Mabwell (Shanghai) Bioscience (688062) Q2 2025 earnings summary

Executive summary

• H1 revenue was ¥101.17m, down 12.43% YoY, as drug sales growth was offset by lower licensing and technical-service revenue; net loss widened to ¥551.32m.

• Drug sales rose 53.50% to ¥100.79m, led by denosumab at ¥99.54m; R&D investment increased 21.72% to ¥392.09m.

• Key catalysts included approval of first innovative drug 8MW0511, a ¥380m Qilu upfront payment, a CALICO license for IL-11 therapy, and Pakistan approvals for two denosumab biosimilars.

Financial highlights

• Revenue totaled ¥101.17m versus ¥115.53m YoY; prior-year revenue included a larger 9MW3011 licensing payment, while H1 2025 recorded no licensing income from that project.

• Net loss attributable to shareholders was ¥551.32m versus ¥444.98m YoY; adjusted for non-recurring items, net loss was ¥573.54m versus ¥461.62m.

• Operating costs totaled ¥671.70m, including R&D expense of ¥392.09m, selling expense of ¥102.20m, and administrative expense of ¥115.05m.

• Operating cash outflow improved to ¥33.92m from ¥461.62m, primarily due to the Qilu licensing upfront payment; investing cash outflow was ¥100.23m and financing inflow ¥295.36m.

Outlook and guidance

• A pre-NDA consultation for 9MW0813 was submitted in January; an NDA submission was expected in Q3 2025 following completed Phase III DME results.

• 9MW2821 had three pivotal studies underway; interim analyses were planned for H2 2026 in later-line urothelial and cervical cancer trials, and 2027 for first-line urothelial cancer combination therapy.

• A Phase II COPD study of 9MW1911 began in June, with an interim analysis planned after at least 120 participants complete their last visits; Phase III could start by end-2026, subject to results.

• Four marketed products, one near NDA submission, and two assets in pivotal Phase III were expected to support commercialization and future financial improvement; profitability remains dependent on sales execution and continued development progress.