Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company in China, has unveiled positive data from the Phase III ASTRUM-002 study. The study assessed the efficacy of its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), in combination with chemotherapy for first-line treatment of non-squamous non-small cell lung cancer (nsqNSCLC). The trial successfully achieved the primary endpoint of significant improvement in progression-free survival (PFS).
Study Design and Results
The triple-arm, randomized, double-blind, multi-center Phase III study compared the efficacy and safety of serplulimab alone, serplulimab combined with Hanbeitai (bevacizumab), and placebo combined with chemotherapy in patients with first-line advanced nsqNSCLC. The results demonstrated that the serplulimab/chemotherapy combination showed significant improvement in PFS compared to the placebo/chemotherapy combination, meeting the predetermined efficacy criteria. The study also reported a good safety profile with no new safety signals observed.
HanSiZhuang’s Development and Approvals
HanSiZhuang is the first innovative monoclonal antibody (mAb) developed by Henlius. It has received approval from the National Medical Products Administration (NMPA) for the treatment of microsatellite instability-high (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). The drug is also being developed in combination with other drugs, covering a similar range of indications.
Global Partnership and Commercialization
India-based Intas Pharmaceuticals Ltd obtained exclusive development and commercialization rights to HanSiZhuang in Europe and India through an EUR 185 million deal signed late last month. This partnership underscores the global potential of Henlius’ PD-1 inhibitor and its commitment to expanding access to innovative treatments for patients worldwide.-Fineline Info & Tech
