The aims of this study are to assess the real-world effectiveness of efgartigimod in treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), describe the "treatment journey" of participants with CIDP, and assess the utilization of health care services among adult participants with CIDP who initiate treatment with efgartigimod.
As this is a noninterventional study, treatment choices and decisions will be left to the discretion of participants and their physicians, according to the standard of care.
Each participant will be prospectively followed for up to 2 years from the date of initial administration of efgartigimod.

Start Date11 Aug 2025

Sponsor / Collaborator

argenx SE

CTR20252164

/ RecruitingPhase 3

一项在成人原发性干燥综合征受试者中评价预充式注射器皮下给与Efgartigimod PH20 的有效性、安全性和耐受性的III 期、随机、双盲、安慰剂对照、多中心研究接开放标签扩展研究

[Translation] A Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of Efgartigimod PH20 administered subcutaneously via a prefilled syringe in adult subjects with primary Sjögren's syndrome followed by an open-label extension

通过clinESSDAI 比较Efgartigimod PH20 SC 与安慰剂的系统疾病活动度评价有效性

[Translation]

Efficacy of Efgartigimod PH20 SC versus placebo in systemic disease activity assessment by clinESSDAI

Start Date30 Jun 2025

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

[+2]

NCT06637072

/ Active, not recruitingPhase 4

A Phase 4, Open-Label, Single-Group, Multicenter Study in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy Who Transition From Treatment With Intravenous Immunoglobulin to Efgartigimod PH20 SC

This study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.

Start Date10 Dec 2024

Sponsor / Collaborator

argenx SE

100 Clinical Results associated with Efgartigimod/Hyaluronidase

100 Translational Medicine associated with Efgartigimod/Hyaluronidase

100 Patents (Medical) associated with Efgartigimod/Hyaluronidase

Literatures (Medical) associated with Efgartigimod/Hyaluronidase

01 Dec 2024·DRUGS IN R&D

Pharmacokinetics, Pharmacodynamics, and Safety of Intravenous Efgartigimod and Subcutaneous Efgartigimod PH20 in Healthy Chinese Participants

Article

Author: Reinhart, Harald ; Chen, Jiajia ; Van Bragt, Tonke ; Gu, Xiaowen ; Noukens, Jan ; Jing, Shan ; Wang, Lina ; Pu, Xia ; Liu, Jing ; Zhang, Yu ; Lin, Yang ; Guglietta, Antonio

BACKGROUND:

Efgartigimod, a human immunoglobulin G (IgG)1-derived Fc fragment targeting the neonatal Fc receptor, has been developed into intravenous (IV) and subcutaneous (SC) formulations for treating generalized myasthenia gravis (gMG) and other autoimmune diseases. Data in the Chinese population were not available to date, and while both formulations have been approved in the USA, the EU, Japan and China for the treatment of gMG.

OBJECTIVE:

We present the pharmacokinetic, pharmacodynamic, and safety of IV and SC PH20 efgartigimod in healthy Chinese participants.

METHODS:

In two independent, double-blinded, placebo-controlled, phase I studies of the IV and SC formulations of efgartigimod, healthy Chinese adults were randomized 3:1 to receive active treatment or matching placebo once every 7 days for four doses. Primary endpoints were pharmacokinetic parameters.

RESULTS:

After the fourth IV infusion, a mean maximum observed concentration (C_max) of 194 µg/mL was reached at the end of the 1 h infusion; the mean area under concentration-time curve from time zero to 168 h (AUC_0-168h) was 5300 µg × h/mL. After the fourth SC injection, a mean C_max of 42.1 µg/mL was achieved with a median T_max of 47.74 h; the mean AUC_0-168h was 4790 µg × h/mL. Maximal mean reductions from baseline in total IgG levels were reached approximately 24 days after the first dose (60.7%, IV formulation; 66.4%, SC formulation). Treatment-related adverse events (TRAEs) were reported in seven (58.3%) participants receiving SC efgartigimod, mostly injection-site reactions. No TRAEs or AEs of special interest were reported in the IV study.

CONCLUSIONS:

The efgartigimod IV and SC pharmacokinetic, pharmacodynamic, and safety profiles in Chinese participants were similar to the known profiles in non-Chinese participants. Both formulations effectively reduced total IgG levels by a similar percentage.

CLINICAL TRIAL REGISTRATION:

CTR20211952 and CTR20211805.

