Zai Lab Announces First Quarter 2026
Financial Results and Recent Corporate Updates

On May 7, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported financial results for the first quarter of 2026, along with recent product highlights and corporate updates.

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"We continue to accelerate the development of our global pipeline, with numerous clinical trials underway across oncology and immunology," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "During the quarter, we made strong progress advancing zoci, with AACR (Free AACR Whitepaper) data reinforcing its differentiated profile in both SCLC and epNECs, collaborations with Amgen and Boehringer Ingelheim to evaluate zoci as a potential backbone therapy, and rapid enrollment in the registrational DLLEVATE study, which is on track to be fully enrolled in the first half of 2027. We also continue to advance our growing portfolio of global clinical programs, including ZL-1503 (IL-13/IL-31Rα) for atopic dermatitis. This reflects the strength of our R&D engine, which is designed to scale and deliver a pipeline of differentiated new products. At the same time, our commercially profitable regional business provides a stable foundation, with several near-term opportunities expected to support future growth."

"We are deepening our presence in key markets to capitalize on underlying demand for VYVGART and are expanding our regional footprint as we prepare for the launch of KarXT in China in the second quarter," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "Supported by national guidelines and an addressable population of ~8 million schizophrenia patients, KarXT’s launch positions us to bring the first novel therapy in decades to this critical market, with potential NRDL inclusion next year. In addition, we anticipate a potential regulatory approval for TIVDAK this year, and with positive Phase 3 readouts for povetacicept and elegrobart, we have additional opportunities for future growth. Across all efforts, we remain focused on driving consistent execution throughout our commercial portfolio."

First Quarter 2026 Financial Results

•Total revenue was $99.6 million in the first quarter of 2026, compared to $106.5 million for the same period in 2025, representing a decrease of 6% y-o-y. Product revenue, net was $95.6 million in the first quarter of 2026, compared to $105.7 million for the same period in 2025, representing a 10% y-o-y decrease, 12% y-o-y decrease at constant exchange rate (CER). This decrease was primarily driven by decreased sales for ZEJULA, partially offset by increased sales for XACDURO and NUZYRA:

–ZEJULA was $30.0 million in the first quarter of 2026, compared to $49.5 million for the same period in 2025. Sales declined due to a shift in hospital utilization patterns following volume-based procurement for generic olaparib.

–VYVGART was $17.6 million in the first quarter of 2026, compared to $18.1 million for the same period in 2025. Sales declined primarily due to a pricing adjustment related to NRDL renewal.

–XACDURO, was $8.6 million in the first quarter of 2026, compared to $1.1 million for the same period in 2025. Growth was driven by strong patient demand and expanding hospital adoption but was partially constrained by supply limitations.

–NUZYRA was $16.3 million in the first quarter of 2026, compared to $15.1 million for the same period in 2025. This growth was supported by increased market coverage and penetration.

•Research and Development (R&D) expenses were $65.6 million in the first quarter of 2026, compared to $60.7 million for the same period in 2025. This increase was primarily due to increased clinical trial-related expenses and licensing fees.

•Selling, General and Administrative (SG&A) expenses were $65.1 million in the first quarter of 2026, compared to $63.4 million for the same period in 2025. This increase was primarily driven by higher general selling expenses.

•Loss from operations was $69.4 million in the first quarter of 2026, $51.9 million when adjusted to exclude certain non-cash expenses including depreciation, amortization, and share-based compensation. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release.

•Net loss was $51.0 million in the first quarter of 2026, or a loss per ordinary share attributable to stockholders of $0.05 (or loss per American Depositary Share (ADS) of $0.46), compared to a net loss of $48.4 million for the same period in 2025, or a loss per ordinary share of $0.04 (or loss per ADS of $0.45). These increases in net loss were primarily due to lower product revenue and higher research and development expenses, partially offset by foreign currency gains.

•Cash and cash equivalents, short-term investments, and current restricted cash totaled $761.3 million as of March 31, 2026, compared to $789.6 million as of December 31, 2025.

Recent Corporate Updates

–In April 2026, we appointed Yizhe Wang, Ph.D., as Operating Partner, to strengthen Zai Lab’s commercial capabilities and execution. Dr. Wang brings extensive experience in global oncology and immunology commercial operations, having led commercial teams across China, the U.S., and the U.K. at GSK and Eli Lilly.

Recent Pipeline Highlights

Below are key product candidate updates since our last earnings release:

Oncology Pipeline

•Zocilurtatug Pelitecan (zoci, DLL3-Targeting ADC) (formerly ZL-1310):

–In April 2026, Zai Lab presented compelling clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 demonstrating that zoci delivers rapid and robust intracranial responses in patients with previously treated extensive stage small cell lung cancer (ES-SCLC) and brain metastases as measured by blinded independent assessment using mRANO-BM criteria, as well as promising data in patients with extrapulmonary neuroendocrine carcinomas (epNECs).
◦SCLC with Brain Metastases: Zoci showed a 53.7% confirmed intracranial objective response rate (iORR) with 62.5% (10/16) at the 1.6 mg/kg dose, including complete responses. Notably, responses were observed in patients without prior brain radiotherapy (9/15, 60%), highlighting the net drug effect on the intracranial lesions. Zoci was well tolerated, with Grade ≥3 treatment-related adverse events (TRAEs) in 19.9% (27/136) of the overall population and in 16.4% (9/55) of patients who received 1.6mg/kg.
◦epNECs: Encouraging activity was observed with a 38.2% confirmed objective response rate across epNEC tumors of different primary origins. The safety profile in epNEC was consistent with that previously observed in SCLC with Grade ≥3 TRAEs in 15.2% of patients in Phase 1b.

