Henlius Biotech's HANSIZHUANG (Serplulimab) Approved for Treatment of Esophageal Cancer (ESCC)

Shanghai, China, Sep 22nd, 2023 – Shanghai Henlius Biotech, Inc. (2696. HK) has received approval from the National Medical Products Administration (NMPA) for the new indication of HANSIZHUANG (serplulimab injection). This innovative anti-PD-1 monoclonal antibody, developed independently by the company, will be used in combination with drugs containing fluorouracil and platinum for the first-line treatment of patients with PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This milestone brings new hope to patients facing this challenging form of gastrointestinal cancer.

HANSIZHUANG, known as serplulimab, has been on a remarkable journey since its launch in March 2022. It has garnered approvals for various indications, including microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC), and extensive stage small cell lung cancer (ES-SCLC). Its latest approval for ESCC marks its fourth approved indication, further cementing its reputation as a high-quality anti-PD-1 monoclonal antibody with a strong brand effect.

Wenjie Zhang, Chairman, and Executive Director of Henlius, expressed optimism about the new approval, emphasizing the impact it will have on gastrointestinal cancer treatment. He stated, "ESCC is the fourth approved indication of HANSIZHUANG and its approval signifies that this high-quality anti-PD-1 mAb offers a new ray of hope for the treatment of difficult-to-treat gastrointestinal cancer."

Jason Zhu, Executive Director, Chief Executive Officer, President, and Chief Financial Officer of Henlius, highlighted the company's commitment to addressing unmet clinical needs. He said, "Henlius is driven by unmet clinical needs and has devoted itself to precision immunotherapy for tumors. We are focusing on major cancer types, steadily expanding the clinical layout of HANSIZHUANG in multiple cancer types, and actively initiating immune combination therapy trials worldwide."

The approval of HANSIZHUANG for ESCC is based on the results of ASTRUM-007, a phase 3 clinical study. The study, which compared serplulimab with placebo in combination with chemotherapy for previously untreated, PD-L1–positive advanced ESCC patients, demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS). Notably, the combination of serplulimab and chemotherapy showed an absolute extension of 4.7 months in median OS compared to the control group, reducing the risk of death by 41%.

Prof. Jing Huang, the leading principal investigator of ASTRUM-007, emphasized the potential benefits of serplulimab for patients. He stated, "ESCC is the most common pathological type of esophageal cancer with high clinical demand and relatively poor overall prognosis. The phase 3 clinical study on serplulimab plus chemotherapy for unresectable locally advanced/metastatic esophageal cancer achieved promising results."

Esophageal cancer is a significant global health concern, ranking as the sixth leading cause of cancer-related deaths worldwide and a prevalent malignant tumor in China. The approval of HANSIZHUANG for ESCC provides a vital treatment option for patients facing this disease, especially those diagnosed at the mid-to-late stage when surgical treatment is not feasible.

Combining immunotherapy, such as anti-PD-1 mAb, with chemotherapy has become the standard first-line treatment for advanced esophageal cancer in China. The positive results from ASTRUM-007 and HANSIZHUANG's approval for ESCC further solidify this approach's efficacy in addressing the unmet clinical needs of these patients.

Henlius continues to expand the indications for HANSIZHUANG, with a focus on lung and gastrointestinal cancer. The company has initiated more than 10 clinical trials on immuno-oncology combination therapies worldwide, with over 3,600 subjects enrolled in various countries.

In the field of gastrointestinal cancer, HANSIZHUANG has shown promise in the treatment of MSI-H solid tumors, bringing hope to patients with colorectal and gastric cancers. Additionally, the phase 3 clinical study on neoadjuvant/adjuvant therapies for gastric cancer is underway, aiming to benefit patients at an early stage of immunotherapy.

In lung cancer, HANSIZHUANG has secured approvals for sqNSCLC and ES-SCLC, making it the world's first anti-PD-1 monoclonal antibody for the first-line treatment of SCLC. Further expansion into the treatment of non-squamous non-small cell lung cancer (nsNSCLC) is anticipated, with plans for a marketing application in China in the near future.

Henlius has also made significant progress in securing approvals and partnerships for HANSIZHUANG in international markets. Collaborations with organizations like Kalbe Genexine Biologics and Fosun Pharma aim to broaden the availability of HANSIZHUANG to a wider range of global patients.

Henlius remains committed to enhancing its capabilities in innovation, manufacturing, and commercialization. The company is dedicated to developing a system for precision treatment and translational medicine research to maximize the clinical value of HANSIZHUANG. Their goal is to lead the way in tumor immunotherapy, providing hope and warmth to patients worldwide.

Approval of HANSIZHUANG for ESCC is a significant milestone in the fight against esophageal cancer and underscores Henlius Biotech's commitment to addressing unmet medical needs in oncology. With a growing portfolio of indications and a focus on precision immunotherapy, Henlius continues to make strides in providing innovative and accessible treatments for cancer patients around the world.