Full Press Release Details
Zai Lab Reports First Quarter 2021 Financial Results
Company to Host Conference Call and Webcast Today at 8:00 a.m. EDT
SHANGHAI and SAN FRANCISCO, May 10, 2021 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company,
today announced financial results for the first quarter of 2021, along with recent product highlights and corporate updates.
Zai Lab continued to
execute well in all aspects of the business during the first quarter, said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. We entered into several strategic collaborations to further strengthen our
gastric and lung cancer disease strongholds; significantly bolstered our autoimmune franchise with an exclusive agreement with argenx for efgartigimod, a pipeline-in-a-product opportunity; advanced numerous clinical programs toward key data readouts; gained regulatory approval for QINLOCK, our third innovative oncology product approval in the last 15
months in China and the first commercial product in what we expect to become a world-class gastric cancer franchise; and generated solid revenue growth, in part from increased volume of ZEJULA driven by its recent inclusion on the National
Reimbursement Drug List (NRDL). In addition, we recently received encouraging news on several key assets from our partners. The Biologics License Application (BLA) filing of efgartigimod in generalized myasthenia gravis (gMG) was accepted by the
U.S. Food and Drug Administration (FDA). The Phase 3 pivotal LUNAR trial of Tumor Treating Fields in non-small cell lung cancer (NSCLC) was recommended to continue with reduced sample size based on an
accelerated interim analysis. Bemarituzumab was granted Breakthrough Therapy Designation by the FDA as first-line treatment for gastric cancer patients who overexpress FGFR2b.
With the completion of our recent global public offering with gross proceeds of nearly $860 million, we significantly strengthened our capital
position. This new capital will allow us to accelerate our growth by entering into additional strategic partnerships, advancing our clinical development pipeline, and scaling our commercial and R&D organizations to drive strong revenue growth
and enhance our global pipeline.
We remain on target to advance all stages of our product pipeline throughout 2021. We continue to expect approval
of Nuzyra for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) by the National Medical Products Administration (NMPA). We plan to file margetuximab for Her2-positive breast cancer, Tumor
Treating Fields for mesothelioma and ZEJULA for late-line ovarian cancer in China. We are engaging with the NMPA on the regulatory filing strategy for efgartigimod in gMG in China. And we anticipate numerous data readouts, including for Tumor
Treating Fields in liver cancer and ovarian cancer, for QINLOCK in second-line GIST, for margetuximab in gastric cancer, for CLN-081 in NSCLC and for TPX-0022 in NSCLC
In our mission to address serious unmet medical needs for patients in China and around the world, we believe that we have built
a sustainable platform that we can leverage, Dr. Du concluded. Our team continues to deliver on our aggressive growth objectives. I believe that the future of Zai Lab has never been brighter.
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, the European Union and mainland China (hereinafter, China ) as
a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.
Anticipated 2021 Zai Milestones
Tumor Treating Fields
Tumor Treating Fields is a
cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cell death.
Recent Product Highlights
Anticipated 2021 Zai Milestones
Anticipated 2021 Partner Milestones
QINLOCK is a switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and
PDGFR -mutated kinases. It is the only therapeutic approved in the United States for advanced GIST patients who have received prior treatment with three or more kinase inhibitors in the
Recent Product Highlight
Anticipated 2021 Zai Milestones
Anticipated 2021 Partner Milestones
Odronextamab is a 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).
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner Milestones
Repotrectinib is a next-generation
tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A/B/C, with the potential to treat TKI-na ve or TKI-pretreated patients.
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner
MARGENZA (Margetuximab)
MARGENZA is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2).
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner Milestones
Bemarituzumab is a first-in-class antibody that is being developed in gastric and gastroesophageal junction cancer as a targeted therapy for tumors that overexpress FGFR2b.
Recent Product Highlight
Anticipated 2021 Zai Milestone
CLN-081 is an orally available, small-molecule, next-generation, irreversible epidermal growth factor receptor (EGFR) inhibitor designed to selectively target cells expressing mutant EGFR variants, including EGFR
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner Milestone
TPX-0022 is an orally bioavailable, multi-targeted kinase inhibitor with a novel three-dimensional macrocyclic structure that inhibits the MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinases.
Anticipated 2021 Partner Milestones
Tebotelimab is an investigational, first-in-class, bispecific, tetravalent
DART molecule targeting PD-1 and LAG-3.
Anticipated 2021 Zai and
Retifanlimab is an investigational
monoclonal antibody that inhibits PD-1.
Recent Product Highlight
Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod
binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation.
Recent Product Highlight
Anticipated 2021 Zai Milestones
Anticipated 2021 Partner Milestones
NUZYRA (omadacycline)
NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with CABP and ABSSSI.
Anticipated 2021 Zai Milestone
Sulbactam-Durlobactam (SUL-DUR)
Sulbactam-Durlobactam is a beta-lactam/beta-lactamase inhibitor combination that provides unique activity against Acinetobacter organisms,
including carbapenem-resistant strains.
Anticipated 2021 Zai and Partner Milestone
Internal Programs with Global Rights
ZL-2309 is an orally active, selective and ATP-competitive cell division
cycle 7 (CDC7) kinase inhibitor.
Anticipated 2021 Zai Milestone
Business Development Updates
First-Quarter 2021 Financial Results
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, May 10, 2021, at 8:00 a.m. ET. 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:
Conference ID: 2374839
All participants must use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each
participant will receive a dial-in number, Direct Event passcode and a unique access PIN, which can be used to join the conference call.
A replay will be available shortly after the call and can be accessed by visiting the Company s website at http://ir.zailaboratory.com.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an
innovative, research-based, commercial-stage biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders and infectious disease. To that end, our
experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and product candidates. We have also built an
in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading
global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide.
additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking
This press release contains references to statements about future expectations, plans and prospects for Zai Lab, including, without
limitation, statements regarding our ability to advance our product pipeline and further demonstrate our commercial and discovery capabilities, anticipated milestones for our approved products and product candidates and other statements containing
words such as aim, anticipate, believe, estimate, expect, intend, may, plan, predict, project, seek,
target, potential, will, would, could, should, continue, contemplate 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 neither historical facts nor assurances of future performance. Forward-looking statements are based on Zai Lab s expectations and