Zai Lab (ZLAB) 44th Annual J.P. Morgan Healthcare Conference summary

Strategic vision and business model

• Operates a dual-engine model: a profitable commercial business in China and a growing global innovation portfolio, leveraging 11 years of expertise to bridge Western and Chinese biotech markets.

• Integrated U.S.-China R&D model enables rapid, capital-efficient execution and industry-leading development speed.

• Maintains a strong balance sheet with $817 million in cash as of September 30, 2025, supporting ongoing investment in R&D and business development.

• Strategic capital allocation aims for near-term margin expansion and long-term profitability, with a clear path toward corporate-level profitability by 2030.

• Focuses R&D on immunology and oncology, emphasizing advanced modalities such as ADCs, bispecifics, and T-cell engagers.

Pipeline progress and clinical highlights

• Lead asset Zoci (DLL3 ADC) is in global phase III for small cell lung cancer, showing a 68.4% ORR in second-line and 80% ORR in brain metastases, with a favorable safety profile and no discontinuations due to adverse events.

• Zoci advanced from IND to pivotal phase III in under two years, with a phase III trial initiated in Q4 last year targeting accelerated US approval by 2028.

• IL-13/31 program (ZL-1503) for atopic dermatitis began phase I in 2023, with data expected by end of next year and preclinical models showing rapid, durable itch suppression.

• Additional oncology programs include LRRC15 ADC (ZL-6201, phase I in solid tumors), ZL-1222 (PD-1/IL-12), and a newly in-licensed MUC17 x CD3 T-cell engager (ZL-1311), with global studies ongoing or planned.

• 2026 catalysts include key data readouts and study initiations across multiple programs, including Zoci, ZL-1503, and ZL-6201.

Commercial performance and growth drivers

• Eight commercial products are approved in China, generating over $460 million in sales and providing a strong financial foundation for global expansion.

• VYVGART for gMG is now a preferred agent in China, with strong growth expected through 2026 and beyond.

• COBENFY, recently approved for schizophrenia and included in national guidelines, will launch in the first half of this year, targeting NRDL listing in 2027.

• ZEJULA leads the ovarian cancer market in China, and Xacduro, a hospital-based antibiotic, is expected to contribute to growth after resolving supply constraints.

• Supportive regulatory and market access environment in China, with faster review timelines, improved insurance coverage, and NRDL transparency supporting long-term market optimism.