Full Press Release Details
Zai Lab Announces Full-Year 2022 Financial Results and
Recent Corporate Updates
-Total revenue of $215.0 million for 2022, representing a 49.0% increase y-o-y ZEJULA achieved 55.2% y-o-y growth
-Strong balance sheet with a cash position of $1.0 billion as of December 31, 2022
-Company to host conference call and webcast on March 2, 2023, at 8 00 a.m. EST
SHANGHAI and CAMBRIDGE, Mass., March 1, 2023 -- Zai Lab Limited (NASDAQ ZLAB HKEX 9688) today announced full-year 2022 financial results, along with recent product highlights and corporate updates.
"In 2022, our four marketed products each had substantial sales growth, and we made exciting progress across our pipeline globally," said Dr. Samantha Du, Founder, Chief Executive Officer, and Chairperson of the Board of Directors of Zai Lab. "Our pipeline assets continued to demonstrate potential global best-in-class and or first-in-class profile with numerous positive late-stage data readouts announced during the year, including adagrasib in non-small cell lung cancer, KarXT in schizophrenia, and efgartigimod in primary immune thrombocytopenia and generalized myasthenia gravis. We are also pleased to have contributed to several successful registrational studies, including the Tumor Treating Fields LUNAR study and the repotrectinib TRIDENT-1 study. We are also pleased to have added QINLOCK and NUZYRA to China's National Reimbursement Drug List (NRDL) in 2023. We further deepened our women's cancer franchise through our strategic collaboration with Seagen for TIVDAK. And, we continued to significantly enhance our talented global team."
"Zai Lab is already a leading global biotech with relevant scale, a world-class pipeline, and a growing commercial portfolio in China. We expect to achieve commercial profitability this year, and we are preparing to launch at least 8 additional products and achieve overall corporate profitability by the end of 2025," Dr. Du continued. "We will continue to invest in research and development as we seek to advance our product pipeline, including our internal discovery activities, and accelerate medicines to patients in need. We also aim to strengthen our portfolio and strategic positioning with potentially transformative assets and partnerships."
"We believe that the global regulatory environment will continue to be supportive of innovative biopharmaceutical companies like Zai Lab," Dr. Du concluded. "We will continue to build on our success in pursuit of our overall goal of improving human health, in China and globally."
2023 Strategic Priorities
Zai Lab will focus on the following strategic priorities in 2023 to drive innovation in China and beyond
Regulatory and Commercial
BLA approval by China's National Medical Products Administration (NMPA) and commercial launch for efgartigimod alfa injection for the treatment of adult patients with generalized myasthenia gravis (gMG)
NDA submission to the NMPA for repotrectinib for ROS1+ advanced non-small cell lung cancer (NSCLC)
BLA submission to the NMPA for subcutaneous (SC) efgartigimod for gMG in mid-2023
ZEJULA becoming the leader in PARP inhibitors sales for ovarian cancer in China
A significant increase in sales of QINLOCK and NUZYRA following their inclusion on the NRDL
Research and Clinical Development
Topline data readouts of the SC efgartigimod study for chronic inflammatory demyelinating polyneuropathy (CIDP) in the second quarter of 2023, and for pemphigus and immune thrombocytopenia (ITP) in the second half of 2023
Full data readout of the Tumor Treating Fields LUNAR study in NSCLC in the first half of 2023
Clinical data update for adagrasib in combination with pembrolizumab in first-line KRASG12C-mutated NSCLC in the second half of 2023
Complete enrollment in the global Phase 3 innovaTV 301 study of TIVDAK in second- and third-line cervical cancer in the first half of 2023
Join the global Phase 3 FORTITUDE-101 study of bemarituzumab in first-line gastric cancer in China in mid-2023
Initiate a bridging study of KarXT for schizophrenia in China in mid-2023
Initiate a global Phase 2 study for ZL-1102 (IL-17 Humabody ) in chronic plaque psoriasis (CPP)
Initiate a global Phase 1 study for ZL-1218 (CCR8) in the first half of 2023
Recent Product Highlights and Anticipated Milestones
ZEJULA is an oral, once-daily small-molecule poly (ADP-ribose) polymerase (PARP) 1 2 inhibitor. It is the only PARP inhibitor approved in the United States (FDA), the European Union (EMA), and mainland China (NMPA) as a first-line maintenance monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.
Recent Product Highlights
In February 2023, Zai Lab received the complete approval of ZEJULA in first-line ovarian cancer maintenance treatment by the NMPA. The complete approval was based on the data of Phase 3 PRIME study in Chinese patients.
