Full Press Release Details
Zai Lab Announces Financial Results
for Second-half and Full-year 2020
Company to Host Conference Call and Webcast Today at 8:00 a.m. ET
SHANGHAI and SAN FRANCISCO, March 1, 2021 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company,
today reported financial results for the second half and full year of 2020, along with corporate updates.
2020 was another year of great
accomplishment for Zai Lab, said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. We successfully launched ZEJULA for both second-line and first-line ovarian cancer and Optune for glioblastoma in China.
We submitted NDAs and were granted priority reviews by China s National Medical Products Administration (NMPA) for both QINLOCK for advanced gastrointestinal stromal tumors (GIST) and NUZYRA for community-acquired bacterial pneumonia (CABP) and
acute bacterial skin and skin structure infections (ABSSSI) in China. We continued to expand our pipeline by forming new strategic partnerships with four companies for five compounds that we believe can address significant unmet medical needs. We
and our partners continued to execute in clinical development, and we now have 21 product candidates, including 17 in clinical development, 11 in late-stage development and five that have been approved in the United States. Our pipeline of
internally developed products with global rights grew to seven, including three in global clinical development.
Looking ahead to 2021, we
expect to receive approval for and launch QINLOCK and NUZYRA in China, bringing our total number of commercial products to four. In addition, ZEJULA for second-line ovarian cancer has been included in the National Reimbursement Drug List (NRDL), and
we expect this will drive strong volume growth for the product this year and beyond. We also plan to submit regulatory filings for Tumor Treating Fields in mesothelioma and for MARGENZA in HER2-positive breast cancer in China in 2021. We expect to
hold regulatory discussions with the NMPA regarding a potential accelerated regulatory pathway for efgartigimod, which has already been filed by our partner argenx for generalized myasthenia gravis in the United States. And we expect to obtain new
clinical data for many products and product candidates.
We are focused on building disease strongholds in China in three therapeutic areas
oncology, autoimmune disorders and infectious diseases. Within oncology, we have focused on five cancer franchises that account for over half of all new cancer patients in China. These cancer franchises include lung cancer and gastric cancer,
where we have a world-class portfolio of product candidates, as well as women s cancer, brain cancer and hematology. We plan to continue to expand this product pipeline both vertically within these areas of focus and horizontally into new
therapeutic areas of significant unmet medical need.
Over the next three years, our mission is to become a leading global biopharmaceutical
company. In addition to seeking to deliver a steady stream of approvals and launches in China from our existing pipeline and forming new strategic collaborations and transformative partnerships, we aim to discover and develop innovative medicines.
To accomplish our mission, we will continue to build upon our current scale, which currently consists of nearly 1,200 employees across eight operational locations around the world. While the challenges of
COVID-19 continue for all of us, we at Zai Lab remain committed to extending our track record of execution in pursuit of our overall goal of improving human health globally.
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 China as a monotherapy for patients with advanced ovarian cancer, regardless of
their biomarker status.
Second-half 2020 Accomplishments
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.
Second-half 2020 Accomplishments
Anticipated 2021 Zai Milestones
Anticipated 2021 Partner Milestones
QINLOCK (ripretinib)
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
Second-half 2020 and 2021 Accomplishments
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner Milestone
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 Milestones
MARGENZA (Margetuximab)
MARGENZA is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2).
Second-half 2020 Accomplishments
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner Milestones
Bemarituzumab is a first-in-class antibody that is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b.
Second-half 2020 Accomplishment
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner 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 exon 20 insertions.
Anticipated 2021 Zai
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 Milestone
Tebotelimab is an investigational, first-in-class, bispecific,
tetravalent DART molecule targeting PD-1 and LAG-3.
2020 Accomplishments
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner Milestone
Retifanlimab is an investigational
monoclonal antibody that inhibits PD-1.
Second-half 2020 Accomplishments
Partner Accomplishment
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.
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 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
ZL-1201 is a humanized, IgG4 monoclonal antibody, engineered to reduce effector function, that specifically targets
CD47. Its therapeutic potential will be assessed in both solid tumors and hematological malignancies, in both monotherapy and combination opportunities.
ZL-1102 is a novel human nanobody targeting IL-17 with high affinity and
avidity. Unlike other anti-IL-17 products, ZL-1102 is being developed as a topical treatment for chronic plaque psoriasis (CPP).
Business Development
Second-half 2020 and Early 2021 Accomplishments
Anticipated 2021 Zai Milestone
Full-Year 2020 Financial Results
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast on March 1, 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: