SystImmune Reports the NMPA Approval of Iza-bren to Treat Recurrent or Metastatic ESCC

Shots: The NMPA has approved iza-bren (izalontamab brengitecan) for the treatment of adult pts with recurrent or metastatic ESCC whose disease has progressed following prior Pt-based CT & PD-1/PD-L1 inhibitor therapy Approval was based on the P-III (PANKU-Esophagus01) trial assessing iza-bren vs CT in the above-mentioned pts (n=497) across China, which met its dual 1EP…

ByRidhi RastogiJuly 20, 2026

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

Insights+: The US FDA New Drug Approvals in March 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of March 2024 The US FDA approved a total of 14 drugs including 12 new molecular entities and 2 biologics leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was BeiGene’s Tevimbra for treating Advanced…

ByDipanshu DixitApril 15, 2024

SystImmune Reports the NMPA Approval of Iza-bren to Treat Recurrent or Metastatic ESCC

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

Insights+: The US FDA New Drug Approvals in March 2024

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