In December 2022, Zai Lab presented new interim overall survival (OS) data in Chinese patients with platinum-sensitive recurrent ovarian cancer (PSROC) from the Phase 3 NORA study for ZEJULA at the European Society for Medical Oncology (ESMO) Virtual Plenary.
-Median OS (mOS) was numerically longer for patients receiving ZEJULA regardless of biomarker status, at 46.3 months compared to 43.4 months in the placebo group HR 0.82 95% CI, 0.56-1.21 .
-Based on the OS analysis adjusted for subsequent PARP inhibitor therapy, mOS for patients receiving ZEJULA was 46.3 months compared to 34.3 months in the placebo group HR 0.69 95% CI, 0.45-1.07 .
-No new safety issues were identified based on long-term follow-up.
Anticipated 2023 Zai Milestone
Present final OS analysis of the Phase 3 NORA study.
Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that disrupt cancer cell division. Optune and Optune Lua, commercial TTFields devices, are approved or marketed in certain countries or regions, including the United States, Greater China (mainland China, Hong Kong, Macau, and Taiwan), Europe, and Japan, for the treatment of newly diagnosed and recurrent glioblastoma and malignant pleural mesothelioma.
Recent Product Highlights
In March 2023, NovoCure Ltd. announced that the last patient has been enrolled in the pivotal METIS study evaluating the efficacy of TTFields therapy following stereotactic radiosurgery (SRS) for treatment of patients with brain metastases resulting from NSCLC. Zai Lab participated in the study in Greater China.
In February 2023, NovoCure announced that the last patient has been enrolled in the pivotal PANOVA-3 study evaluating the efficacy of TTFields together with nab-paclitaxel and gemcitabine for treatment of patients with locally advanced pancreatic cancer. Zai Lab participated in the study in Greater China.
In January 2023, Zai Lab and NovoCure announced that the pivotal LUNAR study for patients with stage 4 NSCLC who progressed during or after platinum-based therapy met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in OS for patients treated with TTFields and standard therapies (either immune checkpoint inhibitor or docetaxel) versus standard therapies alone.
As of December 31, 2022, Optune had been listed in 87 regional customized commercial health insurance plans guided by provincial or municipal governments (or supplemental insurance plans) since its commercial launch in mainland China for the treatment of glioblastoma in the third quarter of 2020, up from 33 such plans as of December 31, 2021.
In November 2022, the Marketing Authorization Application (MAA) for malignant pleural mesothelioma was accepted by the NMPA.
Anticipated 2023 Partner and Zai Milestones
Present data from the LUNAR study in NSCLC at a future medical conference.
Provide topline data readout from the pivotal INNOVATE-3 clinical study testing the efficacy of TTFields together with paclitaxel in platinum-resistant ovarian cancer in the second half of 2023.
QINLOCK (ripretinib)
QINLOCK is an orally administered switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and PDGFR -mutated kinases. It is the only therapeutic approved in the United States and mainland China for the treatment of advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.
Recent Product Highlights
In January 2023, the NRDL released by China's National Healthcare Security Administration (NHSA) was updated to include QINLOCK for advanced GIST patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.
In January 2023, Zai Lab partner Deciphera Pharmaceuticals, Inc. (Deciphera) presented additional data from the planned exploratory analysis from the INTRIGUE Phase 3 clinical study of QINLOCK using circulating tumor DNA (ctDNA) for second-line GIST patients. Patients with mutations in KIT exon 11 and 17 and or 18 and the absence of mutations in KIT exon 9, 13, and or 14 (also referred to as patients with mutations in KIT exon 11 and 17 18) derived substantially improved clinical benefit with QINLOCK versus sunitinib. Deciphera plans to initiate the INSIGHT pivotal Phase 3 clinical study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17 18 in the second half of 2023.
TIVDAK (tisotumab vedotin)
TIVDAK is an antibody-drug conjugate (ADC) composed of Genmab's human monoclonal antibody directed against cell surface tissue factor (TF) and Seagen's ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody.
Recent Product Highlight
In February 2023, Zai Lab dosed the first patient in China for the global Phase 3 confirmatory innovaTV 301 study in second- or third-line recurrent or metastatic (r m) cervical cancer.
Anticipated 2023 Partner and Zai Milestone
Complete global patient enrollment for the innovaTV 301 study in the first half of 2023, with potential for topline data readout by year-end 2023.
Anticipated 2023 Partner Milestones
Clinical data update for the innovaTV 207 study in head and neck cancer in the first half of 2023.
Clinical data update for the innovaTV 205 study in first-line+ r m cervical cancer in the second half of 2023.
