The goal of this clinical trial is to test in Chinese Subjects with Metastatic or Recurrent Solid Malignancies. The main questions it aims to answer are:
How is the PK of tisotumab vedotin?
How is the immunogenicity of tisotumab vedotin?
How is the safety and tolerability of tisotumab vedotin?
How is the clinical efficacy of tisotumab vedotin? Participants will receive 2.0 mg/kg tisotumab vedotin (up to a maximum of 200 mg in subjects ≥ 100 kg) as a 30-minute IV infusion 1Q3W with the aim to characterize the PK profiles and to evaluate immunogenicity, safety, and tolerability of tisotumab vedotin in the Chinese population.
Subjects will receive study treatment until disease progression or any other discontinuation criteria are met, whichever occurs first. Subjects will undergo an end of treatment (EOT) visit 30 days (± 5 days) after the last dose of study treatment or within 7 days after treatment discontinuation has been decided, whichever occurs later.

Start Date16 Jun 2023

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

CTR20231348

/ CompletedPhase 1

一项在复发或转移性的中国实体瘤受试者中评估Tisotumab Vedotin药代动力学的开放性Ⅰ期试验

[Translation] An open-label phase I trial evaluating the pharmacokinetics of tisotumab vedotin in Chinese subjects with recurrent or metastatic solid tumors

主要：评估tisotumab vedotin的PK。次要：评估tisotumab vedotin的免疫原性。评估tisotumab vedotin的安全性和耐受性。探索性：评估tisotumab vedotin的临床疗效。

[Translation]

Primary: To evaluate the PK of tisotumab vedotin. Secondary: To evaluate the immunogenicity of tisotumab vedotin. To evaluate the safety and tolerability of tisotumab vedotin. Exploratory: To evaluate the clinical efficacy of tisotumab vedotin.

Start Date06 Jun 2023

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

[+2]

CTR20223290

/ Active, not recruitingPhase 3

一项在二线或三线复发性或转移性宫颈癌患者中比较 Tisotumab vedotin 与研究者所选化疗方案的随机、开放标签、III 期试验

[Translation] A randomized, open-label, phase III trial comparing tisotumab vedotin with investigator's choice of chemotherapy in patients with second- or third-line recurrent or metastatic cervical cancer

主要目的：在 2L-3L 宫颈癌参与者中证明 Tisotumab vedotin 相较于化疗的临床疗效改善次要目的：1.在 2L-3L 宫颈癌参与者中评估 Tisotumab vedotin 相较于化疗的临床疗效改善 2.在 2L-3L 宫颈癌参与者中证明 Tisotumab vedotin 相较于化疗的抗肿瘤活性改善 3.在 2L-3L 宫颈癌参与者中表征 Tisotumab vedotin 和化疗的抗肿瘤应答 4.评估 Tisotumab vedotin 的安全性和耐受性 5.评估健康相关生活质量 (HRQOL) 6.评估 Tisotumab vedotin 的药代动力学 (PK) 和免疫原性

[Translation]

Primary objective: To demonstrate improved clinical efficacy of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer Secondary objectives: 1. To evaluate the improved clinical efficacy of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer 2. To demonstrate improved antitumor activity of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer 3. To characterize the antitumor response of Tisotumab vedotin and chemotherapy in participants with 2L-3L cervical cancer 4. To evaluate the safety and tolerability of Tisotumab vedotin 5. To evaluate health-related quality of life (HRQOL) 6. To evaluate the pharmacokinetics (PK) and immunogenicity of Tisotumab vedotin

Start Date09 Feb 2023

Sponsor / Collaborator

Rps Medical Technology (Beijing) Co Ltd

100 Clinical Results associated with Tisotumab Vedotin-tftv

100 Translational Medicine associated with Tisotumab Vedotin-tftv

100 Patents (Medical) associated with Tisotumab Vedotin-tftv

644

Literatures (Medical) associated with Tisotumab Vedotin-tftv

01 Mar 2025·ANNALS OF EMERGENCY MEDICINE

Antibody-Drug Conjugates: The Toxicities and Adverse Effects That Emergency Physicians Must Know

Review

Author: Markides, Danna Michelle ; Merlin, Jeffrey ; Hita, Angel Guido ; Reyes-Gibby, Cielto ; Yeung, Sai-Ching J

