Innovative Therapeutics in Oncology and Neuroscience
Autoimmune Disorders
Neuroscience
Infectious Disease
Validated and Differentiated Clinical Pipeline (Cont'd)
Program
Preclinical
Phase I
Phase II
Phase III /
Pivotal
Registration
US
NUZY RA®
(omadacycline)
Sulbactam-Durlobactam
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Community-Acquired Bacterial Pneumonia (CABP)
Acinetobacter Baumannii-calcoaceticus Complex (ABC)
Mainland China
★
Schizophrenia (psychosis)
★ US
Xanomeline-Trospium (KarXT)
Schizophrenia (adjunctive therapy)*
Psychosis in Alzheimer's Disease*
Generalized Myasthenia Gravis (gMG)
VÝVGART
Ⓡ
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
★ US
VYVGART Hytrulo
Bullous Pemphigoid
Efgartigimod (FcRn)
Thyroid Eye Disease (TED)*
Lupus Nephritis 12
Membranous Nephropathy12
Psoriasis
Approved
Commercial
Mainland
China
Territories
Greater China
Asia Pacific 11
O Greater China
Greater China
21
ZL-1102 (IL-17)
Global
Abbreviations: Immuno-oncology (I/O), B-cell non-Hodgkin lymphoma (B-NHL), relapsed or refractory (r/r), recurrent or metastatic (r/m), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), neurotrophic tropomyosin receptor kinase (NTRK), small
cell lung cancer (SCLC).
Notes: The trademarks and registered trademarks within are the property of their respective owners.*Greater China trial in preparation or under planning. Greater China = mainland China, Hong Kong, Macau and Taiwan. (1) Also launched in Hong Kong and
Macau; (2) Commercially available in Hong Kong; (3) Greater China-only trial; (4) Also approved in Hong Kong and Taiwan; (5) FDA accelerated approval; continued approval may be contingent on verification and confirmation of clinical benefit in confirmatory
trials; (6) Combination with carboplatin and KEYTRUDA +/- bevacizumab; (7) 1st line+ locally advanced or metastatic disease in solid tumors including colorectal cancer, pancreatic cancer, non-small cell lung cancer, and head and neck cancer; monotherapy and
combination with KEYTRUDA and either carboplatin or cisplatin; (8) FDA accelerated approval of KRAZATI for 2L+ NSCLC with KRAS G12C mutation in December 2022; (9) Global Ph3 studies continue to enroll patients; (10) Global Ph3 study in 1L NSCLC with
exon 20 insertion mutations is active enrolling; (11) Zai Lab has exclusive license to develop and commercialize SUL-DUR in mainland China, Hong Kong, Taiwan, Macau, Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, the
Philippines, Singapore, Australia, New Zealand, and Japan; (12) Initiated enrollment of two proof-of-concept trials in autoimmune renal diseases in China in February 2023.
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