–In April 2026, Zai Lab announced a global clinical trial collaboration with Amgen to evaluate zoci in combination with Amgen’s IMDELLTRA (tarlatamab-dlle), a DLL3/CD3 bispecific T-cell engager (TCE), for ES-SCLC and a clinical collaboration with Boehringer Ingelheim to evaluate zoci in combination with obrixtamig, a DLL3/CD3 bispecific TCE, for SCLC and other NECs.

Immunology, Neuroscience, and Infectious Disease Pipeline

•ZL-1503 (IL-13/IL-31Rα): In April 2026, Zai Lab announced new data from a preclinical study of ZL-1503, demonstrating that the company’s internally developed IL-13/IL-31Rα bispecific antibody may lead to sustained suppression of intense pruritus (itch) and inflammation caused by atopic diseases. The findings reinforce the potential of ZL-1503 to be a first-in-class treatment option 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 the 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 partner Vertex announced positive data from a pre-specified Week 36 interim analysis of the global Phase 3 RAINIER trial of pove in IgA nephropathy (IgAN). The trial met its primary objective, with povetacicept-treated patients achieving a 52.0% reduction from baseline in 24-hour urine protein to creatinine ratio (UPCR), representing a statistically significant and clinically meaningful 49.8% UPCR reduction versus placebo (p<0.0001). Povetacicept was generally safe and well tolerated. Zai Lab participated in the global Phase 3 study in Greater China.

–Primary membranous nephropathy (pMN): Zai Lab partner Vertex has completed enrollment in the Phase 2 portion of the global pivotal Phase 2/3 OLYMPUS study and has initiated the Phase 3 portion. Zai Lab participated in the global study in Greater China.

•Elegrobart (anti-IGF-1R, subcutaneous): Zai Lab partner Viridian Therapeutics announced positive topline data in both REVEAL-1 and REVEAL-2, elegrobart’s two pivotal phase 3 clinical trials for active and chronic TED, respectively. Elegrobart was generally well tolerated across both studies. Zai Lab holds 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 in active TED: met its primary endpoint with a highly statistically significant treatment effect. Both elegrobart Q4W and Q8W treatment arms showed rapid onset of treatment effect and achieved clinically meaningful 54% and 63% proptosis responder rates, respectively, versus 18% placebo at week 24. The Q4W treatment arm additionally provided meaningful diplopia benefit to patients with active TED.

–REVEAL-2 in chronic TED: met its primary endpoint with a highly statistically significant treatment effect. Both elegrobart Q4W and Q8W treatment arms achieved statistically significant and clinically meaningful 50% and 54% proptosis responder rates, respectively, versus 15% placebo at week 24. The Q4W treatment arm additionally provided meaningful diplopia benefit to patients with chronic TED.

Anticipated Major Milestones in 2026

Expected Clinical Developments and Data Readouts

Global Pipeline

Zocilurtatug Pelitecan (zoci, DLL3-Targeting ADC) (formerly ZL-1310)

•First-Line ES-SCLC: Zai Lab to provide data readout from the Phase 1 study evaluating zoci combination therapy (with atezolizumab and/or chemotherapy) in the second half of 2026 and advance zoci into a registrational study in 2026 based on emerging data.

•Extrapulmonary NECs: Zai Lab to complete the enrollment for the global Phase 2 portion of the ongoing Phase 1b/2 study evaluating zoci in patients with selected solid tumors and advance into registrational development in 2026.

ZL-1503 (IL-13/IL-31Rα)

•Zai Lab to provide the first-in-human data readout from the global Phase 1/1b study in 2026.

Regional Pipeline

Upcoming Potential NMPA Approvals

•TIVDAK (Tisotumab Vedotin, Tissue Factor ADC) in recurrent or metastatic cervical cancer following progression on or after chemotherapy

•Tumor Treating Fields (TTFields) in locally advanced pancreatic cancer

Expected Data Readouts

Efgartigimod (FcRn)

•Myositis: Zai Lab partner argenx to provide topline results from the global Phase 2/3 ALKIVIA study evaluating autoimmune inflammatory myopathies (AIM or myositis) in the third quarter of 2026. Zai Lab participated in the study in Greater China.

Elegrobart (Anti-IGF-1R, subcutaneous)

•Zai Lab to complete the enrollment for the Phase 3 registrational study in China in the third quarter of 2026.

Conference Call and Webcast Information

Zai Lab will host a live conference call and webcast today, May 7, 2026, at 8:00 a.m. ET (8:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call.

Details are as follows:

•Registration link for webcast (preferred): View Source
•Registration link for dial-in: View Source

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

(Press release, Zai Laboratory, MAY 7, 2026, View Source [SID1234665347])