Boryung Pharmaceutical "New Drug for Small Cell Lung Cancer, Application for Orphan Drug Designation"

[Asia Economy Reporter Cho Hyun-ui] Boryung Pharmaceutical announced on the 13th that it has completed the application for orphan drug designation of the small cell lung cancer (SCLC) new drug 'Lurbinectedin (brand name: Zepzelca)' with the Ministry of Food and Drug Safety.

Boryung Pharmaceutical plans to proceed with a conditional domestic approval application for phase 3, the same as in the United States, once the Ministry of Food and Drug Safety completes the orphan drug designation for Lurbinectedin.

Lurbinectedin was approved by the U.S. Food and Drug Administration (FDA) in June. It submitted phase 2 clinical trial data proving superiority in safety and efficacy through an indirect comparison with the existing treatment Topotecan as approval data to the FDA, which recognized it and granted conditional accelerated approval for phase 3 and priority review.

Boryung Pharmaceutical signed a technology licensing agreement for Lurbinectedin with PharmaMar in Spain in 2017, through which it holds exclusive rights for domestic development and sales. Currently, the ingredients approved in Korea as second-line treatments for small cell lung cancer are Topotecan (brand name: Hycamtin Injection) and Belotecan (brand name: Camtobel Injection).

Kim Young-seok, head of Boryung Pharmaceutical's ONCO division, said, “Small cell lung cancer has a poor treatment prognosis and limited treatment options. If Lurbinectedin proceeds with rapid approval through orphan drug designation, it will provide new treatment options to domestic patients and medical staff and be of great help.”

This content was produced with the assistance of AI translation services.