01 Dec 2024·ADVANCES IN THERAPY

Risk–Benefit Analysis of Novel Treatments for Patients with Generalized Myasthenia Gravis

Article

Author: Qi, Cynthia Z. ; Brauer, Edward ; Smith, A. Gordon ; Yang, Hongbo ; Wolfe, Gil I ; Gelinas, Deborah ; Saccà, Francesco ; Smith, A Gordon ; Chen, Xin ; Phillips, Glenn ; Qi, Cynthia Z ; Habib, Ali A ; Wolfe, Gil I. ; Habib, Ali A. ; Du, Mandy

INTRODUCTION:

This study used network meta-analysis (NMA) to inform and compare the number needed to treat (NNT), number needed to harm (NNH), and cost per improved outcome (CPIO) associated with more recently approved treatments for anti-acetylcholine receptor antibody-positive (anti-AChR Ab+) generalized myasthenia gravis (gMG).

METHODS:

Clinical trials of neonatal Fc receptor (FcRn) inhibitors, efgartigimod intravenous (IV) and rozanolixizumab, and complement inhibitors, ravulizumab and zilucoplan, versus placebo (with background conventional treatment) were included in the primary NMA to compare efficacy and safety outcomes. The outputs from the NMAs were used to estimate NNT and NNH of each treatment versus placebo. CPIO (2024 USD) was estimated for a ≥ 3- or ≥ 5-point reduction from baseline in Quantitative Myasthenia Gravis (QMG) and Myasthenia Gravis-Activities of Daily Living (MG-ADL) scores. Sensitivity analyses were performed adding efgartigimod PH20 subcutaneous (SC) and eculizumab to the NMA.

RESULTS:

Efgartigimod IV had the lowest NNT versus placebo for achieving a ≥ 3- and ≥ 5-point reduction in QMG, as well as a ≥ 5-point reduction in MG-ADL, whereas rozanolixizumab had the lowest NNT for a ≥ 3-point reduction in MG-ADL. The NNH versus placebo was similar across comparator treatments. Efgartigimod IV had the lowest CPIO among all treatments for all assessed efficacy outcomes. Sensitivity analyses yielded results consistent with primary analysis and indicated that efgartigimod PH20 SC had comparable NNT and CPIO values to efgartigimod IV, whereas eculizumab had comparable NNT and higher CPIO values compared to other complement inhibitors.

CONCLUSIONS:

FcRn inhibitors and complement inhibitors assessed in this study all demonstrated clinical benefit in terms of NNT as well as an acceptable safety profile in terms of NNH. Within the limitations of this meta-analysis, efgartigimod was associated with a favorable benefit-risk profile as well as a better economic value compared to ravulizumab, rozanolixizumab, and zilucoplan as treatments for anti-AChR Ab+ gMG.

01 Nov 2024·DRUGS

Efgartigimod: A Review in Generalised Myasthenia Gravis

Review

Author: Blair, Hannah A. ; Blair, Hannah A

Efgartigimod (Vyvgart^®; Vyvgart^® Hytrulo) is a neonatal fragment crystallizable receptor (FcRn) antagonist indicated for the treatment of generalised myasthenia gravis (gMG) in adults who are acetylcholine receptor (AChR) antibody positive (Ab+). Efgartigimod is approved for both intravenous (IV) and subcutaneous (SC) use. In a pivotal phase III trial, IV efgartigimod was associated with significant and clinically meaningful improvements in myasthenia gravis symptoms and reductions in disease burden. The beneficial effects of IV efgartigimod were reproducible, durable and maintained over the long term. IV efgartigimod also improved health-related quality of life (HRQOL). In another phase III trial, SC efgartigimod PH20 was noninferior to IV efgartigimod in reducing total immunoglobulin G levels. Clinical improvement with SC efgartigimod PH20 was consistent with that of IV efgartigimod and was reproducible over the long term. Efgartigimod was generally well tolerated; the most common adverse events were headache and infections (with IV efgartigimod) and injection-site reactions (with SC efgartigimod PH20). Although further long-term data are required, IV and SC formulations of efgartigimod provide effective, generally well-tolerated and flexible treatment options for adults with AChR Ab+ gMG.

