GlobeNewsWire
19 Jun 2026, 10:31 UTC · 2h ago
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Japan's Ministry of Health, Labour and Welfare approved the subcutaneous (SC) formulation of Sanofi's Sarclisa for multiple myeloma. — Approval in a major market like Japan expands patient access and provides a competitive advantage through a more convenient delivery method.
+0.40A regulatory submission for the CirCLIQ on-body injector (OBI) for Sarclisa SC is currently under review in Japan. — Potential first-in-class status for an anticancer OBI in Japan could significantly increase market share and patient adherence.
+0.30The IRAKLIA phase 3 study demonstrated that the SC formulation is non-inferior to the IV version, with infusion reactions dropping from 25% to 1.5%. — Strong clinical data on safety and efficacy supports the commercial transition from IV to SC, reducing clinical risk.
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An application for Sarclisa SC administered via OBI and manual injection is currently under review in the United States. — The US is the largest pharmaceutical market; pending approval here represents a significant potential catalyst for future revenue growth.
+0.20Which stocks this story touches
Sanofi received regulatory approval in Japan for the subcutaneous formulation of Sarclisa, expanding patient access and convenience.
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