– Total revenue for the first quarter of 2026 was $99.6 million, reflecting expected first-quarter dynamics, including certain competitive impacts on Zejula and price adjustments related to the renewal of Vygart’s inclusion in the National Reimbursement Drug List (NRDL)
– Zocilurtatug pelitecan (zoci) presented outstanding, differentiated data at the 2026 AACR Annual Meeting: confirmed intracranial objective response rate (iORR) of 62.5% in small cell lung cancer (SCLC) patients with brain metastases; clinically meaningful anti-tumor activity in extrapulmonary neuroendocrine carcinomas (epNECs) (confirmed ORR of 38.2%). The registrational study DLLEVATE is ongoing, with patient enrollment expected to be completed in the first half of 2027
– Entered into collaborations with Amgen and Boehringer Ingelheim to evaluate zoci in combination with tarlatamab for SCLC, and zoci in combination with obrixtamig for SCLC and other neuroendocrine carcinomas (NEC), respectively, advancing zoci as a potential cornerstone therapy
– ZL-1503 (IL-13/IL-31Rα) preclinical data presented at IMMUNOLOGY2026 demonstrated rapid, durable dual pathway activity, supporting less frequent dosing, and showed broad potential in atopic diseases including asthma. Phase 1/1b study is ongoing, with initial data expected in 2026
– Launch preparations for xanomeline trospium are underway, and TIVDAK is under NMPA review; positive Phase 3 results for povetacicept in IgA nephropathy and elegrobart in thyroid eye disease provide additional growth opportunities for our regional business
The Company will hold a conference call and webcast today, May 7, 2026, at 8:00 AM ET (8:00 PM HKT)
Shanghai, China and Cambridge, Massachusetts, USAMay 7, 2026 /PRNewswire/ — Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the first quarter of 2026, along with recent product highlights and corporate updates.
Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab, said: “We are accelerating the development of our global pipeline, with multiple clinical studies underway in oncology and immunology. In the first quarter, we made significant progress with zoci: data presented at AACR further confirmed zoci’s differentiated profile in SCLC and epNECs; we entered into collaborations with Amgen and Boehringer Ingelheim to explore zoci’s potential as a cornerstone therapy; and patient enrollment in the registrational study DLLEVATE is progressing rapidly, with completion expected in the first half of 2027. At the same time, we continue to advance our growing global clinical research program, including ZL-1503 (IL-13/IL-31Rα) for atopic dermatitis. These developments fully demonstrate the strength of our R&D engine, which is built to scale and create a differentiated pipeline of innovative products. Meanwhile, our regional business, which has already achieved commercial profitability, provides a solid foundation, along with several near-term opportunities to support future growth.”
Josh Smiley, President and Chief Operating Officer of Zai Lab, said: “We are deepening our presence in key markets to meet potential demand for efgartigimod, while expanding our regional business coverage in preparation for the launch of xanomeline trospium in China in the second quarter of this year. With approximately 8 million schizophrenia patients in China, and supported by national treatment guidelines, the launch of xanomeline trospium will allow us to introduce the first novel therapy in decades to this important market, with the goal of inclusion in the NRDL next year. Additionally, we expect TIVDAK to receive marketing approval this year, and positive Phase 3 results for povetacicept and elegrobart will bring further growth opportunities. We remain focused on driving steady execution across our entire commercial portfolio.”
First Quarter 2026 Financial Results
– Total revenue for the first quarter of 2026 was $99.6 million, compared to $106.5 million in the same period of 2025, a decrease of 6% year-over-year. Net product revenue for the first quarter of 2026 was $95.6 million, compared to $105.7 million in the same period of 2025, a decrease of 10% year-over-year, or 12% at constant exchange rate (CER). This decrease was primarily due to lower sales of Zejula, partially offset by increased sales of Qinlock and Nuzyra:
- Zejula: Net product revenue for the first quarter of 2026 was $30.0 million, compared to $49.5 million in the same period of 2025. The decline was due to changes in hospital prescribing patterns following the Volume-Based Procurement (VBP) of olaparib.
- Vygart and Vyvgart: Net product revenue for the first quarter of 2026 was $17.6 million, compared to $18.1 million in the same period of 2025. The decline was primarily due to price adjustments related to the renewal of Vygart’s inclusion in the NRDL.
