The NDA of Henlius Novel Anti-PD-1 mAb Serplulimab for the First-Line Treatment of Small Cell Lung Cancer Accepted by NMPA

SHANGHAI, April 11, 2022 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of HANSIZHUANG (serplulimab), a novel anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with chemotherapy for the first-line treatment of extensive stage small cell lung cancer (ES-SCLC) has been accepted by the National Medical Products Administration (NMPA). Henlius also plans to file MAA in the EU in 2022. There's no PD-1 has been approved globally for first-line treatment of SCLC up to date and HANSIZHUANG potentially the world's first PD-1 inhibitor for the first-line treatment of SCLC.

Professor Ying Cheng, the principal investigator of the study, Director of Jilin Department of Medical Oncology Cancer Center, Jilin Province Lung Cancer Diagnosis and Treatment Center, and Jilin Cancer Hospital Malignant Tumor Clinical Research Integrated Diagnosis and Treatment Center, said, "ASTRUM-005 is the first and largest ES-SCLC international multi-center clinical study led by Chinese researchers for anti-PD-1 mAb. The favorable clinical results demonstrated that the predefined primary study endpoint had been reached, providing evidence of safety and efficacy. We are hoping that the approval of HANSIZHUANG for the treatment of ES-SCLC comes soon to mend the gap and bring a new treatment option to patients living with ES-SCLC. "

Mr. Jason Zhu, President of Henlius, said, "HANSIZHUANG is an innovative mAb independently developed by Henlius, and SCLC is the third indication for which the NDA has been accepted by NMPA and Orphan-Drug Designation has been recently granted by the United States Food and Drug Administration (FDA). Based on the large number of unmet clinical needs as well as the intractable cancers both globally and in China, the company has implemented a comprehensive first-line treatment strategy for lung cancer with multiple multi-center Phase 3 clinical trials. Going forward, we will proactively promote the combination immunotherapy of HANSIZHUANG and clinical research, thereby benefiting more patients in China and around the world."

HANSIZHUANG significantly improves the overall survival and fill the gap in demand for patients with SCLC

Small cell lung cancer (SCLC) accounts for 15%–20% of all cases and is the most aggressive type of lung cancer (LC). It is classified into two stages: limited stage (LS-SCLC) and ES-SCLC, with both exhibiting high malignancy, strong invasiveness, early metastasis, fast disease progression, and a poor prognosis. At present, anti-PD-L1 mAb combined with chemotherapy has been recommended by the latest NCCN guidelines and CSCO guidelines as the first-line treatment for ES-SCLC. In recent years, however, a number of PD-1 mAbs have failed in the area.

The NDA is based on the results from a randomised, double-blind, international, multi-centre, phase 3 clinical study (ASTRUM-005) that aims to compare the efficacy and safety of HANSIZHUANG with placebo when combined with chemotherapy (carboplatin-etoposide) in previously untreated patients with ES-SCLC. This study has set up about 128 sites in China, Turkey, Poland, Georgia, etc. and 585 subjects were enrolled, among whom 31.5% were Caucasian. In December 2021, ASTRUM-005 had met its primary study endpoint of the overall survival (OS) in the interim analysis results. The study results demonstrated that HANSIZHUANG can significantly extend the OS to 15.38 months for the group of HANSIZHUANG, reducing risk of death by 38% (41% in the Asian subgroup) a manageable safety profile. The global clinical data lays a solid foundation for future applications across the world.

China has the highest incidence of LC, and HANSIZHUANG is intended as a first-line treatment option for all subtypes of LC

According to GLOBOCAN 2020, LC is the second most common cancer around the world. There were 2.2 million new LC cases worldwide, with China accounting for 0.8 million new LC cases. Moreover, with 1.8 million new deaths in 2020, LC is the leading cause of cancer deaths worldwide. Non-small cell lung cancer (NSCLC) accounts for about 85% among LC, with squamous non-small cell lung cancer (sqNSCLC) accounting for about 30%. Most lung cancer patients are diagnosed at an advanced stage and lack the opportunity for surgical resection. The advent of immune checkpoint inhibitors has been proved to bring hope to patients with LC.

Henlius has carried out a comprehensive first-line immune-oncology treatment layout for LC in sqNSCLC, non-squamous non-small cell lung cancer (nsNSCLC), ES-SCLC, and LS-SCLC. For NSCLC, the company has conducted a randomised, double-blind, global multi-centre Phase 3 clinical trial in patients with locally advanced or metastatic sqNSCLC patients to compare HANSIZHUANG in combination with chemotherapy versus chemotherapy in respect of efficacy and safety. The NDA was accepted as a result of the study meeting the primary endpoints. Also, a study to explore dual mAbs combination therapy of HANSIZHUANG and HANBEITAI (bevacizumab) for the first-line treatment of nsNSCLC has entered the pivotal Phase 3 stage. For SCLC, on the other hand, the investigational new drug application (IND) of international multicenter phase 3 studies of HANSIZHUANG in patients with LS-SCLC has been approved by NMPA in addition to ASTRUM-005 for the treatment of ES-SCLC. Notably, FDA has granted Orphan-Drug Designation for HANSIZHUANG for the treatment of SCLC, benefiting the continuous development of HANSIZHUANG and the enjoyment of certain policy support in terms of registration and commercialization in the United States.

In the future, the company will continue to emphasize unmet clinical needs and actively promote the combination immunotherapy of HANSIZHUANG and international regulatory registration to benefit more patients around the world.

About HANSIZHUANG

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. It is approved by the NMPA for the treatment of MSI-H solid tumors in March 2022. Henlius actively promotes HANSIZHUANG in conjunction with in-house products of the company and innovative therapies. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 9 clinical trials on immuno-oncology combination therapies of HANSIZHUANG worldwide in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. Up to date, the company has enrolled more than 2,800 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of Caucasian is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDA of the treatment for squamous non-small cell lung cancer (sqNSCLC) has been accepted by the NMPA and is expected to be approved in 2022. Furthermore, the global multi-center phase 3 clinical study of HANSIZHUANG in combination with chemotherapy in previously untreated extensive small-cell lung cancer (ES-SCLC) met the primary endpoint of overall survival (OS) with remarkable readouts. Its NDA in China has been accepted by the NMPA and MAA in the EU are expected to be filed in 2022, making this product potentially the world's first anti-PD-1 mAb for the first-line treatment of SCLC.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 in Europe, 13 indications approved worldwide, and 2 New Drug Application (NDA) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, Zercepac^® in Europe), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 9 combination therapies.

SOURCE Henlius