121

News (Medical) associated with Efgartigimod/Hyaluronidase

26 Feb 2026

·www.fiercepharma.com

OMG—argenx scores again with Vyvgart in ocular myasthenia gravis

Argenx has posted trial results that could allow for its blockbuster drug to reach a new indication—ocular myasthenia gravis. The company reported Vyvgart sales at $1.3 billion in the fourth quarter of last year and $4.2 billion for 2025 overall. Already on a roll with its first-in-class FcRn blocker Vyvgart, argenx has reported successful trial results that could pave the way for the fast-rising blockbuster to reach a new indication—ocular myasthenia gravis.The phase 3 Adapt Oculus study, which is the first to specifically evaluate a targeted treatment for ocular myasthenia gravis (oMG), has achieved its primary endpoint, demonstrating that Vyvgart can improve vision by a statistically significant margin, argenx reported Thursday.The company hailed the victory the same day it unveiled its 2025 earnings, showing that Vyvgart sales came in at $1.3 billion in the fourth quarter and $4.2 billion for the full year.A year ago, argenx posted fourth-quarter 2024 sales of $737 million and full-year sales of $2.2 billion. The 90% annual revenue boost allowed the Dutch drugmaker to turn an operating profit for the first time, at $1.05 billion for the year.As for the success in the oMG study, it comes after argenx sustained a rare defeat with Vyvgart, coming up short in a trial for thyroid eye disease (TED) two months ago. The loss convinced argenx to scrap the development of Vyvgart in the indication.The oMG trial included 141 patients from the U.S., Europe and Asia with a mild (Class 1) form of the disorder who received four weekly subcutaneous injections of Vyvgart or placebo, followed by a 4-week follow-up. Using patient-reported outcomes on the Myasthenia Impairment Index (MGII), those in the Vyvgart arm had a mean 4.04-point change versus a mean change of 1.99 in the placebo arm. Patients treated with Vyvgart also saw a reduction of key ocular symptoms—diplopia (double vision) and ptosis (drooping of the upper eyelids).“There is a long-standing gap for a patient population that has historically been excluded from clinical trials,” Luc Truyen, M.D., Ph.D., argenx’s chief medical officer, said in the company’s quarterly conference call. “Patients are still relying on chronic steroids and symptomatic therapy, which causes an unacceptable treatment burden over time. For the first time, we are bringing forward a therapy that specifically addresses the underlying pathological mechanism of ocular MG.” The company will provide full results at a future medical conference, and argenx will file an application for FDA approval. A month ago, argenx announced that the FDA had accepted its application to expand Vyvgart to those with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG), for which the U.S. regulator has assigned a decision date of May 10.With the potential label expansions, argenx is on track to reach an additional 18,000 patients, including 7,000 in oMG, chief commercialization officer Sandrine Piret-Gerard said during the call. oMG is a chronic autoimmune disease causing weakness in eye muscles. It is caused by antibodies blocking acetylcholine receptors at the neuromuscular junction, affecting only eye muscles or progressing to general weakness.“Ocular myasthenia gravis significantly impacts patients’ daily lives, affecting vision, independence and the ability to do routine tasks, such as work or drive a car. Yet today, there are no approved targeted medicines for this disease,” Carolina Barnett-Tapia, M.D., Ph.D., of the University of Toronto, said in a release.The FDA originally approved Vyvgart in December 2021 for the treatment of generalized myasthenia gravis (gMG). A year later, the agency signed off on Vyvgart Hytrulo, a subcutaneous formulation, which provided more convenience for patients. In 2024, an approval for Vyvgart Hytrulo came for the rare immune-mediated neuromuscular disorder chronic inflammatory demyelinating polyneuropathy.

Clinical ResultDrug ApprovalPhase 3

26 Feb 2026

·firstwordpharma.com

argenx makes case for Vyvgart in ocular myasthenia gravis with pivotal win

argenx on Thursday said the subcutaneous (SC) version of its human IgG1 antibody fragment efgartigimod alfa, sold as Vyvgart Hytrulo, met the primary endpoint of a Phase III study in patients with ocular myasthenia gravis (oMG).The ADAPT OCULUS trial randomised 141 adults with Myasthenia Gravis Foundation of America (MGFA) Class I oMG — both AChR-antibody seropositive and seronegative — to receive either four once-weekly SC injections of Vyvgart or placebo, followed by a four-week follow-up period.Top-line results showed that the trial met its main goal, with the Vyvgart arm demonstrating a statistically significant mean 4.04-point improvement from baseline in Myasthenia Gravis Impairment Index patient-reported outcome (MGII-PRO) ocular scores at week four versus a mean change of 1.99 points for those receiving placebo — a clinically meaningful difference driven by reductions in ocular symptoms of diplopia and ptosis.Luc Truyen, chief medical officer of argenx, said "[oMG] has been historically under-studied and represents a significant unmet need," adding that the "positive results…bring us one step closer to our vision of delivering a targeted, transformative treatment option to as many MG patients as possible."Safety-wise, Vyvgart's profile aligned with previous studies, with no new signals identified. The biotech will present detailed findings from ADAPT OCULUS at an upcoming medical conference and submit them to the FDA by the end of the third quarter.Vyvgart was first approved as an intravenous infusion by the FDA in 2021 to treat generalised MG (gMG), while the subcutaneous variant — which combines Vyvgart with hyaluronidase — was authorised for gMG in 2023 and subsequently for chronic inflammatory demyelinating polyneuropathy the following year. The 'pipeline-in-a-product', which generated $4.2 billion in sales last year, is being investigated in over 15 severe autoimmune diseases driven by pathogenic IgG antibodies including myositis and Sjögren's disease, although Phase III studies in thyroid eye disease were recently ended due to futility.

