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Zai Lab Announces Financial Results and Corporate Updates for Twelve Months Ended

Key Takeaway: Zai Lab Announces Financial Results and Corporate Updates for Twelve Months Ended December 31, 2021 Company to Host Conference Call and Webcast on March 2, 2022, at 8:00 a.m. EST SHANGHAI, SAN FRANCISCO, and CAMBRIDGE, Mass., March 1, 2022 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9

Full Press Release Details

Zai Lab Announces Financial Results and Corporate Updates for Twelve Months Ended December 31, 2021
Company to Host Conference Call and Webcast on March 2, 2022, at 8:00 a.m. EST
SHANGHAI, SAN FRANCISCO, and CAMBRIDGE, Mass., March 1, 2022 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative,
commercial-stage, global biopharmaceutical company, today announced financial results for the twelve months ended December 31, 2021, along with recent product highlights and corporate updates.
2021 marked another year of strong growth and execution for Zai Lab in all areas of our business, said Dr. Samantha Du, Founder, Chairperson
and Chief Executive Officer of Zai Lab. We significantly expanded our portfolio of potential first-in-class and/or best-in-class assets. We made meaningful advances with our global pipeline of 11 assets, including achieving proof of concept for ZL-1102, our internally developed anti-IL-17A Humabody for chronic plaque psoriasis with global rights. Through business development, we deepened our
world-class gastric and lung cancer franchises with four additional promising drug candidates; we bolstered our autoimmune franchise with efgartigimod, a pipeline-in-a-product opportunity; and we expanded into neuroscience with an exciting anchor asset KarXT. We achieved additional regulatory submissions and approvals, including our first non-oncology approval with NUZYRA . Our commercial execution is gaining strong momentum for our four marketed products. We are pleased to have ZEJULA included
in the NRDL for first-line ovarian cancer maintenance treatment, and we expect that ZEJULA can become the leading PARP inhibitor in ovarian cancer in China given its unique label for ovarian cancer patients regardless of biomarker status. Lastly, we
grew our talented global team both in the United States and China, building a solid foundation for continuing growth and excellent execution.
Other Recent Achievements
Clinical Development
Business Development
We have set clear strategic priorities for 2022 to position ourselves to lead the next wave of biopharma innovation,
Dr. Du continued. We will plan to expedite bringing medicines to patients by accelerating important data readouts and regulatory filings across our entire portfolio. We plan to file the NDA for efgartigimod in China in mid-2022, subject to ongoing discussion with the NMPA, and initiate a registrational study in China for bemarituzumab in first-line advanced gastric and gastroesophageal junction (GEJ) cancer. We will continue to
invest in R&D and advance our internal pipeline of assets with global rights. We plan to move ZL-1102, our anti-IL-17A
Humabody , into full global development and submit up to two Investigational New Drug Applications (INDs) for compounds with global rights in 2022. We intend to leverage our leading position
in China to accelerate our growing revenue base and to source innovation internally and externally with potentially transformative assets and partnership opportunities. Our mission is to build a leading global biopharmaceutical company.
Looking ahead, we aim to have at least 15 marketed products approved in more than 30 indications by 2025, Dr. Du concluded. We believe
that the regulatory environment will continue to be supportive of innovative biopharma companies like Zai Lab. We are also confident in the long-term market potential of our differentiated world-class portfolio designed to address significant unmet
medical needs and to create significant value for all of our constituents, including our shareholders. For example, we are presently forecasting that peak-year sales of the assets currently in our lung and GI cancer franchises could generate up to a
combined total of $2.5 to $3 billion through 2030.1,2 We remain as committed as ever
to continuing to invest in internal R&D and 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.
Recent Product Highlights
Anticipated 2022 Zai Milestones
Tumor Treating Fields
Tumor Treating Fields
(TTFields) are electric fields tuned to specific frequencies that disrupt cancer cell division.
Recent Product Highlights
Anticipated 2022 Partner and Zai 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 and China for 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
Adagrasib 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
Anticipated 2022 Zai Milestone
Anticipated 2022 Partner Milestones
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 2022 Zai Milestone
Anticipated 2022 Partner Milestone
Odronextamab is a bispecific 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 2022 Partner and Zai Milestone
Anticipated 2022 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.
Recent Product Highlights
Anticipated 2022 Partner Milestones
CLN-081 is an orally available, small-molecule, irreversible epidermal growth factor receptor (EGFR) inhibitor that
selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR, in development by Cullinan Pearl, a subsidiary of Cullinan Oncology, Inc., for the treatment of patients with EGFR exon 20 insertion
Recent Product Highlight
Anticipated 2022 Zai Milestone
Anticipated 2022 Partner Milestone
Elzovantinib (TPX-0022)
Elzovantinib 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 Highlights
Anticipated 2022 Partner Milestones
MARGENZA (Margetuximab)
MARGENZA is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2).
Recent Product Highlight / Update
Tebotelimab is an investigational, first-in-class, bispecific, tetravalent DART molecule targeting PD-1 and LAG-3.
Recent Product Update
BLU-945 is a selective and potent inhibitor of EGFR harboring either the activating L858R or exon 19 deletion mutations combined with the acquired T790M and C797S mutations, common
on-target resistance mutations to first-generation EGFR inhibitors and osimertinib, respectively, for potential treatment of EGFR-driven NSCLC.
Recent Product Highlights
Anticipated 2022 Partner Milestone
BLU-701 is a selective and potent inhibitor of EGFR harboring either the activating L858R or exon 19
deletion mutations combined with the acquired C797S mutation, a common on-target resistance mutation to osimertinib, for potential treatment of EGFR-driven NSCLC.
Recent Product Highlight
Anticipated 2022 Partner Milestone
Simurosertib, ZL-2309 (CDC7 Inhibitor, Global Rights)
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 2022 Zai Milestone
ZL-1201 (CD47 Inhibitor, Global Rights)
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 2022 Zai Milestones
Other Internal R&D Programs
Anticipated 2022 Zai Milestone
VYVGART (Efgartigimod)
Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) autoantibodies 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 from degradation.
Recent Product Highlights
Anticipated 2022 Partner Milestones
(IL-17 Human VH Antibody Fragment, Global Rights)
novel human VH antibody fragment (Humabody ) targeting the IL-17A cytokine with high affinity and avidity. Unlike other
anti-IL-17 products, ZL-1102 is being developed as a topical treatment for mild-to-moderate chronic plaque psoriasis (CPP).
Recent Product Highlight
NUZYRA (omadacycline)
NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute
bacterial skin and skin structure infections (ABSSSI).
Recent Product Highlight
Last updated: Mar 1, 2022