“Yuhan Corporation’s good Lazertinib results… Janssen’s strategy will be important”

analyzed that Janssen’s commercialization strategy would be important, saying that ‘Rexraza’ (ingredient: Lazertinib) had good results on the 5th. We maintain our Buy rating and target price of W80,000.

Yuhan announced the results of a global phase 3 monotherapy (LASER301) of Lazertinib, an EGFR target non-small cell lung cancer treatment, at the Asian Conference of the European Society of Oncology (ESMO Asia). Overall survival data for LASER301 were not disclosed, but the primary endpoint, progression-free survival (PFS), was 20.6 months in the Lazertinib group. It was higher than that of the control group, a group administered by ‘gefitinib’, which was 9.7 months. The PFS in patients with brain metastases was 16.4 months with Lazertinib and 9.5 months in the control group.

Researcher Park Byung-guk said, “This data makes us look forward to the results of MARIPOSA, a combined clinical trial of Lazertinib and amivantamab for primary treatment, and the global release of monotherapy.” “There is growing interest in whether to apply for approval.”

Data is a good position, and Janssen’s commercialization strategy, which considers the market situation as well as data, is important now. Janssen holds international rights to Lazertinib outside of Korea. It is explained that the global release through LASER301 will also be decided by Janssen.

Researcher Park said, “Considering the market situation, such as the phase 3 trial of Tagrisso and chemotherapy (FLAURA2) and drug pricing strategy, will be very important to launch in developed and underdeveloped countries.”

It is considered that Janssen’s strategy in developed countries will focus on combination therapy.

is conducting FLAURA2, which compares ‘Tagrisso’ in combination with chemotherapy and Tagrisso monotherapy for the purpose of primary treatment. The results will be published in the first half of next year.

In undeveloped markets, the marketability of Lazertinib monotherapy was expected to be large. Tagrisso achieved sales of $600 million in emerging countries (emerging countries) and other countries in the third quarter of this year. This is 44% of total sales. Researcher Park said, “LASER301 is also intended to be released as a first-line monotherapy in underdeveloped countries such as Asia with a drug price that is more favorable than Tagrisso.

He said the variable for the release of Lazertinib monotherapy in underdeveloped countries would be the reference price (IRP) system. IRP is a system for negotiating drug prices by reference to drug prices in other countries. It is explained that most of the popular new drugs are approved from the United States, so the IRP also affects this. The monthly drug price of Tagrisso in Australia and China is one-half and one-sixth of the US, respectively.

Researcher Park said, “It would be possible for Janssen to first apply for approval in the United States for monotherapy to launch in underdeveloped countries.

Reporter Kim Ye-na yena@hankyung.com

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