Antibody-drug conjugates are novel antineoplastic agents whose use is expanding, both in terms of the number of drugs and the number of patients being treated. This article reviews the known toxicities and complications of antibody-drug conjugates that are currently approved for the treatment of cancer in the United States, with a focus on their emergency presentation and management. Similar to many other cancer therapies, most antibody-drug conjugates can cause diarrhea, nausea/vomiting, rash, peripheral neuropathy, and cytopenia, which are generally treated following standard-of-care. Interstitial lung disease, which may mimic pneumonia and cause respiratory failure and death, has been seen with trastuzumab deruxtecan and mirvetuximab soravtansine; emergency treatment of this condition includes oxygenation, ventilatory support, and corticosteroids. Inotuzumab ozogamicin and gemtuzumab ozogamicin are both associated with sinusoidal obstruction syndrome, a potentially fatal liver dysfunction that presents with weight gain, fluid overload, and jaundice. Abnormal liver function tests in patients who have been recently treated with these agents should be cautiously evaluated. Cardiac adverse events with antibody-drug conjugates are rare, but trastuzumab emtansine and trastuzumab deruxtecan may cause a decrease in cardiac contractility, and heart rate corrected QT interval prolongation is a rare effect of trastuzumab deruxtecan. Ocular adverse events, especially blurred vision, and keratopathy, are common with mirvetuximab soravtansine and tisotumab vedotin. Progressive multifocal leukoencephalopathy has been reported with brentuximab vedotin and polatuzumab vedotin. Tumor lysis syndrome may occur after treatment with gemtuzumab ozogamicin, polatuzumab vedotin, and brentuximab vedotin. Patients receiving enfortumab vedotin or brentuximab vedotin may develop hyperglycemia, sometimes presenting as diabetic ketoacidosis. Tisotumab vedotin and trastuzumab emtansine are associated with bleeding; although it is minor in most cases, severe bleeding and intracranial hemorrhage have occurred. Several antibody-drug conjugates can cause an anaphylactoid infusion-related reaction, which occurs most commonly during or soon after infusion but may be delayed up to 24 hours. Further research is needed to establish the real-world incidence of rare complications and how often patients with these complications present to the emergency department.

19 Feb 2025·BIOCONJUGATE CHEMISTRY

A Unique Prodrug Targeting the Prostate-Specific Membrane Antigen for the Delivery of Monomethyl Auristatin E

Article

Author: Bomba, Hunter N. ; Langton-Webster, Beatrice ; Fulton, Melody D. ; Berkman, Clifford E. ; Savoy, Emily A.

Monomethyl auristatin E (MMAE) is a promising treatment option for patients diagnosed with prostate cancer (PCa); however, toxicities prevent MMAE from being administered as free drug. No MMAE-based treatment is currently marketed for PCa. Herein, we describe a small-molecule-drug conjugate, CTT2274, for the selective delivery of MMAE. CTT2274 is composed of a prostate-specific membrane antigen (PSMA)-binding scaffold, a biphenyl motif, a pH-sensitive phosphoramidate linker, and MMAE payload. We demonstrate that CTT2274 shows selective binding to PSMA, which is overexpressed on PCa cells, and induces tumor cell death in vitro. In a patient-derived xenograft tumor model of PCa in mice, we show that weekly intravenous dosing of CTT2274 at 3.6 mg/kg for six weeks is superior to treatment with free MMAE at equivalent doses. Mice treated with CTT2274 experienced prolonged tumor suppression and significantly greater overall survival than mice treated with PBS. Additionally, the safety of CTT2274 compared to an equivalent dose of MMAE was assessed in healthy, non-tumor-bearing mice. Our results demonstrate that CTT2274 therapy is as efficacious as MMAE, results in superior overall survival, and has a more favorable safety profile. Together, these data indicate that CTT2274 is a candidate for clinical translation for the treatment of PCa.

18 Feb 2025·ACS Nano

Nanobody-Mediated Cellular Uptake Maximizes the Potency of Polylysine Dendrimers While Preserving Solid Tumor Penetration

Article

Author: Fletcher, Nicholas L. ; Humphries, James ; Yuen, Daniel ; Hufton, Richard ; Porter, Christopher J.H. ; Johnston, Angus P.R. ; Feeney, Orlagh M. ; Houston, Zachary H ; McLeod, Victoria M. ; Thurecht, Kristofer J. ; Owen, David J. ; Tsegay, Sammi ; Shengule, Sudhir ; Cullinane, Carleen ; Reitano, Pauline ; Noi, Leo

Dendrimers are branched macromolecular structures that are useful nanocarriers for small-molecule drugs, such as cancer therapeutics. Their small size permits penetration into solid tumors, coupled with functionalization with a low-fouling PEG coating that minimizes transient cellular interactions and enhances plasma circulation time. While PEGylated dendrimers show significant promise as anticancer therapeutics, there is potential to increase tumor cell specificity and drive uptake of drugs into cells by conjugating cell-targeting ligands onto the dendrimers. To achieve this, we used an expanded genetic code and bio-orthogonal click chemistry to functionalize monomethyl auristatin E (MMAE)-loaded PEGylated dendrimers with a single tumor cell-targeting nanobody per dendrimer. The uniform addition of a single nanobody ligand facilitated greater intracellular uptake of the drug payload into HER2-positive target cells, while preserving the desirable circulatory characteristics of dendrimers. While the nanobody-dendrimer conjugates show similar levels of tumor infiltration over 24 h compared to unmodified dendrimers, the targeted dendrimers had significantly greater inhibition of tumor growth and long-term retention in the tumors. Our results highlight that biodistribution studies alone are poor predictors of therapeutic performance. The controlled conjugation strategy presented here preserves the size advantage and tissue penetration of dendrimers while maximizing targeted cellular uptake and potency in difficult-to-access solid tumor tissue.

