Leclaza secures Korea's first anticancer approval from U.S. FDA

Korea's Leclaza, a lung cancer treatment, secured U.S. FDA approval.

Yuhan Corporation's lung cancer drug Leclaza [YUHAN]

Leclaza, a lung cancer treatment from Yuhan Corporation, received approval from the U.S. Food and Drug Administration (FDA), becoming the first domestically developed anticancer drug to achieve the milestone.

The U.S. FDA approved the combination of amivantamab, branded as Rybrevant, and lazertinib as a first-line treatment for adult patients with nonsmall lung cancer on Tuesday, according to Yuhan and Johnson & Johnson (J&J).

Yuhan, the leading pharmaceutical company in Korea in terms of revenue, signed a $1.25-billion licensing deal with J&J-owned Janssen for the nonsmall lung cancer treatment lazertinib, branded as Leclaza in Korea and Lazcluze in the United States, with an upfront of $50 million in 2018.

Lung cancer, a cancer with one of the highest mortality rates, is responsible for 1.8 million deaths each year, with non-small lung cancer accounting for 80 to 85 percent of all cases.

Korea's Ministry of Food and Drug Safety approved Leclaza for first-line chemotherapy last year after greenlighting the medication for second-line treatment in 2021. The drug has been covered by Korea's national health care insurance since January.

J&J and Yuhan are now waiting for the approval of the chemo-free combination from European, Japanese and Chinese regulators.

“The FDA approval of Leclaza is a result of Yuha’s investments in research and development,” said Yuhan Corporation CEO Cho Wook-je, adding that, “we hope this milestone to be a passing point, rather than a destination.”

Yuhan aims to become one of the top 50 pharmaceutical companies globally by 2026.

Yuhan rose 0.32 percent to close at 94,300 won ($70.54) on Wednesday following the announcement. Its share price soared to 109,700 won, up 16.7 percent from the previous session, mid-trading.

BY SHIN HA-NEE [shin.hanee@joongang.co.kr]