China’s National Medical Products Administration (NMPA) has granted approval for Shanghai-based Henlius Biotech’s Hansizhuang (serplulimab injection) for use in PD-L1 positive unresectable locally advanced/recurrent or metastatic oesophageal squamous cell carcinoma (ESCC) patients. 

This treatment is indicated for usage as a first-line regimen along with the therapeutics fluorouracil and platinum.

The regulator granted the approval based on data from the Phase III ASTRUM-007 clinical trial of serplulimab plus chemotherapy in PD-L1–positive, advanced ESCC patients.

Trial findings showed that serplulimab plus chemotherapy provided substantial improvement in progression-free survival and overall survival.

Hansizhuang is a recombinant humanised anti-PD-1 monoclonal antibody injection.

The latest approval of the new drug application for Hansizhuang marks the fourth indication of the drug to be authorised in China.

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In January 2023, the Chinese regulator approved Henlius’ Hansizhuang plus carboplatin and etoposide for the treatment of extensive stage small cell lung cancer (ES-SCLC).

The monoclonal antibody also received approval for treating microsatellite instability-high solid tumours and squamous non-small cell lung cancer.

A marketing application for the therapy for ES-SCLC is currently being reviewed in the European Union and more than ten clinical trials are progressing globally.

Henlius chairman and executive director Wenjie Zhang stated: “Since it launched in March 2022, Hansizhuang has benefited a wide range of patients with lung cancer, gastrointestinal cancer and other tumours, 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.”