Yuhan, Janssen Korea to jointly promote Leclaza+Rybrevant combo for EGFR-mutated lung cancer

Yuhan Corp. said it has signed an agreement with Janssen Korea, the Korean pharmaceutical arm of Johnson & Johnson, to jointly promote the combination therapy of Leclaza (ingredient: lazertinib) and Rybrevant (ingredient: amivantamab) for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in Korea.

The two companies held a signing ceremony on Oct. 31, agreeing to collaborate on marketing activities for the Leclaza–Rybrevant combination regimen in Korea. Until now, Johnson & Johnson has led the global promotional activities for the combination, while Yuhan has been responsible for marketing Leclaza monotherapy domestically. Under the new agreement, Yuhan will expand its role to co-promote the combination regimen alongside Janssen Korea.

Through the partnership, both companies plan to strengthen their collaboration to enhance patient access to the Leclaza–Rybrevant combination. Distribution channels will remain unchanged, with Johnson & Johnson continuing to handle Rybrevant and Yuhan overseeing Leclaza.

Rybrevant is the first bispecific antibody designed to target both EGFR and MET, while Leclaza is a third-generation EGFR tyrosine kinase inhibitor (TKI) developed by Yuhan. The co-marketing agreement builds on the positive efficacy and safety results demonstrated in the global phase 3 MARIPOSA trial, which confirmed the clinical value of the combination regimen as a first-line treatment for EGFR-mutated NSCLC.

“Leclaza has set a new milestone as a homegrown treatment for EGFR-mutated non-small cell lung cancer,” Yuhan CEO Cho Wook-je said. “With the clinical benefits of the Leclaza–Rybrevant combination now validated, we will actively collaborate with Janssen Korea to establish it as a key first-line therapy option.”

The Leclaza–Rybrevant combination received regulatory approval from Korea’s Ministry of Food and Drug Safety in January this year as a first-line treatment for patients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

In Korea, Yuhan continues to handle the rights and promotion for Leclaza monotherapy in second-line or later treatments for EGFR-mutated NSCLC, while Johnson & Johnson exclusively manages the promotion and supply of Rybrevant and other indications, including treatment of patients with EGFR exon 20 insertion mutations.