130

News (Medical) associated with Tisotumab Vedotin-tftv

12 Mar 2025

·ir.zailaboratory.com

Zai Lab Announces Acceptance of Biologics License Application for TIVDAK for the Treatment of Patients with Recurrent or Metastatic Cervical Cancer

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 12, 2025-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. “In China, cervical cancer is a serious health concern with approximately 150,000 new cases diagnosed annually1,” said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. “Treatment options for patients experiencing recurrence or metastasis after initial treatment are limited. TIVDAK, the only antibody-drug conjugate (ADC) therapy in cervical cancer, demonstrated promising benefits including a clinically meaningful improvement in overall survival (OS) in the pivotal global innovaTV 301 trial. If approved, TIVDAK will leverage our existing commercial infrastructure for ZEJULA, expanding our ability to offer treatment for women's cancer.” The BLA submission is supported by the results from the global, randomized, Phase 3 innovaTV 301 clinical trial (NCT04697628) and the results from the China subpopulation of this study. As reported in January 2025, the China subpopulation results were consistent with those in the global population: TIVDAK demonstrated a 45% reduction in the risk of death compared to chemotherapy (HR: 0.55 [95% CI: 0.27-1.15] in the China subpopulation who had received prior standard systemic therapies, with more than half of this Chinese population having received prior anti-PD(L)1 therapy. After a median follow-up of 11.5 months, the median OS was not reached in the TIVDAK arm versus 10.7 months in the chemotherapy arm. Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) also favored treatment with TIVDAK. The safety of TIVDAK in the China subpopulation was manageable and consistent with the global profile. About TIVDAK® (tisotumab vedotin-tftv) TIVDAK® (tisotumab vedotin) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. TIVDAK received full approval from U.S. Food and Drug Administration (FDA) in April 2024 for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Please see full U.S. prescribing information, including BOXED WARNING for TIVDAK here. Zai Lab has an exclusive license from Seagen Inc., acquired by Pfizer in 2023, to develop and commercialize TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively). About Cervical Cancer in China Cervical cancer remains one of the leading causes of cancer death in women in China. An estimated 150,000 new cases of cervical cancer occur annually in China1. Current treatment options are limited for patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is well positioned to provide a new option for previously treated advanced cervical cancer patients who currently have limited treatment options and poor outcomes. Note: 1 Bingfeng Han et al., "Cancer incidence and mortality in China, 2022" Journal of the National Cancer Center, 2024. DOI: 10.1016/j.jncc.2024.01.006. 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 in China and worldwide. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global. Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements relating to our prospects and plans for developing and commercializing TIVDAK in Greater China, the potential benefits of TIVDAK, and the potential treatment of cervical cancer. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “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 statements of historical fact or 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. 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 decisions, (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.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and 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 may be 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. Our SEC filings can be found on our website at www.zailaboratory.com and the SEC’s website at www.sec.gov. View source version on businesswire.com: https://www.businesswire.com/news/home/20250312721980/en/ Investor Relations: Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Source: Zai Lab Limited

Clinical ResultLicense out/inPhase 3Drug ApprovalADC

06 Mar 2025

·www.prnewswire.com

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. 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Drug ApprovalImmunotherapyPriority Review

