On March 21, 2023 HLB Life Science reported that it received approval from the Ministry of Food and Drug Safety for a phase 3 clinical trial plan for the anticancer drug ‘Pyrotinib’ (Press release, HLB Life Science, MAR 21, 2023, View Source;word=&page=1&v=381 [SID1234649274]).
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The title of the clinical trial is ‘A randomized, active-controlled, open-label, multi-center phase 3 clinical trial to evaluate the efficacy and safety of Pyrotinib + Capecitabine combination compared to Lapatinib + Capecitabine combination in patients with HER2-positive metastatic or recurrent breast cancer’. The clinical trial will be conducted on 204 patients in 11 hospitals in Korea (total of 12 hospitals) excluding Seoul National University Hospital. (Clinical period: 36 months from the date of approval by the Institutional Review Board)
The company plans to confirm the progression-free survival period (PFS, primary endpoint) through this clinical trial.
Pyrotinib is a small molecule compound independently developed by Hengrui Pharmaceutical of China, and is an oral targeted anticancer drug targeting EGFR/HER2/HER4. In 2020, it received official approval in China as a second-line treatment for HER2 metastatic breast cancer. In
2020, HLB Life Science signed an exclusive licensing agreement for Pyrotinib in Korea with Hangseo Pharmaceutical, and has exclusive rights to the clinical development and sales of Pyrotinib as a treatment for various cancers, including breast cancer and lung cancer, in Korea.
HLB Life Science applied for the clinical trial to the Ministry of Food and Drug Safety on July 29, 2022.