Yuhan Corporation's lung cancer new drug 'Lecraza (ingredient name Lazertinib)' will be officially sold in Japan starting from the 21st. The company will receive a milestone payment of $15 million (210 billion won) as well as additional local sales royalties.
According to Japan's Ministry of Health, Labour and Welfare (MHLW) on the 20th, Yuhan Corporation's Lecraza (international product name Razaclutuz) is included in the list of new pharmaceuticals being listed for insurance coverage that will be sold starting from the 21st.
Lecraza, used in combination therapy with Johnson & Johnson's lung cancer treatment Librevant (Amivantamab), received marketing approval from the Ministry of Health, Labour and Welfare in March as a treatment for progressive or recurrent unresectable epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC). Lecraza has been approved in Japan in two types: 80 mg and 240 mg. The price is set at 4,403.3 yen (42,000 won) for a single 80 mg tablet and 12,354.7 yen (119,000 won) for a single 240 mg tablet.
In Japan, if there are no special issues with the approved new drugs, all will enter the insurance market. The price determination and insurance listing announcement is the procedure that notifies the market entry of a specific drug. The Ministry of Health, Labour and Welfare simultaneously publishes revenue forecasts for the assessment of the impact on insurance finances along with the drug price announcement. According to this, the Ministry of Health, Labour and Welfare expects that over the next 10 years, a maximum market size of 13 billion yen (1.25 billion won) will result from 6,400 lung cancer patients taking Lecraza in Japan.
With the launch of Lecraza on the 21st, Yuhan Corporation is expected to sequentially receive subsequent milestones from Johnson & Johnson. The milestone due to the launch is $15 million, and a certain percentage of royalties will also be received upon local sales. Previously, on the 13th, John Reed, Executive Vice President of Innovation Research and Development at Johnson & Johnson, noted at the Bank of America Healthcare Conference that the prescription of the combination therapy of Librevant and Lecraza has significantly increased, following the unveiling of study results showing that it could extend patient survival compared to existing standard therapies.
Lecraza is expected to receive a milestone payment of $30 million (41.75 billion won) due to European approval last December. It is anticipated to be launched in Europe in the third quarter. Additionally, with the anticipated marketing approval in China within this year, Yuhan Corporation is expected to receive further milestones. If Lecraza is launched in China, Yuhan Corporation will secure $45 million (62.65 billion won) solely from milestones.