27 Feb 2025

·ir.zailaboratory.com

Zai Lab Announces Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Updates

Total revenues grew 66% y-o-y to $109.1 million for the fourth quarter of 2024 and 50% y-o-y to $399.0 million for the full-year 2024; Full-year 2025 revenue guidance of $560 million to $590 million VYVGART® and VYVGART Hytrulo® sales reached $30.0 million for the fourth quarter of 2024 and $93.6 million for the full-year 2024 Loss from operations decreased 45% y-o-y to $67.9 million for the fourth quarter of 2024 and 23% y-o-y to $282.1 million for the full-year 2024 Early clinical data from the global Phase 1 SCLC trial highlights first- and best-in-class potential for ZL-1310 (DLL3 ADC) with ORR of 74%; Zai Lab holds global rights to ZL-1310 and expects to present updated SCLC data at a major medical conference and to explore its potential in other neuroendocrine tumors in the first half of 2025 Key regional programs advancing, including NDA acceptance of KarXT for schizophrenia; Zai Lab’s immunology franchise bolstered with late-stage assets including povetacicept in IgAN Conference call and webcast today, February 27, 2025 , at 8:00 a.m. ET ( 9:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass. --(BUSINESS WIRE)--Feb. 27, 2025-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the fourth quarter and full-year 2024, along with recent product highlights and corporate updates. “2024 was a defining year for Zai Lab , marked by strong sales growth, financial strength, and significant pipeline progress. As we look ahead, 2025 is set to be a transformative year with VYVGART’s continued momentum, three new product launches, progress with ZL-1310, and potential regulatory milestones for key assets,” said Dr. Samantha Du , Founder, Chairperson, and Chief Executive Officer of Zai Lab . “The VYVGART franchise generated $93.6 million in net product revenue in its exceptional first full year of launch, highlighting the strong demand for innovative therapies in China . With the recent acceptance of KarXT’s New Drug Application (NDA) by China’s National Medical Products Administration (NMPA) in January, we are one step closer to bringing this novel medicine to patients in need in China . Meanwhile, our global asset, ZL-1310, demonstrated strong safety and efficacy data, reinforcing its potential as a first- and best-in-class DLL3 antibody-drug conjugate (ADC) for the treatment of small cell lung cancer (SCLC). Zai Lab is stronger than ever, with the infrastructure, innovation, and execution needed to bring medicines to patients around the world and create value for our shareholders.” “Our total revenue for the fourth quarter and full-year 2024 grew 66% and 50% y-o-y, respectively, driven by the continued strong uptake of VYVGART along with continued growth in ZEJULA® and NUZYRA® sales,” said Josh Smiley , President and Chief Operating Officer of Zai Lab . “Looking ahead, we expect substantial topline growth, targeting $2 billion in revenue by 2028, fueled by the VYVGART franchise for generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) as well as upcoming potential blockbuster launches, including KarXT for schizophrenia and bemarituzumab for gastric cancer. Our innovative pipeline with global rights remains a key focus, with multiple data readouts expected this year and the potential for U.S. Food and Drug Administration (FDA) approval of ZL-1310 as early as 2027. Additionally, we significantly improved our financial position, delivering a substantial reduction in operating loss and advancing towards our goal of achieving profitability1 in the fourth quarter of 2025. With a robust cash position2, we are well-funded to reach this milestone while continuing to invest in high-impact growth opportunities.” 1 Profitability refers to adjusted income from operations (non-GAAP), calculated as GAAP income (loss) from operations adjusted to exclude certain non-cash expenses, including depreciation, amortization, and share-based compensation. For additional information on this adjusted profitability measure, refer to the “Non-GAAP Measures” section. 2 Cash position includes cash and cash equivalents, current restricted cash, and short-term investments. Fourth Quarter and Full-Year 2024 Financial Results Product revenue, net was $108.5 million in the fourth quarter of 2024, compared to $65.8 million for the same period in 2023, representing 65% y-o-y growth at both actual exchange rate and constant exchange rate (CER); and was $397.6 million in full-year 2024, compared to $266.7 million for the same period in 2023, representing 49% y-o-y growth and 50% y-o-y growth at CER. This revenue growth was primarily driven by increased sales for VYVGART and was also supported by increased sales for ZEJULA and NUZYRA. VYVGART and VYVGART Hytrulo were $30.0 million in the fourth quarter of 2024, compared to $5.1 million for the same period in 2023; and was $93.6 million in full-year 2024, compared to $10.0 million for the same period in 2023. This growth was driven by increased sales of VYVGART since its launch in September 2023 and listing on China’s National Reimbursement Drug List (NRDL) for the treatment of gMG effective January 1, 2024 . ZEJULA was $48.4 million in the fourth quarter of 2024, an increase of 16% y-o-y from $41.6 million ; and was $187.1 million in full-year 2024, an increase of 11% y-o-y from $168.8 million . ZEJULA sales remained strong as it continued to be the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China . NUZYRA was $11.0 million in the fourth quarter of 2024, an increase of 81% y-o-y from $6.1 million ; and was $43.2 million in full-year 2024, an increase of 99% y-o-y from $21.7 million . This growth was supported by the inclusion in the NRDL for its IV formulation in January 2023 and its oral formulation