LEADS BIOLABS-B Posts Wider Interim Loss as NDA for Core Asset LBL-024 Enters Priority Review

Bulletin Express09-23 22:02

LEADS BIOLABS-B reported its first operating revenue yet booked a broader net loss for the six months ended 30 June 2026, while advancing flagship oncology antibody LBL-024 toward a potential first-in-class approval.

Revenue reached RMB 36.00 million, all generated from an FDA-cleared milestone on lupus fusion protein LBL-047 and supply of clinical material to U.S. partner Dianthus Therapeutics. The group reported no revenue in the prior-year period.

Research and development expenses rose 44.9 % to RMB 191.02 million, reflecting accelerated clinical programmes for five assets and four IND-enabling projects. Administrative costs increased 15.5 % to RMB 41.37 million on post-listing compliance and office expansion.

Loss for the period widened to RMB 221.93 million from RMB 166.39 million a year earlier. Adjusted loss, which excludes share-based compensation, foreign-exchange movements and IPO fees, reached RMB 171.12 million versus RMB 147.38 million in the 2025 interim period.

The balance of cash and time deposits stood at RMB 1.24 billion as of 30 June 2026, down from RMB 1.55 billion at end-2025 following R&D spending and a RMB 120.95 million H-share buy-back for the award scheme. Interest-bearing bank borrowings totalled RMB 355.22 million, up from RMB 260.09 million.

Clinical Pipeline Highlights • LBL-024 (PD-L1/4-1BB bispecific antibody): NDA for third-line extrapulmonary neuroendocrine carcinoma accepted by China’s NMPA on 21 August 2026 after being placed on priority review in July. Approximately 800 patients have been treated across 12 indications. Phase III confirmatory trial in first-line EP-NEC is slated to begin enrolment in H2 2026; Phase III studies in first-line NSCLC and BTC are in planning for 2027.

• LBL-034 (GPRC5D/CD3 T-cell engager): more than 100 RRMM patients enrolled in Phase I/II. Updated data will be presented at ESMO 2026; FDA Fast-Track received in January.

• LBL-047 (BDCA2/TACI fusion protein): Phase I Part A in healthy volunteers ongoing in China; Sjögren’s disease, SLE and dermatomyositis selected as first indications outside Greater China by partner Dianthus.

• LBL-051 (CD19/BCMA/CD3 trispecific): first European subject dosed in August 2026; Oblenio Bio exercised its option, triggering a US$10 million payment to be recognised in H2 2026.

• Early-stage assets: six IND-enabling programmes, including first-in-class TCE-ADC LBL-054, target submissions from H2 2026.

Business Development Global partnering for LBL-024 launched in August 2026; discussions on LBL-034 continue. Upfront and milestone receipts to date: around US$30 million from Dianthus and US$35 million from Oblenio Bio.

Outlook Management expects potential conditional approval of LBL-024 in 1H 2027 and aims to commence commercial sales in China in the same period, subject to regulatory review. Four IND submissions are scheduled within the next 12 months, while cash on hand is viewed as sufficient to fund operations through upcoming clinical and pre-commercial milestones.

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