Investor Presentaiton
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Updates on Innovation
NCE: ZYIL1 (NLRP3 inhibitor)
zydus
Dedicated To Life
Initiated Phase II(a) CTs in Australia to study the safety, tolerability, pharmacokinetics and pharmacodynamics of the
molecule in patients with CAPS in Australia.
⚫ The molecule is an oral NLRP3 inflammasome inhibitor targeted at selectively supressing inflammation.
Biosimilars
⚫ Submitted marketing authorization to DCGI for Rituximab and submitted an application to initiate Phase III clinical trials for
one mAb during the quarter.
Received permission from RCGM to initiate pre-clinical toxicity study for one product during the quarter.
⚫ On the emerging markets front, received cGMP approval for the manufacturing facility from the Mexican regulatory
authority COFEPRIS for 3 products during the quarter.
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505(b)(2) and Specialty initiatives
During the quarter, concluded pIND meeting with USFDA for 1 product in orphan space and received pNDA follow-up
response for another product during the quarter.
During the year, received tentative approval for 1 NDA, received a clearance from the USFDA for an IND application for a pain
management product and concluded 3 pNDA meetings and 2 pIND meetings with USFDA.
CAPS = Cryopyrin- Associated Periodic Syndrome, CTs = Clinical Trials, IND = Investigational New Drug, NDA = New Drug Applications, RCGM = Review Committee on Genetic Manipulation, mAb = monoclonal antibody 11View entire presentation