in January 2024 for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and/or skin structure infections (ABSSSI). The NRDL listing for the IV formulation of NUZYRA was renewed in January 2025 . Research and Development (R&D) expenses were $52.3 million in the fourth quarter of 2024, compared to $81.9 million for the same period in 2023; and were $234.5 million for full-year 2024, compared to $265.9 million for the same period in 2023. These decreases were primarily driven by the progress of existing studies, partially offset by increases in licensing fees. Selling, General and Administrative (SG&A) expenses were $82.6 million in the fourth quarter of 2024, flat compared to the same period in 2023. SG&A expenses were $298.7 million for full-year 2024, compared to $281.6 million for the same period in 2023, primarily due to higher general selling expenses related to the launch of VYVGART and growing sales for NUZYRA, partially offset by a decrease in selling expenses for other products and a decrease in general and administrative expenses. Loss from operations was $67.9 million and $282.1 million in the fourth quarter of 2024 and full-year 2024, respectively, $47.6 million and $199.6 million , respectively, when adjusted to exclude non-cash expenses, including depreciation, amortization, and share-based compensation. Loss from operations was $124.0 million and $366.6 million in the fourth quarter of 2023 and full-year 2023, 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 $81.7 million in the fourth quarter of 2024, or a loss per ordinary share attributable to common stockholders of $0.08 (or loss per American Deposit Share (ADS) of $0.80 ), compared to a net loss of $95.4 million for the same period in 2023 or a loss per ordinary share of $0.10 (or loss per ADS of $0.98 ). The net loss was $257.1 million for full-year 2024, or a loss per ordinary share attributable to common stockholders of $0.26 (or loss per ADS of $2.60 ), compared to a net loss of $334.6 million for full-year 2023, or a loss per ordinary share of $0.35 (or loss per ADS of $3.46 ). These decreases in net loss were primarily due to product revenue growing faster than net operating expenses, offset by decreased interest income and increased foreign currency loss. Cash and cash equivalents, short-term investments and current restricted cash totaled $879.7 million as of December 31, 2024 , compared to $806.5 million as of December 31, 2023 . 2025 Strategic Priorities Zai Lab will focus on the following strategic priorities in 2025 to drive innovation and growth in China and beyond: Commercial Execution and Readiness Drive the ramp-up of VYVGART in gMG and VYVGART Hytrulo in gMG and CIDP through new patient acquisition and expansion of duration of treatment Maintain ZEJULA leadership position in ovarian cancer in China Prepare for launch of potential blockbuster products including bemarituzumab in gastric cancer and KarXT in schizophrenia Clinical Development Rapidly advance the global Phase 1 study for ZL-1310 (DLL3 ADC with global rights) in SCLC and explore its potential in other neuroendocrine tumors Advance other assets with global rights including ZL-6201 (LRRC15 ADC) and ZL-1503 (IL-13/IL-31R) into Phase 1 development Within our regional immunology franchise, accelerate the clinical development of efgartigimod (FcRn), povetacicept (APRIL/BAFF), and ZL-1108 (IGF-1R) with several indications in registrational stage Clinical Data and Regulatory Actions Data readouts for ZL-1310 (DLL3 ADC) in second-line+ and first-line SCLC Data readouts for Phase 3 studies of bemarituzumab in first-line gastric cancer; and potential Biologics License Application (BLA) submission to NMPA in the first half of 2025 Potential NMPA submissions for Tumor Treating Fields (TTFields) in second-line+ non-small cell lung cancer (NSCLC) and first-line pancreatic cancer 2025 Guidance Zai Lab expects continued rigorous financial discipline and: Total revenue to be in the range of $560 million to $590 million for full-year 2025 On a non-GAAP basis, achieve profitability1 in the fourth quarter of 2025 1 Profitability refers to adjusted income from operations (non-GAAP), calculated as GAAP income (loss) from operations adjusted to exclude non-cash expenses, including depreciation, amortization, and share-based compensation. For additional information on this adjusted profitability measure, refer to the “Non-GAAP Measures” section. Corporate Updates Below are key corporate updates since our last earnings release: Business Development: We expanded and strengthened our global and regional pipelines through synergistic business development activities, including a strategic collaboration and worldwide license agreement with MediLink to use MediLink’s TMALIN ADC platform for the development of ZL-6201, a novel potential first-in-class LRRC15 ADC consisting of an antibody discovered by Zai Lab , for the treatment of certain solid tumors; a strategic collaboration with Vertex for the license of povetacicept, a potential best-in-class treatment for immunoglobulin A nephropathy (IgAN) and other B-cell mediated diseases, in mainland China , Hong Kong , Macau , Taiwan , and Singapore ; and the license of ZL-1108, or veligrotug, a differentiated humanized monoclonal antibody targeting IGF-1R from Zenas BioPharma for the treatment of thyroid eye disease (TED) in mainland China , Hong Kong , Macau , Taiwan , and Singapore . We also entered into a strategic collaboration with Pfizer on the novel antibacterial drug XACDURO® (Sulbactam-Durlobactam), which was launched in mainland China in January 2025 . Through this collaboration, Zai Lab will leverage the industry-leading commercialization infrastructure of Pfizer’s affiliated companies in the anti-infective therapeutic area to help accelerate access to this important