- Qinlock: Net product revenue for the first quarter of 2026 was $8.6 million, compared to $1.1 million in the same period of 2025. This increase was mainly driven by strong patient demand and continued expansion of hospital coverage, partially offset by supply constraints.
- Nuzyra: Net product revenue for the first quarter of 2026 was $16.3 million, compared to $15.1 million in the same period of 2025. This increase was primarily due to improved market coverage and penetration.
– Research and development (R&D) expenses for the first quarter of 2026 were $65.6 million, compared to $60.7 million in the same period of 2025. The increase was primarily due to higher clinical study-related expenses and licensing fees.
– Selling, general and administrative (SG&A) expenses for the first quarter of 2026 were $65.1 million, compared to $63.4 million in the same period of 2025. The increase was primarily due to higher general selling expenses.
– Loss from operations for the first quarter of 2026 was $69.4 million, and adjusted loss from operations, excluding non-cash expenses such as depreciation, amortization, and share-based compensation, was $51.9 million. A reconciliation of loss from operations (U.S. GAAP) to adjusted loss from operations (non-U.S. GAAP) is included at the end of this press release.
– Net loss for the first quarter of 2026 was $51.0 million, with a net loss per ordinary share attributable to common shareholders of $0.05 (loss per American Depositary Share (ADS) of $0.46), compared to a net loss of $48.4 million, with a net loss per ordinary share of $0.04 (loss per ADS of $0.45) in the same period of 2025. The increase in net loss was primarily due to lower product revenue and higher R&D expenses, partially offset by foreign exchange gains.
– As of March 31, 2026, the Company had cash and cash equivalents, short-term investments, and restricted cash of $761.3 million, compared to $789.6 million as of December 31, 2025.
Recent Corporate Updates
– In April 2026, Zai Lab appointed Dr. Yizhe Wang as an Operating Partner to strengthen the Company’s commercialization capabilities and execution. Dr. Wang has extensive experience in global commercial operations in oncology and immunology, having led commercialization teams covering markets in China, the United States, and the United Kingdom at GlaxoSmithKline and Eli Lilly.
Recent Pipeline Highlights
Key product developments since the last earnings release include:
Oncology Pipeline
- Zocilurtatug Pelitecan (zoci, DLL3-targeting ADC) (formerly ZL-1310):
– In April 2026, Zai Lab presented positive clinical data at the American Association for Cancer Research (AACR) 2026 Annual Meeting. The data showed that zoci demonstrated rapid and significant intracranial responses, as assessed by blinded independent review according to mRANO-BM criteria, in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) with brain metastases; additionally, zoci showed encouraging data in patients with epNEC.
-
- SCLC with brain metastases: Zoci showed a confirmed intracranial objective response rate (iORR) of 53.7%, reaching 62.5% (10/16) at the 1.6 mg/kg dose, including complete responses. Notably, responses were also observed in patients who had not received prior brain radiotherapy (9/15, 60%), highlighting the drug’s net effect on intracranial lesions. Zoci was well-tolerated, with ≥Grade 3 treatment-related adverse events (TRAEs) occurring in 19.9% (27/136) of the overall population and 16.4% (9/55) of patients receiving the 1.6 mg/kg dose.
- epNECs: Encouraging anti-tumor activity was observed, with a confirmed objective response rate of 38.2% across epNEC tumors of different primary origins. The safety profile in epNEC was consistent with that previously observed in SCLC, with ≥Grade 3 TRAEs occurring in 15.2% of patients in the Phase 1b portion.
– In April 2026, Zai Lab announced a global clinical research collaboration with Amgen to evaluate zoci in combination with Amgen’s IMDELLTRA® (tarlatamab, a DLL3/CD3 bispecific T-cell engager (TCE)) for the treatment of ES-SCLC; and a clinical research collaboration with Boehringer Ingelheim to evaluate zoci in combination with obrixtamig (a DLL3/CD3 bispecific T-cell engager) for the treatment of SCLC and other NECs.
Immunology, Neuroscience, and Infectious Disease Pipeline
- ZL-1503 (IL-13/IL-31Rα): In April 2026, Zai Lab presented updated preclinical data for ZL-1503, demonstrating that this internally developed IL-13/IL-31Rα bispecific antibody may persistently suppress intense itching and inflammation associated with atopic diseases. These findings further support the potential of ZL-1503 to become a first-in-class therapy for moderate-to-severe atopic dermatitis and other IL-13 and IL-31-driven diseases. A global Phase 1/1b study is ongoing, and Zai Lab expects to report first-in-human data from the global Phase 1 portion in the second half of 2026.
