Zai Lab Reports Strong Q3 2024 Growth, Highlights Pipeline Advances Including KarXT and ZL-1310
Key Insights
Zai Lab's Q3 2024 net product revenue reached $101.8 million, a 47% year-over-year increase, driven by VYVGART, ZEJULA, and NUZYRA sales.
A China bridging study of KarXT in schizophrenia (search) showed positive results, with regulatory submission expected in early 2025, potentially expanding treatment options.
Phase 1 data for ZL-1310, a DLL3 (search)-targeted ADC for extensive-stage SCLC (search), demonstrated promising antitumor activity, suggesting best-in-class potential.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has announced its financial results for the third quarter of 2024, showcasing significant revenue growth and pipeline advancements. The company reported a 47% year-over-year increase in net product revenue, reaching $101.8 million, driven primarily by strong sales of VYVGART, ZEJULA, and NUZYRA. These results, along with promising clinical data from key pipeline assets, position Zai Lab for continued growth and expansion in the coming years.
Commercial Performance and Key Product Updates
VYVGART, indicated for generalized myasthenia gravis (search) (gMG), demonstrated robust sales growth, reaching $27.3 million in Q3 2024 compared to $4.9 million in the same period last year. This growth is attributed to its successful launch in September 2023 and subsequent inclusion on China’s National Reimbursement Drug List (NRDL) effective January 1, 2024. ZEJULA, a PARP inhibitor for ovarian cancer (search), also maintained strong sales, increasing by 16% year-over-year to $48.2 million, solidifying its position as a leading treatment option in mainland China. NUZYRA sales increased by 82% year-over-year, reaching $10.0 million, boosted by NRDL listings for both IV and oral formulations for community-acquired bacterial pneumonia (search) (CABP) and acute bacterial skin and skin structure infections (search) (ABSSSI).
Pipeline Advancements
Zai Lab's pipeline continues to progress, with several key milestones achieved in Q3 2024. A China bridging study of KarXT (xanomeline and trospium chloride) for schizophrenia (search) yielded positive topline results, demonstrating a statistically significant and clinically meaningful 9.2-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at Week 5 (-16.9 KarXT vs. -7.7 placebo, p=0.0014). The company plans to submit a New Drug Application (NDA) to the NMPA for KarXT in early 2025.
Additionally, promising data from a global Phase 1 study of ZL-1310, a DLL3 (search)-targeted antibody-drug conjugate (ADC) being developed for small cell lung cancer (SCLC (search)), were presented. The data, from 25 patients with extensive-stage SCLC (ES-SCLC) who had received platinum-based therapy, showed an overall response rate of 74% across multiple dose levels. The treatment was well-tolerated, with most adverse events being Grade 1 or 2.
Subcutaneous Efgartigimod Approved for CIDP
China’s National Medical Products Administration (NMPA) approved the supplemental Biologics License Application (sBLA) for the subcutaneous formulation of efgartigimod, under the brand name VYVGART Hytrulo, for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (search) (CIDP (search)). It is the first and only NMPA-approved treatment for patients with CIDP in China. The product is to be administered as a single subcutaneous injection per week (1,000 mg fixed dose) delivered over 30 to 90 seconds.
Financial Position
Zai Lab maintains a strong balance sheet, with a cash position of $716.1 million as of September 30, 2024. The company is focused on driving substantial value through its commercial portfolio and advancing global and late-stage pipeline.
Anticipated Milestones
Zai Lab anticipates several major milestones in the near future, including the expected commercial launches of XACDURO, VYVGART Hytrulo, and AUGTYRO in China by the end of 2024. The company also plans to submit an NDA for KarXT in schizophrenia (search) in early 2025, along with other regulatory submissions for TTFields and tisotumab vedotin.