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The NDA for New Indication of Henlius Anti-PD-1 mAb Serplulimab in Combination with Chemotherapy for the First-line Treatment of Patients with Esophageal Squamous Cell Carcinoma Accepted by the NMPA

2022-08-26

  

Shanghai, China, Aug 26th, 2022 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the NDA for new indication of HANSIZHUANG, serplulimab, an anti-PD-1 mAb independently developed by the company, in combination with chemotherapy for the first-line treatment of patients with locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) has been accepted by the National Medical Products Administration (NMPA). HANSIZHUANG has been approved by NMPA for the treatment of microsatellite instability-high (MSI-H) solid tumors, and the NDAs of first-line squamous non-small cell lung cancer (sqNSCLC) and first-line extensive-stage small cell lung cancer (ES-SCLC) indications have been accepted. ESCC is the fourth indication for HANSIZHUANG has been accepted by NMPA.

Professor Jing Huang, the principal investigator of ASTRUM-007 from Cancer Hospital Chinese Academy of Medical Sciences, said, "ASTRUM-007 is a phase 3 clinical study enrolled locally advanced/recurrent or metastatic ESCC patients with PD-L1 CPS≥1 of serplulimab. In the planned interim analysis evaluated by the Independent Data Monitoring Committee (IDMC), the study has met the co-primary endpoints, providing evidence of safety and efficacy. PD-1 inhibitors combined with chemotherapy has become the first-line standard treatment for advanced esophageal cancer in China. We are hoping that the approval of HANSIZHUANG for the treatment of ESCC comes soon and bring a new treatment option to patients living with ESCC. "

Mr. Jason Zhu, President of Henlius, said, "HANSIZHUANG is an innovative mAb independently developed by Henlius, and ESCC is the fourth indication for which the company filed application. Based on the large number of unmet clinical needs as well as the intractable cancers both globally and in China, we developed differentiation strategy around serplulimab to promote the combination immunotherapy of HANSIZHUANG and clinical research, thereby benefiting more patients in China and around the world."


Immuno-oncology has become one of the first-line standard of care in ESCC


Esophageal cancer is one of the most common malignancies worldwide, mainly classified as squamous cell carcinoma and adenocarcinoma, and ESCC accounts for more than 90% of esophageal cancer[1]. Esophageal cancer is high incidence in China. According to estimates of the prevalence of malignant tumours in China in 2016, there were 253,000 new cases and 194,000 deaths of esophageal cancer, ranking sixth and fifth in malignant tumors in China, respectively[2]. Since the symptoms of early esophageal cancer are often subtle, most patients are diagnosed in the middle or late stages, missing out on surgical treatment. The mainly treatment for advanced patients is systematic treatment (chemotherapy or targeted therapy), but the treatment result is often limited with the highly recurrence and metastasis rate. Therefore, new drugs and treatments are urgently needed. In recent years, immuno-oncology therapy has become one of the research priorities at home and abroad. Many studies have shown that anti-PD-1 mAb combined with chemotherapy can bring survival benefits to patients with esophageal cancer. Immune checkpoint inhibitor combined with chemotherapy has become the first-line standard treatment for esophageal cancer in China[3].

The NDA is mainly based on the results from a randomized, double-blind, multicenter phase 3 clinical study (ASTRUM-007) comparing HANSIZHUANG in combination with chemotherapy (Cisplatin + 5-FU) or placebo in combination with chemotherapy (Cisplatin + 5-FU) as a first-line treatment for patients with locally advanced/recurrent or metastatic esophageal squamous cell carcinoma. In May 2022, the results of interim analysis conducted by IDMC stated that HANSIZHUANG in combination with chemotherapy showed a significant improvement in PFS and OS against placebo in combination with chemotherapy, which met the pre-defined efficacy criteria, with good safety and no detection of new safety signal.

Underpinned by the patient-centric strategy, serplulimab clinical layout covered high incidence tumours

HANSIZHUANG (serplulimab) is the first innovative mAb developed by Henlius. It has been approved by the NMPA for the treatment of microsatellite instability-high (MSI-H) solid tumours. Henlius actively promotes HANSIZHUANG in conjunction with in-house products of the company such as tumour-specific target, angiogenesis target, immunotherapeutic target, etc. and chemotherapy drugs to conduct immune combination therapies. Underpinned by the patient-centric strategy, Henlius has carried out a differentiated and multi-dimensional layout in the field of gastrointestinal cancer and lung cancer, covering a wide variety of indications, such as lung cancer, hepatocellular carcinoma, ESCC, head and neck squamous cell carcinoma and gastric cancer, etc. Up to date, more than 3,100 subjects have been enrolled worldwide for HANSIZHUANG clinical trials.

In the field of gastrointestinal cancer, HANSIZHUANG has been approved for the treatment of MSI-H solid tumours, which could benefit for patients with MSI-H colorectal cancer and MSI-H gastric cancer. In addition, PD-1 inhibitors are less explored in neoadjuvant/adjuvant therapies for gastric cancer, and Henlius has led the way with a Phase 3 clinical study, striving to benefit gastric cancer patients from the early line of immunotherapy. As for the first-line lung cancer treatment, HANSIZHUANG would potentially be the world's first PD-1 inhibitor for the first-line treatment of SCLC. Furthermore, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of SCLC for the treatment of ES-SCLC and was also granted orphan drug designation by the FDA for treatment of SCLC.

Going forward, Henlius will continue conducting clinical studies for more innovative products, proactively exploring immuno-oncology combination therapy, bispecific antibodies and the antibody-drug conjugates (ADC), committing to bringing affordable and high-quality innovative biologics to patients around the world.

About Serplulimab

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 1 indication is approved for marketing in China, 3 NDAs have been accepted by the NMPA, and 11 clinical trials are ongoing across the world.

HANSIZHUANG was approved by the NMPA for the treatment of MSI-H solid tumors in March 2022 and actively promotes its synergy 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 11 clinical trials on immuno-oncology combination therapies 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. As of now, the company has enrolled more than 3,100 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 NDAs of the first-line treatment for squamous non-small cell lung cancer (sqNSCLC), extensive small-cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) have been accepted by the NMPA, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Furthermore, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC) for the treatment of ES-SCLC and was also granted orphan drug designation by the FDA for treatment of SCLC. 

Reference
[1] Leng, Xue-Feng et al. Optimal preoperative neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma[J]. Ann N Y Acad Sci. 2020 Dec;1482(1):213-224.
[2] Zheng R, Zhang S, Zeng H, et al. Cancer incidence and mortality in China, 2016[J]. Journal of the National Cancer Center, 2022, 2(1): 1-9.
[3] 食管癌诊疗指南(2022年版). 中国国家卫生健康委员会.