Shanghai, China, December 3rd, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the new drug application (NDA) for new indication of its self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), in combination with pemetrexed and carboplatin for the first-line treatment of 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), has been approved by the National Medical Products Administration (NMPA). This marks the fifth approved indication for HANSIZHUANG in China and the third indication in the field of lung cancer, following squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), bringing more treatment options to lung cancer patients in China.
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated:“The approval of a new indication for HANSIZHUANG in the treatment of lung cancer signifies a broadened therapeutic application, directly benefiting a large number of patients with advanced non-small cell lung cancer. Being patient-centric and driven by innovation, the company has developed a differentiated and multi-faceted strategy centered around HANSIZHUANG. Looking ahead, we are committed to advancing diverse research endeavors and expanding its use in lung cancer, gastrointestinal tumors, and beyond, ensuring that innovative treatment solutions reach and benefit an even greater number of patients.”
Prof. Yuankai Shi, the leading principal investigator from Cancer Hospital Chinese Academy of Medical Sciences, said, "lung cancer stands as one of the most prevalent malignancies in China. Immunotherapy in combination with chemotherapy is the standard of care for advanced nsNSCLC that is negative for driver mutations. Recent clinical research has demonstrated that serplulimab in combination with chemotherapy significantly extends progression-free survival among patients with driver-gene-negative locally advanced or metastatic nsNSCLC. The approval of serplulimab introduces a novel and effective treatment alternative for patients with advanced nsNSCLC. "
Wenjie Zhang, Chairman and Executive Director of Henlius, said: "Henlius continues to delve deeply into the field of lung cancer treatment, committed to bringing more and better treatment options to lung cancer patients worldwide. The successful approval of HANSIZHUANG for nsNSCLC not only marks a significant milestone in the product's development but also signifies another key advancement for the company in the field of lung cancer treatment. We will maximize the strengths of HANSIZHUANG to expedite its market penetration, ensuring wider patient access and propelling the medical sector forward."
Addressing clinical needs by offering novel treatment options
The approval was primarily based on a randomized, double-blind, multicentre phase 3 clinical study. The results indicated that HANSIZHUANG in combination with chemotherapy (carboplatin-pemetrexed) versus chemotherapy (carboplatin-pemetrexed) as first-line treatment of advanced nsNSCLC significantly prolonged PFS, met the prespecified superiority criteria, with good safety profile and no new safety signals were observed.
Lung cancer is the cancer with the highest global mortality rate. According to the latest data from the National Cancer Centre, there were 1.06 million new cases of lung cancer and 733,000 deaths from lung cancer in China in 2022. Both the incidence and mortality rates of lung cancer rank first among all cancers[1]. NSCLC accounts for approximately 80-85% of lung cancer cases in China[2,3], with around 70% being nsNSCLC. In recent years, immune checkpoint inhibitors (ICI), such as PD-1/PD-L1, have developed rapidly, notably, the anti-PD-1 mAb plus chemotherapy has been recommended by the latest NCCN guidelines and CSCO guidelines as the first-line treatment for nsNSCLC[4-5]. The approval of HANSIZHUANG provides a new treatment option for patients with advanced nsNSCLC in China, bringing better survival benefits and contributing to further improvement in the current state of lung cancer treatment.
Expanding reach for the first-line treatment of lung cancer
HANSIZHUANG, Henlius’ first self-developed innovative Anti-PD-1 mAb, is the world’s first anti-PD-1 mAb for first-line treatment of ES-SCLC. Up to date, It has been approved in China and several Southeast Asian countries, benefiting over 80,000 patients. Previously in China, it has been approved by the NMPA for the treatment of microsatellite instability-high (MSI-H) solid tumours, sqNSCLC, ES-SCLC, and esophageal squamous cell carcinoma (ESCC). Besides, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of HANSIZHUANG as a first-line treatment of ES-SCLC.
Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. The company has initiated over 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,400 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. Notably, Henlius covers the full range of first-line treatment of lung cancer. In addition to sqNSCLC, ES-SCLC and nsNSCLC, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). Henlius is also running a bridging head-to-head trial in the U.S. to compare HANSIZHUANG with standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC, which is expected to propel the product towards U.S. market approval further.
Going forward, Henlius stays dedicated to its patient-centred approach, bolstering its R&D innovation to tackle real clinical needs and making high-quality, affordable, and innovative treatments accessible to a broader audience.
【Reference】
[1] Bingfeng Han, Rongshou Zheng, Hongmei Zeng, Shaoming Wang, Kexin Sun, Ru Chen, Li Li, Wenqiang Wei, Jie He, Cancer incidence and mortality in China, 2022, Journal of the National Cancer Center, 2024.
[2] 中华医学会肿瘤学分会，中华医学会杂志社. 中华医学会肺癌临床诊疗指南（2023版）. 中国综合临床，2023，39(06):401-423.
[3] 中国抗癌协会肺癌专业委员会，中华医学会肿瘤学分会肺癌学组. Ⅲ期非小细胞肺癌多学科诊疗专家共识(2019版). 中华肿瘤杂志，2019，41(12):881-890.
[4] 中国临床肿瘤学会（CSCO）非小细胞肺癌诊疗指南2023
[5] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023
About HANSIZHUANG
HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China and several SEA countries. Up to date, 5 indications are approved for marketing, 1 marketing applications is under review in EU, and more than 10 clinical trials are ongoing across the world.
HANSIZHUANG was approved in China in March 2022 and has been approved by the National Medicinal Products Administration (NMPA) for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). The marketing applications of the first-line treatment for ES-SCLC is under review by the European Medicines Agency (EMA). Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. The company has initiated more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,400 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. The results of 4 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was respectively recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.