Shanghai Henlius Biotech Inc., (HKG: 2696) 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).
Phase III ASTRUM-002 Study Results
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.
HanSiZhuang’s Broadening Indications and Global Reach
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
Leave a Reply