Zai Lab (NASDAQ:ZLAB) executives used the company’s fourth-quarter and full-year 2025 earnings call to outline progress toward a more globally oriented pipeline while emphasizing that the company’s China commercial business remains a key source of stability and funding for research and development.
Founder, CEO, and Chairperson Dr. Samantha Du said Zai Lab is “building a company increasingly defined by global innovation,” supported by a “commercially profitable China business and R&D infrastructure.” She highlighted the company’s global oncology and immunology pipeline as reaching “a scale and maturity that fundamentally changes the profile of this company,” and pointed to a “clear path toward our first potential U.S. approval by 2028.”
Pipeline focus: Zoci and additional global programs
Amado said Zai anticipates a potential accelerated approval submission in 2027 and “a first global approval in 2028.” He also pointed to clinical activity in patients with brain metastases, including an 80% objective response rate in 10 patients with untreated brain metastases, and said the company plans to present additional data in coming months.
During the Q&A session, Amado provided enrollment expectations for the global phase III study, which started in December. He said Zai plans to have about 75% of patients enrolled by the end of 2026, with enrollment completion expected by the end of the first quarter of the following year, followed by an interim analysis for response and a subsequent filing. He also said the trial is expected to include about 30% of patients from the U.S., about 30% from China, with the rest from Europe and other regions, and that the study is stratified for patients who are post-tarlatamab versus not.
On the question of intracranial activity, Amado said brain metastases are a major issue in SCLC and estimated that about 70% of patients develop brain metastases. He said zoci’s rapid responses have been “well appreciated among investigators,” and described two potential clinical advantages: enabling systemic therapy without delaying for local brain treatments in some cases and potentially reducing brain relapse where the brain can be a sanctuary site. He added that Zai plans to report brain metastasis responses using RANO criteria in the first half of 2026.
Beyond zoci, Amado highlighted additional global pipeline efforts:
- ZL-6201, an LRRC15-targeting ADC, received U.S. IND clearance and entered a global phase I study.
- ZL-1222, a PD-1/IL-12 immunocytokine, is progressing through IND-enabling studies.
- ZL-1311, a MUC17-targeting T-cell engager (TCE), is planned for IND filing by year-end.
- ZL-1503, an IL-13/IL-31R bispecific for atopic dermatitis, is enrolling in a global phase I/1b study, with first-in-human data expected later in 2026.
For NECs, Amado said enrollment in a global phase Ib/2 study is progressing well and that the company expects to present an initial dataset in the first half of 2026, potentially including “60-plus patients.” He said Zai is initiating regulatory discussions on whether a single-arm study could support an approval pathway in second line, while noting the uncertainty around control arms in a randomized approach.
Regional late-stage programs and upcoming data
Management also reviewed key late-stage regional programs and planned readouts. Amado said povetacicept remains on track for an interim analysis in the global RAINIER phase III study in IgA nephropathy (IgAN) planned for the first half of 2026, and that enrollment is ongoing in the global pivotal OLYMPUS phase II/3 study in primary membranous nephropathy.
For thyroid eye disease (TED), Amado said partner Viridian expects top-line data from the global registrational REVEAL 1 study in active TED in the first quarter of 2026 and top-line results from REVEAL 2 in chronic TED in the second quarter of 2026, adding that the therapy has the potential to become the first subcutaneous IGF-1R therapy approved for TED in China.
In oncology, Amado said Zai expects approval in China for TIVDAK in the first half of 2026. He also cited an FDA approval earlier in the month for Optune Pax in locally advanced pancreatic cancer and said Zai plans to work with China’s NMPA under the Innovative Medical Device Pathway to support expedited review.
Commercial performance and 2026 launch priorities
President and COO Josh Smiley said the company made progress in 2025 across market access, portfolio optimization, and business development. He said Zai completed NRDL renewals for key products and achieved guideline updates supporting VYVGART in generalized myasthenia gravis and KarXT in schizophrenia. Smiley added that Zai divested non-core assets and regions to reallocate resources and improve operational efficiency, and that the company entered targeted collaborations to explore first-line SCLC combination strategies and strengthen its oncology platform, including adding a MUC17/CD3 T-cell engager.
On results, Smiley said fourth-quarter revenue increased 17% year-over-year to $127 million, while full-year revenue grew 15% to $460 million.
Smiley said VYVGART physician confidence remains strong and patient demand has been stable, though fourth-quarter revenue reflected channel dynamics related to NRDL renewal and hospital purchasing patterns. Looking to 2026, he said the company expects a “more measured near-term growth profile” influenced by pricing dynamics and evolving competition, while emphasizing that the long-term trajectory remains supported by guideline expansion, affordability initiatives, and additional indications and formulations.
Smiley also highlighted ZEJULA performance, saying the company delivered a strong fourth quarter driven by first-line BRCA-positive new patient starts, while noting potential early-year variability tied to procurement dynamics and seasonality.
KarXT was framed as a key near-term growth opportunity. Smiley said Zai expects to initiate the commercial launch in the second quarter of 2026, with focus on disease awareness, clinical confidence, and building the foundation for broader adoption. In the Q&A, Smiley said the company does not expect NRDL listing for KarXT in 2026 due to timing and expects it in 2027, with initial efforts centered on a concentrated set of prescribing institutions.
Financial results: improving operating leverage and cash position
Chief Financial Officer Dr. Yajing Chen said fourth-quarter total revenue rose 17% year-over-year to $127.6 million, driven by contributions from XACDURO and NUZYRA. She said XACDURO saw strong patient demand and expanding hospital adoption, though supply constraints limited the ability to fully meet demand, while NUZYRA benefited from broader market coverage and increased penetration.
For the full year, Chen said R&D and SG&A declined as a percentage of revenue year-over-year. She reported full-year R&D expense declined 6% (driven by lower personnel compensation costs, with a fourth-quarter increase tied to rapid progression of global clinical trials) and SG&A decreased 12% and 7% year-over-year for the fourth quarter and full year, respectively, largely due to reduced G&A expense from resource optimization.
Chen said loss from operations improved 19% for the full year to $229.4 million and improved 25% on an adjusted basis excluding certain non-cash expenses. Zai ended the quarter with $790 million in cash.
Asked about profitability, Chen said corporate cash flow breakeven remains a “very clear objective,” but timing depends primarily on top-line growth and the level of investment the company chooses to make in high-value global programs. She said the company did not provide full-year 2026 guidance, citing moving pieces such as VYVGART IV price adjustments, rebate dynamics, and hospital purchasing behavior.
About Zai Lab (NASDAQ:ZLAB)
Zai Lab Ltd (NASDAQ: ZLAB) is a biopharmaceutical company focused on the research, development, manufacturing and commercialization of innovative therapies. Headquartered in Shanghai, China, Zai Lab operates R&D centers in Asia and the United States and maintains commercial offices across Greater China, North America, Europe and Australia. The company’s end-to-end platform encompasses discovery biology, translational development, clinical research and global supply chain management.
The company’s marketed portfolio is anchored by Brukinsa (zanubrutinib), a next-generation Bruton’s tyrosine kinase inhibitor approved for several B-cell malignancies.
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