Clinical ResultPhase 3Drug Approval

26 Feb 2026

·www.biospace.com

Zai Lab Announces Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Updates

– Total revenues grew 17% y-o-y to $127.6 million for the fourth quarter of 2025 and 15% y-o-y to $460.2 million for the full-year 2025 – Zocilurtatug pelitecan (zoci) on track to become Zai Lab’s first global oncology launch, with three registration-enabling studies across 2L+ SCLC, 1L SCLC, and extrapulmonary NECs by the end of 2026 – Advancing a differentiated global pipeline, including ZL-1503 (IL-13/IL-31Rα), ZL-6201 (LRRC15 ADC), ZL-1222 (PD-1/IL-12) and ZL-1311 (MUC17/CD3 TCE) – Key regional programs continue to advance, with KarXT approved in China and commercial launch preparations underway; pivotal data readouts for povetacicept in IgAN and elegrobart in TED expected in 2026 Conference call and webcast today, February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the fourth quarter and full-year 2025, along with recent product highlights and corporate updates. “2025 was a year of disciplined execution across both engines of our business with significant advancement across our global innovation pipeline and steady progress in our commercial business,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “We accelerated multiple global programs, including the rapid progression of zoci into pivotal development, enabled by our integrated U.S./China infrastructure which allows us to operate with speed and capital efficiency. In 2026, our focus is on executing against important catalysts – advancing late-stage immunology and oncology programs while preparing for the next wave of commercial growth. Together, these efforts mark an important step in Zai Lab’s continued evolution into a global biopharma leader.” “KarXT represents a significant new growth driver for Zai Lab, and its recent inclusion in a national expert consensus underscores the growing recognition of its novel mechanism and potential to meaningfully impact patients living with schizophrenia,” said Josh Smiley, President and Chief Operating Officer of Zai Lab. “We are strengthening the VYVGART franchise by expanding hospital coverage and supporting longer treatment persistence. Concurrently, we are preparing for the potential approvals of TIVDAK, which would further strengthen our women’s health franchise, and TTFields in pancreatic cancer. Looking beyond 2026, the combination of new launches, potential label expansions and advancing global programs, positions us for multi-year growth and continued financial improvement.” Fourth Quarter and Full-Year 2025 Financial Results Total revenue was $127.6 million in the fourth quarter of 2025 and $460.2 million for the full-year 2025. Product revenue, net was $127.1 million in the fourth quarter of 2025, compared to $108.5 million for the same period in 2024, representing 17% y-o-y growth and 16% at constant exchange rate (CER); and was $457.2 million in full-year 2025, compared to $397.6 million for the same period in 2024, representing 15% y-o-y growth and 16% y-o-y growth at CER. This increase was primarily due to higher revenue for XACDURO and NUZYRA. – ZEJULA was $56.0 million in the fourth quarter of 2025, an increase of 16% y-o-y from $48.4 million; and was $189.0 million in full-year 2025, compared to $187.1 million for the same period in 2024. ZEJULA continued to be the leading PARP inhibitor in hospital sales for ovarian cancer despite evolving competitive dynamics within the PARPi class in mainland China. – VYVGART and VYVGART Hytrulo were $21.9 million in the fourth quarter of 2025 which includes a $5.6 million rebate for VYVGART related to the National Reimbursement Drug List (NRDL) renewal, compared to $30.0 million for the same period in 2024; and was $94.2 million in full-year 2025, compared to $93.6 million for the same period in 2024. – XACDURO, which was launched in the fourth quarter of 2024, was $10.7 million in the fourth quarter of 2025, an increase of 225% y-o-y from $3.3 million; and was $22.9 million in full-year 2025, an increase of 593% y-o-y from $3.3 million. Growth was driven by strong patient demand and expanding hospital adoption but was partially constrained by supply limitations during the year. – NUZYRA was $16.0 million in the fourth quarter of 2025, an increase of 45% y-o-y from $11.0 million; and was $60.8 million in full-year 2025, an increase of 41% y-o-y from $43.2 million. This growth was supported by increased market coverage and penetration. Research and Development (R&D) expenses were $61.6 million in the fourth quarter of 2025, compared to $52.3 million for the same period in 2024, and $220.9 million for full-year 2025, compared to $234.5 million for the same period in 2024. The fourth-quarter increase resulted from progress in clinical