Henlius and Intas’ Hetronifly (Serplulimab) Receives the CHMP’s Positive Opinion to Treat Extensive-Stage SCLC
Shots:
- The positive opinion of Hetronifly (anti-PD-1 mAb) was supported by ASTRUM-005 study assessing it with CT vs PBO as a 1L treatment of ES-SCLC patients (n=585) in various regions. It is approved in China under the brand name Hansizhuang for the same
- Henlius partnered with Intas in 2023 to develop & commercialize Hetronifly across >50 countries in the EU & India. Intas’ subsidiary, Accord Healthcare, will commercialize the drug in the EU on approval
- In addition, the NMPA has accepted the application of Hetronifly as a 1L treatment of non-squamous NSCLC. It is further being assessed under P-III global study with CT & radiotherapy for LS-SCLC and under a bridging head-to-head US trial in comparison to atezolizumab (SoC) as a 1L treatment of ES-SCLC
Ref: Henlius and Intas | Image: Henlius and Intas | Press Release
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