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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Since Boehringer Ingelheim’s u-turn on its lung cancer partnership with Hanmi Pharmaceutical, the South Korean company has seen its stock prices falling and latterly a government investigation. Confidence in the country’s burgeoning drug development industry has taken a hit but there are still plenty of reasons to believe in the country’s R&D engine.
Following up on its May announcement of a conditional approval scheme to shorten R&D and approval periods, and aiming to ensure the prompt and stable supply of life-saving drugs, South Korea is planning a new law on breakthrough therapies and for drugs for public health crises.
Samsung BioLogics has set out plans for one of the biggest ever IPOs in South Korea that could help reignite investor sentiment battered by recent events surrounding Hanmi.