Korea To Limit Olmutinib Usage, Monitor All Patients
After distributing safety letters on several cases of serious adverse skin reactions that occurred during the clinical development of Hanmi’s olmutinib, South Korean authorities have decided to limit the EGFR inhibitor to consenting patients and are closely monitoring its use.
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Hanmi is set to focus on other assets in its innovative drug pipeline after it ends development of novel lung cancer drug olmutinib amid ZAI Lab’s recent cancellation of a licensing agreement with the South Korean pharma.
For the South Korean pharma industry, 2016 was largely about major global advances for a wide range of biosimilars, accompanied but some setbacks in the area of novel drug development.
South Korean firm teams with Speragen to develop enzyme-replacement therapy for the genetic disorder and with Mirum for maralixibat. Plus deals involving Takeda/PeptiDream, Hanmi/LegoChem, Sun/Cassiopea, LegoChem/Cellectar, ChubLab/CJ CheilJedang Corp., Alebund/Chugai, Kintor/Fosun, Astellas/ExCellThera and I-Mab/neoX/Immorna.