The National Medical Products Administration (NMPA) of China has approved Shanghai Henlius Biotech’s monoclonal antibody Hansizhuang (serplulimab injection) along with carboplatin and etoposide to treat extensive stage small cell lung cancer (ES-SCLC).

Hansizhuang is the company’s first self-developed anti-PD-1 monoclonal antibody (mAb).

It is claimed to be the first anti-PD-1 mAb approved as the first-line treatment for SCLC worldwide.

The anti-PD-1 mAb has already received approval to treat squamous non-small cell lung cancer (sqNSCLC) and Microsatellite Instability-High (MSI-H) solid tumours.

The Food and Drug Administration (FDA) and European Commission (EC) granted orphan drug designations to Hansizhuang for SCLC last year.

Henlius chairman, executive director, and CEO Wenjie Zhang said: “This is the second approval Hansizhuang has received in the first-line treatment of lung cancer, after approval of sqNSCLC, demonstrating its great potential in lung cancer treatment.

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“It is another milestone for Hansizhuang and a remarkable achievement for anti-PD-1 mAbs to improve survival notably in patients with SCLC.

“Looking forward, as the representative of China’s innovative drugs, HANSIZHUANG is expected to be approved in overseas markets to benefit more lung cancer patients with its consistent efficacy.”

The regulatory approval was based on the data obtained from the double-blind, multi-centre, randomised, placebo-controlled, global Phase III ASTRUM-005 clinical study.

ASTRUM-005 enrolled 585 participants at up to 128 sites in multiple countries including Georgia, Poland, China, and Turkey.

The findings demonstrated a 38% reduction in the death risk, and the median overall survival (OS) was also significantly longer in the serplulimab-treated group compared to the placebo group.

They also indicated that the combination of Hansizhuang (serplulimab injection) and chemotherapy (Carboplatin-Etoposide) could benefit previously untreated ES-SCLC patients.