China’s NMPA accepts Innovent’s sintilimab‑GC101 application for advanced melanoma
Innovent Biologics announced that the China National Medical Products Administration has accepted its new indication application for sintilimab combined with Nolgileucel injection (GC101) to treat unresectable or metastatic melanoma that has progressed after at least two prior systemic therapies. The filing relies on the Phase II MIZAR‑003 trial, which showed a median progression‑free survival of 4.3 months versus 1.6 months with chemotherapy and a 57 % risk reduction (hazard ratio 0.43). If approved, this would become the 11th approved indication for sintilimab in China.
Why it matters
The acceptance moves the combo therapy toward regulatory approval, potentially expanding sintilimab’s market share in China’s melanoma segment. The company expects the new indication to strengthen sintilimab’s role as a cornerstone immuno‑oncology product.
Key facts
- 1The NMPA accepted Innovent’s new indication application for sintilimab plus GC101 on Oct. 26 2026. prnewswire.com
- 2The application targets patients with unresectable or metastatic melanoma who have progressed after at least two prior systemic treatments, including anti‑PD‑1 therapy. prnewswire.com
- 3The filing is based on the Phase II MIZAR‑003 trial, which met its primary endpoint as of the data cut‑off date of May 12 2026. prnewswire.com
- 4In the trial, median progression‑free survival was 4.3 months for the experimental arm versus 1.6 months for the chemotherapy control arm. prnewswire.com
- 5The study demonstrated a 57 % reduction in the risk of disease progression or death (hazard ratio 0.43, 95 % CI 0.26–0.68, P = 0.0002). prnewswire.com
- 6If approved, this would be the 11th indication for sintilimab in China. prnewswire.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.