{"id":16712,"date":"2024-12-04T16:28:12","date_gmt":"2024-12-04T08:28:12","guid":{"rendered":"https:\/\/flcube.com\/?p=16712"},"modified":"2024-12-04T16:28:15","modified_gmt":"2024-12-04T08:28:15","slug":"shanghai-henlius-biotechs-serplulimab-approved-for-first-line-nsnsclc-treatment-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=16712","title":{"rendered":"Shanghai Henlius Biotech’s Serplulimab Approved for First-Line nsNSCLC Treatment in China"},"content":{"rendered":"\n

Shanghai Henlius Biotech Inc., (HKG: 2696<\/a>) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10), marking its fifth indication approval in China. The drug can now be used in combination with pemetrexed and carboplatin as a first-line treatment for patients with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC) who are negative for epidermal growth factor receptor (EGFR) gene mutation and anaplastic lymphoma kinase (ALK).<\/p>\n\n\n\n

Phase III ASTRUM-002 Study Results<\/strong>
The endorsement is based on the results of the randomized, double-blinded, multi-center Phase III ASTRUM-002 study. The study demonstrated that serplulimab in combination with chemotherapy (carboplatin-pemetrexed) significantly prolonged progression-free survival (PFS) compared to chemotherapy alone as a first-line treatment of advanced nsNSCLC, meeting the prespecified superiority criteria. Additionally, the combination therapy showed a good safety profile, with no new safety signals observed.<\/p>\n\n\n\n

HanSiZhuang’s Broadening Indications and Global Reach<\/strong>
HanSiZhuang is the first innovative monoclonal antibody (mAb) developed by Henlius. It has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) since March 2022. The drug’s global reach expanded in December 2023 with its approval in Indonesia for use in ES-SCLC. Furthermore, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval for the drug in September this year.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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