- Povetacicept (APRIL/BAFF):
– IgA Nephropathy (IgAN): In March 2026, Zai Lab’s partner Vertex announced positive results from a pre-specified 36-week interim analysis of the global Phase 3 RAINIER clinical study of povetacicept in IgAN. The study met its primary endpoint, with patients in the povetacicept treatment group achieving a 52.0% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) from baseline, representing a 49.8% reduction compared to placebo, which was statistically significant and clinically meaningful (p<0.0001). Povetacicept was generally safe and well-tolerated. Zai Lab participated in this global Phase 3 study in Greater China.
– Primary Membranous Nephropathy (pMN): Zai Lab’s partner Vertex has completed patient enrollment in the Phase 2 portion of the global pivotal Phase 2/3 OLYMPUS study and has initiated the Phase 3 portion. Zai Lab is participating in this global study in Greater China.
- Elegrobart (Insulin-like Growth Factor 1 Receptor Inhibitor, subcutaneous injection): Zai Lab’s partner Viridian Therapeutics announced positive top-line results from two pivotal Phase 3 clinical studies of elegrobart (REVEAL-1 for active thyroid eye disease (TED) and REVEAL-2 for chronic TED). Elegrobart was generally well-tolerated in both studies. Zai Lab obtained an exclusive license from Zenas BioPharma to develop and commercialize elegrobart in Greater China and is currently conducting a Phase 3 bridging study in the region.
– REVEAL-1 study in active TED: The study met its primary endpoint with highly statistically significant treatment effects. Both the every-4-week (Q4W) and every-8-week (Q8W) dosing regimens of elegrobart showed rapid onset of action, with proptosis response rates at Week 24 reaching clinically meaningful 54% and 63%, respectively, compared to 18% for placebo. Additionally, the Q4W dosing group achieved meaningful complete resolution of diplopia in patients with active TED.
– REVEAL-2 study in chronic TED: The study met its primary endpoint with highly statistically significant treatment effects. Both the Q4W and Q8W elegrobart treatment groups achieved proptosis response rates of 50% and 54% at Week 24, respectively, which were statistically significant and clinically meaningful, compared to 15% for placebo. Additionally, the Q4W group provided meaningful complete resolution of diplopia in patients with chronic TED.
Anticipated Key Milestones in 2026
Anticipated Clinical Development and Data Readouts
Global Pipeline
Zocilurtatug Pelitecan (zoci, DLL3-targeting ADC) (formerly ZL-1310)
- First-line extensive-stage small cell lung cancer: Zai Lab will present a data readout from the Phase 1 study evaluating zoci combination therapy (in combination with atezolizumab ± chemotherapy) in the second half of 2026, and plans to advance zoci into a registrational study in 2026 based on the latest data.
- Extrapulmonary neuroendocrine carcinomas: Zai Lab will complete patient enrollment in the Phase 2 portion of the ongoing global Phase 1b/2 study of zoci in specific solid tumors, and plans to advance into registrational development in 2026.
ZL-1503 (IL-13/IL-31Rα)
- Zai Lab will report first-in-human data from the global Phase 1/1b study in 2026.
Regional Pipeline
New Drug Applications (NDAs) Expected to Receive NMPA Approval
- TIVDAK (tisotumab vedotin, tissue factor ADC) for recurrent or metastatic cervical cancer with disease progression during or after chemotherapy
- Tumor Treating Fields (TTFields) for locally advanced pancreatic cancer
Anticipated Data Readouts
Efgartigimod (FcRn)
- Myositis: Zai Lab’s partner argenx will announce top-line results from the global Phase 2/3 ALKIVIA study evaluating autoimmune inflammatory myopathy (AIM, myositis) in the third quarter of 2026. Zai Lab is participating in this study in Greater China.
Elegrobart (Insulin-like Growth Factor 1 Receptor Inhibitor, subcutaneous injection)
- Zai Lab will complete patient enrollment in the Phase 3 registrational study in China in the third quarter of 2026.
Conference Call and Webcast Information
Zai Lab will hold a conference call and webcast today, May 7, 2026, at 8:00 AM ET (8:00 PM HKT). Participants can access the live webcast by visiting the Company’s website at http://ir.zailaboratory.com. To participate in the conference call, pre-registration is required.
