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Zai Lab (ZLAB)

Earnings summaries and quarterly performance for Zai Lab.

Recent press releases and 8-K filings for ZLAB.

Zai Lab Secures 2025 NRDL Renewals for Key Medications
ZLAB
Product Launch
New Projects/Investments
  • Zai Lab has secured the renewal of VYVGART, NUZYRA (oral formulation), and ZEJULA in China's 2025 National Reimbursement Drug List (NRDL), expanding patient access and bringing its total NRDL-listed products to six.
  • The company reported $441.63 million in revenue with a three-year revenue growth rate of 37.5%, but faces profitability challenges with a negative EPS of -1.9, an operating margin of -50.32%, and a net margin of -46.83%.
  • Zai Lab's market capitalization is approximately $2.22 billion, with a beta of 0.77, suggesting lower volatility compared to the broader market.
1 day ago
Zai Lab Reports Q3 2025 Results, Updates Full-Year Revenue Guidance
ZLAB
Earnings
Guidance Update
New Projects/Investments
  • Zai Lab reported Q3 2025 total revenue of $116.1 million, a 14% year-over-year increase, and an adjusted loss from operations of $28 million, a 42% improvement from the prior year.
  • The company updated its full-year total revenue guidance to at least $460 million and now expects profitability to shift beyond the fourth quarter of 2025.
  • Performance of key products like Vyvgart and Zejula has been slower than expected due to market dynamics and competition, while XACDURO faces supply constraints.
  • Zai Lab's global pipeline is advancing, with ZL1310 (Josie) entering a pivotal Phase 3 trial for small cell lung cancer, aiming for global approval by 2027 or early 2028.
Nov 6, 2025, 1:00 PM
Zai Lab announces Q3 2025 financial results and pipeline updates
ZLAB
Earnings
Guidance Update
Product Launch
  • Zai Lab reported total revenues of $116.1 million for Q3 2025, a 14% year-over-year increase, while the adjusted loss from operations narrowed to ($28 million).
  • The company maintained a strong cash position of $817.2 million as of September 30, 2025.
  • Key product performance highlights include continued strong growth for NUZYRA and increased market penetration for VYVGART/VYVGART Hytrulo, despite softer ZEJULA sales due to competitive dynamics.
  • Pipeline advancements include Zoci's rapid progression for SCLC, Povetacicept receiving FDA Breakthrough Designation for IgA nephropathy in September 2025, and anticipated NMPA approval for KarXT in early 2026.
Nov 6, 2025, 1:00 PM
Zai Lab Announces Third Quarter 2025 Financial Results and Recent Corporate Updates
ZLAB
Earnings
Guidance Update
Product Launch
  • Zai Lab reported total revenues of $116.1 million for the third quarter of 2025, marking a 14% year-over-year growth.
  • The company's operating loss improved by 28% year-over-year to $48.8 million (GAAP) and 42% to $28.0 million on an adjusted basis in Q3 2025.
  • Full-year 2025 total revenue guidance has been revised to at least $460 million.
  • A global registrational study for zocilurtatug pelitecan (zoci, DLL3 ADC) was initiated in October 2025 for second-line+ extensive-stage small cell lung cancer.
  • KarXT was included in China's national-level treatment guidelines, with launch preparations underway.
Nov 6, 2025, 12:04 PM
Zai Lab Initiates Phase III Trial for ZOSI in SCLC and Reports Positive Clinical Data
ZLAB
New Projects/Investments
  • Zai Lab has initiated a global Phase III trial for its potential first-in-class DLL3-targeted ADC, ZOSI, in second-line small cell lung cancer (SCLC).
  • Clinical data for ZOSI monotherapy demonstrated an Overall Response Rate (ORR) of 68% at 1.6 mg/kg in second-line SCLC patients and an 80% ORR in patients with untreated brain metastases, with a median duration of response of 6.1 months.
  • ZOSI exhibited a well-tolerated safety profile, with only 13% of patients experiencing grade three or higher treatment-related adverse events and zero discontinuations in the 1.6 mg/kg cohort.
  • Zai Lab expects to file for accelerated approval for ZOSI as early as 2027, with potential approval in late 2027 or early 2028.
  • The company is also expanding ZOSI's development into first-line SCLC and neuroendocrine carcinomas, with registrational trials planned for next year.
Oct 24, 2025, 3:00 PM
Zai Lab Initiates Phase 3 Trial for Zosi and Provides Clinical Data Update
ZLAB
Product Launch
Guidance Update
  • Zai Lab has initiated a global Phase 3 trial for Zosi, its DLL3-targeted ADC, in second-line small cell lung cancer (SCLC).
  • Zosi demonstrated strong efficacy in Phase 1 data, achieving a 68% Overall Response Rate (ORR) in second-line SCLC patients at 1.6 mg/kg and an 80% ORR in patients with untreated brain metastases, with a median duration of response of 6.1 months.