trials. The full year decline was primarily driven by lower personnel compensation due to strategic resource optimization. Selling, General and Administrative (SG&A) expenses were $73.0 million in the fourth quarter of 2025, compared to $82.6 million for the same period in 2024, and $277.6 million for full-year 2025, compared to $298.7 million for the same period in 2024. The decrease was primarily due to a reduction in general and administrative expenses due to strategic resource optimization. Loss from operations was $69.4 million and $229.4 million in the fourth quarter of 2025 and full-year 2025, respectively, and $49.6 million and $148.8 million, respectively, when adjusted to exclude non-cash expenses, including depreciation, amortization, and share-based compensation. Loss from operations was $67.9 million and $282.1 million in the fourth quarter of 2024 and full-year 2024, respectively. 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 $50.4 million in the fourth quarter of 2025, or a loss per ordinary share attributable to common stockholders of $0.05 (or loss per American Deposit Share (ADS) of $0.46), compared to a net loss of $81.7 million for the same period in 2024 or a loss per ordinary share of $0.08 (or loss per ADS of $0.80). The net loss was $175.5 million for full-year 2025, or a loss per ordinary share attributable to common stockholders of $0.16 (or loss per ADS of $1.60), compared to a net loss of $257.1 million for full-year 2024, or a loss per ordinary share of $0.26 (or loss per ADS of $2.60). These decreases in net loss were primarily due to product revenue growing faster than net operating expenses and shift from foreign currency losses to foreign currency gains, offset by decreased interest income. Cash and cash equivalents, short-term investments and current restricted cash totaled $789.6 million as of December 31, 2025, compared to $879.7 million as of December 31, 2024. 2026 Strategic Priorities Zai Lab will focus on the following strategic priorities in 2026 to drive near-term performance and long-term global value creation: Advancing Differentiated Global Programs Across Oncology and Immunology Zocilurtatug pelitecan (zoci) (DLL3-targeting ADC): Advance three registration-enabling studies across 2L+ SCLC, 1L SCLC, and other neuroendocrine carcinomas (NECs) by the end of 2026. Three data readouts expected in 2026, including: – 2L+ SCLC: Updated global Phase 1 data highlighting intracranial response in patients with brain metastases. – 1L SCLC: Data from an ongoing Phase 1 combination study evaluating doublet and triplet regimens with a PD-L1 inhibitor, with or without chemotherapy; initiation of global Phase 1 study with novel combination. – Extrapulmonary NECs: Data from the Phase 1b portion of the ongoing global Phase 1b/2 study. ZL-1503 (IL-13/IL-31Rα bispecific antibody): First-in-Human (FIH) data from the ongoing global Phase 1/1b study expected in the second half of 2026, paving the way for Phase 2 development in atopic dermatitis (AD). ZL-6201 (LRRC15-targeting ADC): Global Phase 1 ongoing. ZL-1222 (PD-1/IL-12 immunocytokine): Investigational New Drug (IND)-enabling studies expected to be completed in 2026. ZL-1311 (T-cell engager (TCE) targeting MUC17): IND submission expected by year end. Zai Lab is building capabilities in TCEs and exploring additional immunocytokines beyond IL-12, with further details to be provided throughout the year. Commercial Execution and Key Near-Term Regional Launches to Drive Steady Growth VYVGART and VYVGART Hytrulo: Continue to increase patient utilization and duration of treatment in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). KarXT: Planned commercial launch in the first half of 2026, supported by a targeted commercial strategy, physician education, real-world evidence generation, and preparation for potential NRDL inclusion in 2027. Povetacicept and elegrobart: Both have pivotal readouts in 2026 and are expected to further strengthen regional revenue growth in the near term. Key Corporate Updates Below are key corporate updates since our last earnings release: Business Development: – We obtained the exclusive worldwide rights to develop and commercialize ZL‑1311, a next‑generation TCE targeting MUC17, which is a promising and druggable antigen overexpressed in up to ~50% of gastric and gastroesophageal junction cancers. This program represents Zai Lab’s first globally owned TCE and strategically expands our immuno‑oncology portfolio while leveraging our established expertise in GI cancers. ZL‑1311 is expected to enter global clinical development this year. – We formed a strategic collaboration with SciClone Pharmaceuticals (SciClone) for AUGTYRO™ (repotrectinib), which was approved in mainland China for ROS1‑positive non‑small‑cell lung cancer in May 2024 