Details are as follows:
- Webcast (recommended) registration link: https://edge.media-server.com/mmc/p/s7q4ox5h
All participants must complete online registration via the link above prior to the conference call. After successful registration, you will receive a confirmation email containing the specific dial-in information for the conference call.
A replay of the call will be available by visiting Zai Lab’s website after the meeting.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is a research-based, commercial-stage innovative biopharmaceutical company headquartered in China and the United States. We are dedicated to addressing significant unmet medical needs in oncology, immunology, neuroscience, and infectious diseases through the discovery, development, and commercialization of innovative products. Our goal is to leverage our capabilities and resources to make a positive impact on human health.
For more information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global.
Non-GAAP Financial Measures
In addition to our results presented in accordance with U.S. GAAP, we disclose adjusted growth rates to exclude the impact of differences arising from the translation of foreign currencies into U.S. dollars. We also provide an adjusted loss from operations measure, which adjusts U.S. GAAP loss from operations to exclude the impact of certain non-cash expenses, including depreciation, amortization, and share-based compensation. We refer to this as “achieving non-GAAP operating profit profitability.” These adjusted growth rates and adjusted loss from operations are non-GAAP financial measures. We believe these non-GAAP measures are important for understanding our operating and financial performance and provide investors with an additional perspective on trends. While we believe that non-GAAP financial measures enhance investors’ understanding of our business and performance, these non-GAAP financial measures should not be considered a substitute for the corresponding U.S. GAAP financial measures.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to, among other things: our strategies and plans; the potential and expectations for our business, commercial products, and pipeline programs; our goals, objectives, and priorities, and our expectations based on our growth strategy (including our expectations regarding commercial products and launches, clinical-stage products, revenue growth, profitability, and cash flow); clinical development plans and related clinical studies; clinical study data, data interpretation, and publication; risks and uncertainties related to drug development and commercialization; regulatory discussions, submissions, applications, approvals, and timelines; the potential benefits, safety, and efficacy of our products and product candidates and those of our partners; the expected benefits and potential of investments, collaborations, and business development activities; our profitability and timeline to achieve profitability; our future financial and operating results; and financial guidance (including our capital allocation and investment strategy and our path to expected profitability). All statements in this press release that are not statements of historical fact are forward-looking statements, which can be identified by terms such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “prepare,” “position,” “possible,” “potential,” “will,” “would,” and other similar expressions. These statements constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of future performance or assurance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those anticipated in the forward-looking statements. We may not actually achieve, execute, or satisfy the plans, intentions, expectations, or forecasts disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to: (1) our ability to successfully commercialize our approved products and generate revenue from them; (2) our ability to secure funding for our operations and business activities; (3) the results of clinical development and preclinical development of our product candidates; (4) the content and timing of decisions by relevant regulatory authorities regarding our product candidates; (5) risks associated with doing business in China; and (6) other factors identified in our most recent annual and quarterly reports and other filings with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, but we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
For documents filed by the Company with the SEC, please visit the Company’s website at www.zailaboratory.com and the SEC’s website at www.SEC.gov.
|
Zai Lab Limited |
||||
|
Unaudited Condensed Consolidated Balance Sheets |
||||
|
(In thousands of U.S. dollars, except share and per share data) |
||||
|
March 31, |
December 31, |
|||
|
Assets |
||||
|
Current assets |
||||
|
Cash and cash equivalents |
651,316 |
679,573 |
||
|
Restricted cash, current |
100,000 |
100,000 |
||
|
Short-term investments |
10,000 |
10,000 |
||
|
Accounts receivable (net of allowance for credit losses of $16 and $31 as of March 31, 2026 and December 31, 2025, respectively) |
54,069 |
106,116 |
||
|
Notes receivable |
7,929 |
12,169 |
||
|
Inventories, net |
85,961 |
74,745 |
||
|
Prepayments and other current assets |
35,454 |
36,683 |
||
|
Total current assets |
944,729 |
1,019,286 |
||
|
Restricted cash, non-current |
1,117 |
1,116 |
||
|
Property and equipment, net |
47,067 |
47,389 |
||
|
Operating lease right-of-use assets |
17,585 |
19,152 |
||
|
Land use rights, net |
rocky TTArticles: 2464
Subscribe
Login
0 Comments
Oldest
| |||