Innovative Therapeutics in Oncology and Neuroscience
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Infectious
Oncology
Autoimmune
Disorders
Neuroscience
Disease
2024 Milestones and Catalysts
Zai Lab
Partner
ZEJULA (PARPi)
Tumor Treating Fields
Key Events
1H'24
2H'24
Data
Regulatory
Final OS analysis of the China Ph3 NORA study
MAA submission to the NMPA in 2L+ NSCLC
Data
Data
Tisotumab Vedotin
Regulatory
Topline data readout from the Ph3 METIS study in 1L NSCLC BM in 1Q'24
Topline data readout from the Ph3 PANOVA-3 study in 1L PC in 4Q'24
NDA submission to the NMPA in 2L+ CC
(TIVDAK)
Adagrasib (KRAS G12C)
Data
Data
Enrollment
Regulatory
Bemarituzumab (FGFR2b)
Repotrectinib (ROS1/TRK)
Zipalertinib (EGFRex20ins)
Sulbactam-Durlobactam
Regulatory
Enrollment
Regulatory
Regulatory
Enrollment
Regulatory
Enrollment
Clinical data update for the global confirmatory Ph3 KRYSTAL-12 study in 2L+ NSCLC
Clinical data update for the global Ph2 KRYSTAL-17 study in 1L NSCLC with TPS < 50%
Join the global Ph3 KRYSTAL-7 study in 1L NSCLC with TPS ≥ 50% in China
Potential FDA approval in 3L+ CRC (PDUFA goal date on Jun 21, 2024)
NDA submission to the NMPA in 2L+ NSCLC
Join the global Ph3 FORTITUDE-102 study in 1L GC / GEJ cancer in China
Xanomeline-Trospium
(KarXT)
Efgartigimod (FcRn)
ZL-1102 (IL-17A)
Regulatory
Data
Enrollment
Regulatory
Enrollment
Regulatory
Regulatory
Data
Enrollment
SBLA submission to the NMPA in CIDP in 1H'24
Potential NDA approval in ROS1+ NSCLC by the NMPA
Potential FDA approval in NTRK+ solid tumors (PDUFA goal date on Jun 15, 2024)
Join the global Ph3 REZILIENT3 study in 1L NSCLC with exon 20 insertion mutations in China
Potential NDA approval for ABC by the NMPA
Enrollment completion in the China bridging study in schizophrenia in 4Q'24
Topline data from the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety in 2H'24
Join the global Ph3 ADEPT-2 and ADEPT-3 studies in ADP in China in mid-24
Potential sBLA approval for gMG (SC) by the NMPA
Join the global Ph3 studies in TED in China in 2H'24
Potential FDA approval in CIDP (PDUFA goal date on Jun 21, 2024)
POC data readouts for Primary Sjogren's syndrome (1H'24), PC-POTS (1H'24) and myositis (2H'24)
Initiate a global Ph2 study for mild-to-moderate chronic plaque psoriasis in mid-24
Abbreviations: Marketing Authorisation Application (MAA), colorectal cancer (CRC), thyroid eye disease (TED), proof of concept (POC), Alzheimer's Disease Psychosis (ADP), Post-COVID Postural Orthostatic Tachycardia Syndrome (PC-POTS).
Potential FDA approval and launch in schizophrenia (PDUFA goal date on Sept 26, 2024)View entire presentation