Henlius’ Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Receives NMPA Approval for the Treatment of sqNSCLC

SHANGHAI, Nov. 1, 2022 /PRNewswire/ — Shanghai Henlius Biotech, Inc. (2696. HK) 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. HANSIZHUANG 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.

Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius, said, “the approval marks that HANSIZHUANG steps into the clinical practice of lung cancer, benefiting patients with its world-class quality, and actively expands its presence. Lung cancer is a kind of cancer with high incidence in China and world, which has a huge demand for clinical treatment. Henlius has a sound indication plan in a diverse variety of lung cancer, in which many clinical studies are forging ahead. We will fully tap the potential of HANSIZHUANG and look forward to more positive study results to make further contributions in cancer treatment.”

Prof. Caicun Zhou, the leading principal investigator and Chief of Oncology Department of Shanghai Pulmonary Hospital Affiliated to Tongji University and Director of Cancer Institute of Tongji University School of Medicine, said, “sqNSCLC accounts for about 25%-30% of non-small cell lung cancer (NSCLC), with the 2nd highest incidence rate among NSCLC, and has a large demand for clinical treatment. In terms of the study, this is the largest sqNSCLC MRCT (Multi-Regional Clinical Trials) led by Chinese researchers, with more than 500 subjects enrolled globally. The study results demonstrate that serplulimab injection has reached the predefined primary study endpoint and extended progression-free survival (PFS) significantly. It is another key achievement of immunotherapy and is ready to benefit more patients.”

Fulfill the clinical medication needs with world-class quality

The approval was primarily based on a randomized, double-blind, global multi-center Phase 3 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. 

Lung cancer is one of the most common cancers in the world, and it is the malignant tumor with the highest morbidity and mortality in China. According to the latest national cancer statistics released by the National Cancer Center, there are 828,000 new cases of lung cancer, with a total death toll of 657,000 [1], in which NSCLC accounts for about 80% – 85% of all lung cancers [2], and about 50% of NSCLC patients are in local advanced stage that is not suitable for surgical resection or have metastasized at the time of diagnosis. The advanced sqNSCLC, making up about 30% of the advanced NSCLC, is given first place to a platinum-based doublet chemotherapy, which has limited efficacy, and the median survival time (MST) is quite short, many of which are less than 1 year. Therefore, there are huge unmet medical needs. In recent years, immune checkpoint inhibitors have made breakthroughs in NSCLC treatment, especially, the anti-PD-1 mAb combined with carboplatin and albumin-bound paclitaxel have been recommended by domestic and international authoritative guidelines for the treatment of advanced or metastatic sqNSCLC, which push forward the treatment of the advanced NSCLC into the era of immunotherapy. Furthermore, the approval of HANSIZHUANG brings a new option for sqNSCLC, promoting immunotherapy in clinical treatment of lung cancer, and boosting innovation-driven development.

Keep innovating in the first-line treatment of lung cancer

As the first innovative monoclonal antibody developed by Henlius, HANSIZHUANG covers a wide variety of indications and has initiated more than 10 clinical studies on immuno-oncology combination therapies around the world, including many high-incidence cancers such as lung cancer, hepatocellular carcinoma, esophageal cancer, head and neck squamous cell carcinoma and gastric cancer. As of now, the company has enrolled more than 3,100 subjects worldwide and HANSIZHUANG is also an anti-PD-1 mAb with one of the largest global clinical data pools, which speed up the commercial expansion in overseas markets. Notably, HANSIZHUANG covers the full range of first-line treatment of lung cancer, including sqNSCLC, non-squamous non-small cell lung cancer (nsqNSCLC) and small cell lung cancer (SCLC), etc., in which HANSIZHUANG achieved positive results in the phase 3 clinical trial of extensive-stage small cell lung cancer (ES-SCLC) and it is also the first anti-PD-1 mAb in the world gaining positive results in the first-line treatment of ES-SCLC. Its NDA is under review and potentially to be the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. In terms of NSCLC, HANSIZHUANG has initiated many clinical studies, such as in combination with innovative anti-EGFR mAb HLX07 for the first-line treatment of sqNSCLC with EGFR overexpression, in combination with HANBEITAI (bevacizumab) for the first-line treatment of nsqNSCLC. The company has devoted itself to lung cancer with a sound indication plan and makes explorations in combination therapies, aiming for a higher quality of life and long-term survival in patients.

Henlius has consistently adhered to the principle of patient-centered care and keeps innovating to address the difficulties and pain points in clinical treatment, while HANSIZHUANG will explore more in lung cancer and other tumors to bring confidence and hope to patients.


[1] Rongshou Zheng, Siwei Zhang, Hongmei Zeng, et al. Cancer incidence and mortality in China, 2016. Journal of the National Cancer Center, 2022, ISSN 2667-0054, dio: 10.1016/j.jncc.2022.02.002

[2] About Lung Cancer. American Cancer Society. https://www.cancer.org/content/dam/CRC/PDF/Public/8703.00

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