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
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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
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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
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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, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
