04-Nov-2026 12:47:44
ZYDUS LIFESCIENCES Q2 FY27: AWAITS US APPROVAL FOR SAROGLITAZAR; PEMBROLIZUMAB BIOSIMILAR ACCEPTED FOR FDA REVIEW, US SPECIALTY EXPANSION IN FOCUS
• Saroglitazar US Launch: Management looks forward to US regulatory approval and launch of Saroglitazar, its first indigenously discovered New Chemical Entity (NCE) • Saroglitazar Clinical Pipeline: Presented new Phase III trial analysis for Primary Biliary Cholangitis (PBC) and successfully completed the global Phase II(b) trial for MASH indication • Keytruda Biosimilar: USFDA accepted the Biologics License Application for Pembrolizumab biosimilar FYB206, developed by partner Formycon AG, for regulatory review • Biotech Expansion: Received regulatory approval to initiate Phase III clinical trials for a monoclonal antibody in India • New Licensing Agreement: Sentynl Therapeutics signed an agreement with Mereo BioPharma for Alvelestat, a late-stage therapy being prepared for Phase III development in Alpha-1 Antitrypsin Deficiency-associated Lung Disease • US Product Pipeline: Received 12 ANDA approvals, including two tentative approvals, and filed four new ANDAs, supporting future generic product launches • New US Launch: Launched the first generic version of Riociguat tablets in October 2026 • US Specialty Business: Focused on expanding Rolvedon and its 505(b)(2) product portfolio, strengthening its shift towards differentiated and specialty pharmaceuticals • USFDA Compliance: Ahmedabad SEZ-II and Moraiya facilities received one and five USFDA inspection observations, respectively; management is working to resolve them • Regulatory Milestone: Moraiya facility received approval for a transdermal patch product on October 21, 2026, following its inspection • India Growth Strategy: Focused on new product launches, chronic therapies and specialty treatments, including Oncology, Cardiology, Diabetology and Nephrology • MedTech Expansion: Investing in capabilities across selected high-growth medical technology segments to build differentiated products • Future Growth Plans: Prioritising specialty pharmaceuticals, innovative therapies, biosimilars, international expansion and strengthening the branded product portfolio
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