therapy for patients in need in mainland China . NRDL Updates: In November 2024 , Zai Lab announced the inclusion of AUGTYRO® (repotrectinib) for ROS1+ NSCLC as well as the successful renewals of NUZYRA (omadacycline) for CABP and ABSSSI and QINLOCK® (ripretinib) for fourth-line+ gastrointestinal stromal tumor (GIST) patients in China’s NRDL. Capital Markets: In November 2024 , Zai Lab completed a public offering of ADSs, which resulted in aggregate net proceeds to the Company of approximately $215.1 million , after deducting underwriting discounts and commissions and other offering expenses payable by the Company. Recent Pipeline Highlights Below are key product updates since our last earnings release: Oncology Pipeline ZL-1310 (DLL3 ADC): In January 2025 , the FDA granted Orphan Drug Designation to ZL-1310 for the treatment of SCLC. Receiving an Orphan Drug Designation for ZL-1310 reflects its potential to treat patients with SCLC, and ZL-1310 will be eligible for certain development incentives, including the potential to receive a seven-year U.S. market exclusivity period granted by the FDA upon product approval. Tumor Treating Fields (TTFields): In December 2024 , Zai Lab and partner Novocure announced that the pivotal Phase 3 PANOVA-3 trial for pancreatic cancer met its primary endpoint, demonstrating a statistically significant improvement in median overall survival versus control group. PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer. Zai Lab participated in the study in Greater China and plans to file for regulatory approval in China in the second half of 2025. Tisotumab Vedotin (Tissue Factor ADC): In January 2025 , Zai Lab announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, demonstrating a clinically meaningful improvement in overall survival with TIVDAK® treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy. Zai Lab plans to submit an NDA to the NMPA in the first quarter of 2025 and will leverage its commercial footprint of ZEJULA in women’s cancer to accelerate patient access to this therapy in China if approved. Repotrectinib (ROS1/TRK): In February 2025 , China’s NMPA granted priority review to repotrectinib for the treatment of patients with advanced solid tumors that have an NTRK gene fusion. Zai Lab plans to submit a supplemental NDA to the NMPA in the first half of 2025. Immunology, Neuroscience, and Infectious Disease Pipeline Efgartigimod (FcRn): In November 2024 , Zai Lab partner argenx announced the decision to advance clinical development of the subcutaneous formulation of efgartigimod (efgartigimod SC) in the ongoing Phase 2/3 ALKIVIA study for the treatment of idiopathic inflammatory myopathies (IIM, or myositis), following analysis of topline data from the Phase 2 portion of the study. Zai Lab is participating in the study in Greater China . Xanomeline and Trospium Chloride (KarXT) (M1/M4-agonist): In January 2025 , China’s NMPA accepted the NDA for KarXT for the treatment of schizophrenia in adults. If approved, KarXT has the potential to redefine the treatment landscape for patients with schizophrenia in mainland China . Anticipated Major Milestones in 2025 Upcoming Potential NMPA Submissions Tisotumab Vedotin (Tissue Factor ADC): BLA submission in recurrent or metastatic cervical cancer following progression on or after chemotherapy in the first quarter of 2025. Bemarituzumab (FGFR2b): BLA submission in first-line gastric cancer in the first half of 2025. Repotrectinib (ROS1/TRK): supplementary NDA submission in NTRK+ solid tumors in the first half of 2025. Tumor Treating Fields (TTFields): Marketing Authorization Application submissions in second-line+ NSCLC following progression on or after platinum-based chemotherapy and in first-line pancreatic cancer. Expected Clinical Developments and Data Readouts in 2025 Global Pipeline ZL-1310 (DLL3 ADC) Second-Line+ Extensive-Stage SCLC (ES-SCLC): Zai Lab to present updated data at a major medical conference in the first half of 2025. Zai Lab plans to initiate a pivotal study in 2025. First-Line ES-SCLC: Zai Lab to provide data readout for dose escalation of ZL-1310 doublet in combination with atezolizumab and initiate dose escalation for ZL-1310 triplet in combination with atezolizumab and platinum-based chemotherapy. Other neuroendocrine tumors: Zai Lab to initiate a global Phase 1 study in the first half of 2025. ZL-1102 (IL-17 Humabody®) Zai Lab to provide interim analysis in the global Phase 2 study in chronic plaque psoriasis in the first half of 2025. ZL-1503 (IL-13/IL-31R) Zai Lab to provide preclinical data update and initiate a global Phase 1 study in moderate-to-severe atopic dermatitis. ZL-6201 (LRRC15 ADC) Zai Lab to provide preclinical data update and initiate a global Phase 1 study in sarcoma. Regional Pipeline Bemarituzumab (FGFR2b) Zai Lab partner Amgen to provide data readout from the Phase 3 FORTITUDE-101 study of bemarituzumab combined with chemotherapy versus chemotherapy alone in first-line gastric cancer in the first half of 2025. Zai Lab is participating in the study in Greater China . Zai Lab partner Amgen to provide data readout from the Phase 3 FORTITUDE-102 study of bemarituzumab plus chemotherapy and nivolumab versus chemotherapy and nivolumab in first-line gastric cancer in the second half of 2025. Zai Lab is participating in the study in Greater China . Efgartigimod (FcRn) Seronegative gMG: Zai Lab partner argenx to provide topline results from the Phase 3 ADAPT-SERON study in seronegative gMG. Zai Lab participated in the study in Greater China . Lupus Nephritis (LN): Zai Lab to provide topline results from the Phase 2 study in LN. