PegBio (2565) H2 2025 earnings summary

Executive summary

• PB-119 received NMPA marketing approval in November 2025, moving the lead asset into commercialization preparation; sales are expected in H1 2026.

• Net loss narrowed to RMB208.5 million from RMB283.4 million in 2024, mainly reflecting lower share-based compensation and R&D expense.

• No product-sale revenue was generated in 2025; the business remains dependent on successful PB-119 commercialization and continued pipeline development.

Financial highlights

• Operating loss was RMB205.8 million in 2025 versus RMB280.9 million in 2024; net loss was RMB208.5 million versus RMB283.4 million.

• Basic and diluted loss per share was RMB0.55 in 2025 versus RMB0.77 in 2024.

• Adjusted net loss, excluding non-cash share-based compensation, was RMB126.1 million versus RMB137.9 million in 2024.

• R&D expense fell to RMB50.4 million from RMB95.4 million; administrative expense fell to RMB143.3 million from RMB185.3 million.

Outlook and guidance

• PB-119 commercial sales are expected in H1 2026; near-term priorities include market access, launch readiness, patient accessibility and PRC commercialization.

• PB-722 Phase I is planned for 2026 and Phase II for 2027; PB-718 Phase IIb is expected to start in China in 2026, subject to NMPA communication.

• IND submissions for PB-2301, PB-2309 and APGP6 are expected in China in 2026; plans remain subject to R&D progress and resource allocation.

• Overseas PB-119 development and commercialization discussions are at an early stage under non-binding terms; no binding agreement has been signed.