and for NTRK‑positive solid tumors in January 2026. Through this collaboration, Zai Lab will leverage SciClone’s commercialization infrastructure to broaden access and accelerate the commercial rollout of this innovative therapy for patients in need across mainland China. NRDL Updates: In December 2025, Zai Lab announced the successful renewals of VYVGART (efgartigimod alfa injection) for gMG patients who are anti-acetylcholine receptor (AChR) antibody positive, NUZYRA (omadacycline) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) and ZEJULA (niraparib) for platinum-sensitive, first-line and recurrent ovarian cancer patients in China’s NRDL. Recent Pipeline Highlights Below are key product candidate updates since our last earnings release: Oncology Pipeline Zocilurtatug Pelitecan (zoci, DLL3 ADC): – Second-Line+ ES-SCLC: The global Phase 3 study evaluating the efficacy and safety of zoci versus investigator’s choice therapy (topotecan, lurbinectedin, or amrubicin) in patients with relapsed SCLC is ongoing. This pivotal study plans to enroll approximately 480 patients in 2L SCLC or 3L post‑tarlatamab SCLC, with the majority of enrollment anticipated to be completed this year. – Extrapulmonary NECs : In January 2026, Zai Lab dosed the first patient in the global Phase 2 portion of its ongoing Phase 1b/2 study in NECs. Zai Lab plans to present an initial data readout from the Phase 1b portion in the first half of 2026, complete enrollment for the Phase 2 portion, and advance the program into the registrational stage within the year. ZL-6201 (LRRC15 ADC): In January 2026, the FDA cleared the IND application for a global Phase 1 study in patients with sarcoma and potentially other LRRC15-positive solid tumors. The global Phase 1 study has been initiated. Tumor Treating Fields (TTFields): In February 2026, the FDA approved Optune Pax ® for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel. It is the first treatment approved by the FDA for locally advanced pancreatic cancer in nearly 30 years. China’s NMPA granted Innovative Medical Device Designation for the treatment of pancreatic cancer in August 2025. AUGTYRO™ (repotrectinib, ROS1/TRK): In December 2025, China’s NMPA approved the supplemental New Drug Application (sNDA) for AUGTYRO™ (repotrectinib) for the treatment of adult patients with solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Immunology, Neuroscience, and Infectious Disease Pipeline ZL-1503 (IL-13/IL-31Rα): In December 2025, Zai Lab dosed the first participant in a global Phase 1/1b study evaluating the safety, tolerability, pharmacokinetics, and efficacy of ZL-1503 for the treatment of AD. Zai Lab expects to report the first-in-human data from the global Phase 1 portion in the second half of 2026. VYVGART (FcRn): – Ocular myasthenia gravis (oMG): Zai Lab partner argenx announced in February 2026 that the Phase 3 ADAPT OCULUS met its primary endpoint (p-value=0.012), demonstrating that patients living with oMG and treated with VYVGART demonstrated statistically significant improvement from baseline in Myasthenia Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 compared to placebo. In the overall population, mean change from baseline in patients treated with VYVGART was a 4.04 point improvement in MGII PRO versus a mean change of 1.99 MGII PRO score in patients treated with placebo. VYVGART was well tolerated and had a favorable safety pro patients with oMG, consistent with prior studies. Zai Lab participated in the study in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively). – Seronegative generalized myasthenia gravis (sn-gMG): In January 2026, the FDA accepted for Priority Review a supplemental Biologics License Application (sBLA) for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) sn-gMG, with a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026. Zai Lab participated in the Phase 3 ADAPT SERON study in Greater China. KarXT (xanomeline and trospium chloride) (M1/M4-agonist): In December 2025, China’s NMPA approved the NDA for KarXT for the treatment of schizophrenia in adults. KarXT is the first schizophrenia therapy with a novel mechanism of action approved in more than 70 years, offering a fundamentally new approach to treating schizophrenia. The commercial launch in China is planned for the second quarter of 2026. Povetacicept (APRIL/BAFF): In December 2025, Zai Lab joined the global pivotal Phase 2/3 OLYMPUS study in primary membranous nephropathy (pMN) and dosed the first patient in mainland China. The FDA granted Fast Track and Orphan Drug designations for povetacicept in pMN, and the EMA has granted Priority Medicines (PRIME) designation. Elegrobart (anti-IGF-1R, subcutaneous): In December 2025, Zai Lab dosed the first patient in a registrational study in thyroid eye disease (TED) in mainland China. Partner Viridian plans to report topline results from two global registrational studies in patients with active TED and chronic TED in the first half of 2026. Anticipated Major Milestones in 2026 Expected Clinical Developments and Data Readouts Global Pipeline Zocilurtatug Pelitecan (zoci, DLL3 ADC) (formerly ZL-1310) Second-Line+ ES-SCLC: Zai Lab to present updated data on intracranial activity from the ongoing Phase 1 study in the first half of 2026. 