Innovent's sintilimab got NMPA acceptance of an 11th indication application, this time in advanced melanoma paired with TIL therapy GC101. The pivotal Phase II MIZAR-003 met its primary endpoint in pa

What happened: Innovent announced that China's NMPA has accepted for review a New Indication Application for sintilimab in combination with Nolgileucel injection (GC101) for unresectable or metastatic melanoma that progressed after at least two prior lines of systemic therapy, Why it matters: Innovent said the acceptance consolidates sintilimab's position as a cornerstone therapy in immuno-oncology and marks a milestone in the product's life-cycle management. Professor Guo Jun cited limited treatment options and urgent clinical need for patients progressing after prior PD-1 therapy. Market: -0.2% today ($83.05), +5.4% YTD, 0.6x vol — as of 08:00 UTC

Innovent announced that China's NMPA has accepted for review a New Indication Application for sintilimab in combination with Nolgileucel injection (GC101) for unresectable or metastatic melanoma that progressed after at least two prior lines of systemic therapy,

Innovent said the acceptance consolidates sintilimab's position as a cornerstone therapy in immuno-oncology and marks a milestone in the product's life-cycle management. Professor Guo Jun cited limited treatment options and urgent clinical need for patients progressing after prior PD-1 therapy. Market: -0.2% today ($83.05), +5.4% YTD, 0.6x vol — as of 08:00 UTC