Full Press Release Details
Zai Lab Announces Second Quarter 2021
Financial Results and Corporate Updates
Company to Host Conference Call and Webcast on August 10, 2021, at 8:00 a.m. EDT
SHANGHAI and SAN FRANCISCO, August 9, 2021 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company,
today announced financial results for the second quarter of 2021, along with recent product highlights and corporate updates.
past track record, Zai Lab continued to execute with speed and quality across the organization during the second quarter, said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. We successfully
launched QINLOCK, the first product in what we hope will become a world-class gastric cancer franchise, in China; generated strong revenue growth from ZEJULA and Optune; and entered into strategic collaborations with Mirati, MacroGenics and
Schr dinger to further strengthen our disease strongholds in oncology and our global pipeline.
We anticipate achieving multiple regulatory
milestones across our product pipeline throughout 2021, including the potential approval of NUZYRA for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) by the NMPA. We also continue to
make progress in numerous regulatory activities, and we anticipate a discussion with the NMPA in the near future on the filing strategy for efgartigimod. In addition, we anticipate many important data readouts and updates in the remainder of this
year, including for Tumor Treating Fields in ovarian cancer, for QINLOCK in second-line GIST, for margetuximab in gastric cancer, for CLN-081 in non-small cell lung
cancer (NSCLC), for TPX-0022 in NSCLC and gastric cancer, for adagrasib in NSCLC and colorectal cancer, and for other product candidates in our global pipeline.
We are focused more than ever on our mission to build a leading global biopharmaceutical company addressing the unmet medical needs of patients
in China and around the world, Dr. Du concluded.
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
once-daily PARP inhibitor approved in the United States, the European Union and mainland China (hereinafter, China ) as a monotherapy maintenance treatment for patients with advanced epithelial ovarian, fallopian
tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of their biomarker status.
Recent Product Highlight
Anticipated 2021 Zai Milestones
Tumor Treating Fields
Tumor Treating Fields
(TTFields) are electric fields tuned to specific frequencies to disrupt cell division.
Recent Product Highlights
Anticipated 2021 Zai Milestones
Anticipated 2021 Partner Milestone
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 and China for advanced gastrointestinal stromal tumors (GIST) patients who have received prior treatment with three or more kinase
inhibitors in the all-comer setting.
Recent Product Highlights
Anticipated 2021 Partner Milestones
Adagrasib is a highly selective and potent oral small-molecule inhibitor of KRASG12C for treating
KRAS-G12C-mutated NSCLC, colorectal cancer (CRC), pancreatic cancer and other solid tumors.
Recent Product Highlight
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).
Recent Product Highlight
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner Milestone
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.
Recent Product Highlight
Anticipated 2021 Partner Milestones
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 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.
Recent Product Highlight
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.
Recent Product Highlight
Tebotelimab is an investigational, first-in-class, bispecific, tetravalent
DART molecule targeting PD-1 and LAG-3.
Recent Product Highlight
Anticipated 2021 Zai and Partner Milestone
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 Highlights
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.
Recent Product Highlight
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.
Recent Product Highlight
Anticipated 2021 Zai and Partner Milestone
Clinical Programs with Global Rights
ZL-1102 (IL-17 Nanobody)
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).
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 and in both monotherapy and combination opportunities.
Anticipated 2021 Zai Milestone
Simurosertib, ZL-2309 (CDC7)
Simurosertib, or ZL-2309, is a potential
first-in-class oral selective inhibitor of CDC7, a protein kinase with key roles in DNA replication and in bypassing DNA damage response.
Anticipated 2021 Zai Milestone
Business Development Updates
Second-Quarter 2021 Financial Results
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, August 10, 2021, at 8:00 a.m. EDT. Listeners can 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: http://apac.directeventreg.com/registration/event/7290113
Conference ID: 7290113
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