NMPA (China) approves Hansizhuang + chemotherapy for first line treatment of squamous non-small cell lung cancer
Shanghai Henlius Biotech, Inc. announced that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) Hansizhuang (generic name: serplulimab injection), in combination with carboplatin and albumin-bound paclitaxel for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC), has been approved by the National Medical Products Administration (NMPA), providing an alternative treatment option for patients
HansizhuangG had already been approved for the treatment of Microsatellite Instability-High (MSI-H) solid tumors, and it covers a wide variety of indications to benefit a broader population of patients.
The approval was primarily based on a randomized, double-blind, global multi-center Phase III clinical trial (ASTRUM-004) initiated in many countries around the world, including China, Poland, Turkey, etc., of which more than 30% are white. Its global clinical trial data will support NDAs in overseas markets and lay a foundation for clinical practice all over the world in the future. The results indicate that Hansizhuang in combination with carboplatin and albumin-bound paclitaxel could bring significant benefits in the treatment of previously untreated locally advanced or metastatic sqNSCLC patients, which meets the primary endpoint and has good safety and tolerability.
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