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast today, February 27, 2025 , at 8:00 a.m. ET ( 9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows: Registration Link: https://register.vevent.com/register/BI628d3dd054cb4c45b3d01b61fa5779b1 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 in China and worldwide. For additional information about Zai Lab , please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global. 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 planned sources and uses of cash 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,” “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.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and 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 may be 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. Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.SEC.gov. Zai Lab Limited Consolidated Balance Sheets (in thousands of U.S. dollars (“$”), except for number of shares and per share data) December 31 , 2024 2023 Assets Current assets Cash and cash equivalents 449,667 790,151 Restricted cash, current 100,000 — Short-term investments 330,000 16,300 Accounts receivable (net of allowance for credit losses of $25 and $17 as of December 31, 2024 and 2023, respectively) 85,178 59,199 Notes receivable 4,233 6,134 Inventories, net 39,875 44,827 Prepayments and other current assets 41,527 22,995 Total current assets 1,050,480 939,606 Restricted cash, non-current 1,114 1,113 Long-term investments 3,115 9,220 Prepayments for equipment 18 111 Property and equipment, net 47,961 53,734 Operating lease right-of-use assets 21,496 14,844 Land use rights, net 2,907 3,069 Intangible assets, net 56,027 13,389 Long-term deposits 1,284 1,209 Value added tax recoverable 1,351 — Total assets 1,185,753 1,036,295 Liabilities and shareholders’ equity Current liabilities Accounts payable 100,906 112,991 Current operating lease liabilities 8,048 7,104 Short-term debt 131,711 — Other current liabilities 58,720 82,972 Total current liabilities 299,385 203,067 Deferred income 31,433 28,738 Non-current operating lease liabilities 13,712 8,047 Other non-current liabilities 325 325 Total liabilities 344,855 240,177 Commitments and contingencies Shareholders’ equity Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized, 1,082,614,740 and 977,151,270 shares issued as of December 31, 2024 and 2023, respectively; 1,077,702,540 and 972,239,070 shares outstanding as of December 31, 2024 and 2023) 7 6 Additional paid-in capital 3,264,295 2,975,302 Accumulated deficit (2,453,083 ) (2,195,980 ) Accumulated other comprehensive income 50,515 37,626 Treasury stock (at cost, 4,912,200 shares as of both December 31, 2024 and 2023) (20,836 ) (20,836 ) Total shareholders’ equity 840,898 796,118 Total liabilities and shareholders’ equity 1,185,753 1,036,295 Zai Lab Limited Consolidated Statements of Operations (unaudited for the three months ended December 31, 2024 and 2023) (in thousands of $, except for number of shares and per share data) Three Months Ended December 31 , Year Ended December 31 , 2024 2023 2024 2023 Revenues Product revenue, net 108,512 65,830 397,614 266,719 Collaboration revenue 558 — 1,374 — Total revenues 109,070 65,830 398,988 266,719 Expenses Cost of product revenue (41,782 ) (25,237 ) (147,118 ) (95,816 ) Cost of collaboration revenue (309 ) — (742 ) — Research and development (52,252 ) (81,948 ) (234,504 ) (265,868 ) Selling, general and administrative (82,618 ) (82,626 ) (298,741 ) (281,608 ) Gain on sale of intellectual property — — — 10,000 Loss from operations (67,891 ) (123,981 ) (282,117 ) (366,573 ) Interest income 9,088 10,304 37,105 39,797 Interest expenses (904 ) — (2,254 ) — Foreign currency losses (gains) (23,418 ) 11,465 (15,137 ) (14,850 ) Other income, net 1,441 6,783 5,300 7,006 Loss before income tax and share of loss from equity method investment (81,684 ) (95,429 ) (257,103 ) (334,620 ) Income tax expense — — — — Net loss (81,684 ) (95,429 ) (257,103 ) (334,620 ) Loss per share — basic and diluted (0.08 ) (0.10 ) (0.26 ) (0.35 ) Weighted-average shares used in calculating net loss per ordinary share — basic and diluted 1,026,815,280 972,239,070 989,477,730 966,394,130 Zai Lab Limited Consolidated Statements of Comprehensive Loss (unaudited for the three months ended December 31, 2024 and 2023) (in thousands of $) Three Months Ended December 31 , Year Ended December 31, 2024 2023 2024 2023 Net loss (81,684 ) (95,429 ) (257,103 ) (334,620 ) Other comprehensive income (loss), net of tax of nil: Foreign currency translation adjustments 22,245 (10,326 ) 12,889 11,941 Comprehensive loss (59,439 ) (105,755 ) (244,214 ) (322,679 ) Zai Lab Limited Non-GAAP Measures (unaudited) ($ in thousands) Growth on a Constant Exchange Rate (CER) Basis Three Months Ended December 31 , Year over Year % Growth Year Ended December 31, Year over Year % Growth 2024 2023 As reported At CER* 2024 2023 As reported At CER* Product revenue, net 108,512 65,830 65 % 65 % 397,614 266,719 49 % 50 % Loss from operations (67,891 ) (123,981 ) (45 )% (45 )% (282,117 ) (366,573 ) (23 )% (23 )% * The growth rates at CER were calculated assuming the same foreign currency exchange rates were in effect for the current and prior year periods. Reconciliation of Loss from Operations (GAAP) to Adjusted Loss from Operations (Non-GAAP) Three Months Ended December 31 , Year Ended December 31 , 2024 2023 2024 2023 GAAP loss from operations (67,891 ) (123,981 ) (282,117 ) (366,573 ) Plus: Depreciation and amortization expenses 3,032 2,459 11,856 9,029 Plus: Share-based compensation 17,238 20,470 70,651 79,634 Adjusted loss from operations (47,621 ) (101,052 ) (199,610 ) (277,910 ) View source version on businesswire.com: https://www.businesswire.com/news/home/20250227759111/en/ For more information, please contact: Investor Relations: Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (415) 317-7255 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Source: Zai Lab Limited

