 79.2%. – Phase II 1L SCLC combo recorded ORR 88.1% (n=59). • LBL-034 (GPRC5D/CD3 bispecific): Phase I ORR 82.5% in relapsed/refractory multiple myeloma; Phase II enrolment underway; received FDA Fast Track in January 2026. • LBL-007 (LAG-3 mAb): Phase II NPC combo with tislelizumab and chemo reported ORR 83.3% and mPFS 15.8 months; median OS not reached. • LBL-047 (BDCA2/TACI fusion protein): IND approvals from FDA and NMPA; Phase I healthy volunteer dosing began December 2025. Deal with Dianthus worth up to USD1 billion; USD30 million received to date. • Five pre-clinical oncology assets advanced to IND-enabling stage; five further candidates progressed toward PCC nomination.
Business Outlook Management targets up to two additional cancer indications for LBL-024 Phase II studies in 2026 and plans to file three to five new INDs annually across trispecific antibodies, T-cell engagers and ADCs. Strategic out-licensing remains a core funding strategy, supplemented by an “asset-light” manufacturing model relying on CDMOs.
Dividends No final dividend proposed for 2025.