Shots:
Junshi Biosciences reported that the NMPA has accepted the NDA for roconkibart injection (JS005), for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy
The submission is backed by a multicenter P-III study (n=747) showing significant improvements in PASI 75/90/100 and sPGA 0/1 vs PBO at 12wks., with sustained efficacy…
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…
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 & NorwayÂ
The opinions for NPC & ESCC were supported by P-III (JUPITER-02 & JUPITER-06) trials, respectively;…

