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  • China's mAb 'Hetronifly' secures orphan drug designation
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Apr 7, 2025 05:51am
in Korea
The first PD-1 inhibitor used as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC)
After obtaining China's approval in 2023, the drug also secured European approval recommendations last year
 ¡ã Product photo of Hetronifly
China-made immune checkpoint inhibitor has been designated as an orphan drug in South Korea.

The Ministry of Food and Drug Safety (MFDS) recently announced on a notification board that it has granted Shanghai Henlius Biotech's 'Hetronifly (serplulima)' an orphan drug designation (ODD).

The drug is indicated for 'use in combination with carboplatin and etoposide as a first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).'

Hetronifly was initially approved in China in 2023 under the product name 'Hansizhuang.' This drug also secured approval recommendations in Europe.

Hetronifly has gained attention as the first immunotherapy for cancer as a first-line treatment of ES
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