Pharma Focus Asia

NMPA Approves New Drug Application for Henlius Anti-PD-1 mAb Serplulimab Combined with Chemotherapy in First-Line non-squamous NSCLC Treatment

Wednesday, December 13, 2023

Shanghai Henlius Biotech, Inc. (2696.HK) has recently disclosed that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for a new indication of HANSIZHUANG (serplulimab), an innovative anti-PD-1 monoclonal antibody (mAb) developed independently by the company. This new indication involves combining HANSIZHUANG with chemotherapy as a first-line treatment for patients diagnosed with locally advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC). This marks the fifth indication for HANSIZHUANG accepted by the NMPA.

Lung cancer remains a significant global health issue with high mortality rates. HANSIZHUANG has already obtained approvals for various indications, including 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). Given the rising incidence of lung cancer, especially in China where it is the leading cause of both incidence and mortality, the addition of a new indication for nsNSCLC is noteworthy.

The NDA submission for the new indication is grounded in positive results from a phase 3 clinical study. This study demonstrated that the combination of HANSIZHUANG and chemotherapy significantly extended progression-free survival (PFS) compared to chemotherapy alone. The study met pre-specified superiority criteria and exhibited good safety, with no detection of new safety signals.

HANSIZHUANG, Henlius' first self-developed innovative monoclonal antibody, focuses on lung and gastrointestinal cancers. It has initiated over 10 clinical studies on immuno-oncology combination therapies globally. This includes a head-to-head bridging trial in the U.S. comparing HANSIZHUANG to the standard-of-care atezolizumab for ES-SCLC, contributing to its potential registration and commercialization in the U.S. The Marketing Authorization Application (MAA) for HANSIZHUANG on ES-SCLC has been validated by the European Medicines Agency (EMA), with approval expected in the first half of 2024.

Henlius is committed to advancing clinical research globally, with a phase 3 multi-center clinical study of HANSIZHUANG for limited stage small cell lung cancer (LS-SCLC) underway. The company aims to provide innovative and accessible treatment options for patients worldwide and continues to enhance its capabilities to meet evolving clinical needs.

HANSIZHUANG (serplulimab) is a recombinant humanized anti-PD-1 monoclonal antibody injection developed by Henlius. As of now, it has received approvals for four indications in China, with two marketing applications under review in China and the EU. HANSIZHUANG is actively being studied in more than 10 ongoing clinical trials worldwide, covering various indications. The monoclonal antibody has demonstrated efficacy and safety in treating MSI-H solid tumors, sqNSCLC, ES-SCLC, and ESCC. The company continues to explore its potential synergies with in-house products and other innovative therapies. Henlius has enrolled over 3,600 subjects in global clinical trials, establishing HANSIZHUANG as an anti-PD-1 mAb with one of the largest global clinical data pools. The results of pivotal trials have been published in reputable medical journals, and HANSIZHUANG has received recommendations in various clinical guidelines, providing valuable references for tumor diagnosis and treatment. Serplulimab has also received orphan drug designations from the U.S. FDA and the EC for the treatment of SCLC, with a head-to-head trial against atezolizumab in progress in the United States.



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