April 23, 2024

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[THE INVESTOR] Hanmi Pharmaceutical 's novel lung cancer therapy candidate HM61713 was found to have side effects of serious skin toxicity during the second phase of clinical trial carried out in collaboration with Boehringer Ingelheim, according to the Ministry of Food and Drug Safety on Sept. 30. 

At least one patient has died during the clinical trial due to severe skin adverse reactions.

The pharmaceutical composition showed inspiring therapeutic efficacy in the first phase of clinical trial conducted here and the German pharmaceutical giant bought exclusive rights to develop and commercialize the drug globally for US$680 million in July 2015.

When the pharmaceutical composition’s dosage was reduced to diminish the toxicity, the efficacy also declined, which led to the termination of the clinical trials, an oncology professor told a local news media. 

Side effects can appear any time during clinical trials while developing new drugs, said Hanmi Pharma, adding that the correlation between the skin toxicity and its HM61713 has not been proven.

HM61713, also known as Olmutinib or by trade name Olita, was designated as a “breakthrough therapy” by the US Food and Drug Administration in December 2015, granting the medicine shortened clinical trials and fast track approval procedures.

By Hwang You-mee (glamazon@heraldcorp.com)