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Yuhan¡¯s anticancer drug Leclaza secures European approval

By Cha, Jihyun | translator Alice Kang

25.01.02 05:33:07

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First homegrown anticancer drug to receive approval in the US and Europe

As lung cancer has the highest mortality rate, the company expects sales royalties upon European launch

Additional milestones can be received upon Asian approval in Japan, China, etc.

 ¡ãPic of Yuhan Corp

Yuhan Corp¡¯s new anti-cancer drug Leclaza (Lazertinib) has crossed the European threshold. The European Commission (EC) approved the drug a month after receiving a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). As a result, the company will receive a USD 30 million European launch milestone.

According to industry sources on the 31st, the EC granted final marketing authorization to the combination of Yuhan Corp¡¯s non-small cell lung cancer drug Leclaza and Johnson & Johnson's Rybrevant (amivantamab) as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed epid

Cha, Jihyun(chaji@dailypharm.com)
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