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. Zai Lab also plans to initiate a Phase 1 study to explore zoci in a novel combination in the first half of 2026. Extrapulmonary NECs: Zai Lab to provide data readout from the global Phase 1b portion of the ongoing Phase 1b/2 study evaluating zoci in patients with selected solid tumors in the first half of 2026 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 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 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. Povetacicept (APRIL/BAFF) IgA Nephropathy (IgAN) : Zai Lab partner Vertex remains on track to release interim analysis data of the global Phase 3 RAINIER study in the first half of 2026 and also complete the submission in the first half of 2026, if data from the interim analysis are supportive. The FDA has granted Breakthrough Therapy Designation for this indication. pMN: Zai Lab and partner Vertex plan to complete the Phase 2 portion of the global pivotal Phase 2/3 OLYMPUS study and initiate the Phase 3 portion in mid-2026. Elegrobart (anti-IGF-1R, subcutaneous) Viridian to provide topline results from the global registrational REVEAL-1 study in active TED patients in the first quarter of 2026 and global registrational REVEAL-2 study in chronic TED in the second quarter of 2026. Zai Lab, through its license agreement with Zenas, obtained a sublicense to the Viridian anti-IGF-1R antibody and is proceeding with clinical development. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast today, February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at . Participants must register in advance of the conference call. Details are as follows: Registration link for webcast (preferred): Registration link for dial-in: 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. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit or follow us at . Non-GAAP Measures In addition to results presented in accordance with GAAP, we disclose growth rates that have been adjusted to exclude the impact of changes due to the translation of foreign currencies into U.S. dollars. We have also presented a measure of adjusted loss from operations that adjusts GAAP loss from operations to exclude the impact of certain non-cash expenses including depreciation, amortization, and share-based compensation, which we refer to as “profitability.” These adjusted growth rates and adjusted loss from operations are non-GAAP measures. We believe that these non-GAAP measures are important for an understanding of the performance of our business operations and financial results and provide investors with an additional perspective on operational trends and greater transparency into our historical and projected operating performance. Although we believe the non-GAAP financial measures enhance investors’ understanding of our business and performance, these non-GAAP financial measures should not be considered an exclusive alternative to accompanying GAAP financial measures. Zai Lab Forward-Looking Statements This press release contains certain forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth, profitability, and cash flow); clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities; our profitability and timeline to profitability; our future financial and operating results; and financial guidance, including with respect to our capital allocation and investment strategy and our expected path to profitability. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “poised,” “positioned,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. 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 contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections 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 by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives; (3) the results of our clinical and pre-clinical development of our product candidates; (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates; (5) risks related to doing business in China; and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U. Contacts For more information, please contact: Investor Relations: Christine Chiou / Cyan Liu +1 (917) 886-6929 / +86 195 3130 8895 christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (415) 317-7255 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Read full story here

