PegBio (2565) H1 2025 earnings summary

Executive summary

• Six investigational candidates target chronic and metabolic diseases; three were in clinical trials and one had IND clearance as of June 30, 2025.

• No products were approved for commercial sale and no product-sales revenue was generated in H1 2025.

• H1 net loss narrowed to RMB93.7m from RMB155.5m, mainly on lower share-based compensation and R&D costs as PB-119 advanced to NDA review.

Financial highlights

• Operating loss was RMB92.1m versus RMB154.3m in H1 2024; net loss was RMB93.7m versus RMB155.5m, and loss per share was RMB0.25 versus RMB0.42.

• Adjusted net loss, excluding share-based compensation, was RMB51.1m versus RMB67.8m; share-based compensation was RMB42.6m versus RMB87.7m.

• R&D expenses fell to RMB26.3m from RMB64.0m; administrative expenses fell to RMB61.3m from RMB91.3m.

• No product-sales revenue was generated; no products were approved for commercial sale during the period.

Outlook and guidance

• PB-119 entered NMPA supplementary review in May; China approval and launch were targeted for Q3 2025, with commercial supply preparations completed and market-access planning underway.

• PB-718 Phase IIb in China was expected after NMPA communication in 2025; a Phase III MRCT was planned for 2026 following FDA and EMA discussions.

• PB-1902 Phase II in China and PB-2309 IND submission were planned for 2025; PB-722 Phase I and PB-2301 IND submission were planned for 2026.

• PB-119 obesity Phase Ib/IIa enrollment was completed in June 2024; two early-stage projects with potential BIC prospects were advancing through preclinical work.

• Overseas planning for PB-119 included Middle East and Belt and Road markets; global partnerships were also being explored.