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Henlius and Intas’ Hetronifly (Serplulimab) Receives the CHMP’s Positive Opinion to Treat Extensive-Stage SCLC

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Henlius and Intas’ Hetronifly (Serplulimab) Receives the CHMP’s Positive Opinion to Treat Extensive-Stage SCLC

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  • 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: Shanghai Henlius | Image: Shanghai Henlius

Related News:- Shanghai Henlius and Organon Got EMA’s Validation for the MAA of HLX14 (Biosimilar, Prolia & Xgeva)

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Dipanshu Dixit

A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com

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