Phase 1Clinical ResultLicense out/inPhase 3NDA

100 Deals associated with Tisotumab Vedotin-tftv

External Link

KEGG	Wiki	ATC	Drug Bank
-	Tisotumab Vedotin-tftv	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Cervical Carcinoma	Macao	Zai Lab Ltd.	06 Aug 2024
Recurrent Cervical Cancer	Macao	Zai Lab Ltd.	06 Aug 2024
Uterine Cervical Cancer	United States	Seagen, Inc.	20 Sep 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Carcinoma to the Uterine Cervix	Phase 3	United States	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	China	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Japan	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Argentina	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Austria	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Belgium	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Brazil	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Canada	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Czechia	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Denmark	Genmab A/S	22 Feb 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04697628 (innovaTV 301, Company_Website) Manual	Phase 3	Uterine Cervical Cancer	-	TIVDAK	pzloceltee(hdwozftses) = dcxzpdckyx zxeirfqadl (myfciirmwg )	Positive	15 Jan 2025
				Chemotherapy	pzloceltee(hdwozftses) = uehkyzvghc zxeirfqadl (myfciirmwg, 6.0 - NR)
NCT04697628 (innovaTV 301/ENGOT-cx12/GOG 3057 \| SGNTV-003 \| GOG-3057 \| innovaTV 301 \| ENGOT-cx12 \| innovaTV 301/ENGOT-cx12/GOG-3057, CTgov)	Phase 3	Metastatic Carcinoma to the Uterine Cervix	502	tisotumab vedotin (Tisotumab Vedotin)	apoudcxuyi(hdupynyhfm) = svyroeuzby migotvmbjx (dwbbpzxgbm, ysrgpoyllt - fqxkieyept) View more	-	09 Aug 2024
				pemetrexed+vinorelbine+Gemcitabine+irinotecan+Topotecan (Chemotherapy)	apoudcxuyi(hdupynyhfm) = escpnkpqtl migotvmbjx (dwbbpzxgbm, qwhphfaiey - zamhnxjcbt) View more
NCT04697628 (innovaTV 301, Pubmed) Manual	Phase 3	Recurrent Cervical Cancer Second line \| Third line	502	Tisotumab vedotin	janjdbkfhk(zyucoftfln) = ioiqpnlnro eywlxbmgod (zsliqosond, 9.8 - 14.9) View more	Positive	04 Jul 2024
				Chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)	janjdbkfhk(zyucoftfln) = yvludswhjj eywlxbmgod (zsliqosond, 7.9 - 10.7) View more
NCT03485209 (innovaTV 207, ASCO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	40	Tisotumab vedotin	xzhikztbfd(lrztdeckni) = hhcoxhzsxq jkxgoeqyck (wowzdjcsrn, 18.6 - 49.1) View more	Positive	24 May 2024
				Tisotumab vedotin (≤2 prior lines)	xzhikztbfd(lrztdeckni) = ttxebmtscm jkxgoeqyck (wowzdjcsrn, 21.1 - 61.3) View more
NCT04697628 (ENGOT-cx12 \| GOG-3057 \| innovaTV 301, ASCO2024) Manual	Phase 3	Uterine Cervical Cancer Second line \| Third line	502	Tisotumab vedotin (TV)	yuasosqgvr(wklonqnfcm) = yzyjlwavvz ajjzjzipul (woujveuatq, 13.3 - 23.1) View more	Positive	24 May 2024
				Chemotherapy	yuasosqgvr(wklonqnfcm) = ummfqdwijv ajjzjzipul (woujveuatq, 2.8 - 8.8) View more
NCT04697628 (innovaTV 301 \| ENGOT-Cx12 \| GOG-3057, ESGO2024) Manual	Phase 3	Uterine Cervical Cancer Second line tissue factor	502	Tisotumab vedotin	mowpncivho(wxhrhqyirw) = pnnsfkbkfc ktlvnbltcj (yikvlroaxf, 9.8 - 14.9) View more	Positive	10 Mar 2024
				investigator’s choice of chemotherapy	mowpncivho(wxhrhqyirw) = abqnefmmnx ktlvnbltcj (yikvlroaxf, 7.9 - 10.7) View more
NCT03786081 (innovaTV 205/GOG-3024/ENGOT-cx8, Pubmed \| J Clin Oncol)	Phase 1/2	Metastatic Carcinoma to the Uterine Cervix First line \| Third line tissue factor	142	Tisotumab vedotin + Pembrolizumab	ylkzbplsov(amwecplotb) = kexnqmqzzb stbrroxnvr (noooechevh, 23.7 - 59.4) View more	Positive	20 Dec 2023
				Tisotumab vedotin + Carboplatin	ylkzbplsov(amwecplotb) = rsgddhcfgg stbrroxnvr (noooechevh, 36.4 - 71.9) View more
NCT04697628 (innovaTV 301 \| SGNTV-003 \| GOG-3057 \| ENGOT-cx12, ESMO 12023 \| ESMO 22023) Manual	Phase 3	Uterine Cervical Cancer Third line \| Second line	502	Tisotumab vedotin	msdtglvdxr(tpjthsavpp) = kcbssthfwx swfizzdnnw (wyngszvfwi, 9.8 - 14.9) View more	Positive	22 Oct 2023
				Investigator's choice of chemotherapy	msdtglvdxr(tpjthsavpp) = iesvlcrxfq swfizzdnnw (wyngszvfwi, 7.9 - 10.7) View more
NCT04697628 (innovaTV 301, NEWS) Manual	Phase 3	Uterine Cervical Cancer First line	-	Tivdak	kodgtpwmyg(vpgggltyhb) = 在一线治疗期间或治疗后疾病发生进展的复发性或转移性宫颈癌患者中，与单独化疗相比，接受其“first-in-class”抗体偶联药物（ADC）Tivdak（tisotumab vedotin）患者的OS显著改善 gonpkiehpz (gtiipdurmx ) Met View more	Positive	06 Sep 2023
				chemotherapy
NCT03657043 (CTgov)	Phase 2	Platinum-Resistant Primary Peritoneal Carcinoma \| Peritoneal Neoplasms \| Platinum-Resistant Ovarian Carcinoma ... View more	98	3Q4W (Safety Run-In 0.9 mg/kg 3Q4W)	ssrnjjbdyf = upducvefje jcxjstopgb (azpcgmiaox, upaiwqtfvh - tljtqooerh) View more	-	06 May 2023
				3Q4W (Safety Run-In 1.2 mg/kg 3Q4W)	ssrnjjbdyf = arzxskgdnv jcxjstopgb (azpcgmiaox, majuyrbupc - zpbzifyfkb) View more

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