The drug is a new indication of HANSIZHUANG (serplulimabinjection), an anti-PD-1 monoclonal antibody developed by the company, 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 ESCC.
Up to date, HANSIZHUANG has been approved for the treatment of microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC), and extensive stage small cell lung cancer (ES-SCLC).
Moving forward, Henlius is set to ‘differentiate and optimize’ the roadmap of HANSIZHUANG in lung cancer, gastrointestinal cancer, and other cancers.
The approval was primarily based on ASTRUM-007, a randomized, double-blind, multicenter, phase 3 study comparing the efficacy and safety of serplulimab versus placebo in combination with chemotherapy in patients with previously untreated, advanced ESCC.
Esophageal cancer is the sixth leading cause of cancer-related deaths worldwide as well as a prevalent malignant tumor in China.
According to data from Henlius, the incidence and mortality of esophageal cancer rank sixth and fourth respectively among all malignant tumors in China, of which ESCC is the most common pathological type that accounts for around 85% of all esophageal cancer cases.
As the symptoms of early esophageal cancer are often subtle, about 70% of patients are diagnosed at mid-to-late stage, missing out on surgical treatment.
Jason Zhu, CEO of Henlius, 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 ESCC further validates the potential of HANSIZHUANG and demonstrates the innovation capabilities of Henlius. We look forward to more positive study results of HANSIZHUANG to make further contributions to cancer treatment for more cancer patients."
Wenjie Zhang, chairman, and executive director of Henlius, added: “ESCC is the fourth approved indication of HANSIZHUANGand 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.”
“Since it launched in March 2022, HANSIZHUANG has benefited a wide range of patients with lung cancer,gastrointestinal cancer, and other tumors, further solidifying its positive reputation with a strong brand effect. Moving forward, we will continue leveraging the strengths of HANSIZHUANG and fully tapping its potential to accelerate market expansion to provide affordable, innovative treatments to more patients worldwide."