  • The drug also showed a favorable safety profile, with a 13% rate of Grade 3 or higher treatment-related adverse events and zero discontinuations in the 1.6 mg/kg cohort.
  • Zai Lab anticipates filing for accelerated approval for Zosi in 2027, with potential approval as early as late 2027 or early 2028.
  • The company plans to expand Zosi's development into first-line SCLC and neuroendocrine carcinomas (NECs) with registration studies planned for next year.
Oct 24, 2025, 3:00 PM
Zai Lab Provides Zoci Clinical Data Update and Development Timelines
ZLAB
Product Launch
New Projects/Investments
  • Zai Lab presented updated Phase 1 clinical data for Zoci, a DLL3-targeted ADC, showing a 68% Overall Response Rate (ORR) in second-line small cell lung cancer (SCLC) patients at 1.6 mg/kg and an 80% ORR in patients with untreated brain metastases.
  • The data also highlighted a median duration of response of 6.1 months and a well-tolerated safety profile with zero discontinuations in the 1.6 mg/kg cohort.
  • A global Phase 3 trial for Zoci in second-line SCLC has been initiated, with an anticipated filing for accelerated approval in 2027 and potential approval by late 2027 or early 2028.
  • Zai Lab is rapidly expanding Zoci's development, with plans to initiate first-line SCLC and neuroendocrine carcinoma (NEC) registration trials next year, and expects to share first-line combination data in the first half of next year.
Oct 24, 2025, 3:00 PM
Zai Lab Provides Update on Zocilurtatug Pelitecan (ZL-1310) Clinical Trial
ZLAB
New Projects/Investments
Guidance Update
  • Zai Lab's Zocilurtatug pelitecan (ZL-1310), a DLL3 ADC, is being developed for Small Cell Lung Cancer (SCLC) and other DLL3-expressing tumors.
  • In 2L+ SCLC patients treated at 1.6 mg/kg, ZL-1310 demonstrated a Best Overall Response Rate (ORR) of 68% and a median Duration of Response (DoR) of 6.1 months across all lines and doses.
  • The drug showed high response rates in patients with brain metastasis, achieving an 80% ORR in those without prior brain radiotherapy.
  • ZL-1310 at 1.2 or 1.6 mg/kg was well tolerated, with 13.3% Grade ≥3 TRAEs (for 1.6 mg/kg) and no Grade ≥2 ILD observed.
  • A global, randomized Phase 3 trial for 2L+ ES-SCLC has been initiated, with registrational and novel combination studies for 1L SCLC and a registrational cohort for other NECs planned to start in 2026.
Oct 24, 2025, 3:00 PM
Zai Lab Initiates Global Phase 3 Trial for Zosi and Provides Clinical Data Update
ZLAB
Product Launch
New Projects/Investments
Guidance Update
  • Zai Lab has initiated a global Phase 3 trial for Zosi, a DLL3-targeted ADC, in second-line small cell lung cancer (SCLC), with plans to expand development into first-line SCLC and neuroendocrine carcinomas (NECs).
  • Updated Phase 1 data for Zosi monotherapy showed a 68% Overall Response Rate (ORR) in second-line SCLC patients at the 1.6 mg/kg dose, an 80% ORR in patients with untreated brain metastases, and a median duration of response of 6.1 months.
  • The safety profile demonstrated a low rate of grade three treatment-related adverse events (13%) and zero discontinuations in the 1.6 mg/kg cohort, positioning Zosi as a potential best-in-class treatment.
  • Zai Lab anticipates an accelerated approval submission for Zosi in early 2027, with potential approval as early as end of 2027 or early 2028.
  • Further development includes sharing data for first-line SCLC combination studies in the first half of next year (2026) and initiating a pivotal study in the front-line setting in 2026, alongside advancing NEC studies.
Oct 24, 2025, 3:00 PM
Zai Lab Announces Updated Phase 1 Data for Zocilurtatug Pelitecan and Initiation of Phase 3 Study
ZLAB
Product Launch
New Projects/Investments
  • Zai Lab announced updated Phase 1 clinical trial data for zocilurtatug pelitecan (zoci), a DLL3-targeted ADC for extensive-stage small cell lung cancer (ES-SCLC), with a data cut-off date of September 15, 2025.
  • The data demonstrated robust responses in heavily pre-treated patients, including a 68% Overall Response Rate (ORR) for the 1.6 mg/kg dose in the second-line setting and an 80% ORR in patients with baseline brain metastases without prior brain radiotherapy.
  • Zoci exhibited a well-tolerated safety profile, with a low rate of Grade ≥3 treatment-related adverse events (TRAEs) and no discontinuations in the 1.6 mg/kg cohort.
  • A global Phase 3 registrational study (ZL-1310-003) has been initiated for zoci in second-line plus SCLC, and programs for first-line SCLC and neuroendocrine carcinoma are expected to enter the registrational phase in 2026.
Oct 24, 2025, 1:00 PM