Junshi Biosciences Reports the NMPA’s sNDA Acceptance of Toripalimab + Disitamab Vedotin for Urothelial Carcinoma

Shots: China’s NMPA has accepted sNDA of toripalimab + disitamab vedotin for the treatment of HER2+ locally advanced or metastatic urothelial carcinoma (LA/M UC) sNDA was backed by P-III (RC48-C016) trial assessing toripalimab + disitamab vedotin vs gemcitabine + cisplatin/carboplatin across 74 centres in systemic-treatment-naïve Chinese pts with HER2+ LA/M UC Toripalimab is an anti-PD-1…

ByRidhi RastogiAugust 12, 2025

Junshi Biosciences & LEO Pharma Collaborate to Commercialize Toripalimab in Europe

Shots: Junshi with its subsidiary, TopAlliance, has partnered with LEO to market toripalimab in 32 EU countries incl. EEA, Switzerland & the UK. TopAlliance will remain the authorization holder overseeing development, manufacturing, registration & other activities in the EU LEO Pharma will handle the drug distribution, promotion & sales plus will pay an upfront…

BySenior EditorJanuary 21, 2025

Junshi Biosciences Reports the CHMP’s Positive Opinion of Loqtorzi (Toripalimab) Across Two Indications

Shots: The CHMP has granted positive opinion to 1L Loqtorzi with cisplatin & gemcitabine for recurrent, metastatic NPC as well as with cisplatin & paclitaxel for unresectable advanced, recurrent or metastatic ESCC; valid across the EU plus Iceland & Norway The opinions for NPC & ESCC were supported by P-III (JUPITER-02 & JUPITER-06) trials, respectively;…

ByDipanshu DixitJuly 26, 2024

Junshi Biosciences Reports the NMPA’s sNDA Acceptance of Toripalimab + Disitamab Vedotin for Urothelial Carcinoma

Junshi Biosciences & LEO Pharma Collaborate to Commercialize Toripalimab in Europe

Junshi Biosciences Reports the CHMP’s Positive Opinion of Loqtorzi (Toripalimab) Across Two Indications

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