齐杜斯GLP-1设备请愿引争议 监管途径受限影响肥胖治疗市场增长

Nandan Kulkarni+91 22 6842 1436nandan.kulkarni@bernsteinsg.comShirsh Sawarna+91 226 842 1492shirsh.sawarna@bernsteinsg.com Zydus GLP-1 Device Petition Sparks Noise; Regulatory RouteLimits Impact on Obesity Franchise Growth! Adiabetes patient has petitioned in the Delhi High Court questioningregulators’approval forZydus’ Semaglutide injection-15mg/3ml cartridge used with a reusable multi-dose pen. The Delhi High Court has asked Indian regulators to consider the representation within two months. We believe this is a manageable usability review, with no material risk to India GLP-1 rampup for Zydus or Lupin using this device.Our thesis on commercial case for Zydus’ GLP-1 franchise through a differentiated deliveryplatform entry remains unchanged. Price is a single-most important driver of demand in India, and we continue to model India GLP-1 market reaching about US$2bn by 2030, with 10–15 companies equally sharing this near-perfect competition market. We believeZydus is well-placed through its own brands, SemaglynTM, MashemaTM, and AltermeTM, and through partner-led scale with Torrentand Lupin. We like its asset of 15mg/3ml pre-filled cartridge administered through a reusable multi-dose pen with exclusive rights. We Adiabetes patient has petitioned the Delhi High Court questioningregulators’approval forZydus’ semaglutide injection, focusingon the company’s 15mg/3ml cartridge used with a reusable multi-dose pen. The petitioner’s concern is device usability: the product allowsdose selection during titrations, which the petition argues could create risk of overdose, underdose, wrong administration, or confusionfor diabetes or chronic weight management patients.The Delhi High Court has asked CDSCO to consider the representation withintwo months. No stay, recall, or adverse safety findings as of now, and we believe this as a manageable usability review, with nomaterial risk to India GLP-1 ramp up for Zydus or Lupin using this device. Our analysis of CDSCO’s approval process for GLP-1 drugs 1. Zydus’ published Indian obesity Phase III study also used the same 15mg/3ml test product, enrolled 282 patients across 23 sites,followed an identical weekly titrations schedule versus reference semaglutide, and demonstrated non-inferiority with comparable safety. 2. We thus believe the likely outcome for all companies marketing GLP-1 in India is tighter instructions for use, patient counseling, dose-card discipline, or labeling refinement. Our thesis on commercial case for Zydus’ GLP-1 franchise through a differentiated delivery platform entry remains unchanged. Price is asingle-most important driver of demand in India, and we continue to model India GLP-1 market reaching about US$2bn by 2030, with 10-15credible branded-generic players sharing more or less equal market share in a near-perfect competition Indian market. In this price-driven market structure, we believe Zydus is well-placed through its own brands, SemaglynTM , MashemaTM, and AltermeTM, and through partner-led scale with Torrent and Lupin’s co-marketed portfolio. We like its asset of 15mg/3ml pre-filled cartridge administered through a reusablemulti-dose pen, for which it has exclusive rights. We believe in India and emerging markets; this allows clinicians and patients to move acrosstitrations steps using one device platform. We estimate Zydus’ domestic semaglutide revenue potential at about five to seven billion Indianrupees by FY28-29. We believe integrated GLP-1 value chain developed by Zydus including Drug Substance, differentiated Device IP, and On risk-benefit, we believe the reusable pen remains a net positive as execution is supported by clear physician, pharmacist, and patienteducation. The core risk is dose-selection error, and that can be addressed through indication-specific Titration charts, stronger patient information leaflets, prescribers training, pharmacist counseling, and clear instructions on dose selection and injection technique. Thebenefit set is more durable: lower monthly therapy cost, fewer device switches during escalation, better patient familiarity over time, andless device waste versus repeated single-use pens or PFS. Most importantly, over timea reusable pen saves TONNES OF PLASTIC FORTHE ENVIRONMENTversus repeated disposable devices.Our primary market analysis suggests that thepatient-facing information inthe product leaflet is accuratein material respects including once-weekly administration, subcutaneous injection guidance, GI tolerability, We reiterate Outperform on Zydus; we view this litigation as one-off and that Zydus continues to be well-positioned to monetize India andemerging market GLP-1 opportunity. DISCLOSURE APPENDIX I. REQUIRED DISCLOSURES References to "Bernstein" or the “Firm” in these disclosures relate to the following entities: Bernstein Institutional Services LLC(April 1, 2024 onwards), Sanford C. Bernstein & Co., LLC (pre April 1, 2024), Bernstein Autonomous LLP, BSG France S.A. (April 1,2024