KRAZATITM (adagrasib)
KRAZATITM is a highly selective and potent oral small-molecule inhibitor of KRASG12C for treating KRASG12C-mutated NSCLC, colorectal cancer (CRC), pancreatic cancer and other solid tumors.
Recent Product Highlights
In December 2022, Zai Lab partner Mirati Therapeutics, Inc. (Mirati) announced that the FDA has granted Breakthrough Therapy Designation (BTD) to adagrasib in combination with cetuximab in patients with KRASG12C-mutated, advanced CRC whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy. This designation is supported by results from the Phase 1b cohort of the KRYSTAL-1 trial. Zai Lab is participating in the KRYSTAL-10 Phase 3 trial in patients with second-line KRASG12C-mutated CRC.
In December 2022, Mirati announced that the FDA has granted accelerated approval for KRAZATI , a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
In December 2022, Mirati reported results from the KRYSTAL-7 Phase 2 trial and KRYSTAL-1 Phase 1b cohort evaluating adagrasib concurrently combined with pembrolizumab in patients for the treatment of first-line NSCLC harboring a KRASG12C mutation across all PD-L1 subgroups. These results are the first to demonstrate the tolerability and feasibility of a concurrent combination regimen of a KRASG12C inhibitor and a PD-1 L1 checkpoint inhibitor.
Anticipated 2023 Partner and Zai Milestones
Provide a clinical data update for adagrasib in combination with pembrolizumab in first-line KRASG12C-mutated NSCLC in the second half of 2023.
Initiate Phase 3 studies in first-line KRASG12C-mutated NSCLC in 2023.
Anticipated 2023 Partner Milestones
Submit the supplemental New Drug Application (sNDA) in third-line+ KRASG12C-mutated advanced CRC by year end 2023, and move forward with Accelerated Approval pathway.
Provide a clinical data update for pancreatic cancer and other solid tumors in the second quarter of 2023.
Bemarituzumab is a potential first-in-class humanized monoclonal antibody that is in clinical development as a targeted therapy for gastric and gastroesophageal junction cancer patients whose tumors overexpress FGFR2b.
Recent Product Highlight
Zai Lab partner Amgen Inc. continues to enroll patients in several studies of bemarituzumab, including
-FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy, versus placebo plus chemotherapy in first-line gastric cancer with FGFR2b overexpression.
-FORTITUDE-102, Phase 3 portion of a Phase 1b 3 study of bemarituzumab plus chemotherapy and nivolumab versus chemotherapy and nivolumab in first-line gastric cancer with FGFR2b overexpression.
Anticipated 2023 Zai Milestones
Join the global Phase 3 FORTITUDE-101 study in first-line gastric cancer in China in mid-2023.
Join the global Phase 3 FORTITUDE-102 study in first-line gastric cancer in China.
Odronextamab is an investigational bispecific monoclonal antibody designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).
Recent Product Highlight
In December 2022, Zai Lab partner Regeneron announced positive first interim data from the ELM-2 Phase 2 trial in patients with heavily pre-treated, relapsed refractory (R R) follicular lymphoma (FL) and R R diffuse large B-cell lymphoma (DLBCL). The data were presented at the 64th American Society of Hematology Annual Meeting.
Anticipated 2023 Zai Milestone
Complete enrollment in China in the registrational global ELM-2 Phase 2 trial in B-Cell Non-Hodgkin Lymphoma (B-NHL) in the first quarter of 2023.
Anticipated 2023 Partner Milestones
Initiate confirmatory studies in FL and DLBCL, including in earlier lines in the first half of 2023.
Submit a Biologics License Application (BLA) for R R DLBCL and R R FL in the second half of 2023.
Repotrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A B C in TKI-na ve or TKI-pretreated cancer patients.
Anticipated 2023 Zai Milestones
Discuss regulatory pathway with the NMPA at a pre-NDA meeting in the first quarter of 2023.
Submit an NDA to the NMPA for ROS1+ advanced NSCLC in 2023.
Zipalertinib (previously CLN-081)
Zipalertinib is an orally available small molecule designed as a next-generation, irreversible epidermal growth factor receptor (EGFR) inhibitor in development for the treatment of patients with EGFR exon 20 insertion NSCLC.
Recent Product Highlight
Zai Lab partner Taiho Pharmaceuticals (which acquired Cullinan Pearl in 2022) initiated a pivotal study of zipalertinib in patients with EGFR exon 20 insertion NSCLC progressing after prior systemic therapy in the fourth quarter of 2022.
MARGENZA (margetuximab)
MARGENZA is an investigational, immune-enhancing monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2)-positive tumors, including certain types of breast and gastroesophageal cancers.
Anticipated 2023 Zai Milestone