Phase 1Phase 3License out/inDrug ApprovalBreakthrough Therapy

100 Deals associated with Efgartigimod/Hyaluronidase

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	United States	argenx SE	21 Jun 2024
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	United States	argenx BV	21 Jun 2024
Myasthenia Gravis	United States	argenx BV	20 Jun 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Primary Sjögren's syndrome	Phase 3	United States	argenx BV	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	United States	Zai Lab (Shanghai) Co., Ltd.	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Japan	argenx BV	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Japan	Zai Lab (Shanghai) Co., Ltd.	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Argentina	argenx BV	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Argentina	Zai Lab (Shanghai) Co., Ltd.	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Austria	Zai Lab (Shanghai) Co., Ltd.	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Austria	argenx BV	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Belgium	Zai Lab (Shanghai) Co., Ltd.	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Belgium	argenx BV	17 Dec 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04818671 (ADAPTSC+ \| ADAPT-SC+, CTgov)	Phase 3	Myasthenia Gravis	184	efgartigimod PH20 SC	cfouyhhuae = vcgbzanglq rhjdwkyzix (ruzntfvjbg, zbhkzuuqnx - gfycoilrfi) View more	-	22 Jan 2026
NCT05523167 (ALKIVIA, ACR2025)	Phase 2/3	Idiopathic Inflammatory Myopathies	89	Efgartigimod PH20 SC plus standard of care (SOC)	bnehugjqln(huvuphpiyx) = odzjrlgrvo dvauulcnut (vzdbnhtrux ) View more	Positive	24 Oct 2025
				Placebo PH20 (PBO) plus SOC	bnehugjqln(huvuphpiyx) = iqnwawvqji dvauulcnut (vzdbnhtrux ) View more
NCT05267600 (BALLAD, CTgov)	Phase 2/3	Pemphigoid, Bullous	98	Prednisone+efgartigimod PH20 SC (Efgartigimod PH20 SC)	outcglbnby = blcfddhvzt lbbprtmhkc (cvohmzmzcj, zoxadumbjk - rhsfgagnyb) View more	-	23 Oct 2025
				placebo+Prednisone (Placebo PH20 SC)	outcglbnby = apumblorul lbbprtmhkc (cvohmzmzcj, dpcejjoguq - gmbzyogmrc) View more
NCT04818671 (ADAPT-SC+, Neurology \| AAN2025) Manual	Not Applicable	Myasthenia Gravis	179	Efgartigimod PH20 SC 1000 mg	mwbylxldvn(gpjflzkezp) = jhhjdslyeu yyqufwstue (chgapasbkk, 0.27) View more	Positive	07 Apr 2025
NCT04281472 \| NCT04280718 (ADHERE+, Neurology \| AAN2025) Manual	Phase 2	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	322	Efgartigimod PH20 SC 1000 mg (ADHERE)	seddqfdxdg(pgqqwuqdya) = cnzlucxrsx aorbpcuqoi (fygyprjgdq, 0.10) View more	Positive	07 Apr 2025
				Efgartigimod PH20 SC 1000 mg (ADHERE+)	seddqfdxdg(pgqqwuqdya) = foaqwgkvbv aorbpcuqoi (fygyprjgdq, 0.15) View more
NCT04281472 (ADHERE, AAN2025)	Phase 2	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	-	Efgartigimod PH20 SC 1000 mg	chcyrcmxqp(ecojyukfav) = useerdehuc hksacmeisv (qgrqolpeyh ) View more	Positive	07 Apr 2025
				Placebo	chcyrcmxqp(ecojyukfav) = glqixassdu hksacmeisv (qgrqolpeyh ) View more
NCT04598477 (ADDRESS+, CTgov)	Phase 3	Pemphigus \| Acne Vulgaris	183	efgartigimod PH20+Efgartigimod (Efgartigimod-efgartigimod PH20 SC)	mmoslpwmqs = wnmkciynsp qeugwectke (kwwrdljuzv, dsbrafxnot - vvkhhwhzva) View more	-	30 Mar 2025
				Placebo+efgartigimod PH20 (Placebo-efgartigimod PH20 SC)	mmoslpwmqs = littwnnvsg qeugwectke (kwwrdljuzv, zdszvdsdby - hpugipatao) View more
NCT04281472 (ADHERE, Pubmed \| Lancet Neurol) Manual	Phase 2	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	629	Subcutaneous efgartigimod PH20	dqijsfouvj(oexzgrpbvg) = lgsvgaexxa ctbcqwhnra (znkwqqbgpu, 61.0 - 71.6) View more	Positive	01 Oct 2024
				Subcutaneous efgartigimod PH20 (stage B)	ztptfjtqfy(kisaxjdxng) = ayixkhuksk hoipzyltpo (oyicxcghtw, 19.6 - 36.3) View more
NCT04598451 (ADDRESS, CTgov)	Phase 3	Pemphigus \| Acne Vulgaris	222	prednisone+efgartigimod PH20 SC	rkboypzaic = orltamoxis dxkwopautz (qkwuqxnnmg, xkjylpzowh - rbzyunhlxr) View more	-	01 Oct 2024
NCT04281472 (ADHERE \| ADHERE+, CTgov)	Phase 2	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	322	Efgartigimod PH20 (Stage A: Efgartigimod PH20 SC)	mckyhyuepu = mwucaegzlf lzvwdyrvpo (kwulljpppq, avupdhpgkp - lqzcsztxms) View more	-	20 Aug 2024
				Efgartigimod PH20 (Stage B: Efgartigimod PH20 SC)	fjawpicepv(wwcmokmzxd) = nptvrhgxxd dasemzqwrb (fyxkrqboeq, rneragqjvd - byhvjjsdtp) View more

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